http://ema.europa.eu/fhir/CodeSystem/200000003964
type: CodeSystem
node role: treeRoot
id:
  v: 200000003964
meta:
  version id:
    v: 5.0.0
  last updated:
    v: 2023-08-03T11:35:00.198Z
text:
  status:
    v: generated
  div: Generated Narrative: CodeSystem 200000003964 version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000 This case-sensitive code system http://spor.ema.europa.eu/v1/lists/200000003964 defines the following codes: Code Display 200000004202 A declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application as responsible for batch release. 200000004203 A declaration by the Qualified Person (QP) responsible for batch certification stating that the active substance manufacturer(s) referred to in the marketing authorisation operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. A single declaration may be acceptable under certain circumstances — see the note under variation No B.II.b.1. 200000004204 A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the changes to the manufacturing methods are only those necessitated by scale-up or downscaling, e.g. use of different-sized equipment, that the change does not adversely affect the reproducibility of the process, that it is not the result of unexpected events arising during manufacture or because of stability concerns and that the specifications of the active substance/intermediates remain the same. 200000004205 A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem. 200000004206 A declaration from the marketing authorisation holder or the ASMF holder, where ap…
url:
  v: http://spor.ema.europa.eu/v1/lists/200000003964
version:
  v: 1.2.0
name:
  v: DocumentationCs
title:
  v: Documentation
status:
  v: active
experimental:
  v: false
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: Documentation
case sensitive:
  v: true
content:
  v: complete
count:
  v: 491
concept:
  code:
    v: 200000004202
  display:
    v: A declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application as responsible for batch release.
concept:
  code:
    v: 200000004203
  display:
    v: A declaration by the Qualified Person (QP) responsible for batch certification stating that the active substance manufacturer(s) referred to in the marketing authorisation operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. A single declaration may be acceptable under certain circumstances — see the note under variation No B.II.b.1.
concept:
  code:
    v: 200000004204
  display:
    v: A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the changes to the manufacturing methods are only those necessitated by scale-up or downscaling, e.g. use of different-sized equipment, that the change does not adversely affect the reproducibility of the process, that it is not the result of unexpected events arising during manufacture or because of stability concerns and that the specifications of the active substance/intermediates remain the same.
concept:
  code:
    v: 200000004205
  display:
    v: A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem.
concept:
  code:
    v: 200000004206
  display:
    v: A declaration from the marketing authorisation holder or the ASMF holder, where applicable, that the synthetic route quality control procedures and specifications of the active substance and of the starting material/reagent/intermediate in the manufacturing process of the active substance (if applicable) are the same as those already approved.
concept:
  code:
    v: 200000004207
  display:
    v: A declaration from the marketing authorisation holder or the ASMF Holder, where applicable, that there is no change in qualitative and quantitative impurity profile or in physico-chemical properties, that the synthetic route remains the same and that the specifications of the active substance or intermediates are unchanged.
concept:
  code:
    v: 200000004208
  display:
    v: A declaration that the proposed Summary of Product Characteristics, Labelling and Package Leaflet is identical for the concerned sections to that annexed to the Commission Decision or to the agreement reached by the CMDh (as applicable).
concept:
  code:
    v: 200000004209
  display:
    v: A declaration that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem.
concept:
  code:
    v: 200000004210
  display:
    v: A declaration that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem.
concept:
  code:
    v: 200000004211
  display:
    v: A document including the identification (name and address) of the current PMF Holder (transferor) and the identification (name and address) of the person to whom the transfer is to be granted (transferee) together with the proposed implementation date — signed by both companies.
concept:
  code:
    v: 200000004212
  display:
    v: A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name and/or address is mentioned.
concept:
  code:
    v: 200000004213
  display:
    v: Amendment of product information (where applicable).
concept:
  code:
    v: 200000004214
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate) including revised product information as appropriate.
concept:
  code:
    v: 200000004215
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), and of the approved Active Substance Master File (where applicable), including a direct comparison of the present process and the new process.
concept:
  code:
    v: 200000004216
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate).
concept:
  code:
    v: 200000004217
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), if applicable.
concept:
  code:
    v: 200000004218
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a description of the analytical methodology and a summary of validation data.
concept:
  code:
    v: 200000004219
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a description of the analytical methodology, a summary of validation data, revised specifications for impurities (if applicable).
concept:
  code:
    v: 200000004220
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a detailed drawing of the current and proposed situation, and including revised product information as appropriate.
concept:
  code:
    v: 200000004221
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a detailed drawing or written description of the current and new appearance, and including revised product information as appropriate.
concept:
  code:
    v: 200000004222
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a direct comparison of the present process and the new process.
concept:
  code:
    v: 200000004223
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including description, detailed drawing and composition of the container or closure material, and including revised product information as appropriate.
concept:
  code:
    v: 200000004224
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including description, detailed drawing and composition of the device material and supplier where appropriate, and including revised product information as appropriate.
concept:
  code:
    v: 200000004225
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including identification method for any new colorant, where relevant, and including revised product information as appropriate.
concept:
  code:
    v: 200000004226
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including revised product information as appropriate.
concept:
  code:
    v: 200000004227
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate).
concept:
  code:
    v: 200000004228
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate). This must contain results of appropriate real time stability studies (covering the entire shelf life) conducted in accordance with the relevant stability guidelines on at least two pilot scale batches of the finished product in the authorised packaging material and/or after first opening or reconstitution, as appropriate.
concept:
  code:
    v: 200000004229
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate). This must contain results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on at least two pilot or production scale batches of the active substance in the authorised packaging material and covering the duration of the requested retest period or requested storage conditions.
concept:
  code:
    v: 200000004230
  display:
    v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format).
concept:
  code:
    v: 200000004231
  display:
    v: Amendment of the relevant section(s) of the dossier.
concept:
  code:
    v: 200000004232
  display:
    v: Amendment of the relevant section(s) of the dossiers including the introduction of the new studies to investigate the capability of manufacturing steps to inactivate/reduce adventitious agents.

code:
  v: 200000004233
display:
  v: Amendment of the relevant section(s) of the dossiers.

code:
  v: 200000004234
display:
  v: An expert statement outlining all the changes introduced with the certified PMF and evaluating their potential impact on the finished products including product specific risk assessments.

code:
  v: 200000004235
display:
  v: An expert statement outlining all the changes introduced with the certified VAMF and evaluating their potential impact on the finished products including product specific risk assessments.

code:
  v: 200000004236
display:
  v: Appropriate data on the new packaging (comparative data on permeability, e.g. for O 2 , CO 2 moisture).

code:
  v: 200000004237
display:
  v: Appropriate data on the new packaging (e.g. comparative data on permeability, e.g. for O 2 , CO 2 moisture), including a confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic materials and objects in contact with foodstuffs.

code:
  v: 200000004238
display:
  v: Assurance on GMP or ISO compliance of the site where the sterilisation of the containers is performed.

code:
  v: 200000004239
display:
  v: Attached to the cover letter of the variation application: A reference to the agreement of the competent authority (in the case of marketing authorisations granted under the centralised procedure, the CHMP).

code:
  v: 200000004240
display:
  v: Attached to the cover letter of the variation application: a reference to the Commission Decision concerned or to the agreement reached by the CMDh (as applicable) with the annexed Summary of Product Characteristics, Labelling or Package Leaflet.

code:
  v: 200000004241
display:
  v: Attached to the cover letter of the variation application: A reference to the Commission Decision concerned.

code:
  v: 200000004242
display:
  v: Attached to the cover letter of the variation application: A reference to the list of medicinal products that are subject to additional monitoring.

code:
  v: 200000004243
display:
  v: Attached to the cover letter of the variation application: A reference to the relevant decision of the competent authority.

code:
  v: 200000004244
display:
  v: Attached to the cover letter of the variation application: EMA/NCA request, if applicable.

code:
  v: 200000004245
display:
  v: Attached to the cover letter of the variation application: proof of authorisation of the legal status change (e.g. reference to the Commission Decision concerned).

code:
  v: 200000004246
display:
  v: Attached to the cover letter of the variation application: reference to the agreement/assessment of the competent authority.

code:
  v: 200000004247
display:
  v: Attached to the cover letter of the variation application: The relevant decision of the competent authority.

code:
  v: 200000004248
display:
  v: Batch analysis data (in a comparative tabular format) for at least two batches (minimum pilot scale) of the active substance from the current and proposed manufacturers/sites.

code:
  v: 200000004249
display:
  v: Batch analysis data (in a comparative tabulated format) of at least two batches (minimum pilot scale) of the excipient manufactured according to the old and the new process.

code:
  v: 200000004250
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of one batch manufactured to both the currently approved and the proposed process. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).

code:
  v: 200000004251
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of one production batch manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the MAH if outside specifications (with proposed action).

code:
  v: 200000004252
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of one production batch of the active substance or intermediate as appropriate, manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).

code:
  v: 200000004253
display:
  v: Batch analysis data (in a comparative tabulated format) on two production batches of the relevant substance for all tests in the new specification and additionally, where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004254
display:
  v: Batch analysis data (in comparative tabular format) of at least two batches (minimum pilot scale) manufactured according to the currently approved and proposed process.

code:
  v: 200000004255
display:
  v: Batch analysis data on one production batch and two pilot-scale batches simulating the production process (or two production batches) and comparative data on the last three batches from the previous site; batch data on the next two production batches should be available on request or reported if outside specifications (with proposed action).

code:
  v: 200000004256
display:
  v: Batch analysis data on two batches of the immediate packaging for all specification parameters.

code:
  v: 200000004257
display:
  v: Batch analysis data on two production batches (3 production batches for biological excipients) of the excipient for all specification parameters.

code:
  v: 200000004258
display:
  v: Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the active substance for all specification parameters.

code:
  v: 200000004259
display:
  v: Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the finished product for all specification parameters.

code:
  v: 200000004260
display:
  v: Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the relevant substance for all specification parameters.

code:
  v: 200000004261
display:
  v: Batch analysis data on two production batches for all tests in the new specification.

code:
  v: 200000004262
display:
  v: Change management protocol related to the active substance.

code:
  v: 200000004263
display:
  v: Change management protocol related to the finished product.

code:
  v: 200000004264
display:
  v: Comparative dissolution data on at least one pilot batch of the current and proposed dimensions (no significant differences regarding comparability see the relevant (Human or Veterinary) guidance on Bioavailability). For herbal medicinal product comparative disintegration data may be acceptable.

code:
  v: 200000004265
display:
  v: Comparative table of current and proposed in-process tests and limits.

code:
  v: 200000004266
display:
  v: Comparative table of current and proposed in-process tests.

code:
  v: 200000004267
display:
  v: Comparative table of current and proposed specifications.

code:
  v: 200000004268
display:
  v: Comparative table of current and proposed specifications, if applicable.

code:
  v: 200000004269
display:
  v: Comparative table of the current and proposed immediate packaging specifications, if applicable.

code:
  v: 200000004270
display:
  v: Comparative validation results or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.

code:
  v: 200000004271
display:
  v: Comparison of the current and proposed immediate packaging specifications, if applicable.

code:
  v: 200000004272
display:
  v: Confirmation of the transfer of the complete PMF documentation since the initial PMF certification to the transferee — signed by both companies.

code:
  v: 200000004273
display:
  v: Confirmation that stability studies have been done to the currently approved protocol. The studies must show that the agreed relevant specifications are still met.

code:
  v: 200000004274
display:
  v: Copy of approved and new (if applicable) specifications of the excipient.

code:
  v: 200000004275
display:
  v: Copy of approved end of shelf life finished product specification and where applicable, specifications after dilution/reconstitution or first opening.

code:
  v: 200000004276
display:
  v: Copy of approved release and end-of-shelf life specifications if relevant.

code:
  v: 200000004277
display:
  v: Copy of approved release and end-of-shelf life specifications.

code:
  v: 200000004278
display:
  v: Copy of approved specifications of the active substance (and of the intermediate, if applicable).

code:
  v: 200000004279
display:
  v: Copy of approved specifications of the active substance.

code:
  v: 200000004280
display:
  v: Copy of approved specifications of the finished product.

code:
  v: 200000004281
display:
  v: Copy of the current (updated) Ph. Eur. Certificate of Suitability.

code:
  v: 200000004282
display:
  v: Copy of the EMA letter of acceptance of the new (invented) name.

code:
  v: 200000004283
display:
  v: Copy of the latest PMF Certificate page ‘EMA Plasma Master File (PMF) Certificate of compliance with Community legislation’.

code:
  v: 200000004284
display:
  v: Copy of the modified manufacturing authorisation, if available; or a formal document from a relevant official body (e.g. Chamber of Commerce, or if not available, from a Regulatory Agency) in which the new name and/or address is mentioned.

code:
  v: 200000004285
display:
  v: Data to demonstrate accuracy, precision and compatibility of the device.

code:
  v: 200000004286
display:
  v: Data to demonstrate that the new excipient does not interfere with the finished product specification test methods, if appropriate.

code:
  v: 200000004287
display:
  v: Data to demonstrate the suitability of the monograph to control the substance, e.g. a comparison of the potential impurities with the transparency note of the monograph.

code:
  v: 200000004288
display:
  v: Declaration from the manufacturer or the marketing authorisation holder of the material that it is purely of vegetable or synthetic origin.

code:
  v: 200000004289
display:
  v: Declaration that any change should be within the range of currently approved limits. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.

code:
  v: 200000004290
display:
  v: Declaration that relevant stability studies have been started under ICH/VICH conditions, as appropriate, (with indication of the batch numbers concerned) and relevant stability parameters have been assessed in at least one pilot scale or industrial scale batch and at least 3 months satisfactory stability data are at the disposal of the applicant at time of notification and that the stability profile is similar to the currently registered situation.

code:
  v: 200000004291
display:
  v: Declaration that stability studies will be conducted in accordance with the relevant guidelines for products where stability parameters could be affected. Data to be reported only if outside specifications (with proposed action).

code:
  v: 200000004292
display:
  v: Declaration that the change is in accordance with the approved change management and that the study results meet the acceptance criteria specified in the protocol. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.

code:
  v: 200000004293
display:
  v: Declaration that the PMF Certificate and Evaluation Report are fully applicable for the authorised product, PMF holder has provided the PMF Certificate, Evaluation report and PMF dossier to the MAH (where the MAH is different to the PMF holder), the PMF Certificate and Evaluation Report replace the previous PMF documentation for this Marketing Authorisation.

code:
  v: 200000004294
display:
  v: Declaration that the remaining pack-size(s) is/are consistent with the dosage regimen and duration of treatment and adequate for the dosing instructions as approved in the summary of product characteristics.

code:
  v: 200000004295
display:
  v: Declaration that the remaining product presentation(s) are adequate for the dosing instructions and treatment duration as mentioned in the summary of product characteristics.

code:
  v: 200000004296
display:
  v: Declaration that the VAMF Certificate and Evaluation Report are fully applicable for the authorised product, VAMF holder has submitted the VAMF Certificate, Evaluation report and VAMF dossier to the MAH (where the MAH is different to the VAMF holder), the VAMF Certificate and Evaluation Report replace the previous VAMF documentation for this Marketing Authorisation.

code:
  v: 200000004297
display:
  v: Demonstration of GMP approval of the changes, which should be available at the time of implementation.

code:
  v: 200000004298
display:
  v: Description of the design space in tabular format, including the variables (material attributes and process parameters, as appropriate) and their proposed ranges.

code:
  v: 200000004299
display:
  v: Detailed description for the proposed change.

code:
  v: 200000004300
display:
  v: Details of any new analytical method and summary of validation data.

code:
  v: 200000004301
display:
  v: Details of any new analytical method and validation data, where relevant.

code:
  v: 200000004302
display:
  v: Details of any new non-pharmacopoeial analytical method and validation data, where relevant.

code:
  v: 200000004303
display:
  v: Details of the sterilisation method should be provided and in the event that the method does not use the reference conditions stated in the Ph. Eur., validation data should be provided.

code:
  v: 200000004304
display:
  v: Either a Ph. Eur. Certificate of Suitability for any new component of animal susceptible to TSE risk or where applicable, documentary evidence that the specific source of the TSE risk material has been previously assessed by the competent authority and shown to comply with the scope of the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products.

code:
  v: 200000004305
display:
  v: Either a TSE Ph. Eur. Certificate of Suitability for any new source of material or, where applicable, documentary evidence that the specific source of the TSE risk material has previously been assessed by the competent authority and shown to comply with the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products.

code:
  v: 200000004306
display:
  v: Epidemiological data for viral markers related to the blood/plasma collection centre covering the last 3 years. For newly opened centre(s) or in case no data are yet available, a declaration that epidemiological data will be provided at the time of the next annual update(s).

code:
  v: 200000004307
display:
  v: For a site within the EU/EEA: Attach copy of manufacturing authorisation(s) or where no manufacturing authorisation exists a certificate of GMP compliance issued within the last 3 years by the relevant competent authority. For a manufacturing site outside the EEA where an operational GMP mutual recognition agreement (MRA) exists between the country concerned and the EU: a GMP certificate, issued within the last 3 years by the relevant competent authority.

code:
  v: 200000004308
display:
  v: For centralised procedure only: contact details of new contact person in the EU/EEA for product defects and recalls, if applicable.

code:
  v: 200000004309
display:
  v: For changes to process parameter(s) that have been considered to have no impact on the quality of the finished product, declaration to this effect reached in the context of the previously approved risk assessment.

code:
  v: 200000004310
display:
  v: For devices for medicinal products for human use, proof of CE marking.

code:
  v: 200000004311
display:
  v: For semi-solid and liquid formulations in which the active substance is present in non-dissolved form, appropriate validation data including microscopic imaging of particle size distribution and morphology or any other appropriate imaging technique.

code:
  v: 200000004312
display:
  v: For semi-solid and liquid products in which the active substance is present in non-dissolved form: appropriate validation of the change including microscopic imaging of particles to check for visible changes in morphology; comparative size distribution data by an appropriate method.

code:
  v: 200000004313
display:
  v: For solid dosage forms, comparative dissolution profile data of at least two pilot scale batches of the finished product in the new and old composition. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004314
display:
  v: For solid dosage forms: dissolution profile data of one representative production batch and comparative data of the last three batches from the previous process; data on the next two full production batches should be available on request or reported if outside specification (with proposed action). For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004315
display:
  v: For veterinary medicines intended for use in food producing animal species, proof that the excipient is classified according to Article 14(2)(c) of Regulation (EC) No 470/2009 or, if not, justification that the excipient does not have pharmacological activity at the dose at which it is administered to the target animal.

code:
  v: 200000004316
display:
  v: i) If the new manufacturing site uses the active substance (AS) as a starting material - A declaration by the QP at the site responsible for batch release that the AS is manufactured in accordance with GMP for starting materials. ii) In addition, if the new manufacturing site is located within the EU/EEA and uses the AS as a starting material - A declaration by the QP of the new manufacturing site that the AS used is manufactured in accordance with GCP for starting materials.

code:
  v: 200000004317
display:
  v: If applicable, amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including revised product information as appropriate.

code:
  v: 200000004318
display:
  v: If the manufacturing site and the primary packaging site are different, conditions of transport and bulk storage should be specified and validated.

code:
  v: 200000004319
display:
  v: In case of a change in the headspace or a change in the surface/volume ratio, a declaration that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation for a Type IA notification and time of submission of a Type IB notification, and that the available data did not indicate a problem.

code:
  v: 200000004320
display:
  v: In case of an addition of a manufacturing site, the variation application form should clearly outline the ‘present’ and ‘proposed’ manufacturers as listed in section 2.5 of the application form.

code:
  v: 200000004321
display:
  v: In case of change in the name of the holder of the Active Substance Master File holder, updated ‘letter of access’.

code:
  v: 200000004322
display:
  v: Justification for change in name.

code:
  v: 200000004323
display:
  v: Justification for not submitting a new bioequivalence study according to the current Note for Guidance on The Investigation of Bioavailability and Bioequivalence.

code:
  v: 200000004324
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant (Human or Veterinary) guidance on Bioavailability.

code:
  v: 200000004325
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant (Human, Veterinary) Guideline on Bioavailability, if appropriate.

code:
  v: 200000004326
display:
  v: Justification for the change/choice of excipients etc. must be given by appropriate development pharmaceutics (including stability aspects and antimicrobial preservation where appropriate).

code:
  v: 200000004327
display:
  v: Justification for the deletion of the device.

code:
  v: 200000004328
display:
  v: Justification for the deletion of the target species.

code:
  v: 200000004329
display:
  v: Justification for the deletion, including a statement regarding alternative means to obtain the solvent/diluent as required for the safe and effective use of the medicinal product.

code:
  v: 200000004330
display:
  v: Justification for the new specification parameter and the limits.

code:
  v: 200000004331
display:
  v: Justification for the new/remaining pack-size, showing that the new/remaining size is/are consistent with the dosage regimen and duration of treatment as approved in the summary of product characteristics.

code:
  v: 200000004332
display:
  v: Justification for the proposed change(s).

code:
  v: 200000004333
display:
  v: Justification for the proposed deletion.

code:
  v: 200000004334
display:
  v: Justification from the MAH or ASMF Holder as appropriate for the new in-process test and limits.

code:
  v: 200000004335
display:
  v: Justification from the MAH or ASMF Holder as appropriate of the new specification parameter and the limits.

code:
  v: 200000004336
display:
  v: Justification from the marketing authorisation holder or the ASMF Holder, as appropriate, of the new specification parameter and the limits.

code:
  v: 200000004337
display:
  v: Justification of the new in-process test and limits.

code:
  v: 200000004338
display:
  v: Justification of the new specification parameter and the limits.

code:
  v: 200000004339
display:
  v: Justification that the studies do not modify the risk assessment.

code:
  v: 200000004340
display:
  v: Justification/risk assessment from the marketing authorisation holder or the ASMF Holder, as appropriate, that the in-process parameter is non-significant, or that the in-process parameter is obsolete.

code:
  v: 200000004341
display:
  v: Justification/risk assessment from the marketing authorisation holder or the ASMF Holder, as appropriate, that the in-process tests are non-significant, or that the in-process tests are obsolete.

code:
  v: 200000004342
display:
  v: Justification/risk assessment showing that the in-process test is non-significant or that it is obsolete.

code:
  v: 200000004343
display:
  v: Justification/risk assessment showing that the parameter is non-significant or that it is obsolete.

code:
  v: 200000004344
display:
  v: Latest version of the DDPS and, where applicable, latest version of the product specific addendum. These should include for changes to the QPPV a) summary CV of the new QPPV, b) proof of QPPV EudraVigilance registration, and c) a new statement of the MAH and the QPPV regarding their availability and the means for notification of adverse reactions signed by the new QPPV and the MAH, and reflecting any other consequential changes, e.g. to the organisation chart.

code:
  v: 200000004345
display:
  v: Letter of Authorisation including contact details of the person responsible for communication between the competent authority and the PMF holder — signed by the transferee.

code:
  v: 200000004346
display:
  v: Letter of Undertaking to fulfil all open and remaining commitments (if any) — signed by the transferee.

code:
  v: 200000004347
display:
  v: List of testing centre(s) where the kit is currently used and a list of testing centre(s) where the kit will be used.

code:
  v: 200000004348
display:
  v: List of testing site(s) where the kit is used.

code:
  v: 200000004349
display:
  v: PMF Certificate and Evaluation Report.

code:
  v: 200000004350
display:
  v: Proof of acceptance (by WHO) or copy of the ATC (Vet) Code list.

code:
  v: 200000004351
display:
  v: Proof of acceptance by WHO or copy of the INN list. If applicable, proof that the change is in line with the Ph. Eur. For herbal medicinal product, declaration that the name is in accordance with the Note for Guidance on Quality of Herbal Medicinal Products, and with the guideline on declaration of herbal substances and herbal preparations in (traditional) herbal medicinal products.

code:
  v: 200000004352
display:
  v: Proof of CE marking and if a measuring function is intended the proof of CE marking should also include the 4 digit notified body number.

code:
  v: 200000004353
display:
  v: Proof of establishment of the new holder (Excerpt of the commercial register and the English translation of it) — signed by both companies.

code:
  v: 200000004354
display:
  v: Proof of GMP approval of the changes, which should be available at the time of implementation.

code:
  v: 200000004355
display:
  v: Proof that the proposed site is appropriately authorised for the pharmaceutical form or product concerned.

code:
  v: 200000004356
display:
  v: Proof that the proposed site is appropriately authorised for the pharmaceutical form or product or manufacturing operation concerned.

code:
  v: 200000004357
display:
  v: PSMF number (if available)

code:
  v: 200000004358
display:
  v: Reference of the application/procedure and product in which the change(s) were accepted.

code:
  v: 200000004359
display:
  v: Reference to an assessment / Copy of assessment document from a previous procedure where the temperature of use has been agreed.

code:
  v: 200000004360
display:
  v: Reference to the application/procedure and product in which the DDPS was assessed previously.

code:
  v: 200000004361
display:
  v: Reference to the approved change management protocol.

code:
  v: 200000004362
display:
  v: Results from product and process development studies (including risk assessment and multivariate studies, as appropriate) demonstrating that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the finished product has been achieved.

code:
  v: 200000004363
display:
  v: Results of the appropriate Ph. Eur tests demonstrating equivalence in characteristics/correct dosing.

code:
  v: 200000004364
display:
  v: Results of the studies performed in accordance with the approved change management protocol.

code:
  v: 200000004365
display:
  v: Revalidation studies have been performed in case of sterile products terminally sterilised. The batch numbers of the batches used in the revalidation studies should be indicated, where applicable.

code:
  v: 200000004366
display:
  v: Revised frequency and/or date of submission of the PSUR (for medicinal products authorised via the centralised procedure, the full set of annexes, including the revised Annex II should be provided).

code:
  v: 200000004367
display:
  v: Revised Product Information (and Annex A, if applicable).

code:
  v: 200000004368
display:
  v: Revised product information.

code:
  v: 200000004369
display:
  v: Sample of the new product, where applicable (see Notice to Applicants Requirements for samples in the Member States).

code:
  v: 200000004370
display:
  v: Samples of the finished product where applicable (see NTA, Requirements for samples in the Member States).

code:
  v: 200000004371
display:
  v: Samples of the new container/closure where applicable (see NTA, Requirements for samples in the Member States/EMA).

code:
  v: 200000004372
display:
  v: Samples of the new device where applicable (see NTA, Requirements for samples in the Member States).

code:
  v: 200000004373
display:
  v: Signed declaration that the change does not involve a change of the quality system within the blood establishment.

code:
  v: 200000004374
display:
  v: Signed declaration that there is no change in the list of the collection centres.

code:
  v: 200000004375
display:
  v: Statement that the centre is working under the same conditions as the other centres belonging to the blood establishment, as specified in the standard contract between blood establishment and PMF holder.

code:
  v: 200000004376
display:
  v: Statement that the storage centre is working following the same SOPs as the already accepted establishment.

code:
  v: 200000004377
display:
  v: Statement that the testing is performed following the same SOPs and/or test methods as already accepted.

code:
  v: 200000004378
display:
  v: Study of equivalence of the materials and the impact on production of the final material and impact on behaviour (e.g. dissolution characteristics) of the finished product.

code:
  v: 200000004379
display:
  v: Suitable evidence to confirm compliance of the water used in the final steps of the synthesis of the active substance with the corresponding requirements on quality of water for pharmaceutical use.

code:
  v: 200000004380
display:
  v: Summary of the pharmacovigilance system, or update of the relevant elements (as applicable): - Proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance and a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC. - Contact details of the QPPV, Member States in which the QPPV resides and carries out his/her tasks - PSMF location

code:
  v: 200000004381
display:
  v: The batch numbers of the tested batches having the proposed batch size.

code:
  v: 200000004382
display:
  v: The change should not lead to substantial amendments of the product information.

code:
  v: 200000004383
display:
  v: The changes introduced during the referral procedure should be clearly highlighted in the submission.

code:
  v: 200000004384
display:
  v: The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies demonstrating where relevant that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the active substance has been achieved.

code:
  v: 200000004385
display:
  v: The medicinal product can still be accurately delivered.

code:
  v: 200000004386
display:
  v: The new Detailed Description of the Pharmacovigilance System (DDPS).

code:
  v: 200000004387
display:
  v: The new device is compatible with the medicinal product.

code:
  v: 200000004388
display:
  v: The proposed measuring or administration device must accurately deliver the required dose for the product concerned in line with the approved posology and results of such studies should be available.

code:
  v: 200000004389
display:
  v: The results of stability studies that have been carried out under ICH/VICH conditions, on the relevant stability parameters, on at least one pilot or industrial scale batch, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action).

code:
  v: 200000004390
display:
  v: The results of stability studies that have been carried out under ICH/VICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved retest period (with proposed action).

code:
  v: 200000004391
display:
  v: The results of stability studies that have been carried out under ICH/VICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action).

code:
  v: 200000004392
display:
  v: The section “present/proposed” is filled out completely and correctly.

code:
  v: 200000004393
display:
  v: The updated ASMF must be submitted by the ASMF holder (open and closed part to NCA, open part to MAH), the variation as such has to be submitted by the marketing authorisation holder.

code:
  v: 200000004394
display:
  v: The validation results should be provided.

code:
  v: 200000004395
display:
  v: The variation application form should clearly outline the ‘present’ and ‘proposed’ finished product manufacturers as listed in section 2.5 of the application form.

code:
  v: 200000004396
display:
  v: The variation application form should clearly outline the ‘present’ and ‘proposed’ finished product manufacturers, importer, batch control/testing and batch release sites as listed in section 2.5 of the application form for marketing authorisation.

code:
  v: 200000004397
display:
  v: The variation application form should clearly outline the ‘present’ and ‘proposed’ manufacturers as listed in section 2.5 of the application form for marketing authorisations.

code:
  v: 200000004398
display:
  v: The variation application form should clearly outline the ‘present’ and ‘proposed’ PMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other PMFs to which the medicinal product refers even if they are not the subject of the application.

code:
  v: 200000004399
display:
  v: The variation application form should clearly outline the ‘present’ and ‘proposed’ VAMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other VAMFs to which the medicinal product refers even if they are not the subject of the application.

code:
  v: 200000004400
display:
  v: Update of the relevant section of the dossier.

code:
  v: 200000004401
display:
  v: Updated relevant sections and annexes of the PMF dossier, including a list of all the blood establishments using this transport organisation, a summary of the system in place to ensure that the transport is performed under appropriate conditions (time, temperature and GMP compliance) and confirmation that transport conditions are validated.

code:
  v: 200000004402
display:
  v: Updated relevant sections and annexes of the PMF dossier, including detailed description of the new conditions, confirmation of validation of storage/transport conditions and the name of the blood establishment(s) where the change takes place (if relevant).

code:
  v: 200000004403
display:
  v: Updated relevant sections and annexes of the PMF dossier, including the name of container, manufacturer, anticoagulant solution specification, confirmation of CE-mark and the name of the blood establishments where the container is used.

code:
  v: 200000004404
display:
  v: Updated relevant sections and annexes of the PMF dossier, including updated information on testing as requested in the ‘Guideline on the scientific data requirements for a PMF’.

code:
  v: 200000004405
display:
  v: Updated relevant sections and annexes of the PMF dossier.

code:
  v: 200000004406
display:
  v: Updated relevant sections of the PMF dossier, including the rationale for introduction or extension of inventory hold period, the sites where the inventory hold takes place and for changes to procedure, a decision tree including new conditions.

code:
  v: 200000004407
display:
  v: Updated relevant sections of the PMF dossier.

code:
  v: 200000004408
display:
  v: VAMF Certificate and Evaluation Report.

code:
  v: 200000004409
display:
  v: Where applicable, a document providing information of any materials falling within the scope of the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products including those which are used in the manufacture of the active substance/excipient.

code:
  v: 200000004410
display:
  v: Where applicable, for active substance, a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the QP of each of the manufacturing authorisation holders listed in the application as responsible for batch release.

code:
  v: 200000004411
display:
  v: Where appropriate, comparative dissolution profile data for the finished product of at least two batches (minimum pilot scale). For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004412
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004413
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the active substance complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004414
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products comparative disintegration data may be acceptable.

code:
  v: 200000004415
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch manufactured using the current and new in-process tests. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000004416
display:
  v: Where appropriate, proof must be provided that no interaction between the content and the packaging material occurs (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic material and objects in contact with foodstuffs.

code:
  v: 200000004417
display:
  v: Where relevant the batch numbers, corresponding batch size and the manufacturing date of batches (≥ 3) used in the validation study should be indicated or validation protocol (scheme) be submitted.

code:
  v: 200000004418
display:
  v: Where relevant, a commitment of the manufacturer of the active substance to inform the MA holder of any changes to the manufacturing process, specifications and test procedures of the active substance.

code:
  v: 200000004419
display:
  v: Where relevant, the batch numbers, corresponding batch size and the manufacturing date of batches (≥ 3) used in the validation study should be indicated and the validation data presented, or validation protocol (scheme) to be submitted.

code:
  v: 200000004420
display:
  v: Written confirmation from the manufacturer of the finish product stating verification of compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practices.

code:
  v: 200000023186
display:
  v: Written confirmation from the manufacturer of the finished product stating verification of compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practices.

code:
  v: 200000023187
display:
  v: A declaration from the marketing authorisation holder or the ASMF holder that the synthetic route quality control procedures and specifications of the active substance and of the starting material/reagent/intermediate in the manufacturing process of the active substance are the same as those already approved. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023189
display:
  v: The variation application form should clearly outline the “present” and “proposed” manufacturers as listed in the application form for marketing authorisation.

code:
  v: 200000023190
display:
  v: Proof that the proposed site is appropriately authorised for the pharmaceutical form or product or manufacturing operation concerned (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023191
display:
  v: Amendment of the approved Active Substance Master File, including a direct comparison of the present process and the new process.

code:
  v: 200000023194
display:
  v: A declaration from the ASMF Holder that there is no change in qualitative and quantitative impurity profile or in physico-chemical properties, that the synthetic route remains the same and that the specifications of the active substance or intermediates are unchanged.

code:
  v: 200000023198
display:
  v: Comparative table of current and proposed in-process tests.

code:
  v: 200000023199
display:
  v: Details of any new non-pharmacopoeial analytical method and validation data, where relevant.

code:
  v: 200000023200
display:
  v: Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the active substance for all specification parameters.

code:
  v: 200000023201
display:
  v: Justification from the MAH or ASMF Holder as appropriate for the new in-process test and limits.

code:
  v: 200000023202
display:
  v: Comparative table of current and proposed specifications.

code:
  v: 200000023203
display:
  v: Details of any new analytical method and validation data, where relevant.

code:
  v: 200000023204
display:
  v: Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the relevant substance for all specification parameters.

code:
  v: 200000023205
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the active substance complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000023206
display:
  v: Justification from the MAH or ASMF Holder as appropriate of the new specification parameter and the limits.

code:
  v: 200000023207
display:
  v: Description of the analytical methodology, a summary of validation data, revised specifications for impurities (if applicable).

code:
  v: 200000023208
display:
  v: Comparative validation results, or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.

code:
  v: 200000023209
display:
  v: Appropriate data on the new packaging (e.g. comparative data on permeability e.g. for O2, CO2 moisture), including a confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic materials and objects in contact with foodstuffs.

code:
  v: 200000023210
display:
  v: Where appropriate, proof must be provided that no interaction between the content and the packaging material occurs (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeia requirements or legislation of the Union on plastic material and objects in contact with foodstuffs.

code:
  v: 200000023211
display:
  v: The results of stability studies that have been carried out under VICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved retest period (with proposed action).

code:
  v: 200000023212
display:
  v: Comparison of the current and proposed immediate packaging specifications, if applicable.

code:
  v: 200000023213
display:
  v: Batch analysis data on two batches of the immediate packaging for all specification parameters.

code:
  v: 200000023214
display:
  v: Justification from the marketing authorisation holder or the ASMF Holder, as appropriate, of the new specification parameter and the limits.

code:
  v: 200000023215
display:
  v: Results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on at least two (three for biological medicinal products) pilot or production scale batches of the active substance in the authorised packaging material and covering the duration of the requested re-test period or requested storage conditions.

code:
  v: 200000023216
display:
  v: Confirmation that stability studies have been done to the currently approved protocol. The studies must show that the agreed relevant specifications are still met.

code:
  v: 200000023217
display:
  v: The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies demonstrating where relevant that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the active substance has been achieved. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023218
display:
  v: Description of the Design space in tabular format, including the variables (material attributes and process parameters, as appropriate) and their proposed ranges.

code:
  v: 200000023219
display:
  v: Detailed description for the proposed change.

code:
  v: 200000023220
display:
  v: Change management protocol related to the active substance.

code:
  v: 200000023221
display:
  v: Declaration that the change is in accordance with the approved change management and that the study results meet the acceptance criteria specified in the protocol. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.

code:
  v: 200000023222
display:
  v: Detailed drawing or written description of the current and new appearance.

code:
  v: 200000023223
display:
  v: Samples of the finished product where applicable.

code:
  v: 200000023224
display:
  v: Detailed drawing of the current and proposed situation.

code:
  v: 200000023225
display:
  v: Comparative dissolution data on at least one pilot batch of the current and proposed dimensions (no significant differences regarding comparability see the relevant guidance on bioavailability/bioequivalence). For herbal medicinal product comparative disintegration data may be acceptable.

code:
  v: 200000023226
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant guidance on Bioavailability/bioequivalence.

code:
  v: 200000023227
display:
  v: Identification method for any new colorant, where relevant.

code:
  v: 200000023228
display:
  v: Sample of the new product, where applicable.

code:
  v: 200000023229
display:
  v: Either a Ph. Eur. Certificate of Suitability for any new component of animal susceptible to TSE risk or where applicable, documentary evidence that the specific source of the TSE risk material has been previously assessed by the competent authority and shown to comply with the scope of the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023230
display:
  v: For solid dosage forms, comparative dissolution profile data of at least two pilot scale batches of the finished product in the new and old composition. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000023231
display:
  v: If intended for use in food producing animal species, proof that the excipient is classified according to Article 14(2)(c) of Regulation (EC) No 470/2009 of the European Parliament and the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, or, if not, justification that the excipient does not have pharmacological activity at the dose at which it is administered to the target animal.

code:
  v: 200000023232
display:
  v: Proof that the proposed site is appropriately authorised for the pharmaceutical form or product or manufacturing operation concerned. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023233
display:
  v: Where relevant, the batch numbers, corresponding batch size and the manufacturing date of batches (larger than/equal to 3) used in the validation study should be indicated and the validation data presented, or validation protocol (scheme) to be submitted.

code:
  v: 200000023234
display:
  v: The variation application form should clearly outline the “present” and “proposed” finished product manufacturers as listed in the application form.

code:
  v: 200000023235
display:
  v: Copy of approved release and end-of-shelf life specifications if relevant.

code:
  v: 200000023236
display:
  v: Batch analysis data on one production batch and two pilot-scale batches simulating the production process (or two production batches) and comparative data on the last three batches from the previous site; batch data on the next two production batches should be available on request or reported if outside specifications (with proposed action).

code:
  v: 200000023237
display:
  v: For semisolid and liquid formulations in which the active substance is present in non-dissolved form, appropriate validation data including microscopic imaging of particle size distribution and morphology or any other appropiate imaging technique.

code:
  v: 200000023238
display:
  v: Declaration by the Qualified Person. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023239
display:
  v: Direct comparison of the present process and the new process.

code:
  v: 200000023240
display:
  v: For semi-solid and liquid products in which the active substance is present in non-dissolved form: appropriate validation of the change including microscopic imaging of particles to check for visible changes in morphology; comparative size distribution data by an appropriate method.

code:
  v: 200000023241
display:
  v: For solid dosage forms: dissolution profile data of one representative production batch and comparative data of the last three batches from the previous process; data on the next two full production batches should be available on request or reported if outside specification (with proposed action). For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000023242
display:
  v: For changes to process parameter(s) that have been considered to have no impact on the quality of the finished product, declaration to this effect reached in the context of the previously approved risk assessment.

code:
  v: 200000023243
display:
  v: Copy of approved release and end-of-shelf life specifications.

code:
  v: 200000023244
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of one batch manufactured to both the currently approved and the proposed process. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).

code:
  v: 200000023245
display:
  v: Declaration that relevant stability studies have been started under VICH conditions, as appropriate, (with indication of the batch numbers concerned) and relevant stability parameters have been assessed. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023246
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of one production batch manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the MAH if outside specifications (with proposed action).

code:
  v: 200000023247
display:
  v: Where relevant the batch numbers, corresponding batch size and the manufacturing date of batches (larger than/equal to 3) used in the validation study should be indicated or validation protocol (scheme) be submitted.

code:
  v: 200000023248
display:
  v: The validation results should be provided.

code:
  v: 200000023249
display:
  v: The results of stability studies that have been carried out under VICH conditions. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023250
display:
  v: Comparative table of current and proposed in-process tests and limits.

code:
  v: 200000023251
display:
  v: Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the finished product for all specification parameters.

code:
  v: 200000023252
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch manufactured using the current and new in-process tests. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000023253
display:
  v: Justification of the new in-process test and limits.

code:
  v: 200000023254
display:
  v: Batch analysis data on two production batches (3 production batches for biological excipients) of the excipient for all specification parameters.

code:
  v: 200000023255
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products comparative disintegration data may be acceptable.

code:
  v: 200000023256
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant Guidance on bioavailability/bioequivalence, if appropriate.

code:
  v: 200000023257
display:
  v: Justification of the new specification parameter and the limits.

code:
  v: 200000023258
display:
  v: Description of the analytical methodology, a summary of validation data, revised specification for impurities (if applicable).

code:
  v: 200000023259
display:
  v: Comparative validation results or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.

code:
  v: 200000023260
display:
  v: Declaration from the manufacturer or the marketing authorisation holder of the material that it is purely of vegetable or synthetic origin.

code:
  v: 200000023261
display:
  v: Study of equivalence of the materials and the impact on production of the final material and impact on behaviour (e.g. Dissolution characteristics) of the finished product.

code:
  v: 200000023262
display:
  v: Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000023263
display:
  v: Justification of the new specification parameter and the limits.

code:
  v: 200000023264
display:
  v: Appropriate data on the new packaging (comparative data on permeability e.g. for O2, CO2 moisture).

code:
  v: 200000023265
display:
  v: Comparative table of the current and proposed immediate packaging specifications, if applicable.

code:
  v: 200000023266
display:
  v: Samples of the new container/closure where applicable.

code:
  v: 200000023267
display:
  v: Description, detailed drawing and composition of the container or closure material.

code:
  v: 200000023268
display:
  v: Re-validation studies have been performed in case of sterile products terminally sterilised. The batch numbers of the batches used in the re-validation studies should be indicated, where applicable.

code:
  v: 200000023269
display:
  v: In case of a change in the headspace or a change in the surface/volume ratio, a declaration that the required stability studies have been started under VICH conditions. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023270
display:
  v: Justification for the new pack-size, showing that the new size is consistent with the dosage regimen and duration of treatment as approved in the summary of product characteristics.

code:
  v: 200000023271
display:
  v: Declaration that stability studies will be conducted in accordance with the relevant guidelines for products where stability parameters could be affected. Data to be reported only if outside specifications (with proposed action).

code:
  v: 200000023272
display:
  v: Results of appropriate real time stability studies (covering the entire shelf life) conducted in accordance with the relevant stability guidelines on at least two pilot scale batches of the finished product in the authorised packaging material and/or after first opening or reconstitution, as appropriate; where applicable, results of appropriate microbiological testing should be included.

code:
  v: 200000023273
display:
  v: Copy of approved end of shelf life finished product specification and where applicable, specifications after dilution/reconstitution or first opening.

code:
  v: 200000023274
display:
  v: Results from product and process development studies (including risk assessment and multivariate studies, as appropriate) demonstrating that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the finished product has been achieved.

code:
  v: 200000023275
display:
  v: Change management protocol related to the finished product.

code:
  v: 200000023276
display:
  v: Declaration that any change should be within the range of currently approved limits. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.

code:
  v: 200000023277
display:
  v: Copy of approved specifications of the finished product.

code:
  v: 200000023279
display:
  v: In case of an addition of a manufacturing site, the variation application form should clearly outline the “present” and “proposed” manufacturers as listed in the application form.

code:
  v: 200000023280
display:
  v: Where applicable, a document providing information of any materials falling within the scope of the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products including those which are used in the manufacture of the active substance/excipient. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023281
display:
  v: Where applicable, for active substance, a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the QP of each of the manufacturing authorisation holders listed in the application as responsible for batch release. (SEE FULL DESCRIPTION IN GUIDELINE)

code:
  v: 200000023283
display:
  v: Description, detailed drawing and composition of the device material and supplier where appropriate.

code:
  v: 200000023284
display:
  v: Data to demonstrate accuracy, precision and compatibility of the device.

code:
  v: 200000023285
display:
  v: Samples of the new device where applicable.

code:
  v: 200000023286
display:
  v: Details of any new analytical method and summary of validation data.

code:
  v: 200000023287
display:
  v: Batch analysis data on two production batches for all tests in the new specification.

code:
  v: 200000023291
display:
  v: The variation application form should clearly outline the “present” and “proposed” VAMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other VAMFs to which the medicinal product refers even if they are not the subject of the application.

code:
  v: 200000023292
display:
  v: Attached to the cover letter of the variation application: a reference to the Commission Decision concerned with the annexed Summary of Product Characteristics, Labelling or Package Leaflet.

code:
  v: 200000023293
display:
  v: A declaration that the proposed Summary of Product Characteristics, Labelling and Package Leaflet is identical for the concerned sections to that annexed to the Commission Decision.

code:
  v: 200000023294
display:
  v: Attached to the cover letter of the variation application: a reference to the agreement/assessment of the competent authority.

code:
  v: 200000023295
display:
  v: Attached to the cover letter of the variation application: a reference to the procedure where the wording for one of the active substances was approved.

code:
  v: 200000023296
display:
  v: Attached to the cover letter of the variation application: proof of authorisation of the legal status change (e.g. reference to the Commission Decision concerned)

code:
  v: 200000023297
display:
  v: Justification for the deletion of the target species

code:
  v: 200000032254
display:
  v: A confirmation that the related signal has been submitted in the Union Pharmacovigilance database, in the module for Veterinary Signal Management (VSM) submissions (IRIS). The procedure number for the VSM submission in IRIS (e.g. EMA/VS/XXXXXXXXXX) will suffice.

code:
  v: 200000032255
display:
  v: The veterinary signal assessment report for MAHs in line with the relevant template available on the EMA website, and any references or supporting documentation.

code:
  v: 200000051923
display:
  v: Amendment of the relevant section(s) of the dossier, including revised product information as appropriate.

code:
  v: 200000051924
display:
  v: A declaration by the qualified person (QP) of each of the manufacturing authorisation holders listed in the application, where the active substance is used as a starting material, and a declaration by the gualified person of each of the manufacturing authorisation holders listed in the application as responsible for batch release. These declarations should state that the active substance manufacturer(s) referred to in the application operate in compliance with the detailed ...

code:
  v: 200000051925
display:
  v: A declaration by the qualified person (QP) responsible for batch certification stating that the active substance manufacturer(s) referred to in the marketing authorisation operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. A single declaration may be acceptable under certain circumstances (see the note under variation no. Q.II.b.1).

code:
  v: 200000051926
display:
  v: A declaration from the marketing authorisation holder (and the ASMF holder as appropriate) that the changes to the manufacturing methods are only those necessitated by scale-up or downscaling, e.g. use of different-sized equipment, that the change does not adversely affect the reproducibility of the process, that it is not the result of unexpected events arising during manufacture or because of stability concerns and that the specifications of the active substance/intermediates remain the same.

code:
  v: 200000051927
display:
  v: A declaration from the marketing authorisation holder (and the ASMF holder, where applicable) that the starting material (specifications and analytical procedures) and that the synthetic route, quality control procedures and specifications of the active substance and of the intermediate used in the manufacturing process of the active substance are the same as those already approved. For herbal active substances, a declaration that the geographical source, production ...

code:
  v: 200000051928
display:
  v: A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the required stability studies have been started under ICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem. Assurance should also be given that the studies will be finalised and ...

code:
  v: 200000051929
display:
  v: A declaration from the marketing authorisation holder that an evaluation has been performed and the minor changes do not impact the quality, safety or efficacy of the active substance/finished product (e.g. minor amendments to process description without actual process change, such as details of reagents (e.g. buffers, media preparation). For herbal starting materials/active substances, this evaluation should include a detailed comparison regarding quality determining process characteristics ...

code:
  v: 200000051930
display:
  v: A declaration from the marketing authorisation holder that an evaluation of the concerned manufacturing step(s) has been performed and the minor change does not impact the quality, safety or efficacy of the finished product.

code:
  v: 200000051931
display:
  v: A declaration that the required stability studies have been started under ICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem. Assurance should also be given that the studies will be finalised and that data will be provided immediately to the competent authorities if ...

code:
  v: 200000051932
display:
  v: A declaration that the required stability studies have been started under ICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem. Assurance should also be given that the studies will be finalised and that data will be provided immediately to the competent authorities if...

code:
  v: 200000051933
display:
  v: A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name or new address is mentioned.

code:
  v: 200000051934
display:
  v: A formal document from a relevant official body (e.g. Chamber of Commerce, or if not available, from a competent authority) in which the new name and/or address is mentioned, or a copy of the modified manufacturing authorisation, if available.

code:
  v: 200000051935
display:
  v: A summary and justification of the proposed change(s), clearly describing the present and proposed situation and supporting documentation.

code:
  v: 200000051936
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format) including revised product information as appropriate.

code:
  v: 200000051937
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), and revised product information as appropriate.

code:
  v: 200000051938
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), as appropriate.

code:
  v: 200000051939
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a description of the analytical methodology, a summary of validation data, revised specifications.

code:
  v: 200000051940
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a description of the analytical methodology, a summary of validation data.

code:
  v: 200000051941
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a description of the manufacturing and qualification of the new in-house reference standard.

code:
  v: 200000051942
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a detailed drawing of the current and proposed situation, and including revised product information as appropriate.

code:
  v: 200000051943
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a detailed drawing or written description of the current and new appearance, and including revised product information as appropriate.

code:
  v: 200000051944
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a direct comparison of the present process and the new process.

code:
  v: 200000051945
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including description, detailed drawing and composition of the container or closure material, and including revised product information as appropriate.

code:
  v: 200000051946
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including revised product information, as appropriate.

code:
  v: 200000051947
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). This must contain results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on three pilot or production scale batches of the active substance or intermediate in the authorised packaging material.

code:
  v: 200000051948
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). This must contain results of appropriate stability studies conducted in accordance with the relevant stability guidelines on three pilot scale batches(*) of the finished product in the authorised packaging material and/or two batches after first opening or reconstitution, as appropriate. Where applicable, results of appropriate microbiological testing should be included.

code:
  v: 200000051949
display:
  v: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). This should include: Updated consolidated holder/finished product manufacturer list of manufacturers of the active substance (section 3.2.S.2.1); Updated single compiled holder/finished product manufacturer active substance specification, including analytical methods and method validation (where the finished product manufacturer uses analytical procedures which are different from the Ph. Eur. ...

code:
  v: 200000051950
display:
  v: Amendment of the relevant section(s) of the dossier, as appropriate.

code:
  v: 200000051951
display:
  v: Amendment of the relevant section(s) of the dossier, including description, drawing and composition of the device material, compatibility and usability studies as appropriate.

code:
  v: 200000051952
display:
  v: Amendment of the relevant section(s) of the dossier, including revised product information as appropriate.

code:
  v: 200000051953
display:
  v: An updated product lifecycle management document (PLCM) with relevant sections modified.

code:
  v: 200000051954
display:
  v: Appropriate data on the new packaging (comparative data on permeability, e.g. for O2, CO2 moisture). Where appropriate, proof must be provided that no adverse interaction between the content and the packaging material occurs (e.g. data on migration of components of the proposed material into the content and loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeial requirements or legislation of ...

code:
  v: 200000051955
display:
  v: Appropriate data on the new packaging (e.g. comparative data on permeability e.g. for O2, CO2 moisture). Where appropriate, proof must be provided that no interaction between the content and the packaging material has no impact on the active substance quality (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeia requirements or ...

code:
  v: 200000051956
display:
  v: Attached to the cover letter of the variation application: A reference to the relevant decision of the competent authorities.

code:
  v: 200000051957
display:
  v: Attached to the cover letter of the variation application: reference to the agreement/assessment of the competent authoritiesies.

code:
  v: 200000051958
display:
  v: Batch analysis data (in a comparative tabular format) for at least two batches (minimum pilot scale) [or 3 batches (unless otherwise justified) for biologicals] of the active substance/starting material from the current and proposed manufacturers/sites.

code:
  v: 200000051959
display:
  v: Batch analysis data (in a comparative tabulated format) of at least two batches (minimum pilot scale) [or 3 production batches (unless otherwise justified) for biological excipients] of the excipient manufactured according to the present and proposed process, or by the present and proposed manufacturer, as applicable.

code:
  v: 200000051960
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of two batches] manufactured to both the currently approved and the proposed process.

code:
  v: 200000051961
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of two production batches manufactured to both the currently approved and the proposed sizes. Batch analysis data of 3 batches (unless otherwise justified) for biological finished product should be available for the proposed batch size.

code:
  v: 200000051962
display:
  v: Batch analysis data (in a comparative tabulated format) on a minimum of two production batches of the active substance or intermediate, as appropriate, manufactured to both the currently approved and the proposed sizes. Batch analysis data of 3 batches (unless otherwise justified) for biological active substance, should be available for the proposed batch size.

code:
  v: 200000051963
display:
  v: Batch analysis data (in a comparative tabulated format) on two production batches of the relevant substance for all analytical procedures in the new specification and additionally, where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch. For herbal finished products, comparative disintegration data may be acceptable.

code:
  v: 200000051964
display:
  v: Batch analysis data on one production batch and two pilot scale batches simulating the production process (or two production batches) and comparative data on the last three batches from the previous site; batch data on the next two production batches should be available on request or reported if outside specifications (with proposed action). Batch analysis data of 3 batches (unless otherwise justified) of the biological finished product, manufactured from the current and ...

code:
  v: 200000051965
display:
  v: Batch analysis data (in comparative tabular format) of at least two batches (minimum pilot scale), of the active substance or intermediate as appropriate, manufactured according to the currently approved and proposed process.

code:
  v: 200000051966
display:
  v: Batch analysis data on two production batches [3 production batches (unless otherwise justified) for biologicals] of the finished product for all specification attributes.

code:
  v: 200000051967
display:
  v: Batch analysis data on two production batches [3 production batches (unless otherwise justified) for biologicals]) of the relevant substance for all specification attributes.

code:
  v: 200000051968
display:
  v: Batch analysis data on two production batches of the active substance for all specification attributes.

code:
  v: 200000051971
display:
  v: Batch analysis data on two production batches of the excipient for all specification attributes [3 production batches (unless otherwise justified) for biological excipients or novel excipients].

code:
  v: 200000051972
display:
  v: Batch analysis data on two production of the finished product for all specification attributes.

code:
  v: 200000051973
display:
  v: Comparative batch analysis data and comparative dissolution profile data of at least two pilot scale batches of the finished product in the current and proposed formulation. For herbal medicinal products where dissolution testing may not be feasible, comparative disintegration data should be provided.

code:
  v: 200000051974
display:
  v: Comparative dissolution data on at least one pilot batch of the current and proposed dimensions (no significant differences regarding comparability see the relevant guideline on Investigation of Bioequivalence). For herbal medicinal product comparative disintegration data may be acceptable.

code:
  v: 200000051975
display:
  v: Comparative study results or comparative analysis results showing that the current analytical procedure and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new analytical procedure.

code:
  v: 200000051976
display:
  v: Comparative table of current and proposed in-process controls and limits.

code:
  v: 200000051977
display:
  v: Comparative test results, showing that the current in-house reference standard and the proposed one are equivalent.

code:
  v: 200000051978
display:
  v: Comparative validation results (or, if justified, comparative analysis results) showing that the current analytical procedure and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new analytical procedure unless the new analytical procedure is added as an alternative procedure to a current one.

code:
  v: 200000051979
display:
  v: Comparative validation results or if justified comparative analysis results showing that the current analytical and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new analytical procedure.

code:
  v: 200000051980
display:
  v: Comparative validation results or if justified comparative analysis results showing that the current analytical procedure and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new analytical procedure.

code:
  v: 200000051981
display:
  v: Comparative validation results, or if justified comparative analysis results showing that the current analytical procedure and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new analytical procedure unless the new analytical procedure is added as an alternative procedure to a current one.

code:
  v: 200000051982
display:
  v: Confirmation and data demonstrating compliance with equivalent quality standard as CE-mark as requested in the ‘Guideline on the scientific data requirements for a PMF’.

code:
  v: 200000051983
display:
  v: Confirmation no changes other than administrative (Type IA) have been implemented.

code:
  v: 200000051984
display:
  v: Confirmation of equivalence of the materials and that there is no impact on the quality of the finished product.

code:
  v: 200000051985
display:
  v: Confirmation of the transfer of the complete PMF documentation since the initial PMF certification to the transferee - signed by both companies.

code:
  v: 200000051986
display:
  v: Confirmation that any anticoagulant solution complies with Ph. Eur. requirements.

code:
  v: 200000051987
display:
  v: Confirmation that standard contract between blood establishment/centre and PMF holder is in place.

code:
  v: 200000051988
display:
  v: Confirmation that the proposed summary of product characteristics, labelling and package leaflet is identical for the concerned sections to that annexed to the Commission Decision or to the agreement reached by the CMDh (as applicable).

code:
  v: 200000051989
display:
  v: Copy of approved and new (if applicable) specifications of the excipient (as annex to the application form).

code:
  v: 200000051990
display:
  v: Copy of approved end of shelf life finished product specification and where applicable, specifications after dilution/reconstitution or first opening (as annex to the application form).

code:
  v: 200000051991
display:
  v: Copy of approved release and end-of-shelf life specifications (as annex to the application form).

code:
  v: 200000051992
display:
  v: Copy of approved release and end-of-shelf life specifications if relevant (as annex to the application form).

code:
  v: 200000051993
display:
  v: Copy of approved specifications of the active substance (as annex to the application form).

code:
  v: 200000051994
display:
  v: Copy of the current (updated) Ph. Eur. certificate of suitability (CEP) and the letter of access (where available).

code:
  v: 200000051995
display:
  v: Data to demonstrate performance, safety and compatibility of the device, as appropriate.

code:
  v: 200000051996
display:
  v: Data to demonstrate that the new excipient does not interfere with the finished product specification analytical procedures, if appropriate.

code:
  v: 200000051997
display:
  v: Data to demonstrate the suitability of the monograph to control the substance (e.g. a comparison of the potential impurities with the transparency note of the monograph).

code:
  v: 200000051998
display:
  v: Data to validate the proposed change in holding time and/or storage conditions of the intermediate or bulk product (minimum of two batches at pilot or commercial scale). Composition of the intermediate or bulk container should be described and its specification stated. If pilot scale batches are provided, a commitment to verify these data on commercial scale batches. Declaration that the finished product shelf life is set in accordance with ...

code:
  v: 200000051999
display:
  v: Declaration of changes introduced, and variation applications submitted.

code:
  v: 200000052000
display:
  v: Declaration that relevant stability studies have been started under ICH conditions, as appropriate, (with indication of the batch numbers concerned) and relevant stability parameters have been assessed in at least one pilot scale or industrial scale batch. Assurance is given that these studies will be finalised and that the data will be provided immediately to the competent authorities if outside specifications or ...

code:
  v: 200000052001
display:
  v: Declaration that the change is in accordance with the post-approval change management protocol and that the study results meet the acceptance criteria specified in the protocol(*).

code:
  v: 200000052002
display:
  v: Declaration that the change is in accordance with the approved change management protocol and that the study results meet the acceptance criteria specified in the protocol.(*)

code:
  v: 200000052003
display:
  v: Declaration that the changes do not change the overall strategy defined in the protocol and are not broader than the currently approved protocol.

code:
  v: 200000052004
display:
  v: Declaration that the serotype, strain, antigen or coding sequence is no longer appropriate in relation to the epidemiological evolution of the human virus of concern.

code:
  v: 200000052005
display:
  v: Declaration that the finished product specification has only been updated in respect of weight and dimensions.

code:
  v: 200000052006
display:
  v: Declaration that the PMF Certificate and Evaluation Report are fully applicable for the authorised product, PMF holder has provided the PMF Certificate, Evaluation report and PMF dossier to the holder (where the marketing authorisation holder is different to the PMF holder), the PMF Certificate and Evaluation Report replace the previous PMF documentation for this marketing authorisation.

code:
  v: 200000052007
display:
  v: Declaration that the remaining product presentation(s) are adequate for the dosing instructions and duration as mentioned in the summary of product characteristics, and the deletion has been agreed in principle with the Agency.

code:
  v: 200000052008
display:
  v: Declaration that the VAMF Certificate and Evaluation Report are fully applicable for the authorised product, VAMF holder has submitted the VAMF Certificate, Evaluation report and VAMF dossier to the holder (where the marketing authorisation holder is different to the VAMF holder), the VAMF Certificate and Evaluation Report replace the previous VAMF documentation for this marketing authorisation.

code:
  v: 200000052009
display:
  v: Declaration that, while the establishment(s)/centre(s) has remained in non-operational, the epidemiology data have been submitted annually.

code:
  v: 200000052010
display:
  v: Description of the design space in tabular format, and/or in the form of mathematical equation, as relevant, including the variables (material attributes and process parameters, as appropriate) with their proposed ranges and limits.

code:
  v: 200000052011
display:
  v: Description of the sterilisation method and sterilisation cycle. Validation of the sterilisation cycle should be provided if it does not use the reference conditions stated in Ph. Eur..

code:
  v: 200000052012
display:
  v: Description of the sterilisation method and sterilisation cycle. Validation of the sterilisation cycle should be provided if the sterilisation cycle does not use the reference conditions stated in the Ph. Eur.

code:
  v: 200000052015
display:
  v: Details of any new analytical procedure and validation data, where relevant.

code:
  v: 200000052016
display:
  v: Details of any new analytical procedure and validation, where relevant.

code:
  v: 200000052017
display:
  v: Either a Ph. Eur. certificate of suitability for any new component of animal susceptible to TSE risk or where applicable, documentary evidence that the specific source of the TSE risk material has been previously assessed by the competent authority and shown to comply with the scope of the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products...

code:
  v: 200000052018
display:
  v: Either a TSE Ph. Eur. certificate of suitability for any new source of material or, where applicable, documentary evidence that the specific source of the TSE risk material has previously been assessed by the competent authority and shown to comply with the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. The information should include the following:...

code:
  v: 200000052019
display:
  v: Epidemiological data for viral markers related to the blood/plasma collection centre to be provided as requested in the Guideline on epidemiological data on blood transmissible infections.

code:
  v: 200000052020
display:
  v: Evidence that the sterilisation has been conducted and validated in accordance with GMP and/or relevant ISO standards, as per guideline on the sterilisation of the medicinal product, active substance, excipient and primary container.

code:
  v: 200000052021
display:
  v: For active substance and excipients, proof of acceptance by WHO or copy of the INN list. If applicable, proof that the change is in line with the Ph. Eur.. For herbal medicinal product, declaration that the name is in accordance with the guideline on declaration of herbal substances and herbal preparations in (traditional) herbal medicinal products.

code:
  v: 200000052022
display:
  v: For biological active substance, a justification that an assessment of comparability is not required.

code:
  v: 200000052059
display:
  v: For biological finished products, a justification that an assessment of comparability is not required.

code:
  v: 200000052060
display:
  v: For herbal active substances a detailed comparison regarding specifications and critical quality attributes (e.g. for extracts: reference to the herbal starting material (incl. scientific binominal name and plant part), physical state, extraction solvent (nature and concentration), drug extract ratio (DER) and manufacturing process (including a stepwise comparison of all manufacturing steps in tabular format).

code:
  v: 200000052063
display:
  v: For herbal active substances/herbal starting materials a detailed comparison regarding their characteristics (e.g. for extracts: reference to the herbal starting material (incl. scientific binominal name and plant part, physical state extraction solvent (nature and concentration), drug extract ratio (DER) and the manufacturing process) should be provided.

code:
  v: 200000052064
display:
  v: For herbal starting material supplier, a GACP declaration from the new supplier (and updated QP declaration if the new supplier is also involved in the herbal active substance manufacture).

code:
  v: 200000052065
display:
  v: For herbal starting material, a detailed comparison regarding specifications and critical quality attributes of the herbal starting material. For herbal active substance, a detailed comparison regarding specifications and critical quality attributes (e.g. for extracts: reference to the herbal starting material (incl. scientific binominal name and plant part), physical state, extraction solvent (nature and concentration), drug extract ratio (DER) and manufacturing process...

code:
  v: 200000052066
display:
  v: For medical devices, updated CE certificate and/or declaration of conformity, if available.

code:
  v: 200000052067
display:
  v: For semisolid and liquid formulations in which the active substance is present in non-dissolved form, appropriate validation data including microscopic imaging of particle size distribution and morphology or any other appropriate imaging technique.

code:
  v: 200000052068
display:
  v: For semi-solid and liquid products in which the active substance is present in non-dissolved form: appropriate validation of the change including microscopic imaging of particles to check for visible changes in morphology; comparative size distribution data by an appropriate method.

code:
  v: 200000052069
display:
  v: For solid dosage forms: dissolution profile data of one representative production batch and comparative data of the last three batches from the previous process; data on the next two full production batches should be available on request or reported if outside specification (with proposed action). For herbal medicinal products, comparative disintegration data may be acceptable.

code:
  v: 200000052070
display:
  v: For the addition or replacement of a co-packaged medical device, evidence that relevant standards have been met e.g. EU declaration of conformity or, where applicable, EU certificate, or other appropriate documentation such as summary information confirming compliance with relevant General Safety and Performance Requirements.

code:
  v: 200000052071
display:
  v: For the biosimilar medicinal product aligning the product information with an indication of the reference medicinal product: a justification that the comparability exercise performed for the biosimilar medicinal product is valid for the applied indication.

code:
  v: 200000052072
display:
  v: If the manufacturing site and the immediate packaging site are different, conditions of transport and bulk storage should be specified and validated.

code:
  v: 200000052074
display:
  v: In case of a change in the headspace or a change in the surface/volume ratio, a declaration that the required stability studies have been started under ICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data (at least three months stability data for at least one pilot scale or industrial scale batches) were at the disposal of the applicant at time of implementation for a Type IA notification and time of submission of

code:
  v: 200000052075
display:
  v: In case of change in the name of the holder of the Active Substance Master File, updated “letter of access”.

code:
  v: 200000052076
display:
  v: In the case of herbal starting materials, an updated GACP declaration and a declaration from the marketing authorisation holder that the manufacturing process of the herbal active substance remains the same.

code:
  v: 200000052077
display:
  v: Justification for not submitting a new bioequivalence study according to the current guideline on Investigation of Bioequivalence.

code:
  v: 200000052078
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant guidance on Investigation of Bioequivalence.

code:
  v: 200000052079
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant guideline on Investigation of Bioequivalence.

code:
  v: 200000052080
display:
  v: Justification for not submitting a new bioequivalence study according to the relevant Guideline on The Investigation of Bioequivalence, if appropriate.

code:
  v: 200000052081
display:
  v: Justification for the absence of a Notified Body opinion/EU certificate/EU declaration of conformity, based on the risk-assessment performed, which concluded that the proposed change has no significant impact on the medicinal product.

code:
  v: 200000052082
display:
  v: Justification for the deletion, including a statement regarding alternative means to obtain the solvent / diluent as required for the safe and effective use of the finished product.

code:
  v: 200000052083
display:
  v: Justification from the holder for the change in the testing of specification attribute. A change from routine testing to skip/periodic testing is warranted when the manufacturing process is under control and supported by a sufficient amount of historical data compliant with the specification. A change from skip/periodic testing to routine testing should be supported by analytical data demonstrating failure to meet the approved acceptance criteria for the skip tested specification.

code:
  v: 200000052084
display:
  v: Justification from the holder or ASMF holder as appropriate for the new in-process control and limits.

code:
  v: 200000052085
display:
  v: Justification from the marketing authorisation holder or ASMF holder as appropriate of the new specification attribute and the acceptance criteria.

code:
  v: 200000052086
display:
  v: Justification from the marketing authorisation holder or the ASMF holder for the change in the testing of specification attribute. A change from routine testing to skip/periodic testing is warranted when the manufacturing process is under control and supported by sufficient amount of historical data compliant with the specification or as foreseen by relevant guidelines. A change from skip/periodic testing to routine testing should be supported by analytical data demonstrating failure to meet the

code:
  v: 200000052087
display:
  v: Justification from the marketing authorisation holder or the ASMF Holder, as appropriate, of the new specification attribute and the acceptance criteria.

code:
  v: 200000052088
display:
  v: Justification of the new in-process control and limits.

code:
  v: 200000052089
display:
  v: Justification of the new specification attribute and the acceptance criteria.

code:
  v: 200000052090
display:
  v: Justification of the specification attribute and its acceptance criteria.

code:
  v: 200000052091
display:
  v: Justification that the studies modify the risk assessment resulting in equivalent or lower risk.

code:
  v: 200000052092
display:
  v: Justification that there is no impact on the quality criteria of the blood in the container.

code:
  v: 200000052093
display:
  v: Justification/risk assessment from the marketing authorisation holder or the ASMF holder, as appropriate, that the in-process controls are non-significant, or that the in-process controls are obsolete.

code:
  v: 200000052094
display:
  v: Justification/risk assessment from the marketing authorisation holder or the ASMF Holder, as appropriate, that the specification attribute is non-significant, or obsolete.

code:
  v: 200000052095
display:
  v: Justification/risk assessment from the marketing authorisation holder or the ASMF holder, as appropriate, that the specification attribute is non-significant, or that the specification attribute is obsolete.

code:
  v: 200000052096
display:
  v: Justification/risk assessment showing that the attribute is non-significant or that it is obsolete.

code:
  v: 200000052097
display:
  v: Justification/risk assessment showing that the in-process control is non-significant or that it is obsolete.

code:
  v: 200000052098
display:
  v: Letter of Authorisation including contact details of the person responsible for communication between the competent authority and the PMF holder - signed by the transferee.

code:
  v: 200000052099
display:
  v: Letter of Undertaking to fulfil all open and remaining commitments (if any) - signed by the transferee.

code:
  v: 200000052100
display:
  v: List of testing site(s) where the test is currently used and a list of testing centre(s) where the kit will be used.

code:
  v: 200000052101
display:
  v: Proof of acceptance (by WHO) or copy of the ATC Code list.

code:
  v: 200000052102
display:
  v: Proof of establishment of the new holder (Excerpt of the commercial register and the English translation of it) - signed by both companies.

code:
  v: 200000052103
display:
  v: Results of consultation with target patient groups (user test or bridging report).

code:
  v: 200000052104
display:
  v: Results of the studies performed and any other supporting documentation in accordance with the post-approval change management protocol.

code:
  v: 200000052105
display:
  v: Re-validation studies have been performed in case of sterile products. The batch numbers of the batches used in the re-validation studies should be indicated, where applicable.

code:
  v: 200000052106
display:
  v: Revised product information, as appropriate.

code:
  v: 200000052107
display:
  v: Statement that the testing is performed following the same SOPs and/or analytical procedures as already accepted.

code:
  v: 200000052108
display:
  v: Suitable evidence to confirm compliance of either the water used in the final steps of the synthesis of the active substance, or the active substance, itself with the corresponding requirements of the guideline on quality of water for pharmaceutical use regarding bacterial endotoxins and microbiological quality.

code:
  v: 200000052109
display:
  v: The analytical procedure transfer protocols in accordance with Eudralex Volume 4 Chapter 6 article 6.39 (which pre-define the acceptance criteria), from the old site to the new site (or new test laboratory).

code:
  v: 200000052110
display:
  v: The content of the product lifecycle management document has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies (e.g. interaction of the different parameters, including risk assessment and multivariate studies, as appropriate) demonstrating where relevant that a systematic understanding of how material attributes and process parameters impact the critical ...

code:
  v: 200000052111
display:
  v: The content of the product lifecycle management document has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies (including risk assessment and multivariate studies, as appropriate) demonstrating where relevant that a systematic understanding of how material attributes and process parameters impact the critical quality attributes of the finished product has been achieved.

code:
  v: 200000052112
display:
  v: The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product and process development studies (including risk assessment and multivariate studies, as appropriate) demonstrating that a systematic understanding of material attributes and process parameters to the critical quality attributes of the finished product has been achieved.

code:
  v: 200000052113
display:
  v: The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies including risk assessment and multivariate studies or process modelling, as appropriate, demonstrating where relevant that a systematic understanding of how material attributes and process parameters impact the critical quality attributes of the active substance has been achieved.

code:
  v: 200000052114
display:
  v: The product lifecycle management document includes a description of the material attributes, quality attributes and process parameters (or analytical procedure parameters), their proposed limits and ranges, and future variation reporting categories, in a tabular format.

code:
  v: 200000052115
display:
  v: The results of stability studies that have been carried out under ICH conditions, on the relevant stability parameters, on at least one pilot or industrial scale batch, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action).

code:
  v: 200000052116
display:
  v: The results of stability studies that have been carried out under ICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved retest period (with proposed action).

code:
  v: 200000052117
display:
  v: The results of stability studies that have been carried out under ICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action).

code:
  v: 200000052121
display:
  v: Updated affected sections of the dossier for the medicinal product.

code:
  v: 200000052122
display:
  v: Updated epidemiological data for viral markers related to the blood/plasma collection centre.

code:
  v: 200000052123
display:
  v: Updated product information whenever this is required by the relevant national legislation.

code:
  v: 200000052124
display:
  v: Updated relevant sections and annexes of the PMF dossier including also inspections and audit information.

code:
  v: 200000052125
display:
  v: Updated relevant sections and annexes of the PMF dossier including inspections and audit information, as needed.

code:
  v: 200000052128
display:
  v: Updated relevant sections and annexes of the PMF dossier including inspections and audit information.

code:
  v: 200000052129
display:
  v: Updated relevant sections and annexes of the PMF dossier, including detailed description of the new conditions, confirmation of validation of storage/transport conditions and the name of the blood establishment(s) where the change takes place (if relevant).

code:
  v: 200000052131
display:
  v: Updated relevant sections and annexes of the PMF dossier, including updated information on testing as requested in the 'Guideline on the scientific data requirements for a PMF'.

code:
  v: 200000052133
display:
  v: Valid proof that the proposed site is GMP compliant for the manufacturing and/or testing operation(s) concerned: For a site within the EU/EEA: a copy of manufacturing authorisation(s) or where no manufacturing authorisation exists a certificate of GMP compliance issued within the last 3 years by the relevant competent authority. A reference to the EudraGMP database will suffice. For a third country site where a GMP mutual recognition agreement (MRA) or other relevant agreement...

code:
  v: 200000052135
display:
  v: Valid proof that the proposed site is GMP compliant for the manufacturing and/or testing operation(s) concerned: For a site within the EU/EEA: a copy of the current manufacturing authorisation or where no manufacturing authorisation exists a certificate of GMP compliance issued within the last 3 years by the relevant competent authority. A reference to the EudraGMP database will suffice. For a third country site where a GMP mutual recognition agreement (MRA) or other relevant agreement on GMP is

code:
  v: 200000052139
display:
  v: Where applicable, a document providing information of any materials falling within the scope of the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products, including those which are used in the manufacture of the active substance/excipient. The following information should be included for each such material: Name of manufacturer, species and tissues from which the material is a derivative...

code:
  v: 200000052141
display:
  v: Where applicable, for active substance, a declaration by the qualified person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the QP of each of the manufacturing authorisation holders listed in the application as responsible for batch release.

code:
  v: 200000052143
display:
  v: Where appropriate, proof must be provided that no interaction between the medicinal product and the device (part) occurs (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the device), including confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic material and objects in contact with foodstuffs.

code:
  v: 200000052145
display:
  v: Where relevant the batch numbers, corresponding batch size and the manufacturing date of batches (³3) used in the validation study should be indicated or validation protocol (scheme) be submitted.

code:
  v: 200000052146
display:
  v: Where relevant, a commitment of the manufacturer of the active substance to inform the marketing authorisation holder of any changes to the manufacturing process, specifications and analytical procedures of the active substance.

code:
  v: 200000052211
display:
  v: A declaration from the marketing authorisation holder (and the ASMF holder, where applicable) that there is no change in qualitative and quantitative impurity profile or in physico-chemical properties, that the synthetic route remains the same and that the specifications of the active substance or intermediates are unchanged

code:
  v: 200000052212
display:
  v: Valid proof that the proposed site is GMP compliant for the manufacturing and/or testing operation(s)concerned: For a manufacturing site within the EU/EEA: a copy of the current manufacturing authorisation. A reference to the EudraGMP database will suffice; For a third country site where a GMP mutual recognition agreement (MRA) or other relevant agreement is in place between the country concerned and the EU: a proof of GMP compliance issued within the last 3 years...