EMA Write PMS API Implementation Guide - Enrichments
1.2.1 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis | Version: 1.2.1 | |||
| Active as of 2026-06-26 | Computable Name: MarketingAuthorisationApplicationLegalBasisVs | |||
XEVMPD medicinal product type
References
Expansion performed internally based on codesystem Marketing Authorisation Application Legal Basis v1.2.1 (CodeSystem)
This value set contains 85 concepts
| System | Code | Display (en) | JSON | XML |
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116046 | Full application (Article 8(3) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116047 | New active substance (Article 8(3) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116048 | Known active substance (Article 8(3) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116049 | Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116050 | Generic application (Article 10(1) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116051 | Hybrid application (Article 10(3) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116052 | Similar biological application (Article 10(4) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116053 | Well-established use application (Article 10a of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116054 | Fixed combination application (Article 10b of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116055 | Informed consent application (Article 10c of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116056 | Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116057 | Full application (Article 12(3) of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116058 | Full application - New active substance (Article 12(3) of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116059 | Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116060 | Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116061 | Generic application (Article 13(1) of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116062 | Hybrid application (Article 13(3) of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116063 | Similar biological application (Article 13(4) of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116064 | Well-established use application (Article 13a of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116065 | Fixed combination application (Article 13b of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116066 | Informed consent application (Article 13c of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116067 | Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116068 | Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116069 | Bibliographical application (stand-alone) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116070 | Informed consent (abridged application) - Council Directive 81/851/EEC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116071 | Fixed combination | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116072 | Complete application (stand-alone) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116073 | Complete mixed application | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116074 | Generic (abridged application) - art 10(1) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116075 | Last paragraph (abridged application) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116076 | Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93 | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116077 | Complete application (stand-alone) - Directive No 2001/82/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116078 | Generic (abridged application) - art 13(1) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116079 | Informed consent (abridged application) - art 10c | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116080 | Complete application (stand-alone) - Council Directive 81/851/EEC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116081 | Article 58 of Regulation (EC) No 726/2004 | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 100000116082 | Informed consent (abridged application) - Council Regulation 2001/82/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013166 | Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013167 | Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013168 | Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013169 | Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013170 | Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013171 | Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013173 | Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013174 | Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013175 | Legal basis not covered by Directive 2001/82/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013176 | Authorisations for temporary use (article 8 of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013177 | Legal basis reviewed according to Acquis communautaire | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013178 | Full application - new active substance (Article 8 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013179 | Full application - known active substance (Article 8 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013180 | Generic application (Article 18 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013181 | Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013182 | Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013183 | Informed Consent application (Article 21 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013184 | Bibliographic application (Article 22 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013185 | Applications for limited markets (Article 23 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013186 | Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013187 | Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013188 | Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013189 | Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013906 | Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000013907 | Parallel traded products as referred to in article 102 of Regulation 2019/6 | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016435 | Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016436 | Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016437 | Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016438 | Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016439 | Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016440 | Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016456 | Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000016457 | Medicinal product authorised according to Article 126a of Directive No 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000022794 | Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000023331 | Authorisation according to Article 5(1) of Directive 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000023341 | Authorisation according to Article 5(2) of Directive 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000023342 | Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000023343 | Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000023344 | Available under Article 83(2) of Regulation (EC) No 726/2004 | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000029645 | Hybrid application (Article 19(1) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000029646 | Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000029648 | Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000029650 | Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000029651 | Full application (Article 8 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000043394 | New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000043395 | Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000043396 | New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6) | ||
http://spor.ema.europa.eu/v1/lists/100000116045 | 200000043397 | Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6) |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |