http://ema.europa.eu/fhir/CodeSystem/100000116045
type: CodeSystem
node role: treeRoot
id:
  v: 100000116045
meta:
  version id:
    v: 5.0.0
  last updated:
    v: 2023-08-03T11:35:00.198Z
text:
  status:
    v: generated
  div: Generated Narrative: CodeSystem 100000116045 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/100000116045 defines the following codes: Code Display 100000116046 Full application (Article 8(3) of Directive No 2001/83/EC) 100000116047 New active substance (Article 8(3) of Directive No 2001/83/EC) 100000116048 Known active substance (Article 8(3) of Directive No 2001/83/EC) 100000116049 Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC) 100000116050 Generic application (Article 10(1) of Directive No 2001/83/EC) 100000116051 Hybrid application (Article 10(3) of Directive No 2001/83/EC) 100000116052 Similar biological application (Article 10(4) of Directive No 2001/83/EC) 100000116053 Well-established use application (Article 10a of Directive No 2001/83/EC) 100000116054 Fixed combination application (Article 10b of Directive No 2001/83/EC) 100000116055 Informed consent application (Article 10c of Directive No 2001/83/EC) 100000116056 Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) 100000116057 Full application (Article 12(3) of Directive No 2001/82/EC) 100000116058 Full application - New active substance (Article 12(3) of Directive No 2001/82/EC) 100000116059 Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC) 100000116060 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) 100000116061 Generic application (Article 13(1) of Directive No 2001/82/EC) 100000116062 Hybrid application (Article 13(3) of Directive No 2001/82/EC) 100000116063 Similar biological application (Article 13(4) of Directive No 2001/82/EC) 100000116064 Well-established use application (Article 13a of Directive No 2001/82/EC) 100000116065 Fixed combination application (Article 13b of Directive No 2001/82/EC) 100000116066 Informed consent application (Article 13c…
url:
  v: http://spor.ema.europa.eu/v1/lists/100000116045
version:
  v: 1.2.0
name:
  v: MarketingAuthorisationApplicationLegalBasisCs
title:
  v: Marketing Authorisation Application Legal Basis
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: Marketing Authorisation Application Legal Basis
case sensitive:
  v: true
content:
  v: complete
count:
  v: 85
concept:
  code:
    v: 100000116046
  display:
    v: Full application (Article 8(3) of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116047
  display:
    v: New active substance (Article 8(3) of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116048
  display:
    v: Known active substance (Article 8(3) of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116049
  display:
    v: Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116050
  display:
    v: Generic application (Article 10(1) of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116051
  display:
    v: Hybrid application (Article 10(3) of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116052
  display:
    v: Similar biological application (Article 10(4) of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116053
  display:
    v: Well-established use application (Article 10a of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116054
  display:
    v: Fixed combination application (Article 10b of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116055
  display:
    v: Informed consent application (Article 10c of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116056
  display:
    v: Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)
concept:
  code:
    v: 100000116057
  display:
    v: Full application (Article 12(3) of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116058
  display:
    v: Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116059
  display:
    v: Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116060
  display:
    v: Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116061
  display:
    v: Generic application (Article 13(1) of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116062
  display:
    v: Hybrid application (Article 13(3) of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116063
  display:
    v: Similar biological application (Article 13(4) of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116064
  display:
    v: Well-established use application (Article 13a of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116065
  display:
    v: Fixed combination application (Article 13b of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116066
  display:
    v: Informed consent application (Article 13c of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116067
  display:
    v: Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
concept:
  code:
    v: 100000116068
  display:
    v: Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC)
concept:
  code:
    v: 100000116069
  display:
    v: Bibliographical application (stand-alone)
concept:
  code:
    v: 100000116070
  display:
    v: Informed consent (abridged application) - Council Directive 81/851/EEC
concept:
  code:
    v: 100000116071
  display:
    v: Fixed combination
concept:
  code:
    v: 100000116072
  display:
    v: Complete application (stand-alone)
concept:
  code:
    v: 100000116073
  display:
    v: Complete mixed application
concept:
  code:
    v: 100000116074
  display:
    v: Generic (abridged application) - art 10(1)
concept:
  code:
    v: 100000116075
  display:
    v: Last paragraph (abridged application)
concept:
  code:
    v: 100000116076
  display:
    v: Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93

code:
  v: 100000116077
display:
  v: Complete application (stand-alone) - Directive No 2001/82/EC

code:
  v: 100000116078
display:
  v: Generic (abridged application) - art 13(1)

code:
  v: 100000116079
display:
  v: Informed consent (abridged application) - art 10c

code:
  v: 100000116080
display:
  v: Complete application (stand-alone) - Council Directive 81/851/EEC

code:
  v: 100000116081
display:
  v: Article 58 of Regulation (EC) No 726/2004

code:
  v: 100000116082
display:
  v: Informed consent (abridged application) - Council Regulation 2001/82/EC

code:
  v: 200000013166
display:
  v: Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)

code:
  v: 200000013167
display:
  v: Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)

code:
  v: 200000013168
display:
  v: Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)

code:
  v: 200000013169
display:
  v: Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)

code:
  v: 200000013170
display:
  v: Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746)

code:
  v: 200000013171
display:
  v: Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745)

code:
  v: 200000013173
display:
  v: Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC)

code:
  v: 200000013174
display:
  v: Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC)

code:
  v: 200000013175
display:
  v: Legal basis not covered by Directive 2001/82/EC

code:
  v: 200000013176
display:
  v: Authorisations for temporary use (article 8 of Directive No 2001/82/EC)

code:
  v: 200000013177
display:
  v: Legal basis reviewed according to Acquis communautaire

code:
  v: 200000013178
display:
  v: Full application - new active substance (Article 8 of Regulation (EU) 2019/6)

code:
  v: 200000013179
display:
  v: Full application - known active substance (Article 8 of Regulation (EU) 2019/6)

code:
  v: 200000013180
display:
  v: Generic application (Article 18 of Regulation (EU) 2019/6)

code:
  v: 200000013181
display:
  v: Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000013182
display:
  v: Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6)

code:
  v: 200000013183
display:
  v: Informed Consent application (Article 21 of Regulation (EU) 2019/6)

code:
  v: 200000013184
display:
  v: Bibliographic application (Article 22 of Regulation (EU) 2019/6)

code:
  v: 200000013185
display:
  v: Applications for limited markets (Article 23 of Regulation (EU) 2019/6)

code:
  v: 200000013186
display:
  v: Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6)

code:
  v: 200000013187
display:
  v: Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6)

code:
  v: 200000013188
display:
  v: Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6)

code:
  v: 200000013189
display:
  v: Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6)

code:
  v: 200000013906
display:
  v: Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6)

code:
  v: 200000013907
display:
  v: Parallel traded products as referred to in article 102 of Regulation 2019/6

code:
  v: 200000016435
display:
  v: Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000016436
display:
  v: Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000016437
display:
  v: Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000016438
display:
  v: Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000016439
display:
  v: Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)

code:
  v: 200000016440
display:
  v: Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6)

code:
  v: 200000016456
display:
  v: Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC)

code:
  v: 200000016457
display:
  v: Medicinal product authorised according to Article 126a of Directive No 2001/83/EC

code:
  v: 200000022794
display:
  v: Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC)

code:
  v: 200000023331
display:
  v: Authorisation according to Article 5(1) of Directive 2001/83/EC

code:
  v: 200000023341
display:
  v: Authorisation according to Article 5(2) of Directive 2001/83/EC

code:
  v: 200000023342
display:
  v: Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC

code:
  v: 200000023343
display:
  v: Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC

code:
  v: 200000023344
display:
  v: Available under Article 83(2) of Regulation (EC) No 726/2004

code:
  v: 200000029645
display:
  v: Hybrid application (Article 19(1) of Regulation (EU) 2019/6)

code:
  v: 200000029646
display:
  v: Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000029648
display:
  v: Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000029650
display:
  v: Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6)

code:
  v: 200000029651
display:
  v: Full application (Article 8 of Regulation (EU) 2019/6)

code:
  v: 200000043394
display:
  v: New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)

code:
  v: 200000043395
display:
  v: Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)

code:
  v: 200000043396
display:
  v: New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)

code:
  v: 200000043397
display:
  v: Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)