EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

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CodeSystem: Marketing Authorisation Application Legal Basis

Official URL: http://spor.ema.europa.eu/v1/lists/100000116045 Version: 1.0.0
Active as of 2025-04-04 Computable Name: MarketingAuthorisationApplicationLegalBasisCs

Marketing Authorisation Application Legal Basis

This Code system is referenced in the content logical definition of the following value sets:

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:

CodeDisplay
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)
200000003511 Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)
200000003512 Exceptional Circumstances Marketing Authorisation (Article 14(6) (8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC)
200000003513 Authorised homeopathic medicinal product
200000003514 Authorised herbal medicinal product
200000003515 Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006)
200000003516 Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004)
200000003517 Other