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Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 12

Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 12

Article 12

1.   In order to ensure that the requirements laid down in Article 10 are complied with, authorisation may be made conditional on the carrying out of certain obligations imposed either when authorisation is granted or at a later date. 2.   An authorisation shall apply only to the premises specified in the application and to the types of medicinal products and pharmaceutical forms specified in that application pursuant to point (a) of Article 10(1).

Read the full instrument → · Read this in context: CHAPTER 3 — MANUFACTURING OR IMPORT AUTHORISATION →

Other provisions in CHAPTER 3 — MANUFACTURING OR IMPORT AUTHORISATION

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 12 of Commission Directive 2005/28/EC of 8 April 2005 laying down… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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