Directive 2001/83/EC of the European Parliament and of the… Article 42

Article 42

1. The competent authority of the Member State shall issue the manufacturing authorization only after having made sure of the accuracy of the particulars supplied pursuant to Article 41, by means of an inquiry carried out by its agents. 2. In order to ensure that the requirements referred to in Article 41 are complied with, authorization may be made conditional on the carrying out of certain obligations imposed either when authorization is granted or at a later date. 3. The authorization shall apply only to the premises specified in the application and to the medicinal products and pharmaceutical forms specified in that same application.

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CitationArticle 42 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

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