Safety features for medicinal products for human use questions and answers – Version 11

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This documents sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on the safety features for medicinal products for human use.

These rules are enshrined in Articles 47a, 54(o) and 54a of Directive 2001/83/EC, and in Commission Delegated Regulation (EU) 2016/1612.

This document is only available in English.

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