Verifications to be performed before removing or replacing the safety features
Article 16
1. Before removing or covering, either fully or partially, the safety features in accordance with Article 47a of Directive 2001/83/EC, the manufacturer shall verify the following: (a) the integrity of the anti-tampering device; (b) the authenticity of the unique identifier and decommission it if replaced. 2. Manufacturers holding both a manufacturing authorisation according to Article 40 of Directive 2001/83/EC and an authorisation to manufacture or import investigational medicinal products to the Union as referred to in Article 61 of Regulation (EU) No 536/2014 of the European Parliament and of the Council ( 3 ) shall verify the safety features and decommission the unique identifier on a pack of medicinal product before repackaging or re-labelling it for the purpose of using it as authorised investigational medicinal product or authorised auxiliary medicinal product.