Commission Delegated Regulation (EU) 2016/161Show full title

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)

Article 21Derogations from Article 20(b)

Verification of the authenticity of the unique identifier of a medicinal product is not required under Article 20(b) in any of the following situations:

(a)

that medicinal product changes ownership but remains in the physical possession of the same wholesaler;

(b)

that medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place.