Saturday, 16 September 2017

Plan for the introduction of the safety features on medicinal packaging


The European Medicines Agency (EMA) has issued a new guidance document titled “Implementation plan for the introduction of the safety features on the packaging of centrally authorized medicinal products for human use.”

Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features (Commission Delegated Regulation (EU) 2016/161 - "the Delegated Regulation") may impact on the product information and the marketing authorization dossier; in particular the placing of safety features, a unique identifier (UI) carried by a 2-D barcode and an anti-tampering device (ATD), on the packaging of prescription medicines and certain nonprescription medicines for the purposes of authentication and identification.

The European Medicines Agency and the European Commission have prepared this implementation plan to guide applicants and Marketing Authorisation Holders (MAHs) through the regulatory changes necessary to accommodate the new legislative requirements.

The document can be accessed here.



Posted by Dr. Tim Sandle