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.
Posted by Dr. Tim Sandle
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