The EMA Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders and EU GDP Guide 2013/C 343/01 establish a comprehensive framework for the oversight and quality control of medicinal products within the European Union, focusing on Good Distribution Practice (GDP) and the responsibilities of the Marketing Authorisation Holder (MAH) in relation to Good Manufacturing Practice (GMP).

Many pharmaceutical companies today operate virtual business models, outsourcing storage and distribution while retaining full responsibility for product quality. In this short video, VQP explain how Good Distribution Practice (GDP) obligations apply to virtual companies, and the key steps needed to maintain HPRA compliance.

Here's a short explainer video on the "Virtual MAH WDA model", where its activities might be limited to only procurement and sale, or it might fully outsource its activities via contract.

VQP provide a full Marketing Authorization Holder service to companies looking to quickly launch their medicinal products in Europe (EU/EEA) at optimal cost (no significant investment in local licencing/personnel/affiliate offices), tailored for virtual or non-EU based pharmaceutical organizations.

Unsure about MAH requirements in EU/EEA, listen to this VQP explainer podcast and learn more…