Sunday, 23 August 2015

Guidance for importers of medicinal products


The European Medicines Agency has issued a new concept paper “Guidance for importers of medicinal products.”

The paper poses and addresses the following problem statement:

“The increased complexity of supply chains and the observation that most GMP non-compliance statements uploaded into EudraGMDP pertain to third country manufacturers have created new areas where further guidance is desired by both the regulators and the industry. In particular, the requirements applicable to importers of medicinal products and concerning the application of GMP requirements, which are traditionally oriented to activities performed at true manufacturing sites.”

To review the paper, go to EMA.

Posted by Tim Sandle