European Medicinal Agency soon to issue New GMP annex for importers of medicinal products

The European Medicinal Agency (EMA) will soon release a new GMP annex to EU GMP Guidelines.

EMA has released its concept paper on new guidance for importers of medicinal products. This document most likely would take the form of a new annex (Annex 21). The scope of the project will be focused on importation activities not addressed in detail in the GMP guide and annexes, taking into consideration recent changes in GMP chapters and annexes as well as changes in other regulatory documents.

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. The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates. 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. The deadline for comments is 29 August 2015.