Notice: Could not load module: 'blacklist' (required module files not found) in /kunden/228602_82418/webseiten/gmp/ on line 700

Warning: Warning: output buffer is not empty, but dispatching and rendering content has not been started yet. in /kunden/228602_82418/webseiten/gmp/ on line 170
EMA: Concept Paper for new GMP Annex on Importation
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE


TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


Your benefits:

> no shipping costs
> no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.


>>> Click here to find more Downloads!

News about GMP/cGMP


EMA: Concept Paper for new GMP Annex on Importation

EMA has released a concept paper on new guidance for importers of medicinal products. GMP/GDP Inspectors Working Group agreed to draft a specific guidance for import authorisation holders. This document most likely would take the form of a new annex (annex 21). The deadline for comments is 29 August 2015.


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. 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.

This new annex would have a positive impact for both industry and regulators by incorporating importation activities to the new regulatory concepts, clarifying requirements and contributing to a harmonised approach across the EU. It is not intended to create new requirement.


EMA - What's new?

Concept Paper

No comment has yet been written about this news.