Good Distribution Practices News

The ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. Read more about the GDP Guidance Chapter 6.

All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. The MHRA has established a formalized procedure and also lists the brokers on their webpage. Read more about the Guideline for Brokers of Medicinal Products

As one of the consequences from the Counterfeit Directive a European wide authorisation and monitoring system has been established. Each Wholesaler will need a Wholesale Distributor Authorisation (WDA). Those facilities that have been audited will receive a GDP certificate. Please read more about the WDAs and GDP certificates in EudraGMDP.

Our article deals with the implementation of the EU requirements into national law of the EU Member States and uses Germany as an example. In Germany, GDP implementation is laid down in the Trade Regulation for medicinal products. Nevertheless, the regulation contains some ambiguous formulations which lead to problems for implementing GDP. Read more about the implementation of GDP in Europe.

The implementation of the new EU Good Distribution Practice Guideline is a challenging task for pharmaceutical companies, wholesalers, storage facilities and transportation companies. However, a very helpful document is available from the EU Commission which provides answers to a number of questions for GDP implementation. Read more about the Good Distribution Practice Q&As here.

The USP has announced that the deadline for comments on the new General Chapters on Storage and Distribution would be extended. Detailed information can be found in this News.