Current Issues of GDP Oversight

Recommendation

Wednesday, 19 August 2020 14.00 - 15.30 h

Webinar: Cold Chain Management and its Validation

Since the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues.

1) Deliveries by the internet pharmacies

Transports from the wholesaler to the pharmacy are regulated by the GDP guidelines. How about orders of medicinal products from an internet pharmacy? While patients cover a short distance when they go to the pharmacy in their town, medicinal products ordered online have a longer journey to go to the patients and are thus subject to risks like temperature variations, medicines being replaced by counterfeits, etc. Currently, such delivery transports are not covered by the GDP guidelines. 

2) Pharmacies as wholesalers

When talking about wholesalers of medicinal products, one often thinks of well-known large companies. There are plenty of small wholesalers though. Before the introduction of the GDP guidelines, Germany alone counted 10% of the pharmacies which also were wholesalers. Now, this number has significantly decreased. One of the reasons for this is the complexity posed by the GDP requirements: many pharmacies aren't able or don't want to implement them. Besides, authorities represent very different opinions. So far, the pharmacy business and the wholesale business of medicinal products had to be strictly separated. In Germany, the federal states have the responsibility for inspections. Now, there have been cases where the authority of a federal state said this separation isn't required any longer while the authority of another federal state said it still is. A current case has to be clarified by the Administrative Court of Wiesbaden. More details can be found in an article from the branch service Apotheke Adhoc (in German language). The authors also point out that pharmacies reselling medicinal products to doctors, veterinarians and hospitals or to colleagues within purchasing groups or branch systems are not concerned and do not require a wholesale licence for those activities. The same applies for occasional help.
 
3) Certificates of GDP Compliance

Nowadays, every wholesaler of medicinal products wants to have a GDP certificate; GPD warehouses and GDP transport providers too. However, the procedures in the different EU Member States are not uniform. According to the wording of the GDP guidelines, only wholesalers of medicinal products should receive a GDP certificate. On the one hand, some inspection authorities also issue GDP certificates for GDP warehouses whose operators do not run wholesale activities but only manage the finished goods warehouse on behalf of pharmaceutical manufacturers and take on their logistics activities. On the other hand, some inspection authorities are strictly opposed to that. Even some transport service providers are said to already have received a GDP certificate. Such exceptional cases lead to a curious situation though. Indeed, companies holding a GDP certificate have a clear competitive advantage. Moreover, international companies running GDP warehouses without GDP certificates are facing considerable difficulties to explain to their customers and potential customers why a competitor can present such a certificate.