13/14 December 2023
One of the main reasons for the revision of the EU GDP Guideline in November 2013 was securing the so-called supply chain from falsified medicinal products. Indeed, there has been in many countries (like in South America but also in the USA) an increasing number of cases where large quantities of medicinal products have been robbed to be then partly marketed with counterfeited contents. Because of their original packaging materials, it is hard to recognize such counterfeits.
The EU GDP Guideline therefore requires in section 3.2. Premises that:
"Unauthorised access to all areas of the authorised premises should be prevented. Prevention measures would usually include a monitored intruder alarm system and appropriate access control. Visitors should be accompanied."
In addition, section 5.2. Qualification of suppliers sets strong requirements which should prevent medicinal products from illegal sources from entering the legal supply chain. It states:
"Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor, must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10 ( 1 )."
A current case shows how important this new regulation is. The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) is informing that diverse medicinal products from CSL Behring and Pfizer have been stolen at the logistics service provider Thermomed GmbH. According to the AMK news, pharmacies are asked to be particularly aware as it can't be excluded that there may be an attempt to bring illegally the stolen medicinal products (including refrigerated products) into the supply chain. In this context, medicinal products should be basically purchased from authorised pharmaceutical wholesalers only.
The problem of falsified medicinal products entering the legal supply chain through stolen goods has long since arrived in Europe as you can see in HIV medicinal product case Viread (Tenofovir) in Germany and the theft of Herceptin in Italy. The case in Italy caused spectacular headlines as many attempts were taken by counterfeiters to bring manipulated Herceptin into the legal supply chain.