Court Judgement: A Medical Product can not be Marketed Anymore if it has Left the Legal Supply Chain

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6/7 November 2024

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The distribution and the storage of medicinal products have been strictly regulated since the introduction of the new EU Good Distribution Practice Guideline (EU GDP Guideline). Basically, the reason for the revision in 2013 was the so-called EU Counterfeit Directive. It should be ensured that no counterfeits can enter the legal supply chain. The so-called Track&Trace regulations - according to which a 2D Matrix Code must be applied to the packaging of certain medicinal products - have also been established to fight against counterfeit medicines.

Now, the Higher Regional Court for the Land of North Rhine Westphalia in Germany (Oberverwaltungsgericht Nordrhein-Westfalen) has decided a case in which a medicinal product had seemingly the quality required but had left the legal supply chain temporarily. The court stated that an abstract risk may be sufficient for the competent monitoring authorities to take a medicinal product out of the market. The branch service Apotheke Adhoc (in German language) has written a report about the case. According to Apotheke Adhoc, the case in question concerns the company Orifarm: "The re-importer from Leverkusen bought medicinal products from Romania which were brought back to the supply chain by pharmacies without wholesale authorisation. This is forbidden in Romania. The case leaked out because from the same background three situations of visible falsified medicines had been discovered."

The company Orifarm placed the medicinal products in quarantine after the competent authority in Romania had issued a product recall. Although Orifarm checked the products again, the District Government (Bezirksregierung) in Cologne rejected the release of these products onto the market. The District Government justified the rejection of the release indicating that the medicinal products had been handed on by pharmacies in Romania. Yet, the court clarified that pharmacies do not comply with the Good Distribution Practice in principle. For this, a wholesale authorisation is required which can only be issued when the EU GDP requirements are established within an internal QM system. Therefore, the company Orifarm couldn't consistently demonstrate whether the quality of the medicinal products hadn't been reduced - for example through inappropriate storage. According to the court, as illegal medicines had already entered the supply chain in the past, it can't be fully ensured that the medicinal products have the quality required and that falsifications or modifications can be excluded to 100%.

The decision of the Higher Regional Court stresses the importance of the EU GDP Guideline in the course of medicines safety. It is not possible to argue that quality is guaranteed when the legal distribution channel can't be maintained to 100%. This principle has been common practice in the GMP environment for many years. Only the compliance with all necessary measures laid down in the EU GMP Guide can ensure the quality of the medicinal product. Comprehensive release testing can't remedy the fact that certain QA/GMP requirements have not been met in production. This principle also applies to the GDP compliant storage and transport within the legal supply chain.