The Daily Barriers of RP’s in the Qualification of Wholesalers

Taking responsibility is simply part of my job as the Responsible Person for wholesale distribution in accordance with Section 52a of the German Medicines Act (AMG). It sounds fairly straightforward on paper, but in practice it comes with plenty of challenges — especially when it comes to qualifying wholesalers as part of customer qualification.

Almost instinctively, my first stop is the EudraGMDP database. In theory, it should be the go-to source for checking whether a customer holds the necessary authorisations, such as a Wholesale Distribution Authorisation (WDA). In reality, it’s not that simple: even after a successful inspection, some entries still aren’t published—sometimes for years. So while the database can be helpful, it’s not always sufficient for a quick, complete, up-to-date check. When in doubt, you end up requesting copies of the original documents directly from the authorisation holder.

Another complication is that WDAs aren’t issued in a consistent way across Europe. Even the level of detail can vary significantly depending on the inspector.

It is particularly difficult for the sensitive categories listed under “3. Medicinal products with special requirements”. In the case of narcotic drugs or psychotropic substances, the competent authority may decide not to make details of these activities publicly available. *

It gets especially tricky with the sensitive categories listed under “3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS”. For narcotics or psychotropic substances, the competent authority may decide not to make the relevant details publicly available.* And for blood products, immunologicals, radiopharmaceuticals, or products requiring (cold-chain) refrigeration, the information isn’t always fully published either.

On top of all that, the legal definitions themselves can be confusing. Under Article 1 of EU Directive 2001/83, “immunological medicinal products” refers only to vaccines, toxins, sera and allergens. Under the German Medicines Act (§ 4), however, the term “serum” also includes antibodies, antibody fragments, or fusion proteins with a functional antibody component. These country-specific differences create real uncertainty in everyday work—especially when you’re trying to determine which products are actually covered by a WDA and which aren’t. It quickly becomes clear how complex the details can be, and why standardising—or “blindly” delegating—qualification decisions is so difficult.

For example, if the crucial tick under section 3 is missing—the one that would explicitly allow wholesale distribution of cold-chain products—the question remains: does “not specified” automatically mean “allowed”? Or does it mean the opposite?

Clear, harmonised definitions and guidance on how WDAs should be completed would make life much easier. Until then, the reality for Responsible Persons is to check carefully, challenge assumptions, and—when in doubt—ask one more question rather than one too few. Otherwise, during an inspection you may have to prove that a wholesaler was permitted to source certain products even though the WDA doesn’t make this unambiguous.

But there is a positive side: you don’t just grow with your tasks—you also grow with your barriers, and in the end you come out more confident and more experienced.

^{* Interpretation of the Union format for a wholesale distribution authorisation, Publication Date 1 August 2024}

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