Fiscal Importation of Medicinal Products and the Role of the Qualified Person by Walid El Azab | QP Pro Services
Executive summary
The separation between physical supply chains and financial flows in the pharmaceutical sector has created a regulatory grey zone now formally addressed by Belgian authorities. Under the interpretation of the Federal Agency for Medicines and Health Products (AFMPS), so-called fiscal importation arises when medicinal products are purchased from a non-EU entity, even if those products never physically leave the European Union.
This interpretation, grounded in Belgian law (notably the Law of 25 March 1964) and EU GMP/GDP frameworks including Annex 21, fundamentally shifts the compliance focus from physical logistics to legal and financial ownership. In practice, inspectors assess not only where goods are manufactured or stored, but critically who pays, who invoices, and where the economic benefit ultimately flows. As a result, financial structuring within multinational pharmaceutical groups has become a primary determinant of regulatory classification.
Where fiscal importation is identified, a Manufacturing and Importation Authorisation (MIA) is required, irrespective of whether the medicinal products have already been manufactured and QP-certified within the EU. This triggers additional obligations for the Qualified Person (QP), who must certify not only batch compliance but also the integrity of the underlying supply and financial chain.
A key compliance challenge lies in distinguishing between EU subsidiaries and branches of non-EU entities, as well as correctly interpreting intra-group financial flows and ERP-based ownership structures. These factors determine whether a transaction is considered intra-EU distribution or a regulated import activity.
This article provides a structured regulatory interpretation of fiscal importation in Belgium, clarifies the operational role of the QP under such conditions, and outlines the compliance implications for multinational supply chains.
Key compliance points
- Fiscal importation can be triggered by purchase and invoicing flows, even when goods remain physically inside the EU.
- Belgian AFMPS interpretation places legal and financial ownership at the centre of importation classification.
- A Belgian MIA may be required when a non-EU entity sits in the purchasing or payment chain.
- The QP must evaluate batch compliance together with the integrity of the supply, fiscal and financial chain.
- ERP ownership models, intra-group flows, branches and subsidiaries should be mapped before inspection.
The full PDF gives the detailed Belgian regulatory perspective, including the WDA/MIA divide, branch versus subsidiary interpretation, QP obligations and practical compliance pathways for multinational pharmaceutical organisations.