In many cases, pharmaceutical companies market their veterinary medicinal products both in Germany and in other Member States of the European Union (EU) or the European Economic Area (EEA). As a result, they have separate national marketing authorisations in many of these Member States.
With regard to parallel trade, a distinction must be made between parallel import and parallel distribution.
The parallel trade of veterinary medicinal products that are not centrally authorised is regulated in Article 102 of Regulation (EU) 2019/6.
This refers to the introduction of a veterinary medicinal product from an EU/EEA Member State in which that medicinal product is authorised to another member state in which a veterinary medicinal product of the same origin is already authorised in accordance with Art. 102 (1) of Regulation (EU) 2019/6. It must be ensured that the veterinary medicinal product that is to be obtained from one Member State ("Source Member State") and distributed in another Member State ("Destination Member State") has the same origin as the product that is already authorised in the Destination Member State.
The "parallel import" of a veterinary medicinal product must be approved before the product is introduced from a Member State to Germany and marketed. In Germany, the Paul-Ehrlich-Institut (PEI) is the competent authority for the approval of certain veterinary medicinal products, such as immunological veterinary medicinal products.
The parallel trade of veterinary medicinal products that are centrally authorised does not require approval from the Paul-Ehrlich-Institut, but must be reported to the European Medicines Agency (EMA).
Further information on parallel trade and administrative procedures at the Paul-Ehrlich-Institut, which can also be applied to veterinary medicinal products, can be found on the websites of the EMA, the Coordination Group for the Mutual Recognition of Veterinary Medicinal Products and Decentralized Procedures (CMDv) and the Paul-Ehrlich-Institut.
Updated: 26.09.2024
