In a parallel import, an importing company (usually specialised in the pharmaceutical sector) purchases a medicine in another EU / EEA Member State, imports it to Germany and then places it on the market "in parallel" with the original pharmaceutical operator. The parallel importer exploits the price differences in Europe in the pharmaceutical market.

The imported medicinal product must be essentially identical to the medicinal product for which there is already a valid national authorisation for the original pharmaceutical company in Germany (reference medicinal product). However, as for any other authorisation, only the pharmaceutical company named in the authorisation has the right to make use of this (reference) authorisation. for this reason, the parallel importer needs its own national authorisation, which is valid for Germany.

However, the parallel importer does not have as much detailed information about the medicinal product he imports as the original manufacturer of the medicinal product. He is therefore unable to produce a complete dossier and submit it to the German regulatory authority. On the other hand, the drug imported in parallel is already known to the German regulatory authority from the authorisation procedure for the reference drug. For this reason, the parallel importer can obtain a marketing authorisation in the so-called simplified procedure, which requires only very limited information on the medicinal product.

Parallel distribution involves the import of a medicinal product that has been simultaneously authorised in one centralised procedure throughout the EU. No separate authorisation is required for parallel distribution. A notification procedure must be completed at the European Medicines Agency (EMA) before distribution. The distributor must then notify the Paul-Ehrlich-Institut (PEI) of the intended parallel distribution.

Notifications of changes to parallel distribution activities can be collected over a period of 12 months and then submitted to the Paul-Ehrlich-Institut together in an annual update. The Paul-Ehrlich-Institut has endorsed EMA's recommendation to applicants to submit notifications regarding changes to parallel distribution in an annual update. The administrative practice is described on the EMA website in the "Frequently asked questions" section under the header "Bulk changes/annual updates".

No annual update is required for medicinal products that have been marketed without any changes in the last 12 months. However, the Paul-Ehrlich-Institut requests that an informal letter be sent confirming this fact after 12 months have passed. The option to submit individual notifications regarding changes is still available.

Contact

Email: amg-ev@pei.de

In his application for authorisation, the parallel importer must provide all the information necessary to permit the Paul-Ehrlich-Institut (PEI) to establish the identity of parallel imports and reference medicinal products. The documents to be submitted with the application for authorisation must contain the following information:

• name of the medicine imported in parallel in the country of origin and intended name in Germany;
• number (s) of the marketing authorisation in the country of origin;
• name and authorisation number of the reference medicinal product authorised in Germany;
• name and / or company, as well as the place of residence and / or location of the person or entity responsible for placing the original product on the market in the Member State of importation and in the Member State of origin and, where applicable, the manufacturer(s);
• name / company, place of residence / location of the parallel importer;
• product-related manufacturing authorisation for repackaging;
• samples / copies of the imported goods and the corresponding texts (leaflet and summary of product characteristics, container and external packaging);
• draft texts for summary of product characteristics, package leaflet, container and external packaging, including labeling design for the medicinal product imported in parallel as it is to be placed on the market;
• copies of the inner and external packaging of the reference medicinal product;
• copies of the summary of product characteristics and the package leaflet of the reference medicinal product;
• Pharmacovigilance system documentation at the applicant

Changes in the marketing authorisation documents, including the texts for the summary of productcharacteristics, package leaflet, container and external packaging, must be reported by the parallel importer. For example a frequent change in the authorisation of medicinal products imported in parallel to be notified could be a new / additional exporting country.

According to Section 32 AMG, certain drugs are subject to official batch release by the Paul-Ehrlich-Institut. This regulation also applies without restriction to all batches of medicines imported and distributed in parallel.