Batch Testing of Medicines Traded in Parallel
Batch Testing of Medicines Traded in Parallel
Medicines traded in parallel (imported in parallel or distributed in parallel) are also subject to official batch testing in Germany in accordance with Section 32 of the German Medicines Act (Arzneimittelgesetz, AMG).
Batches of medicinal products subject to official batch testing may only be marketed in Germany by the parallel importer or parallel distributor if they have been released for marketing by the Paul-Ehrlich-Institut (PEI). However, as the parallel importer or distributor is not provided with documentation on the production and control of the batches he imports, the batch release is based on the official control laboratory of the Member State of the European Community (EU) responsible for the verification.
Updated: 21.11.2019
Submission of Documents
Submission of Documents
The following information and documents must be provided by the parallel importer or distributor with the application for batch release:
- Name of the medicinal product, batch number (if different, indicate the bach number of the original and parallel importer / exporter), expiry date
- Evidence from which EU member state the medicine was imported
- Delivery note stating the quantity of the medicine imported/distributed in parallel
- Scans of the outer and inner packaging of the raw material before relabeling
- In the case of medicines subject to the cooling chain obligation, proof of compliance with the cooling chain requirement using the form for cooling chains for parallel imports
- In the case of medicines that are imported in parallel (not in the case of medicines that are traded in parallel): Sample of the medicinal product as intended for marketing in Germany. For vaccines, the special rule applies to submit physical samples only on a biannual basis.
Updated: 30.08.2021
