In many cases, pharmaceutical entrepreneurs market their medicines both in Germany and in other Member States of the European Union (EU) and the European Economic Area (EEA). Consequently, they also have a separate national authorisation in many of these Member States. In parallel trade, parallel imports and parallel distributions must be distinguished from each another.
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.
In a parallel distribution, the imported product is a medicinal product that has been authorised simultaneously in one centralised procedure throughout the EU. Parallel marketing does not require a separate marketing authorisation. Prior to the distribution, the so-called "notification procedure" must be performed at the EMA, after which the entrepreneur must report the intended parallel distribution to the Paul-Ehrlich-Institut (PEI).
Change notifications for parallel sales can be collected over a 12-month period and then submitted to PEI together (as so-called annual reports). Exceptions include changes due to urgent safety instructions ("urgent safety updates").
For medicines that have been marketed in 12 months without any change, no "annual report" has to be submitted. However, after 12 months, the PEI requests for a letter confirming this fact. Companies still have the option to view changes individually.
Until 30 April 2013, change notifications for parallel distribution with the EMA had to be submitted individually as soon as the respective change occurred. Since 1 May 2013, the EMA recommends the Annual Report as an alternative for change notifications for parallel distributions. The procedure described in the "Frequently Asked Questions" under the section "Annual updates and notifications of change" and the conditions described therein will apply in the same way to the administrative practice in the PEI from 1 Jan. 2014.
National Marketing Authorisation Application
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
Follow-Up Procedures - Changes and renewals
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.
Batch Release for Medicines marketed in parallel trade
According to Section 32 AMG, certain drugs are subject to official batch release by the PEI. This regulation also applies without restriction to all batches of medicines imported and distributed in parallel.