Parallel import of medicinal products is a lawful form of trade among the Member States of the European Economic Area (EEA). It consists in purchasing original medicines at licensed EU wholesalers and selling these medicines in another country, after obtaining a marketing authorization.
Parallel import is based on the principle of the free movement of goods, applicable in the EEA pursuant to the EU Treaty.
In different EU Member States the same medicine can be bought at different prices. Those differences allow us to import products by the same manufacturers from one country and sell them in another, at a lower price.
Parallel import of medicinal products has been possible in Poland since 1 May 2004, since Poland’s accession to the European Union. The provisions of the Accession Treaty are applicable in Poland and decisions of the European Court of Justice are binding for legal interpretation by Polish courts. Detailed regulations on parallel import can be found in the Pharmaceutical Law Act.
In order to introduce a product coming from parallel import to the market, a marketing authorization is required. Such authorizations are issued by the President of The Office for Registration of Medicinal Products, Medicinal Devices and Biocidal Products on the basis of a report prepared at the importer’s request. Authorizations are valid for a period of 5 years.
The following conditions must be met under the parallel import procedure:
The imported medicinal product contains the same active substance (active substances), at least: the same indications up to the third level of the ATC/ATCvet code (anatomical therapeutic chemical classification), the same potency, the same route of administration and the same form as the medicinal product authorised for trading in Poland or a similar form, which does not give rise to therapeutic differences with regard to the medicinal product authorised for marketing in Poland.
The imported medicinal product and the medicinal product authorised for marketing in Poland both reference medicinal products, or both substitutes for reference medicinal products, respectively in the country of origin and in Poland.
Before being marketed in Poland, any products from parallel import are repacked in a package labelled in Poland and a Polish leaflet is enclosed. The repacking process does not affect therapeutic qualities or and safety of the product. It is a process which does not interfere with the direct packaging of the medicinal product. The direct packaging remains in its original form, in which it was authorized for marketing in the country of origin. The parallel import medicinal products packaging contains the name of both the parallel importer and the repacking entity. The entire process takes place in accordance with Good Manufacturing Practice. Both the new packaging and the leaflet in the language of the importer’s country must be approved by the Office for Registration of Medicinal Products, Medicinal Devices and Biocidal Products.
Parallel import generates saving for patients due to the lower price of imported products. Currently, according to IMS Health, parallel import market constitutes 1% of the value of the pharmaceutical market in Poland.
We are a member of:
|SIRPL - Stowarzyszenie Importerów Równoległych Produktów Leczniczych (SIRPL). SIRPL is the Association of Parallel Importers of Medicinal Products. The association consists of seven parallel importers in Poland.|
|EAEPC - European Association of Euro-Pharmaceutical Companies. (EAEPC) is a Brussels-based non-profit making organisation, which regroup the European licensed parallel distribution industry. Through national associations and individual company membership, it encompasses over 70 companies from 16 countries in the European Economic Area (EEA).|