WHAT ARE PARALLEL IMPORTS.
Parallel imports are based on a fundamental principle of the European Union, the free circulation of goods and services. This means that medicines can be purchased in other European Member States and sold by the parallel importer in Belgium.
This does not mean that anyone can import and sell medicines. Parallel import of medicines is a strictly regulated and safety-conscious industry. In order to be able to import, repackage, distribute and sell medicines, the importer has to obtain all necessary approvals from the competent Health Authorities. Apart from national and international health regulations, this sector has been influenced by the European Court of Justice where many cases have been fought and more are still pending. All these conditions impose a considerable number of restrictions that carefully have to be managed.
Countries such as the Netherlands, Germany, the United Kingdom, Denmark and Sweden are already completely familiar with medicines from other EU countries. Parallel imports of medicines in these countries have been customary and accepted for years. Belgian companies have been exporting enormous volumes of medicines to other EU countries for years as part of the same procedure.
FAQ.
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I have heard that the quality of imported medicines is sometimes lower?
Parallel imported products are always equivalent (or identical) to medicines that are marketed in the country of origin . The difference is that imported products may initially be produced for another European country and this is why the packaging sometimes looks different. Given that we work according to the same legal regulations as all other pharmaceutical companies, you can be sure that these products are safe and reliable.
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Is it safe to use an imported medicine?
Absolutely! It is the same medicine in fact , but it just comes from another European country. All medicines, including parallel imported medicines – are strictly controlled by the national authorities or the European Medicines Agency (EMEA). Nobody can launch medicines on the market without prior approval.
Although the medicine is checked in the country of origin, imported medicines must undergo a second regulatory inspection in Belgium. All medicines that are imported in Belgium, are registered with the Ministry of Public Health. Careful checks are made to ensure that the medicine is equivalent to the Belgian brand product. The packaging and the leaflet are also checked. If the medicine is considered to be in order, it is registered with the Ministry of Public Health. Although the medicine has already undergone strict checks in the country of origin, this provides a double guarantee that the quality is 100% and that the Belgian government is keeping a very close check on the quality of the parallel imported medicine.
PI Pharma also undergoes checks by the competent authorities, GMP guidelines (Good Manufacturing Practices) etc.
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Can anyone parallel import and sell medicines?
No. In the same way as other pharmaceutical companies, we have to comply with a wide range of laws and regulations that are set up in order to ensure that all documentation, production units, distribution, etc. meet all standards.
LINKS
EU Agencies For the medical authorities in the European Union
EMEA European Agency for the Evaluation of Medicinal Products
EUROPA The official website of the European Union