A medicine sold in Belgium and in another member state of the European Union can be imported by a company from that member state as long as a certain number of legal requirements are met.
That explains why a medicine with the same name can be distributed by several companies.
Such parallel imports are in line with the European principle of free circulation of goods and are applicable in all the member states.
The European legislation does not stipulate that the composition of the imported medicine must be 100% identical to the medicine that is acting as the reference point.
But the qualitative and quantitative composition in terms of active substance must be the same and the imported medicine must have the same therapeutic effect as the reference medicine.
Imported medicines are controlled by the Medicines Commission so that the quality, efficacy, harmlessness and supervision of the medicines are guaranteed.
To obtain authorisation to import in parallel a certain number of conditions have to be met as described in article 3, § 2 from the Royal Decree of 19th April 2001 (French version) which relates to parallel imports of medicines for human use and to parallel distribution of medicines for human and veterinary use.
The conditions that must be met for authorisation of parallel importation to be valid are described in articles 6 and 7 of the Royal Decree of 19th April 2001 (French version).
The company applying for authorisation to import in parallel has to make a file and submit it to the FAMHP (Federal Agency for Medicines and Health Products), place Victor Horta 40, box 40, B-1060 Brussels, for the attention of Mrs. Christine PUTTEMAN.
The type of request must be specified :
- new authorisation
The file should contain the following items (see article 4 of the Royal Decree dated 19th April 2001 (French version)) :
- an accompanying letter
- 1 form : "authorisation for parallel import (in french)"
- a copy of the leaflet of the reference medicine
- a copy of the leaflet of the imported medicine
- a draft patient leaflet: this draft should be the last version of the reference medicine leaflet that must be accompanied, on the first page, by the appropriate form (NL, FR, D) that, upon approval, will be an integral part of the leaflet. It will thus be available in the packaging of each medicine imported in parallel (see press release dated 16/08/2012).
- a declaration of conformity (in french) indicating that the leaflet of the imported medicine is identical to the leaflet with the reference medicine. This is subject to the importer making changes concerning his identity, the identity of the manufacturer and / or other differences that are mentioned in the statement
- a sample of the reference medicine
- a sample of the medicine to be imported in its original packaging
- a sample or a mock up of the medicine as it is intended to be marketed in Belgium
- a statement indicating that the original state of the medicine has not been modified directly or indirectly
- a contract between the parallel importer and the person responsible for the repackaging
- a GMP certificate if the person responsible for the packaging is not based in Belgium
Any application for parallel import authorisation is subject to payment of a fee, in accordance with Article 13 of the Royal Decree of 19 April 2001.
Section 1 1°: Application for parallel import
New application for parallel import in accordance with article 4 or article 7 § 2 and § 3 :
Section 1 2°: Renewal
Renewal of licence for parallel import in accordance with Article 7 § 1 : 975,61 € /licence
Section 2: Application for modification
Application for modification of licence for parallel import, except for modifications in accordance with Article 7 sections 2 and 3 : 650,40 euro/ licence
Parallel imports are based on European legislation (+ jurisprudence), but not on any specifically medical rules : just article 28-30 of the EU Treaty on the ‘free circulation of goods’.
Communication of the European Commission concerning parallel imports.
Important information concerning the names
Several parallel import authorisations were recently issued for medicines whose name in the country of origin differs significantly from the Belgian name.
However it is the same medicine, imported from another Member State, whose secondary packaging (outside) and leaflet mention two names, but whose primary packaging (blister pack) mentions only the name of the Member State of origin.
The list of the relevant medicines mentions the Belgian name and the corresponding name in the Member State of origin stated on the blister pack.
The purpose of this list is to educate pharmacists who deliver these medicines and to allow them to properly advise their patients in order to avoid any doubt about the quality, safety and effectiveness of those medicines.
The obligation to put a label with the Belgian name on the blister pack is currently required for new authorisations for medicines with a different name in the country of origin. This label must be adhered so that it does not impede the removal of the tablets from the packaging.
Parallel importers were also asked to put such a label on the medicines included in the list above.
The label of the blister pack is now a part of the application of a parallel import authorisation. Since publication of the listed no new medicine has been issued without such approval.
Mrs. Christine PUTTEMAN
Federal Agency for Medicines and Health Products
place Victor Horta 40, box 40
Phone: 00 32 2 524 80 99