Parallel import

• Ingevoerd onder de verantwoordelijkheid van: < name and address of the authorisation holder/trade name and address of the registered office>.
• Importé sous la responsabilité de : < name and address of the authorisation holder/trade name and address of the registered office>.
• Importiert unter der Verantwortung von: < name and address of the authorisation holder/trade name and address of the registered office>.

• The PIL in Dutch should start with:

“Het geneesmiddel dat zich in deze verpakking bevindt, is vergund als een parallel ingevoerd geneesmiddel. Parallelinvoer is het in de handel brengen in België van een geneesmiddel waarvoor een vergunning voor het in de handel brengen [of registratie] is verleend in een andere lidstaat van de Europese Unie of in een land dat deel uitmaakt van de Europese Economische Ruimte en dat gelijk of nagenoeg gelijk is aan een referentiegeneesmiddel dat vergund is of vergund geweest is in België. Een vergunning voor parallelinvoer wordt verleend wanneer voldaan is aan bepaalde wettelijke vereisten.”

• The PIL in French should start with:

“Le médicament contenu dans cet emballage est autorisé en tant que médicament importé parallèlement. L'importation parallèle est la mise sur le marché en Belgique d'un médicament pour lequel une autorisation de mise sur le marché [ou un enregistrement] a été accordée [accordé] dans un autre État membre de l'Union européenne ou dans un pays appartenant à l'Espace économique européen et qui est identique ou presque identique à un médicament de référence qui est ou a été autorisé en Belgique. Une autorisation d'importation parallèle est accordée lorsque certaines conditions légales sont remplies.”

• The PIL in German should start with:

“Das Arzneimittel, das sich in dieser Packung befindet, hat eine Parallelimportzulassung bekommen. Parallelimport ist das Inverkehrbringen in Belgien eines Arzneimittels, für das in einem anderen Mitgliedstaat der Europäischen Union oder in einem Land des Europäisches Wirtschaftsraums, eine Genehmigung für das Inverkehrbringen [oder die Registrierung] erteilt wurde und das identisch oder nahezu identisch ist mit dem Referenzarzneimittel, das in Belgien zugelassen ist oder zugelassen war. Eine Parallelimportzulassung wird erteilt, wenn bestimmte gesetzliche Anforderungen erfüllt sind.”

Changes cannot be grouped together. A separate file needs to be submitted for each change per PIA concerned.

However, there is one exception, namely changes according to Article 20 §1, 5° or 6°. If the variation concerns the change of the name or address of the holder of the PIA or the addition or removal of a legal entity, and if this change relates to multiple licenses, this change can be bundled into a single application.

In this case, a single file is submitted, using a general procedure number (PI/H/xxxx/G/001). The last three digits are a serial number that will be assigned by the FAMHP. All affected products can be listed in the section with administrative data.

A fee must be paid for each PIA.

The deadline for the submission of these variations is 90 days.

For changes to the file of the reference medicinal product, the publication date of the amended package leaflet on the FAMHP website counts as a starting date for the 90-day period.

For changes to the file of the medicinal product in the country of origin, the date on which the parallel importer notices that the change has been implemented (the first batch purchased to which the change applies) is the starting date for the 90 days.

For variations in accordance with articles 13, §1, 17, 1§ and 20, §1 of the royal decree, no batches may be released six months after the notification of the approval of the variation if this change has not been implemented.

This period may be shorter if the Minister or his delegate imposes a shorter term due to a risk to public health or the health or life of patients or animals.

For changes in accordance with article 18, §1, no old batches may be released six months after the change to the Belgian reference medicinal product has been implemented (publication date in the medicines database).

No. If the holder of the parallel import licence reports the discontinuation of the parallel import via PharmaStatus or if the FAMHP determines that the import has been discontinued, changes may not be submitted during the period of discontinuation.

However, any changes must be submitted and approved before the parallel imported medicinal product is but back on the market.

1. Section 6 of the package leaflet of the reference medicinal product lists all the countries where the product in question is registered.

   - Is the country of origin of the PI medicinal product not listed in this section? Then the products are not part of the same procedure.

   - Is the country of origin of the PI medicinal product listed in this section? Proceed to step 2.

2. Look up the procedure number in the HMA-MRI database:

   - Enter the product name of the reference medicinal product.

   - Click on the procedure number that corresponds to your search result (If the search term returns too many results, you can refine the search by using “product name BE” as search term).

   - Verify whether both Belgium and the country of origin are part of this MCP/DCP procedure as CMS and/or RMS.

          - If this is not the case: both products are not a part of this procedure.

          - If this is the case: both products are part of this procedure and this is the correct procedure number. Enter this procedure number on the comparison form.