Questions & Answers

 

  1. Questions related to the management and closure of my file
  2. Variation issues
  3. Renewal issues
  4. Parallel import issues

Questions related to the management and closure of my file

Variation issues

How does the new Belgian company code affect an existing MA and how do I amend the MA documents?
In the new Belgian Company Code, the private limited liability company (besloten vennootschap met beperkte aansprakelijkheid - bvba or société privée à responsabilité limitée - SPRL) and cooperative limited liability company (coöperatieve vennootschap met beperkte aansprakelijkheid – cvba or société cooperative à responsabilité limitée – SCRL) are among the corporate forms that have been abolished, having now been restyled as private company (besloten vennootschap - bv or société à responsabilité limitée - SRL) and cooperative company (coöperatieve vennootschap - cv or société coopérative - SC), respectively. The holder of a marketing authorisation (MA) for a medicinal product is stated inter alia in the medicine’s product information. This means that MA holders are now required to amend their documents.

 

The new corporate form will have no impact on the content of your MA dossier. To amend your document, simply do the following:

  • Provide information on the new corporate form as an editorial change, in the context of a planned Type IB or Type II variation, under Chapter C of the Commission Classification Guideline. This is only possible as part of a variation that also amends product information.
  • Clearly state your new corporate form and the “editorial change” message in the application form as part of your variation, as well as in the “present and proposed” section.
  • You can find more information about an editorial change in the  CMDh/v’s Q&A for the Submission of Variations, question 3.16.
  • You can already include your new corporate form in your product information if you submit the amendment by 1 January 2024.

Please note, however, that you are not required to state your corporate form in the product information. If your corporate form is currently stated in your product information but you no longer wish that to be the case, you will have to submit the amendment.

If you amend the form of any companies not included in your product information, such as the distributor’s, you will not have to submit the amendment.

If you fail to replace your ‘bvba/SPRL’ status with ‘bv/SRL’ (or your ‘cvba/SCRL’ status with ‘cv/SC’), yet your company takes on a different form, you have to request that your authorisation be transferred.

Renewal issues

Parallel import issues

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1. Within what period should a variation or renewal be implemented in the package leaflets of a parallel import medicinal product?
Given that the Royal Decree of 19th April 2001 on the parallel import of medicinal products for human use and the parallel distribution for medicinal products for human and veterinary use does not foresee a time-limit for the implementation of a change to the authorisation, the change must be implemented without delay. This means that all batches that are placed on the market after the change of the authorisation, must be in accordance with the authorization. The batches that were already on the market before the approval date of the variation or renewal, can remain on the market.
2a. Must the (trade) name and address (or registered office) be stated on the packaging of a parallel imported medicinal product?
Yes, the name and address of the marketing authorisation holder for the parallel import must be stated on the packaging. Alternatively, the trade name and address of the registered office may also be stated.
2b. How should this be stated?
The following sentence must be stated on the packaging of a parallel imported medicinal product in the three national languages:
 
Ingevoerd door en herverpakt onder de verantwoordelijkheid van: < name and address of the authorisation holder /trade name and address of the registered office>
Importé et reconditionné sous la responsabilité de : < name and address of the authorisation holder /trade name and address of the registered office>
Importiert und umgepackt unter der Verantwortung von: < name and address of the authorisation holder /trade name and address of the registered office>
3. What should I do if, during a current procedure for an application for an amendment (= variation) to the license for parallel import, it appears that changes have been made to the marketing authorisation of the reference medicine and/or to the marketing authorisation granted in the member state of origin of the parallel imported medicine?
Submit a new variation pursuant to article 7 (2) or (3) of the royal decree regarding the parallel import of medicines for human use and the parallel distribution of medicines for human and veterinary use dated 19 April 2001. Once it has been validated, you can no longer amend the variation-application.
4. What should I do if, during a current procedure for an application for a renewal of the license for parallel import, it appears that changes have been made to the marketing authorisation of the reference medicine and/or to the marketing authorization granted in the member state of origin of the parallel imported medicine?
Submit a new variation pursuant to article 7 (2) or (3) of the royal decree regarding the parallel import of medicines for human use and the parallel distribution of medicines for human and veterinary use dated 19 April 2001. Once it has been validated, you can no longer amend the application for renewal.
5. What should I do if, during a current procedure for an application for a renewal of the license for parallel import, it appears that changes have been made to the marketing authorisation of the reference medicine and/or to the marketing authorisation granted in the member state of origin of the parallel imported medicine?
Submit the revised documents, linked to the current file. The delivery of the first authorisation must be fully compliant.
Last updated on 05/07/2019