Point of contact division Marketing Authorisation (variations and renewals)

• Any request for information with regard to:
  • the submission, procedure or approval of a variation or renewal of a marketing authorisation (except for products authorised through the centralised procedure);
  • the submission, procedure, approval of an application for a new authorisation, variation or renewal of a parallel import authorisation;
  • a marketing authorisation revocation;
  • the withdrawal of an ongoing procedure.

• Resending automatic emails (these are emails sent by the FAMHP's internal database when a file is being processed). In processing this application, it is possible that the file turns out not to be included in the database. In this case, the company must resubmit the file to the Dispatching team. You will be given clear instructions in this regard.

• Information about the status of a file. These are all questions related to the progress of a pending variation, renewal or parallel import file.
  If the question falls within the scope of the file and is only about intrinsic elements, you can also contact the file manager. If the question falls outside the scope of the file and deals, for instance, with procedural issues, only use the contact form.

• Concrete questions about fees to be paid for submitting variations, renewals or authorisations for parallel imports.

• Questions about correction of approved documents.
  Note: this is for the correction of minor errors.

• Reporting errors in publication of approved documents or published data in the medicinal products database. It is possible that an error occurs during the process of publishing the documents, e.g. wrong document uploaded, new documents not visible, error during conversion to pdf, images or special characters are not or not correctly displayed...
  Note: this is not for the correction of textual errors. For this, see "Questions about correction of approved documents". Furthermore, it is also possible to report errors of data published in the medicinal products database.

• Questions about the approved data of an authorised medicinal product.
  Please note that some data pertain to the confidential part of the authorised medicinal product's file. See also "How do you submit a question to contact point variations and renewals?"

• Questions on how to apply the sunset clause and to ensure its follow-up.

• Requests for derogation within the framework of the sunset clause.

• Questions on how to notify the risk assessment on the presence of nitrosamines and to ensure its follow-up.

If the subject of your question is not found in the form's dropdown list, the form is not the right channel to ask your question. Submit your questions to the division in charge. You can find more information at the FAMHP's contact page.

Complete the contact form.

If you are acting as a consultant for a particular company, you need to attach a proof of 'delegation of power' or 'power of attorney'. We need this to ensure confidentiality. If our employees do not find a clear link between the person requesting the information and the licensee of the authorised medicinal product, the information will not be passed on to the person requesting the information.

The more specific you are in providing information, the faster and more accurately your question can be answered. Therefore, ask your question as clearly and thoroughly as possible.

The following information should always be given.

When your question is about a specific file:

• name, strength and pharmaceutical form of the medicinal product
• ID number;
• procedure number;
• actual description of the question or problem.

If your question is related to automatic mails:

• cover letter of the relevant submission:
• name, strength and pharmaceutical form of the medicinal product;
• procedure number.

When your question is about a specific licensed product:

• name, strength and pharmaceutical form of the medicinal product;
• procedure number;
• actual description of the question or problem.

When your question is about fees to be paid for submitting variations, renewals or authorisations for parallel imports:

• type of procedure (NAT/DCP/MRP/PI) - role FAMHP (RMS/CMS);
• type of file;
• number of brands (applicable to horizontal grouping and worksharing only); 
• File ID number or procedure number when the question is linked to a specific file:
• description of the question or problem.

When your question is about a correction of approved documents:

• name, strength and pharmaceutical form of the product;
• procedure number;
• annotated and unannotated versions of the documents;
• detailed description of the error to be corrected.
  Note: this is for correcting minor errors. For major errors, a variation or notification is to be submitted.

For reporting errors in publication of approved documents or published data in the medicinal products database:

• name, strength and pharmaceutical form of the medicinal product;
• authorisation number:
• description of the error.

When your question is about the sunset clause:

• name, strength and pharmaceutical form of the medicinal product;
• procedure number;
• actual description of the question or problem.

When submitting a request for an exemption from the provisions of the sunset clause:

• name of the medicinal product
• authorisation number(s) of the concerned medicinal product(s);
• marketing authorisation holder of the concerned medicinal product(s);
• a motivated request, as described in the document “Application of measures relating to the sunset clause in Belgium for medicinal products authorised at the national level” (Dutch version/French version).

When your question is about the notification and follow-up of the risk assessment on the presence of nitrosamines:

• name, strength and pharmaceutical form of the medicinal product;
• procedure number;
• actual description of the question or problem.

To ensure smoother processing of incoming questions, we will work with priority levels from 1/06/2025. This way of working is chosen so that questions linked to critical processes can be handled with priority (e.g. reporting an error in the medicinal products database).

The processing time for your question is: