Questions & Answers

 

  1. Questions related to the management and closure of my file
  2. Questions related to Variations
  3. Questions related to Renewals
  4. Questions related to Parallel import
  5. Questions related to the notification of the risk assessment on the presence of nitrosamines

Questions related to the management and closure of my file

Under construction

Questions related to Variations

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.

 

Questions related to Renewals

Under construction

Questions related to Parallel import

1. What’s the deadline for implementing a variation or renewal in the patient information leaflets of an in parallel imported medicinal product ?
 

The Royal Decree of 19 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 mention a deadline for the implementing changes to the authorisation. Changes must therefore be implemented without delay

All batches brought to market after an authorisation has been altered, must be consistent with this altered authorisation. Batches that were brought to market before the approval date of the variation or renewal, can remain on the market.

2. Should the name and address or trade name and registered office be mentioned on in parallel imported medicinal products’ packaging ?
 

Yes. If the parallel import marketing authorisation holder is a natural person, packaging must mention his/her name and address. If the parallel import marketing authorisation holder is a legal person, packaging must mention its trade name and registered office.

3. How should name and address or trade name and registered office be mentioned on in parallel imported medicinal products’ packaging ?

Packaging of an in parallel imported medicinal product need to mention the following sentence, in the three Belgian official 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>
4. What should I do if in the course of an application procedure for an amendment (variation) to a parallel import authorisation, it becomes apparent that changes were made to the marketing authorisation (MA) of the reference medicinal product and/or the MA granted in the member state of origin of the parallel imported medicinal product ?
 

Submit a new variation (in accordance with article 7 (2) or (3) of the royal decree regarding the parallel import of medicinal products for human use and the parallel distribution of medicinal products for human and veterinary use dated 19 April 2001). Once you have submitted your variation application, you can no longer alter its scope.

5. What should I do if in the course of an application procedure for renewing a parallel import authorisation, it becomes apparent that changes were made to the marketing authorisation of the reference medicinal product and/or the MA granted in the member state of origin of the parallel imported medicinal product ?
 

Submit a new variation (in accordance with article 7 (2) or (3) of the royal decree regarding the parallel import of medicinal products for human use and the parallel distribution of medicinal products for human and veterinary use dated 19 April 2001). Once you have submitted your renewal application, you can no longer alter it.

6. What should I do if in the course of an application procedure for a parallel import authorisation, it becomes apparent that changes were made to the marketing authorisation (MA) of the reference medicinal product and/or the MA granted in the member state of origin of the parallel imported medicinal product ?
 

Submit the revised documents and link them to the ongoing dossier. The first parallel import authorisation must fully correspond with the medicinal product’s MA.

7. Do I need to use templates when submitting a parallel import dossier to the FAMHP ?
 

Yes. Using following templates is mandatory when submitting a parallel import dossier to the FAMHP:

8. How can I obtain a parallel distribution authorisation ?
 

A medicinal, product that has been authorised via the central authorisation procedure can be distributed in parallel between EU member states once it has been notified at the European Medicines Agency (EMA). This parallel distribution takes place independently from the marketing authorisation or registration holder.

The FAMHP is not involved in granting authorisations for parallel distribution. The central authorisation procedure is regulated by regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004.

9. How should the patient information leaflet (PIL) of an parallel imported medicinal product start ?
 
  • The PIL in Dutch should start with:

“Het geneesmiddel dat zich in deze verpakking bevindt, is vergund als een parallel ingevoerd geneesmiddel.

Parallelinvoer is de invoer in België van een geneesmiddel waarvoor een vergunning voor het in de handel brengen is verleend in een andere lidstaat van de Europese Unie of in een land dat deel uitmaakt van de Europese Economische Ruimte en waarvoor een referentiegeneesmiddel bestaat in België. Een vergunning voor parallelinvoer wordt verleend wanneer voldaan is aan bepaalde wettelijke vereisten (koninklijk besluit van 19 april 2001 betreffende parallelinvoer van geneesmiddelen voor menselijk gebruik en parallelle distributie van geneesmiddelen voor menselijk en diergeneeskundig gebruik).”

  • The PIL in French should start with:

“Le médicament contenu dans ce conditionnement est autorisé comme médicament d’importation parallèle.

L’importation parallèle est l’importation en Belgique d’un médicament pour lequel une autorisation de mise sur le marché a été accordée dans un autre État membre de l’Union européenne ou dans un pays faisant partie de l’Espace économique européen et pour lequel il existe un médicament de référence en Belgique. Une autorisation d’importation parallèle est accordée lorsque certaines exigences légales sont remplies (arrêté royal du 19 avril 2001 relatif aux importations parallèles de médicaments à usage humain et à la distribution parallèle de médicaments à usage humain et vétérinaire).”

  • The PIL in German should start with:

“Das Arzneimittel, das sich in dieser Packung befindet, hat eine Parallelimportzulassung bekommen.

Parallelimport ist die Einfuhr nach Belgien eines Arzneimittels, für das in einem anderen Mitgliedstaat der Europäischen Union oder in einem Land des Europäischen Wirtschaftsraums, eine Genehmigung für das Inverkehrbringen erteilt wurde und für das in Belgien ein Referenzarzneimittel besteht. Eine Parallelimportzulassung wird erteilt wenn bestimmte gesetzliche Anforderungen erfüllt sind (Königlicher Erlass vom 19. April 2001 über den Parallelimport von Humanarzneimitteln und über den Parallelvertrieb von Humanarzneimitteln und Tierarzneimitteln).”

10. How will I be informed about the status of my file for parallel import ?

As of May 1, 2020, we will work with automatic e-mails for newly submitted files for parallel import.

You will receive an automatic e-mail:

  • after the validation of the file with the message that the evaluation phase is starting;
  • after the evaluation of the file with the message that the closing phase is starting;
  • after the closing of the file with the message that you will soon receive the (revised) authorization for parallel import.

This automatic e-mail is standard use for multiple processes besides parallel import. In addition to the identification of the file, only the paragraph specifically for parallel import is applicable to parallel import.

 

Questions related to the notification of the risk assessment on the presence of nitrosamines

1. Do I need to fill in a web form for every marketing authorization ?
 

No. You must fill in one web form per group of medicines. If you get two results within the same group of medicines, then you must fill in the corresponding web form for each result.

2. What is a group of medicines ?
 

Medicines for which the procedure number starts with the same product counter are in the same group of medicines.

For example

  • Paracetamol ABC 500 mg tablets NAT-H-1234-01
  • Paracetamol ABC 500 mg, effervescent tablets NAT-H-1234-02
  • Paracetamol ABC 1 g tablets NAT-H-1234-03

All of these drugs belong to the same group of medicines specified by the product counter NAT-1234.

3. How do I fill in the field “number of the procedure” (DCP, MRP, NAT) in the web form ?
 

For a group of medicines authorized via DCP (centralized procedure) or MRP (mutual recognition procedure):

Start the field “Number of the procedure” with the country code. Then add a hyphen and then the product counter that consists of a maximum of four digits.

For a group of medicines authorized via the NP (national procedure):

Start the field “Number of the procedure” with NAT. Then add a hyphen and then the product counter that consists of a maximum of four digits.

It is important that this field is filled in correctly because this is the basis for the electronic linking. Do not add any extra spaces or any extra zeros.

For example

  • Paracetamol ABC 500 mg tablets with procedure number NAT-H-1234-01.

In this case, fill in the “Number of the procedure” as follows: NAT-1234

  • Paracetamol DEF 200 mg tablets with procedure number NAT-H-678-01.

In this case, fill in the “Number of the procedure” as follows: NL-678

4.Do I need to fill in a web form by medicine or by active ingredient ?
 

Under the condition that the result of the risk analysis is the same, you fill in one web form per group of medicines.

On the web form you must specify the active ingredient of the medicine.

5. What if I don't have all of the information available? Can I partially fill in a web form ?
 

No, you must always fill in the web form completely.

6. Will I receive a confirmation of receipt after filling in the web form ?
 

After clicking “send”, you will receive a general confirmation that you have filled in the form without identification of the group of medicines involved. The FAMHP does not send another confirmation of receipt.

7. When do I use the web form “Risk of presence of nitrosamines identified” and how do I fill in the field “Type of product” on this web form ?
 

As soon as you suspect a risk of the presence of nitrosamines in a product, fill in the web form “Risk of presence of nitrosamines identified”.

Where are risk identified?

Type of Product

Risk identified in the active ingredient

API

Risk only identified in the intermediate product

Intermediate product

Risk only identified in the finished product

End product

8. Can I submit the risk assessment in another way than via the web form?
 

The risk assessment for each group of medicines must be submitted using the web form.

Only in special cases, if you are the marketing authorisation holder of a large number of groups of medicines and you may not meet the set timeline, you can report groups of medicines all at once to the FAMHP with the outcome “No risk identified”. You do this by sending an e-mail to postlicensing@fagg-afmps.be. For each of the listed groups of medicines, you must fill in a web form as soon as possible.

 

 

Last updated on 05/05/2020