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

1. What do you need to do if the RMS is changed (RMS switch) ?
 

You can find all the information about changing the RMS and the procedure to follow in the CMDh procedural advice on changing the RMS.

To request an RMS change, please fill out the Template for RMS change.

Any questions? presubmission-HUM@afmps.be

2. Are there guidelines on the denomination of medicines for human use ?
 

First carefully read the "National Guidelines on the Denomination". The proposed denomination will be accepted more easily if you take the requirements into account.

3. Are there any guidelines for how a medicine should be delivered ?
 

The following documents provide you with useful information regarding the delivery of medicines:

  • Strategy on the Delivery status
  • Narcotic drugs used for pain treatment: strategy to restrict the pack sizes available in public pharmacies.
  • FAMHP guideline on the mode of delivery of antidepressants, antipsychotics, hypnotics, sedatives, anxiolytics and antiepileptics (version 6.2).

You can also find more information on submitting a change of delivery mode in the Q&A related to variations below: 2. How should I submit an OTC switch ?

4. Are there any guidelines for how a medicine should be labelled ?
 

Carefully read the document Labelling of medicinal products. The approval of your mock-up and labelling can go more quickly if you take into account these recommendations.

5. What should I do if the active substance is a narcotic* or psychotropic* substance ?
 

* as mentioned in Annexes I, II and/or IV of the Royal Decree regulating narcotic and psychotropic substances

A code must be indicated on the outer packaging of medicines marketed in Belgium that contain substances referred to in Annexes I, II and/or IV.

You must request this code from the FAMHP Specially Reglemented Substances Unit via narcotics@fagg-afmps.be, once the procedure is approved.

You must include the summary of product characteristics (SPC), the draft marketing authorisation, or MA light, and the package sizes that will be marketed with this application.

You will then receive a code per package size, which you must indicate on the outer package mock-up.

6. What can I do if there is not enough room on the package ?
 

You can apply for an exemption of the labelling and packaging requirements. The relevant procedure is explained in the document Exemptions: procedure to be followedTemplate requesting an exemption

7. Can my file be deactivated if I don't submit the documents on time during the closing phase ?
 

A file can be deactivated. You will find more details in the circular 521 + English version

8. Can my deactivated file be reactivated ?
 

A deactivated file can be reactivated. The fee is laid down in law in Article 28 and Annex VII, Title 1, Chapter 3 of the Law of 11 March 2018 on the financing of the Federal Agency for Medicines and Health Products. You can find more details on our website.

9. When can I receive/know the authorisation number for my new medicine ?
 

The procedures do not allow the BE number to be assigned during the evaluation or closing phases. The number is assigned after the closing phase but well before the official documents are sent.

10. How should the sentence regarding the Poison Control Centre be indicated in the three national languages ?
 
  • Wanneer u teveel aan X heeft gebruikt of ingenomen, neem onmiddellijk contact op met uw arts, apotheker of het Antigifcentrum (070 245 245).
  • Si vous avez utilisé ou pris trop de X, prenez immédiatement contact avec votre médecin, votre pharmacien ou le Centre Antipoisons (070 245 245).
  • Wenn Sie eine gröβere Menge von X haben angewendet, kontaktieren Sie sofort Ihren Arzt, Ihren Apotheker oder das Antigiftzentrum (070 245 245).
11. When does the country have to be indicated in an address ?
 

When the address of the manufacturer or MA holder, for example, is located abroad, the country must be added to the address on the documents. When the manufacturer or MA holder is located in Belgium, the country can be added but this is not mandatory.

12. Does the address of the MA holder have to be translated in the relevant documents ?
 

The address of the MA holder may be indicated according to the language of the geographic area where the MA holder is located. If the MA holder is located in Brussels, the language of the address depends on the language role of the MA holder.

13. Can a QR code be added to the packaging of a medicine authorised via the national procedure or MRP/DCP ?
 

As regards the mention of a QR code, the FAMHP follows the recommendations of the CMDh, as stated in the document: CMDh position paper on the use of Quick Response (QR) codes to provide information about the medicinal product.(link is external)

If you prefer to consult with the appropriate FAMHP department before submitting this item, please send an e-mail to postlicensing@afmps.be

14. How does the contact information of the FAMHP for reporting adverse drug reactions have to be included in ?
 

The contact information of the FAMHP for reporting adverse drug reactions has been updated in the "QRD Appendix V - Adverse-drug-reaction reporting details".

Simply indicating the site www.afmps.be is no longer authorised. The SPC (Summary of Product Characteristics) and PIL (Product Information Leaflet) must include:

  • At least one of these mailing addresses :
    • Federal Agency for Medicines and Health Products - Vigilance division
      Avenue Galilée 5/03
      1210 BRUSSELS
    • Federal Agency for Medicines and Health Products - Vigilance division
      Post Box 97
      B-1000 BRUSSELS Madou

AND

Adaptation of the FAMHP contact information in the SPCs and PILs is considered an editorial change and may be included in the subject of a variation, which has an impact on the product information, of Type IB or Type II of Chapter C of the Commission Classification Guideline. Please clearly indicate this change in the subject line of the variation and in the "present and proposed" section of the Electronic Application Form.

More information on editorial changes can be found in the Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008, question 3.16.

>This adaptation may also be submitted separately as a national variation of Type IA C.I.Z.

The deadline for submission of this adaptation is 19/09/2021 (publication of the Appendix (= 19/03/2021) + 6 months).

15. Which procedure can I follow for the removal or addition of a patented indication for medicines for human use ?
 

The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.

Context
Following the judgment C-423/17 of the Court of Justice of 14 February 2019, the FAMHP has reviewed the procedure for the removal of certain patented data from the summary of product characteristics (SmPC) and the package leaflet.

The applicant or marketing authorisation holder can decide to adjust the SmPC and package leaflet themselves.
The removal of information from a patented indication and the inclusion of the standard phrase in the package leaflet are the responsibility of the applicant or marketing authorisation holder.

Procedure for the removal of a patented indication
Follow the procedure applicable to your specific situation in order to remove data from the SmPC and package leaflet that are covered by a patent.

1. During the marketing authorisation (MA) application.

  • Via National Procedure (NP): if the company does not apply for the patented indication during the application for a national MA, then the FAMHP grants the MA without the patented indication.
  • Via Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP):
  • the indication under patent is part of the common EU text: the data under patent can be extracted from the SmPC and package leaflet during the national closing phase.

2. After the MA has been granted.

  • Via NP: via submission of an IB C.I.6.b. variation
  • Via MRP/DCP: via submission of a national IB C.I.6.b. variation

Conditions

  • Only the information on the patented indication in sections 4.1, 4.2 and 5.1 of the SmPC and the corresponding sections of the package leaflet may be removed.
  • In the interest of prescribers and patients, all safety information on the active substance should be retained.
    The safety information in other sections of the SmPC (4.3 to 4.9) and the corresponding sections of the package leaflet that are related to the patented indication should be retained.
    If the marketing authorisation holder nevertheless wishes to remove or change information in these sections, for example, removal of text traceable to the patented indication, this must be justified.
  • If a patented indication is not included, the company shall include the following standard phrase in the package leaflet:
    "<Product name> contains the active substance <substance name>, which is also used in the treatment of conditions not mentioned in this package leaflet. Please contact your doctor or pharmacist if you have any questions."

Procedure for the reinsertion of a patented indication
Follow the procedure applicable to your specific situation in order to reinsert the data to the product information after the patent has expired.

1. MA authorised via NP: via submission of an IB C.I.2.a. variation

2. MA authorised via MRP/DCP:

  • Indication/data included in common EU text: via submission of a national IB C.I.2.a. variation.
  • Indication/data not included in common EU text: via submission of an IB C.I.2.a variation via MRP.

Additional information
In addition to the adapted product information, a declaration must be submitted stating that the adapted documents meet the conditions mentioned above.

For MRPs/DCPs for which you submit a national variation, you should submit a "country-specific" sequence of eCTD, as this variation is national.  In exceptional situations, where a "country-specific" eCTD sequence is not possible, it can also be submitted in NeeS format(link is external).

In the application form, always state the procedure number without chronological serial number, e.g. XY/H/1234/001-002/IB/NP.

The declaration of conformity – MRP/DCP  has also been adapted to this new procedure.

Contact
postlicensing@fagg-afmps.be

 

Questions related to Variations

1. 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.

2. How should I submit an OTC switch ?
 

The legal basis for the classification of a medicine can be found in the law on Medicines of 25.3.64, namely article 6§1bis and in the Royal Decree on medicines for human and veterinary use of 14.12.06, articles 61 to 63 and article 65.

In article 61 of the Royal Decree dated 14.12.06, the criteria are listed that determine whether a medicine is subject to a prescription.

This concerns the following criteria:

  • The medicinal product may, even under normal conditions of use, present a direct or indirect danger if used without the supervision of a doctor;
  • The medicinal product is frequently and extensively used under abnormal conditions and may therefore present a direct or indirect danger to health;
  • The medicinal product contains substances or preparations based on such substances whose action and/or side-effects require further study;
  • The medicinal product is, with exception, prescribed by a doctor to be administered parenterally.

In the case of a submission to change the delivery modus of a medicinal product from prescription to non-prescription, the medicinal product concerned will be evaluated against the criteria indicated above when evaluating this application.

Further explanation on how the medicine is evaluated against these criteria and which data are required for this can be found in the European ‘Guideline on changing the classification for the supply of a medicinal product for human use, dated 16.01.06’.

For changing the delivery modus from POM to OTC, you must submit a national type II clinical variation.  This must include a 'Non-clinical overview' and a 'Clinical overview' which describe in detail the criteria as stipulated in Article 61 of the Royal Decree of 14.12.06 and according to the sub-criteria described in 'Part 1' and the data requirements per sub-criterion described in 'Part 2' of the European guideline.

 

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 15/03/2022