Belgian national regulation for the harmonisation of SPCs, labelling and package leaflets
In the national closing phase of a marketing authorisation (MA) procedure or a variation involving changes to the summary of product characteristics (SPC), the package leaflet and/or the labelling of a medicinal product for veterinary use, applicants or marketing authorisation holders must submit translations to the FAMHP.
- For the SPC, a French and Dutch version must be provided.
- For the labelling and the package leaflet, in addition to French and Dutch translations, a German version must also be submitted.
- Translations by procedure
For the decentralised procedure (DCP) and the mutual recognition procedure (MRP) referred to in article 6(1)(b) and (c) and articles 48, 49, 50, 51 and 52 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products, repealing Directive 2001/82/EC (hereafter: Regulation 2019/6), and in articles 18, 19 and 20 of the Law of 5 May 2022 on veterinary medicinal products, the translations must be a faithful and substantively accurate representation of the English-language documents approved in application of:
- article 49(4) and (7) of Regulation 2019/6 for a DCP procedure;
- article 52(5) and (8) of Regulation 2019/6 for an MRP procedure.
For national procedures, as referred to in article 6(1)(a) of Regulation 2019/6, articles 46 and 47 of Regulation 2019/6 and articles 16 and 17 of the Law of 5 May 2022 on veterinary medicinal products, the translation must be a faithful and substantively correct representation of the Dutch or French language documents approved in application of article 47(2) of Regulation 2019/6 for a national procedure.
- Harmonisation
An MA applicant or MA holder may request the SPC, labelling and package leaflet to be harmonised between Belgium and other countries. That can be done, for example:
- with the Netherlands for Dutch texts;
- with France and Luxembourg for French texts;
- with Germany, Austria and Luxembourg for German texts.
The FAMHP accepts common labelling or a common package leaflet in Belgium and other countries subject to the following two conditions:
- the product’s full name should be identical in all countries for which harmonisation has been requested;
- all the information on the labelling and in the package leaflet should be identical, except for the ‘blue box requirements’ and the national requirements of each country.
Th FAMHP only accepts harmonisation requests at the submission of closing documents:
- for a new marketing authorisation application;
- for a variation requiring assessment (VRA) that affects the documents.
If the legal status (supply method) is not identical in all countries for which an MA applicant or an MA holder submits a harmonisation request, the harmonised texts approved by the Belgian authorities will only mention the supply method in Belgium. The supply methods in Belgium and those in the other countries must be clearly visible and easily identifiable on the common packaging/package leaflet.
Harmonised texts approved by the Belgian authority only include the national Belgian information. They do not include any national information from the other countries involved in the harmonisation process. MA applicants and MA holders are responsible for ensuring that the labelling/package leaflet they place on the national market corresponds to the approved harmonised translations.
It is important for an MA applicant or MA holder to inform all countries involved in the harmonisation process of translations at the time of submitting the closing documents. This facilitates cooperation between the various countries. If such cooperation is not established immediately, the MA applicant or MA holder shall forward the comments of the countries involved to the FAMHP. That way, the FAMHP can accept the comments and forward any additional comments to the countries involved before they have approved the texts. That is important in order to reach a joint agreement on the harmonised text.
As a reminder: MA applicants and MA holders must harmonise texts with the English language version approved at European level (for European procedures), thereby using the applicable template for the Quality Review of Documents (QRD) and the standard terms of the European Directorate for the Quality of Medicines and HealthCare (EDQM).
The FAMHP does not accept a request for harmonisation:
- after a text has been revised during the national closing phase. MA applicants or MA holders must submit a text harmonisation request when they submit the closing documents.
- for VRAs without impact on the documents, or in the case of VNRAs.
In such cases, harmonisation is still possible if the MA applicant or MA holder submits a national VRA G.I.z.
Harmonisation between Belgium, Germany and Austria for German texts
Please refer to the following document ‘Guidance for harmonisation of the German language translation of product information for veterinary medicinal products in MRP/DCP’ for information on the procedure to be followed and the timelines.
Harmonisation between Belgium and the Netherlands for Dutch texts
When the MA holder submits a harmonisation request, the Dutch authorities must submit their comments within three weeks. If that is not the case, harmonisation between Belgium and the Netherlands cannot be guaranteed.
Harmonisation between Belgium and France for French texts
When the MA holder submits a harmonisation request, the French authorities must submit their comments within three weeks. If that is not the case, harmonisation between Belgium and France cannot be guaranteed.
Harmonisation between Belgium and Luxemburg for German and French texts
The Luxembourg authorities accept the approved Belgian texts without further revisions.