Belgian rules for the harmonisation of SPC, labelling and patient information leaflet
Within the context of the closure of a marketing authorisation procedure, its renewal, or variation with changes made to the summary of product characteristics (SPC), patient information leaflet (PIL) or labelling of a medicine for veterinary use, translations of the texts in French and Dutch of the SPC, and texts in French, Dutch and German of the labelling and PIL must be submitted.
For decentralised procedures (DCP) and mutual recognition procedures (MRP), as laid down respectively in articles 14 and 1, paragraphs 27 and 28 of the European directive 2001/82/EC and in article 6, sections 1d and 6f of the Law of 25 March 1964 on medicinal products, the translation must be accurate and correct with respect to the content of the English documents concerned which have been approved pursuant to article 32 of this directive for a MRP or DCP.
For national procedures, such as those laid down respectively in article 6, sections 1d and 6f of the Law of 25 March 1964 on medicinal products, the translation must be accurate and correct with respect to the content of the French or Dutch documents concerned which have been approved under article 6, sections 1d and 6f of the Law of 25 March 1964 on medicinal products for a national procedure.
When submitting these documents to the authorities, the marketing authorisation holder/applicant may request harmonisation between Belgium and other countries, such as the Netherlands for Dutch texts, France and Luxembourg for French texts, and Germany, Austria and Luxembourg for German texts.
Two conditions must be met to approve labelling/PIL used in both Belgium and other countries:
- the product’s full name must be identical;
- all information on the labelling and the package leaflet must be the same, except for the blue box requirements and each country’s national requirements.
Belgian rules from 1 May 2019
Harmonisation request is only acceptable at the time of submission of the closure documents for the following procedures:
- New application for marketing authorisation
- Clinical variations
If the legal classification (method of delivery) is not identical for the countries concerned by the harmonisation request, you will find only the method of delivery for Belgium in the harmonised texts approved by the Belgian authorities, but the delivery method for the other countries as well as Belgium must appear on the common packaging/package leaflet in a visible and clearly identifiable manner.
The national information of the other countries concerned by the harmonisation are not included in the harmonised texts approved by the Belgian authorities. Only the national Belgian information is included. The marketing authorisation holder or applicant is responsible for the compliance of the labelling/PIL published on the national market with the approved harmonised translations.
It is also important to inform all countries concerned by the harmonisation of the translations at the time of submission of the closure documents so that the different countries can easily put in place a collaboration. If the collaboration between the countries is not directly implemented, it is important to send the FAMHP any comments from these countries which may be received by the marketing authorisation holder/applicant to ensure that they do not approve their texts before the FAMHP can accept their comments/send them additional comments, thereby allowing for common approval of the harmonised text.
As a reminder, texts must be harmonised with the English version approved at European level (for European procedures), using the currently valid QRD template and the EDQM standard terms.
Cases for which FAMPH does not accept harmonisation request:
- After the linguistic role’s text review during the closure phase. Harmonisation request of the texts has to be introduce at the time of submission of the closure documents.
- At the time of submission of the closure documents for an administrative or analytic variation
Harmonisation will still be possible in these cases, on condition that a type IA (A.z) administrative national variation is submitted.