The FAMHP would like to bring to the attention of the Marketing Authorisation (MA) or registration holders of medicines the publication of a new version of the document concerning the application of measures relating to the sunset clause in Belgium for medicinal products authorised at the national level. This document outlines the basic rules of the sunset clause and provides all the information on exemptions.
To enforceArticle 6 § 1ter of the law of March 25th 1964 on medicines, a MA or registration of a medicine expires if, within three years after its approval, the medicine has not been put on the market. This also applies to a medicine that has been sold previously but as not been marketed for 3 consecutive years.
A new version of the document on the implementation of measures relating to the sunset clause in Belgium for medicinal products authorised at the national level is available.
The main changes are concerning:
- Clarification of conditions for granting an exemption for procedural reasons or unforeseen circumstances and
- The deadline for responding to a request from FAMHP to obtain documentation or information in support of an application for exemption under the sunset clause