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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance article 50 CELEX: 02012R0528-20240611 Amendment of an authorisation at the request of the authorisation holder
1. Amendments to the terms and conditions of an authorisation shall be made only by the competent authority that authorised the biocidal product concerned, or in the case of a Union authorisation, by the Commission. 2. An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent authorities of relevant Member States having authorised the biocidal product concerned, or in the case of a Union authorisation, the Agency. Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.
The application shall be accompanied by the fees payable under Article 80(1) and (2). 3. An amendment to an existing authorisation shall fall under one of the following categories of changes: (a) administrative change; (b) minor change; or (c) major change. |