1.

Within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft Regulation to grant authorisation or to deny authorisation. This draft shall take into account the requirements of Article 5(2) and (3), Community law and other legitimate factors relevant to the matter under consideration and in particular benefits for animal health and welfare and for the consumer of animal products. Where the draft is not in accordance with the opinion of the Authority, it shall provide an explanation of the reasons for the differences. In exceptionally complex cases, the three-month deadline may be extended.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.