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Chapter III · PROCEDURES FOR MARKETING AUTHORISATIONS  ›  Section 2 · Marketing authorisations valid in a single Member State (‘national marketing authorisations’) › Article 47

Procedure for national marketing authorisation

1.   The procedure for granting or refusing a national marketing authorisation for a veterinary medicinal product shall be completed within a maximum of 210 days of the submission of the valid application.

2.   The competent authority shall prepare an assessment report containing the information referred to in Article 33.

3.   The competent authority shall make the assessment report publicly available, after deleting any commercially confidential information.

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