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1. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be valid for a period of five years.

2. Before the expiry of the five-year period of validity referred to in paragraph 1 of this Article, marketing authorisations for a limited market granted in accordance with Article 23 shall be re-examined on the basis of an application from the holder of that marketing authorisation. That application shall include an updated benefit-risk assessment.

3. A holder of a marketing authorisation for a limited market shall submit an application for a re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least six months before the expiry of the five-year period of validity referred to in paragraph 1 of this Article. The application for re-examination shall be limited to demonstrating that the conditions referred to in Article 23(1) continue to be fulfilled.

4. When an application for re-examination has been submitted, the marketing authorisation for a limited market shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.

5. The competent authority or the Agency, as applicable, shall assess applications for a re-examination and for an extension of the validity of the marketing authorisation. On the basis of that assessment, if the benefit-risk balance remains positive, the competent authority or the Commission, as applicable, shall extend the validity of the marketing authorisation by additional periods of five years.

6. The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised for a limited market, provided that the holder of the marketing authorisation for a limited market submits the missing data on safety or efficacy referred to in Article 23(1).