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Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
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Article 27U.K.Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination
1.By way of derogation from Article 5(2), a marketing authorisation in exceptional circumstances shall be valid for a period of one year.
2.Before the expiry of the one-year period of validity referred to in paragraph 1 of this Article, marketing authorisations granted in accordance with Articles 25 and 26 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 in exceptional circumstances shall submit an application for re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least three months before the expiry of the one-year period of validity referred to in paragraph 1. The application for re-examination shall demonstrate that the exceptional circumstances related to animal health or public health remain.
4.When an application for re-examination has been submitted, the marketing authorisation 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 the application.
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 for one year.
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 in accordance with Articles 25 and 26, provided that the marketing authorisation holder submits the missing data on quality, safety or efficacy referred to in Article 25.
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