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Subsection 5 : Fees charged on application for authorisation

Article D5141-55 of the French Public Health Code

I.-The amounts of the fee provided for in 1° of 1 of I of Article L. 5141-8 for marketing authorisation applications under a national procedure, a mutual recognition procedure or a decentralised procedure for which France acts as the reference Member State are set as follows: 1° €25,000 for an application relating to : a) A veterinary medicinal product which is the subject of a complete dossier referred to in…

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Article D5141-55-1 of the French Public Health Code

I.-The amount of the fee provided for in 8° of 1 of I of Article L. 5141-8 is set at €1,500 per veterinary medicinal product or per series of homeopathic veterinary medicinal products and forming the subject of the dossier referred to in Article 87 of 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. II….

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Article D5141-56 of the French Public Health Code

I.-The amount of the fee provided for in 2° of 1 of I of Article L. 5141-8 for a variation to a marketing authorisation requiring an assessment as part of a national procedure or a mutual recognition procedure for which France acts as the reference Member State is set at €5,000 and €1,000 per additional medicinal product. II. The amount of the fee provided for in 2° of 1 of…

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