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Paragraph 2: Application to vary a marketing authorisation requiring an assessment

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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