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Showing 5381–5390 of 16677 articles for “Art. 25 Oct 1989 — BRDA 6/90 p. 6”
Unless there is a risk to patients' health, proprietary medicinal products which fulfil the conditions for being a reference proprietary medicinal product in an existing hybrid group may, by decision…
…plication for renewal is addressed in accordance with the procedures defined in I of Article R 5121-68 no later than three months before the expiry date of the authorisation.Applications for renewal m…
When the application for early access authorisation concerns a medicinal product composed, in whole or in part, of genetically modified organisms, the holder of the exploitation rights, or his authori…
…the Haute Autorité de santé during the assessment of the application referred to in Article R. 5121-68, where applicable on a proposal from the Agence nationale de sécurité du médicament et des produi…
I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum va…
At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits…
…sionate prescription framework is accompanied by a protocol for therapeutic use and patient follow-up. This protocol specifies in particular 1° The procedures for monitoring patients and the data to b…
…report. Once the summary of the summary report has been approved by the Agency, it is sent to the doctors who prescribed the medicinal product, the pharmacists or persons mentioned in article L. 5126…
…R. 5121-138-2, in accordance with the procedures set out in Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Cou…
For investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or t…
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