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Showing 131–140 of 8303 articles for “Art. CJEU – C-452/17 – 21 Nov. 2018”
The application for authorisation is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not info…
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the…
…he medicinal product is prepared, distributed and administered in accordance with II of Article L. 4211-9-1, information intended to establish the necessity and safety of administering this medicinal…
…uirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or where it appears, particularly following evaluation, that the benefit/ris…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date…
…n the sixth paragraph of II of this article in its wording prior to the entry into force of law no. 2018-1317 du 28 décembre 2018 de finances pour 2019, not charged at the close of the last financial…
The public prosecutor or the public prosecutor informs the administrative department without delay of the decision to discontinue proceedings, except in cases where this decision is based on the premi…
…declarations and accompanying documents for wine products, as provided for in Articles 8 to 10 and 21 to 33 of Commission Delegated Regulation (EU) 2018/273 of 11 December 2017 and Articles 22 to 24…
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