Article R5121-216
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
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Showing 5131–5140 of 25706 articles for “Art. Cass. com. 17 December 1991 · Cass. com. 12 November 1992 · Cass. 3e civ. 24 November 1987”
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…
…11° The public or private health establishments in which the medicinal product may be administered;12° Where the medicinal product is prepared, distributed and administered in accordance with II of A…
…quirements, 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/ri…
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…
…r the law of the issuing State, within one of the categories of offences mentioned in Article D. 48-24; 7° A full description of the offence where it does not fall within one of the categories of offe…
The financial penalties that may be enforced pursuant to the fifth paragraph of Article 707-1 are those resulting from a decision, taken by the competent authority of a Member State of the European Un…
Financial penalties imposed by: 1° A court of the issuing State in respect of a criminal offence under the law of that State; 2° An authority of the issuing State other than a court in respect of a cr…
Financial penalties may be transmitted, for the purpose of enforcement, to any Member State of the European Union in which the sentenced person has his habitual residence, possesses property or income…
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