Article R5121-214
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…
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Showing 5551–5560 of 26178 articles for “Art. Cass. 3e Civ. 25-10-2018 n° 17-26.126”
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…
Articles R. 3116-1, R. 3116-2, R. 3116-3, R. 3116-4 and R. 3116-5 are applicable to Wallis and Futuna in the version resulting from Decree no. 2018-42 of 25 January 2018. Articles R. 3116-16 and R. 31…
The provisions of sub-section 2 of section 7 of this chapter relating to cancer treatment activities are applicable to the holder of the authorisation under grades C and D when it carries out interven…
Authorisation for interventional radiology activities may be issued for the following categories : 1° Category A including, with the exception of procedures specifically covered by categories B, C and…
The authorisation holder guarantees that the medical biology tests required for the activity will be carried out within a timeframe compatible with the quality of patient care.
The interventional radiology activity referred to in 21° of article R. 6122-25 includes all medical procedures for diagnostic or therapeutic purposes performed with medical imaging guidance and contro…
I. - The holder of the authorisation for category A has access to a continuous monitoring unit on site or by agreement, under conditions that allow the patient to be cared for within a timeframe that…
The enforcement measures provided for in Article L. 412-1 : 1° The provisions of Articles 1 and 7 of Commission Regulation (EEC) No 2568/91 of 11 July 1991, as amended, on the characteristics of olive…
Subject to the adaptations provided for in the following chapters, the following provisions of the Code shall apply in the Wallis and Futuna Islands:1° The provisions of Book I mentioned in the left-h…
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