Article R5141-123-18
…holder in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.
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Showing 4121–4130 of 39157 articles for “Art. Cass. com. – 14 May 2013 – no. 12-17637”
…holder in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.
I.-The holder of the authorisation collects and sends to the Regional Health Agency and the National Cancer Institute, on an annual basis, anonymised indicators for monitoring the quality of its healt…
For its application to La Réunion and Mayotte, in article R. 6123-27, after the words "infra-regional", the words "Mahorais, common to La Réunion and Mayotte" are added.
The holder of an authorisation referred to in Article R. 6123-121, with the exception of an authorisation bearing the wording "multi-purpose", provides the following services in its area of competence…
The authorisation holder ensures that data from professional practices is collected and analysed with a view to improving practices and managing risks. The medical team mentioned in 1° of article D. 6…
An operating charter specific to the radiotherapy unit is drawn up by the authorisation holder and specifies in particular: 1° The organisation of the structure, with regard to the procedures for impl…
Minutes of each meeting of the Commission are sent to the Chairman of the Strategy Committee and to the members of the Commission within a fortnight.Each year, the chairman of the committee shall give…
The obligations imposed on the AIF or the management company by virtue of Article D. 214-32-7-13 relate to :1° Any distribution made to shareholders where, at the closing date of the last financial ye…
…L. 231-5, L. 231-5-1, L. 231-8, L. 232-10-2 and L. 232-23-5, the second paragraph of article L. 232-14 and articles R. 232-41-16, R. 232-48, R. 232-52 and R. 232-57 and for being the contact person fo…
The educational actions undertaken as part of the education programme mentioned in 12° of I of article L. 232-5 are provided by educators approved by the agency, under the conditions it determines.
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