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Showing 5171–5180 of 49285 articles for “Art. 515-5-2”
When the number of votes cast in the professional and territorial area of competence of a committee is less than twice the number of seats to be filled for this committee, the votes cast at national l…
Where batches of investigational medicinal products come from another Member State of the European Community or party to the Agreement on the European Economic Area and are manufactured or imported in…
By way of derogation from the provisions of the first sub-section, the provisions of this sub-section apply to the manufacture and importation of investigational medicinal products.
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…
The importing pharmaceutical establishment shall ensure that the investigational medicinal products it imports have been subjected to standards of good manufacturing practice at least equivalent to th…
The authorisation holder has an organisation, set up where appropriate jointly with other cancer treatment authorisation holders, which ensures that each patient is informed of the proposed therapeuti…
On receipt of the application, if the file is complete, the Prefect will inform the applicant of his registration number and the date by which he must be notified of the decision. Subject to the provi…
Establishments belonging to the same regional hospital grouping may be authorised by the Director General of the Regional Health Agency, under conditions laid down by decree in the Conseil d'Etat, wit…
The prior declarations and supporting documents mentioned in articles R. 2213-2-2, R. 2213-5, R. 2213-7, R. 2213-8, R. 2213-8-1, R. 2213-10, R. 2213-13, R. 2213-14, R. 2213-21 and R. 2213-28 are kept…
The purpose of the aptitude test to which the Prefect may decide to subject the applicant in whole or in part, under the conditions laid down in article R. 212-90-1 and in 3° of article R. 212-93, is…
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