Article R15-33-57
When, for serious medical, family, professional or social reasons, the person has been unable to carry out the measures decided upon within the prescribed time limits, and these time limits are less t…
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Showing 271–280 of 5484 articles for “Art. Aut. conc. n° 14-DCC-57”
When, for serious medical, family, professional or social reasons, the person has been unable to carry out the measures decided upon within the prescribed time limits, and these time limits are less t…
The competent administrative authority referred to in articles R. 221-55 and R. 221-56 is the Minister for the Economy.
The operative part of the decisions is divided into articles and preceded by the word: "decides" or, where appropriate, "orders".The commission's decisions are enforceable.
Votes may be cast by post or electronically.
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.
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…
Where manufacturers and importers of investigational medicinal products entrust certain quality control operations to a laboratory in accordance with Article R. 5124-47 (2°), the biomedical research s…
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the appl…
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
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