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Showing 5201–5210 of 58660 articles for “Art. avis 2015-04 of 5 February 2015”
Authorisation may be suspended for a maximum of six months or withdrawn by the prefect where the domiciliation company no longer meets the conditions set out in II of article L. 123-11-3 or has not ma…
I.-The refusal of authorisation to manage a blood establishment, its renewal or the substantial modification of one of its elements is notified to the director of the health establishment or to the ad…
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.
…pt by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or the early termination of the last clinical trial during which the batch was used. Es…
…hall ensure that the investigational medicinal products it imports have been subjected to standards of good manufacturing practice at least equivalent to those laid down in article L. 5121-5 when they…
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…
…o pay or deliver financial instruments resulting from a contract to which a person referred to in I of Article L. 613-34 is bound if all of the following conditions are met: 1° It has been established…
The Director General of the Centre national de gestion, acting on behalf of the Minister for Health, will issue the licences provided for in articles L. 4221-14-1 and L. 4221-14-2, after obtaining the…
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