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Showing 5211–5220 of 11457 articles for “Art. Rép. Kamowski: AN 25-12-2018 n° 13638”
I. - Any changes relating to: 1° The name or administrative address of the registered office of the establishment or authorised body; 2° The appointment of a new director of the establishment or autho…
Establishments and authorised organisations shall implement a procedure for the withdrawal of advanced therapy medicinal products prepared on an ad hoc basis in accordance with the rules of good pract…
Establishments or authorised organisations shall draw up and keep up-to-date a full list of the agreements they have entered into with third parties whose involvement has an influence on the quality a…
Advanced therapy medicinal products prepared on an ad hoc basis are distributed, under the responsibility of the person in charge referred to in article R. 4211-37 or, where applicable, the person in…
An authorised establishment or organisation may transfer to another authorised establishment or organisation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storag…
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
…dy sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as well as, where appropriate, the Di…
Disrupting a competition or endangering the safety of persons or property by entering the competition area of a sports venue is punishable by one year's imprisonment and a fine of €15,000.For the offe…
An individual may only be included on the list if he or she meets the following conditions:1° Be at least thirty and no more than seventy years of age;2° Have been known for a sufficient period of tim…
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