Article R5139-5
The application for authorisation is deemed to be complete if, within 30 days of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not inform…
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Showing 3081–3090 of 51907 articles for “Art. R. 521-5 to R. 521-11”
The application for authorisation is deemed to be complete if, within 30 days of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not inform…
…rocedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé published on…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation ha…
For the purposes of this Title, the following definitions shall apply1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of…
…ss, legal status ; - a precise description of the scope of the assessment requested and a reference to the directives and national provisions transposing them.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall decide on the application within seven months of the date of receipt of the complete file. Failing…
…s well as external experts used by the Agency and appearing on a list drawn up by the Agency's Director General, may receive compensation for work, reports and studies carried out for the Agency under…
The duties of a member of the Board of Directors are incompatible with those of a member of the Scientific Advisory Board.
…vice, before or after a hospital stay or a treatment session. Any healthcare establishment planning to offer the service referred to in the first paragraph must declare this, at least thirty days befo…
…ation, in particular the financial contribution that they and any accompanying person(s) are likely to have to pay, and about the accommodation facility's internal rules. Informed consent is obtained…
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