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Showing 3061–3070 of 36520 articles for “Art. IV & V”
French Public Health CodeIn force
Paragraph 1: Provisions relating to the entry into national territory of the elements or products of the human body mentioned in Article R. 1245-1 when they are not authorised in the Member State of origin
Article R1245-16
…II. - He may request any additional information he considers necessary, by any means capable of providing a definite date for this request. In this case, the time limit stipulated in the previous par…
Subsection 2: Provisions relating to the entry into or exit from national territory of elements or products of the human body mentioned in article R. 1245-1 coming from or destined for Member States of the European Union or parties to the Agreement on the European Economic Area and intended for the manufacture of medicinal products
Article R1245-29
…establishments authorised under articles L. 4211-9-1 and L. 4211-9-2 may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the…
Subsection 2: Provisions relating to the entry into or exit from national territory of elements or products of the human body mentioned in Article R. 1245-1 coming from or destined for Member States of the European Union or parties to the Agreement on the European Economic Area and intended for the manufacture of in vitro diagnostic medical devices.
Article R1245-21
Manufacturers of in vitro diagnostic medical devices may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the European Union o…
Paragraph 2: Conditions for the departure from national territory of human body parts or products mentioned in Article R. 1245-1 when they do not have the authorisation mentioned in Article L. 1243-2
Article R1245-18
…Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application of t…
Paragraph 2: Conditions for the departure from national territory of human body parts or products mentioned in Article R. 1245-1 when they do not have the authorisation mentioned in Article L. 1243-2
Article R1245-17
…a must send the Agence nationale de sécurité du médicament et des produits de santé, before they leave national territory, a dossier containing the following information:1° The precise designation of…
Paragraph 1: Provisions relating to the entry into national territory of the elements or products of the human body mentioned in Article R. 1245-1 when they are not authorised in the Member State of origin
Article R1245-15
I. - The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European…
Paragraph 2: Procedure for authorising the import and export of elements or products of the human body mentioned in Article R. 1245-1, in the emergency situations provided for in III of Article L. 1245-5
Article R1245-12
The application for authorisation provided for in III of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any mean…
Paragraph 1: Procedure for authorising the import and export of elements or products of the human body mentioned in Article R. 1245-1 for therapeutic purposes, as provided for in the first and third paragraphs of II of Article L. 1245-5.
Article R1245-6
…will send a copy of the dossier to the Director General of the Agence de la biomédecine, who will give his opinion within one month. If no response is received within this period, this will be deemed…
Paragraph 1: Procedure for authorising the import and export of elements or products of the human body mentioned in Article R. 1245-1 for therapeutic purposes, as provided for in the first and third paragraphs of II of Article L. 1245-5.
Article R1245-5
I. - The application for an import authorisation for therapeutic purposes, provided for in the first paragraph of II of Article L. 1245-5, is sent by the legal entities or natural persons mentioned in…
Paragraph 1: Procedure for authorising the import and export of elements or products of the human body mentioned in Article R. 1245-1 for therapeutic purposes, as provided for in the first and third paragraphs of II of Article L. 1245-5.
Article R1245-7
In particular, the authorisations specify the type of activity authorised and the category of products imported or exported and, for imported finished products, the therapeutic indications. In the cas…
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Mariela Petrova
Avocate au Barreau de Paris
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