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Showing 2651–2660 of 52381 articles for “Art. R 132-5-3”
The number of sub-departmental, departmental or inter-departmental inspection units and their location are set for each region by order of the Minister responsible for labour. When sectoral or themati…
The responsible person shall ensure that the information referred to in Article 21 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic product…
Prescriptions and all orders for professional use of medicinal products or products intended for human medicine or medicinal products intended for veterinary medicine, classified as narcotics or subje…
Where it appears that a reagent presents risks to public health, including as a result of non-compliance with the rules laid down in this chapter, the Director General of the Agence nationale de sécur…
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…
Any person who sterilizes with a view to placing on the market CE-marked medical devices designed by their manufacturer to be sterilized before use or systems or kits referred to in Section 10 of this…
The bodies responsible for carrying out the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
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…
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
Before examining the application for assessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, addres…
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