The Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé may require the communication of all information essential for checking the accuracy of the advertised characteristics and performances.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt of the complete dossier. Authorisation is deemed to have been granted in the absence of a decision by the Director General of the Agency within this period. If the applicant’s documents are not complete, the Agence nationale…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a period of five years.
Any project to modify the elements mentioned in 1° and 2° of article R. 5223-5 is the subject of a new application for authorisation submitted and examined under the same conditions as the initial application for authorisation. The authorisation continues to run until its initial expiry date.
The authorisation may be suspended or withdrawn by reasoned decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé where the advertising of the in vitro diagnostic medical device no longer complies with the conditions laid down by the provisions of Articles L. 5223-2 and L. 5223-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after…
In an emergency, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation of an advertisement for a maximum period of three months.
No dummy or soother may be manufactured, held with a view to sale, offered for sale, sold or distributed free of charge, exhibited or imported unless the product used in its manufacture meets the requirements of Decree no. 92-631 of 8 July 1992 on materials and objects intended to come into contact with foodstuffs, products and beverages for human or animal consumption.
The equipment and services referred to in article L. 5232-3 may only be supplied by service providers and equipment distributors who have competent staff according to the type of equipment or service concerned. Competent personnel include : a) On the one hand, the staff working with the person who is ill or has an incapacity or disability in order to provide them with the equipment and services, who have first…
The equipment and services referred to in article L. 5232-3, the list of which and the conditions of issue of which are set by order of the Minister for Health, are classified into four categories: Category 1: equipment and services for which the professionals guaranteeing the application of professional rules and good practice are pharmacists holding a diploma, title or certificate authorising them to practise in France. Category 2: equipment…
The number of professionals responsible for guaranteeing the application of professional rules and good practice in the supply of equipment and services must be sufficient and adapted to the number of staff assigned to the supply of this equipment and services to people who are ill or have an incapacity or disability. This number may be defined by order of the Minister for Health. When an item of equipment or…
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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