The person responsible for placing a tattoo product on the market is required, in the event of serious doubt as to the harmlessness of one or more substances, to provide the Director General of the Agence nationale de sécurité du médicament et des produits de santé with a list of his tattoo products containing one or more substances designated by him and the quantity of each of these substances present…
A decree of the Conseil d’Etat shall determine the procedures for applying this chapter, in particular: 1° The procedures for presenting and the content of the declaration provided for in article L. 513-10-2 ; 2° The information that must be included on the container and packaging of a tattoo product pursuant to 1° of article L. 513-10-5 ; 3° The content and storage procedures for the file referred to in…
All stool collection activities intended for the preparation of faecal microbiota used for therapeutic purposes are carried out by establishments or organisations which are authorised by the Agence nationale de sécurité du médicament et des produits de santé, with the exception of collection carried out in the context of research involving the human person mentioned in 1° ofArticle L. 1121-1.
The collection, control, storage, traceability and transport of faeces carried out by the establishments or organisations mentioned inArticle L. 513-11-1, including in the context of research involving the human person, are carried out in accordance with the rules of good practice defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These rules of good practice include in particular the…
In the event of non-compliance with the provisions of articles L. 513-11-1 and L. 513-11-2 by an establishment or body mentioned in article L. 513-11-1 or in the event of a risk to public health, the Agence nationale de sécurité du médicament et des produits de santé may suspend or prohibit the activities mentioned in article L. 513-11-2. Except in the case of imminent risk, a decision to suspend or…
Transplantation of faecal microbiota is carried out in the interests of the recipient and is subject to the principles of donor consent and anonymity of donation. The rules of anonymity of donation do not apply in the case of intrafamilial donation.
The detailed rules for the application of this chapter shall be determined by decree.
The conditions under which the testing, placing on the market, manufacture, import, export, supply, distribution and use of veterinary medicinal products are authorised and the rules applicable to the pharmacovigilance and control of these medicinal products are laid down by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products, this Title, and the provisions adopted for their implementation. Unless otherwise…
I.-The veterinary medicinal products referred to in this chapter are those defined in Article 4 of Regulation (EU) 2019/6 of 11 December 2018 and in this Article. II.-The following definitions apply: 1° Extemporaneous veterinary preparation, any veterinary medicinal product which is not prepared in advance and which meets the conditions laid down in b or c of paragraph 6 of Article 2 of Regulation (EU) 2019/6 of 11 December 2018;…
Non-clinical trials intended to assess the properties and safety of medicinal products for veterinary use must comply with good laboratory practice, the principles of which are laid down by decision of the Director General of the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail. Good laboratory practice must guarantee the quality and integrity of test results. They concern the organisation of the laboratory and…
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
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
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
Resources
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
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
