Part four: Health professions

Notwithstanding the provisions of 4° of article L. 4211-1, legal entities complying with good distribution practices defined by order of the Minister for Health may be authorised to dispense gases for medical use at home, under the responsibility of a pharmacist registered with the Ordre des pharmaciens in sections A, D and E. Authorisation is granted by the Director General of the Regional Health Agency, after consulting the relevant bodies…

Any person who has obtained authorisation from the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Académie nationale de médecine, may prepare and dispense allergens when they are specially prepared for a single individual. Authorisation is granted for a period of five years, renewable thereafter for five-year periods. It may be subject to appropriate conditions. A Conseil d’Etat decree sets the…

Herbalists who qualified on 20 September 1941 have the right to practise for life. Qualified herbalists may hold for sale and sell for medical use medicinal plants or parts of plants, whether indigenous or acclimatised, with the exception of those mentioned in article L. 5132-7. These plants or parts of plants may not, under any circumstances, be supplied to the public in the form of a mixture prepared in advance;…

By way of derogation from 1° and 4° of Article L. 4211-1, establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé may prepare, store, distribute, transfer, import and export the gene therapy preparations referred to in 12° of Article L. 5121-1. This authorisation is issued for a period of five years. It is renewable and may be modified, suspended or withdrawn. A…

By way of derogation from 1° and 4° of Article L. 4211-1, establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé after receiving the opinion of the Agence de la biomédecine may prepare, store, distribute, transfer, import and export the xenogenic cell therapy preparations mentioned in 13° of Article L. 5121-1. This authorisation is issued for a period of five years. It…

I.- By way of derogation from 1° and 4° of Article L. 4211-1, in the context of the research defined in Article L. 1121-1 , advanced therapy medicinal products mentioned in 17° of Article L. 5121-1 may be prepared, stored, distributed, transferred, imported and exported by establishments or organisations, including health establishments, authorised by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for…

By way of derogation from 1° and 4° of Article L. 4211-1 and in the context of the research referred to in the first paragraph of Article L. 1121-1, the manufacture, import, export, distribution and use of advanced therapy medicinal products defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive…

The person responsible for the activities referred to in Articles L. 4211-8 and L. 4211-9 must be a pharmacist, a doctor or a person authorised to practise as a doctor or pharmacist, or a person with appropriate scientific training. These persons must have specific qualifications and work experience in the fields of activity relating to gene therapy preparations and xenogenic cell therapy preparations, as well as skills acquired in these…

The provisions of articles L. 4211-8, L. 4211-9 and L. 4211-10 apply to army hospitals. A decree of the Conseil d’Etat determines the adaptations that may be made, with regard to these hospitals, to the authorisation procedures applicable to health establishments.