For the application of the provisions of sub-section 1, army hospitals and the army blood transfusion centre shall be considered as health establishments and a blood transfusion establishment respectively. For these hospitals and for this centre, the Minister for Defence exercises the powers of the Director General of the Regional Health Agency.
I. – Pharmacy dispensaries and pharmacies for internal use collect, free of charge, unused medicines brought to them by private individuals, in their packaging if applicable. II. – The destruction of medicines classified as narcotics is governed by the provisions of article R. 5132-36. III. – This section specifies the conditions for implementing the extended producer responsibility obligation provided for in I of article L. 541-10 of the Environment Code…
Producers contribute to or provide for the collection of unused medicines and, where applicable, their packaging, under the conditions set out in I of article L. 541-10 of the Environmental Code. They carry out the following operations: 1° Providing pharmacies with receptacles free of charge; 2° Collecting, grouping, sorting and transporting unused medicines and, where applicable, their packaging from pharmacies to their destination; 3° Destruction of unused medicines.
Producers or their eco-organisation may call upon wholesaler-distributors to supply pharmacies with the receptacles mentioned in article R. 4211-24, and to collect and transport these receptacles to their storage site.
Unused medicines are destroyed by incineration with energy recovery in compliance with current regulations.
The quantity of packaging managed by producers or their eco-organisation as part of the system provided for in article R. 4211-24 is deducted from the quantity for which they pay a contribution in application of 1° of article L. 541-10-1 of the Environment Code.
I. – The provisions of this section apply to the categories of establishments or organisations defined in the second paragraph of this article which meet the conditions for obtaining the authorisation provided for in I of Article L. 4211-9-1 to prepare, store, distribute and transfer individually prepared advanced therapy medicinal products as defined in 17° of Article L. 5121-1, including in the context of biomedical research as referred to in…
Establishments or organisations which store and distribute individually prepared advanced therapy medicinal products which have been transferred to them by an establishment or organisation authorised to prepare, store, distribute or transfer these products may not carry out these storage and distribution activities without being authorised to do so under the conditions laid down by the provisions of this section, with the exception of those of articles R. 4211-47 and R….
I. – The application for authorisation or renewal of authorisation of an establishment or organisation to carry out the activities referred to in Article R. 4211-32 relating to advanced therapy medicinal products prepared on an ad hoc basis is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by the legal entity applying for this authorisation, and by any means enabling…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will send a copy of the complete application to the Director General of the Agence de la biomédecine for his opinion. The Director General of the Agence de la biomédecine will send his opinion to the Director General of the Agence nationale de sécurité du médicament et des produits de santé within two months…
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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