I.-The Haute Autorité de santé may, on its own initiative or at the request of the ministers responsible for health and social security, suspend or withdraw an early access authorisation when one of the conditions set out in I and II of article L. 5121-12 is no longer met or for any of the reasons mentioned in 3° of VI of the same article. II.-When the holder of the exploitation…
When the authorisation is suspended, withdrawn or not renewed, or when a decision to modify the authorisation makes this necessary, the holder of the early access authorisation referred to in Article L. 5121-12 will take all necessary steps, in particular with stockholders, to stop distributing the medicinal product. If this measure is not taken within a timeframe compatible with the interests of public health, the Agence nationale de sécurité du…
I.-The Haute Autorité de santé makes public, on its website, all decisions concerning authorisation, refusal, withdrawal, suspension, renewal and modification of early access, summaries of the summary reports mentioned in Article R. 5121-70-1 and any annexes thereto under the conditions mentioned in the present section, and information concerning the submission of the full application mentioned in Article R. 5121-68. The website of the Haute Autorité de santé provides access to…
Any measures taken by the holder of the early access authorisation issued for a medicinal product covered by 1° of II of Article L. 5121-12 to disseminate the authorisation, or any information relating to this authorisation, to the healthcare professionals concerned, must not constitute advertising within the meaning of Article L. 5122-1. These measures are subject to the prior opinion of the Agence nationale de sécurité du médicament et des…
I.-The prescriber’s request for compassionate access authorisation as provided for in II of Article L. 5121-12-1 is sent to the Agence nationale de sécurité du médicament et des produits de santé by electronic means by the pharmacist managing the internal use pharmacy of a healthcare establishment or by the person in charge as referred to in Article L. 5126-10. It includes the following information 1° The name and position of…
I.- When examining any request for authorisation for compassionate access, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has the prerogatives set out in Article R. 5121-34. II.- As soon as a first request for authorisation for compassionate access for a medicinal product in a specific indication is received, the Director General of the Agence nationale de sécurité du médicament et des…
I.- The maximum value of the period referred to in the second paragraph of II of article L. 5121-12-1 is set at twelve months from the date on which the authorisation referred to in this article is granted. By way of derogation from the previous paragraph, when the indication for which authorisation is sought is a rare disease, the maximum value of the period is increased to eighteen months from…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Article L. 5121-12-1 or if the provisions of this section are not complied with, or for any other public health reason.
I.- Authorisation for compassionate access is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé for the duration of treatment of the patient in question, up to a maximum of one year. This authorisation includes: 1° The name and contact details of the prescriber and the contact details of the pharmacy for internal use in the health establishment or of the…
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. This request is accompanied by any clinical data of which the prescriber was aware during the previous authorisation period and a statement from the prescriber attesting to the interest in continuing the…
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.
