French Public Health Code
In forceI.-At the request of the holder of the exploitation rights, the Haute Autorité de santé may modify any early access authorisation mentioned in article L. 5121-12 or the therapeutic use and data collection protocol. Where applicable, this decision is taken after receiving the assent of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) with regard to the presumption of efficacy and safety of the medicinal product in each indication considered for medicinal products covered by 1° of II of article L. 5121-12.
The application for a variation is forwarded by the holder of the marketing rights to the Haute Autorité de santé, the ministers responsible for health and social security and, for medicinal products mentioned in 1° of II of article L. 5121-12, to the Agence nationale de sécurité du médicament et des produits de santé in accordance with the procedures defined in I of article R. 5121-68.
The application for a variation is accompanied, depending on the variation envisaged, by the information and elements of the dossier provided for in article R. 5121-68.
The procedures for examining the request and the conditions under which the decision to grant authorisation for early access is made, as defined in III and IV of article R. 5121-68 and in article R. 5121-69-1, apply to decisions concerning a request for modification of this access.
When its decision to modify leads to a reduction in the scope of the indications covered by the authorisation, the Haute Autorité de santé informs the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) with a view to updating the summary of product characteristics, the package leaflet and the labelling.
The decision to modify the early access authorisation taken by the Haute Autorité de santé accompanied, where applicable, by the Agency's decision updating the summary of product characteristics, package leaflet and labelling, is communicated to the holder of the exploitation rights within three months of receipt of the request.
If no response is received from the Haute Autorité de santé by the end of this period, the application is deemed to have been rejected.
I bis. - For medicinal products covered by 1° of II of article L. 5121-12, the Director General of the Agency may, at the request of the holder of the exploitation rights, amend the summary of product characteristics, the package leaflet and the labelling, excluding the section concerning the therapeutic indication(s). The Agency will immediately send the amended documents to the Haute Autorité de santé for information.
Silence on the part of the Agency for a period of two months will be deemed to constitute rejection of the application.
II.-When a medicinal product which is the subject of an early access authorisation under 1° of II of Article L. 5121-12 obtains its marketing authorisation for an indication including all or part of the indication benefiting from this access:
1° The company will forward this marketing authorisation to the Haute Autorité de santé and to the ministers responsible for health and social security without delay. Where appropriate, the early access authorisation is then amended, in particular to include only the indication for which early access has been granted and which is included in the wording of the marketing authorisation.
Any indication appearing in the marketing authorisation which has not previously benefited from early access may be the subject of a new application for early access by the company;
2° The company also transmits its undertaking to submit an application for registration, in the indication in question, on one of the lists mentioned in the first paragraph of Article L. 5123-2 of this Code or in the first paragraph of Article L. 162-17 of the French Social Security Code within one month of the granting of the corresponding marketing authorisation or, where applicable, the date on which this application was submitted;
3° The company may request a modification to the early access authorisation to include additional presentations or doses in the prior authorisation, provided that these have been the subject of a marketing authorisation in the early access indication, where applicable modified in application of 1°, in particular for the purposes of:
a) Preventing a risk of stock shortage or supply tension for the medicinal product already covered by the early access authorisation;
b) Avoiding the risk of medicinal errors;
c) Improving patient compliance with their treatment;
d) Making it easier to take the medicinal product.
This request is forwarded to the Haute Autorité de Santé and to the Ministers for Health and Social Security. The decision referred to in this 3° is made by the Haute Autorité de santé within three months of acknowledgement of receipt of the application.
If the Haute Autorité de santé does not respond within this period, the application is deemed to have been accepted;
4° If the company is unable to make its medicinal product available under the conditions referred to in III of Article R. 5121-144, it may request the Haute Autorité de santé to make the medicinal product available under the conditions referred to in III of Article R. 5121-144. 5121-144, it may ask the Agence nationale de sécurité du médicament et des produits de santé, no later than fifteen days from the date on which the marketing authorisation was obtained, for an extension and state the reasons for its request.
The Agence nationale de sécurité du médicament et des produits de santé will give its decision within one month of the date of acknowledgement of receipt of the application, and will forward it to the Haute Autorité de santé.
If the Agence nationale de sécurité du médicament et des produits de santé does not respond within this period, the application will be deemed to have been accepted.
III - The Haute Autorité de santé may, on its own initiative or at the request of the ministers responsible for health or social security and after the authorisation holder has been invited to provide its observations, modify an early access authorisation or the therapeutic use protocol and data collection when one of the conditions set out in I and II of Article L. 5121-12 is no longer met. Where applicable, this decision is taken after receiving the assent of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) with regard to the presumption of efficacy and safety of the medicinal product in each indication considered, for medicinal products covered by 1° of II of article L. 5121-12 and after informing the ministers responsible for health and social security.
When its decision to modify leads to a reduction in the scope of the indications covered by the authorisation, the Haute Autorité de santé informs the Agence nationale de sécurité du médicament et des produits de santé so that the summary of product characteristics, package leaflet and labelling can be updated.
The decision to modify the early access authorisation taken by the Haute Autorité de santé, accompanied, where applicable, by the Agency's decision to update the summary of product characteristics, package leaflet and labelling, is communicated without delay to the holder of the exploitation rights.
IV.-When the early access authorisation is modified, the Haute Autorité de santé may renew this authorisation by derogation from the provisions mentioned in Article R. 5121-69-3 subject to the following conditions:
a) The authorisation holder has been able to formulate its agreement within 20 days of the Haute Autorité de santé's request for renewal;
b) All of the updated information mentioned in II of Article R. 5121-68 has been sent within one month of the request for renewal from the Haute Autorité de santé.
IV bis. - For medicinal products covered by 1° of II of article L. 5121-12, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, on his own initiative or at the request of the ministers responsible for health and social security and after the holder of the exploitation rights has been invited to provide his observations, amend the decision relating to the summary of product characteristics, the package leaflet and the labelling, excluding the section concerning the therapeutic indication. The Agency will immediately send the amended documents to the Haute Autorité de santé for information.
V.-The information referred to in this article is sent in accordance with the procedures defined in I of Article R. 5121-68.
