OPINION REQUEST FOR A CUP / NOTIFICATION OF A MNP Minimize

COMPASSIONATE USE PROGRAM

“Compassionate Use” is defined in Article 83 of EC regulation No  726/2004  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL of  31  March  2004, laying  down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products for  human  and  veterinary  use  and  establishing  a  European  Medicines  Agency, in the following manner:

“1. By way of exemption from Article 6 of Directive 2001/83/EC Member States may make a medicinal product for human use belonging to the categories referred to in Article 3(1) and (2) of this Regulation available for compassionate use.

2. For the purposes of this Article, "compassionate use" shall mean making a medicinal product belonging to the categories referred to in Article 3(1) and (2) available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 of this Regulation or must be undergoing clinical trials.”

The notification is submitted to the CNER following the request of a physician or a pharmaceutical company's own initiative, according to the patients' needs. A national coordinating physician should be designated for Luxembourg.

The CNER responds to these notifications with a maximum deadline of 35 days.

Documents to be submitted (1 paper copy + 1 electronic version on cd-rom or sent by email) : 

- synthetic sheet to download and fill
- a recent CV of the Luxembourg coordinating physician
- a copy of the insurance certificate
- a document describing according to which criteria patients can be included in the programme, the indication for which the drug will be made available, the estimated period during which the programme will run, the breakdown of transport and administrative costs, and the modalities by which unused medication will be processed

-  the patient information sheet and informed consent form
-  the user's notice
-  if applicable, any data mentioned in the guidelines relative to the compassionate use of drugs as published by the European Commission in the European Union's regulation of drugs, as they appear in the latest available version. 

To notify the CNER of the participation of further physicians in the programme, a CV needs to be submitted for each. The CNER's maximal response deadline for these futher notifications is 35 days as well.Concernant les notifications ultérieures d'ajout de nouveaux médecins dans le programme, un CV doit être fourni pour chacun. 

 

MEDICAL NEED PROGRAM

 

A Medical Need Program is applicable when a patient faces a seriously debilitating disease or a disease considered to be life-threatening that cannot be treated by a registered drug for this indication, but could be treated by a drug registered for another indication, or a drug registered for this indication but not yet commercialised in Luxembourg. 

Documents to be submitted (1 paper copy + 1 electronic version on cd-rom or sent by email) : 

- synthetic sheet to download and fill
- a recent CV of the Luxembourg coordinating physician
- a copy of the insurance certificate
- a document describing according to which criteria patients can be included in the programme, the indication for which the drug will be made available, the estimated period during which the programme will run, the breakdown of transport and administrative costs, and the modalities by which unused medication will be processed

-  the patient information sheet and informed consent form
-  the user's notice
-  if applicable, any data mentioned in the guidelines relative to the compassionate use of drugs as published by the European Commission in the European Union's regulation of drugs, as they appear in the latest available version. 

To notify the CNER of the participation of further physicians in the programme, a CV needs to be submitted for each. The CNER's maximal response deadline for these futher notifications is 35 days as well.

 

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