Opinion request for a CUP or a MNP

Please note: individual compassionate use requests (for a named patient) must not be submitted to the CNER for advice. Applications must be sent directly to the Division of Pharmacy and Medicines of the Health Directorate (secretariatdpm@ms.etat.lu).

Compassionate use program (CUP)

Compassionate use applies when a disabling, chronic or serious disease, or a disease considered life-threatening, cannot be treated by a registered medicinal product but could be treated by a medicinal product not registered in Luxembourg.

“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 (Text with EEA relevance), as follows:

“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.”

Medical Need Program (MNP)

A Medical Need Program is possible when a registered medicinal product which is necessary to treat a disabling, chronic or serious condition, or a condition considered life-threatening, is not registered for the indication concerned, or is registered for that indication but not yet marketed for that indication.

CNER opinion request procedure for these programs: 

The opinion request is made at the request of a doctor or on the firm's own initiative, depending on the needs of the patients.

Note: a coordinating doctor for Luxembourg should be appointed.

The CNER responds to these opinion requests within a maximum of 35 days.

If the request is urgent, this should be specified in the email through which the request is sent to the CNER, and the urgency should be justified in this email or in a cover letter accompanying the request. If the justification is deemed admissible, the CNER can then treat the request as urgent and accelerate its evaluation process with a view to issuing its opinion as quickly as possible.

Documents to be submitted by email to contact@cner.lu: 

• synthetic sheet to download and fill in
• a recent curriculum vitae of the coordinating doctor in Luxembourg
• a copy of the insurance certificate
• a document describing, among other things, the criteria according to which the patient(s) can be included in the programme, the indication for which the medicine will be made available, the period during which the programme runs, the breakdown of transport and administration costs, as well as the modalities according to which unused medicines will be processed
  
• the information sheet and informed consent form that will be submitted by the treating physician to patients entering the program
• the instructions for use
• if possible, the data mentioned in the detailed guidelines on medicinal products for compassionate use published by the European Commission in the "Regulation of Medicinal Products in the European Union", as contained in the latest available edition.

For subsequent notifications of new doctors being added to the program, a CV must be provided for each. The CNER's maximum response deadline for these notifications is also 35 days.