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EMEA - Guideline on Compassionate Use of Medicinal Products

[2] OJ L 136, 30/4/2004 p. 1 – 33. Regulation (EC) 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.

Article 83 (1) of Regulation (EC) No 726/2004 introduces the legal framework for the provision of compassionate use at the European level for medicinal products that are eligible to be authorised via the centralised procedure, stating that “by way of exemption from Article 6 of Directive 2001/83/EC, MS may make a medicinal product for human use belonging to the categories referred to in Article 3(1) and 3(2) of Regulation (EC) No 726/2004 available for compassionate use”.

Compassionate use implementation remains a Member state’s competence. Article 83 of Regulation (EC) No 726/2004 on compassionate use is complementary to national legislations and provides an option to MS who wish to receive a CHMP opinion regarding the conditions for compassionate use of a specific medicinal product which falls within the scope of Article 83(1) and 83(2).

The objectives of article 83 are to:
- Facilitate and improve the equality of access of European patients to compassionate use programmes,

- Follow a common approach regarding the conditions of use, the conditions for distribution and the patients targeted for the compassionate use of unauthorised new medicinal products,

- Increase transparency between MSs in terms of treatment availability.
This document aims to provide guidance on the criteria and the procedure for using the possibility provided for in article 83 (1) of Regulation (EC) No 726/2004. It should be read in conjunction with article 5 of Directive 2001/83/EC, as well as the respective MS’s legislation, as the case may be.

3. SCOPE AND GENERAL PRINCIPLES

The use of Article 83 is applicable to unauthorised medicinal products for human use falling within the scope[3][4] of articles 3(1) and 3(2) of Regulation (EC) No 726/2004.

[3] Guideline on Therapeutic areas within the mandatory scope of the Centralised Procedure for the evaluation for Marketing Authorisation Applications with reference to Article 3 and Point 3 of Annex of regulation (EC) No 726/2004 (EMEA/282954/2005).

[4] Guideline on the application of Article 3.2 of Regulation (EC) No 726/2004 - Optional scope of the centralised procedure - Human medicinal products


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