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European Medicines Agency (EMA)
Article 83

Article 83

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.
3.
When a Member State makes use of the possibility provided for in paragraph 1 it shall notify the Agency.
4.
When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated on a regular basis.
5.
Member States shall take account of any available opinions.
6.
The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4, which shall be published on its website. ►M5 Article 28(1) and (2) shall apply mutatis mutandis.
7.
The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation.
8.
Where a compassionate use programme has been set up, the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market.
9.
This Article shall be without prejudice to Directive 2001/20/EC and to Article 5 of Directive 2001/83/EC.