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Parliamentary questions
18 May 2017
E-001897/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is not aware of any recommendation to Member States, currently under consideration in the European Medicines Agency (EMA) for the use of cannabidiol through compassionate use programmes for the treatment of Dravet Syndrome.

Compassionate use means making a medicinal product 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 cannot be treated satisfactorily by an authorised medicinal product. It falls under the competence of Member States, which notify EMA and may request opinions on the conditions for use, the conditions for distribution and the patients targeted. Therefore, it is not the role of the Commission to propose a roadmap.

In addition, according to Article 5 of Directive 2001/83/EC(1), a Member State, in accordance with its legislation in force and to fulfil special needs, may allow supply of a medicinal product without marketing authorisation in response to a bona fide unsolicited order formulated in accordance with the specifications of a healthcare professional and for use by an individual named patient under the direct responsibility of the healthcare professional.

(1)http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF

Last updated: 22 May 2017Legal notice