medicinal product
as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6…, Article 1, point (2)
Any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.
Install the extension for EUR-Lex
Also defined in
- Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data… 32025R0327, Article 2(1), point (b)
laid down in Article 3, points (a), (c), (d), (f), (g), (i) and (k), respectively, of Directive 2011/24/EU - Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the… 32022R0123, Article 2, point (c)
a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC - Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(1)
set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply - Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’… 32011L0024, Article 3, point (i)
a medicinal product as defined by Directive 2001/83/EC - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal… 32000R0141, Article 2, point (a)
a medicinal product for human use, as defined in Article 2 of Directive 65/65/EEC