2017/0381/D
EC/EFTA
DE Germany
  • C10P - Pharmaceuticals
2017-11-13
2017-08-17

Medicinal products within the meaning of Directive 2001/83/EC

Draft Ordinance on warnings for analgesics

This Ordinance on warnings for analgesics has been issued in order to limit the risks involved when using over-the-counter (OTC) analgesics. Accordingly, warnings shall be displayed on the outer packaging of any relevant proprietary medicinal product, or on the containers themselves if only a container is present. These warnings are to discourage consumers from using such medicinal products for longer than is described in the package leaflets without first seeking professional medical advice, according to § 11 of the Medicinal Products Act [Arzneimittelgesetz]. For relevant magistral and officinal preparations, there are provisions for applying a separate warning stating that consumers should not use the medicinal product for a period longer than that recommended by the pharmacist. OTC analgesics that are investigational medicinal products within the meaning of Article 2(2)(5) of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1; OJ L 311, 17.11.2016, p. 25), are excluded from the scope of application. Transitional regulations have been provided for pharmaceutical companies as well as wholesalers and pharmacies.