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End of the Transitional Period for Traditional Herbal Medicinal Products Coming Soon*
Published online by Cambridge University Press: 20 January 2017
Abstract
This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.
- Type
- Reports
- Information
- Copyright
- Copyright © Cambridge University Press 2010
Footnotes
*
All views expressed in this paper are strictly personal and should not be understood or quoted as being made on behalf of the European Medicines Agency.
References
1 Please see recital 3 of the Directive 2004/24/EC.
2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 28.11.2001, p. 67).
3 Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal product for human use (OJ L 136 30.4.2004, p. 85).
4 Recital 12 of the Directive 2004/24/EC.
5 Regulation (EC) 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31 1.2.2002, p. 1).
6 Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169).
7 Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17); Directive 93/42/EC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1); Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices (OJ 331, 7.12.1998, p. 1).
8 According to the Article 1 (30) of the Directive 2001/83/EC herbal medicinal product is any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more herbal substances in combination with one or more such herbal preparations.
9 Please see Article 16a(1) of the Directive 2001/83/EC.
10 According to the Article 16c(1)(c) of the Directive 2001/83/EC it should be at least 30 years preceding the date of the application, including at least 15 years within the EU.
11 Standard requirements are described in Article 8 of the Directive 2001/83/EC, while Article 16c describes specific documental requirements for THMP registration.
12 Please see Article 16c(1)(c) of the Directive 2001/83/EC.
13 Please see Article 16a(2) and (3) of the Directive 2001/83/EC.
14 HLH Warenvertrieb and Orthica, para. 56; Commission v. Germany, “Garlic preparation”, para. 37; Hecht-Pharma, “Red Rice”, para. 28; Delattre, paras. 27–29; Commission v. Austria, paras. 59–60; Commission v. Germany, C-387/99, paras. 52–53; Laboratoires Sarget of 12 March 1998, C-270/96, para. 23; Monteil and Samanni, para. 28.
15 HLH Warenvertrieb and Orthica, para. 60.
16 Regulation (EC) 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31 1.2.2002, p. 1).
17 Motte of 10 December 1985, Case 247/84, paras. 20, 24; Delattre, paras. 31–32.
18 Motte, para. 20.
19 Delattre, paras. 31–32.
20 Please see <http://www.ema.europa.eu/pdfs/general/manage/mbpr/16937110en.pdf> (press release from EMA Management Board meeting, 17–18 March 2010).