The Legal and Regulatory Framework of Herbal Medicinal Products in the European Union: A Focus on the Traditional Herbal Medicines Category

Author:

Anquez-Traxler Christelle

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Reference11 articles.

1. 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. Off J Eur Union, 2001;L311/ 67:67–128.

2. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Off J Eur Union. 2004;L136/34:34–57.

3. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Off J Eur Union. 2004; L136/34:34–57.

4. AESGP on behalf of the European Commission. Herbal medicinal products in the European Union. 1998. http://www.aesgp.be/HerbalStudy1998/HerbalMedicines_EN.pdf.

5. Committee on Herbal Medicinal Products. Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations. EMEA/HM PC/104613/2005. September 7, 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09WC500003644.pdf.

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