The legal framework governing the quality of (traditional) herbal medicinal products in the European Union

Author:

Kroes Burt H.

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference17 articles.

1. EMA, 2014a. Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products (EMA/HMPC/71049/2007 Rev.1). 〈http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/05/WC500143161.pdf〉 (accessed on March 2014).

2. EMA, 2014b. Guideline on good agricultural and collection practice for starting materials of herbal origin (EMEA/HMPC/246816/2005). 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pdf〉 (accessed March 2014).

3. EMA, 2014c. Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework (EMEA/P/24143/2004 Rev. 1 corr). 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004011.pdf〉 (accessed March 2014).

4. EMA, 2014d. Mandate, objective and composition for the HMPC quality drafting group (Q DG). 〈http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/02/WC500073692.pdf〉 (accessed March 2014).

5. EMA, 2014e. Guideline on quality of herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2819/00 Rev. 2). 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003370.pdf〉 (accessed March 2014).

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