Transcription of Guideline on specifications: test procedures and ...
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Guideline on specifications: test procedures and ...
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail Website European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 05 June 2018 1 2 EMA/HMPC/162241/20051 Rev. 3 3 4 Committee on herbal Medicinal Products (HMPC) 5 Guideline on specifications: test procedures and 6 acceptance criteria for herbal substances2, herbal 7 preparations3 an d herbal medicinal products4/ traditional 8 herbal medicinal products 9 DRAFT Revision 3 Discussion at the HMPC January March 2005 Draft agreed by Quality Working Party April 2005 Adoption by CHMP for release for consultation 26 May 2005 Adoption by CVMP for release for consultation 15 June 2005 End of consultation (deadline for comments) 15 September 2005 Discussion at the HMPC November 2005 January 2006 Adoption by the HMPC 22 January 2006 Agreed by Quality Working Party February 2006 Adoption by CHMP 23 March 2006 Adoption by CVMP 16 March 2006 Date for coming into effect 1 October 2006 Revis
57 herbal medicinal products/traditional herbal medicinal products’. Further to the adoption of Directive 58 2004/24/EC for traditional herbal medicinal products for human use, the guideline was updated to take 59 account of the newly introduced definitions and responsibilities. In addition, other clarifications and 60
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