New HMPC Guideline Published

GMP News No. 895: New HMPC Guideline Published

GMP News
1 March 2007
 

New HMPC Guideline Published

 
On 11 January 2007 the European Medicines Agency (EMEA) published the HMPC Guideline "Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products". With this document the EMEA Committee on Herbal Medicinal Products wants to provide uniform standards for generating Community herbal monographs. The structure of these common monographs should be alike the structure of the "Summary of Product Characteristics (SPC)". The content should cover the following items:
  • Name of the medicinal product
  • Qualitative und quantitative composition
  • Pharmaceutical form
  • Clinical particulars (therapeutic indications, contraindications, etc.)
  • Pharmacological properties (usually not required for traditional herbal medicinal products!)
  • Pharmaceutical particulars (physical or chemical incompatibilities, special precautions for storage, etc.)

The complete EMEA document on HMPC is available here:
http://www.emea.europa.eu/pdfs/human/hmpc/18232005en.pdf

Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)
 

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