Transcription of Guideline on Inhalational medicinal products
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Guideline on Inhalational medicinal products
European Medicines Agency Inspections 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 21 June 2006 Doc Ref.: EMEA/CHMP/QWP/49313/2005 Corr COMMITTEE FOR medicinal products FOR HUMAN USE (CHMP) Guideline ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL products DRAFT AGREED BY QUALITY WORKING PARTY October 2004 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 19 January 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) 30 July 2005 AGREED BY QUALITY WORKING PARTY February 2006 ADOPTION BY CHMP 23 March 2006 DATE FOR COMING INTO EFFECT 1 October 2006 Note: This Guideline has been prepared in collaboration with Health Canada and represents a harmonised Guideline .
safety testing (e.g., for excipients and leachables) is also addressed. Additional quality aspects (e.g., impurities, process validation, stability testing, specifications) as well as safety and efficacy aspects, are described in other guidance documents, including ICH guidelines.
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