Transcription of Guideline on Active Substance Master File Procedure
{{id}} {{{paragraph}}}
Example: quiz answers
Guideline on Active Substance Master File Procedure
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 8 November 2018 CHMP/QWP/227/02 Rev 4/ Corr * EMEA/CVMP/134/02 Rev 4/ Corr * Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use ( CVMP) Guideline on Active Substance Master File Procedure Discussion at the HMPC November 2005 January 2006 Adoption by the HMPC 22 January 2006 Draft agreed by Quality Working Party 9 February 2006 Adoption by CHMP for release for consultation 23 March 2006 Adoption by CVMP for release for consultation 20 April 2006 End of consultation (deadline for comments) 30 August 2006 Agreed by Quality Working Party 1 December 2011 Adopt
the active substance and its use in the medicinal product needs to be justified in this MAA or MAV. Although the ASMF procedure is developed to keep intellectu al property of the ASM confidential, it is also permissible to use the procedure when there is no confidentiality issue between the Applicant/MA . 1.
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: