Transcription of NOTE: The CMD(h) ‘Annotated’ QRD Template …
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NOTE: The CMD(h) ‘Annotated’ QRD Template …
Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human CMD(h) ANNOTATED QRD Template FOR MR/DC PROCEDURES. (Based on version of the QRD Template for CP). November 2005. Revision 3, October 2006. NOTE: The CMD(h) Annotated' QRD Template provides guidance on how to present the SPC, Labelling and Package Leaflet for an application in the Mutual Recognition or Decentralised Procedure. The clean' QRD Template for use in a MRP, DCP or referral procedure is published in all languages on the website of the EMEA. SUMMARY OF PRODUCT CHARACTERISTICS. [NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC, as amended, for the Mutual Recognition Procedure and the Decentralised Procedure.]
CMD(h) Annotated QRD Template for MR/DC Procedures October 2006 Page 4/20 5.3 Preclinical safety data <Non-clinical data reveal no special hazard for humans based on conventional studies of safety
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