in Tag: Biological Medicines  (clear all)

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Safety of Veterinary Biologicals (MCC: 3.08, Jan 2004)

This guideline provides information on the safety aspects of veterinary biological medicines. Circular 3.0 H

Related Tags (New Search): Biological medicines,   Safety and performance,   Safety,   Veterinary medicine


This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.

Related Tags (New Search): Medical devices,   Biological medicines,   Medicines

Pre-registration Consultation Meeting (MCC: 2.39, Mar 2015)

This document provides guidance on the procedures involved in the scheduling and conduct of pre—registration consultation meetings in respect of applications for biological medicines. It focuses on issues relating to the development of biological medicines in the planning phase of…

Related Tags (New Search): Biological medicines,   Application

Efficacy of Veterinary Biologicals (V 1, MCC: 3.06, Jan 2004)

This guideline provides information to applicants wishing to submit data as evidence of efficacy for veterinary biological medicines

Related Tags (New Search): Biological medicines,   Veterinary medicine,   Efficacy,   Clinical trial

Substitution of Medicines (MCC: 2.10, Apr 2010)

This guideline replaces the guideline on generic substitution published in 2003. It effectively cancels the list of not substitutable medicines. The only medicines declared to be not substitutable following this guideline of Biosimilars.

Related Tags (New Search): Biological medicines