The European Medicines Agency Committee for Medicinal Products for Veterinary Use (CVMP) prepares scientific guidelines, in consultation with the competent authorities of the EU Member States, to help applicants prepare marketing-authorisation applications for medicinal products for human use.
Guidelines are intended to provide a basis for practical harmonisation of the manner in which the EU Member States and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy contained in the Community directives. They also help to ensure that applications for marketing authorisation are prepared in a manner that will be recognised as valid by the Agency.
Quality guidelines are provided for:
- Active substance
- Availability (minor uses / minor species)
- Post approval change management protocols
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