What does CVMP mean in VETERINARY
The Committee on Veterinary Medical Products (CVMP) is a regulatory body created by the European Medicines Agency to assess and monitor veterinary medicines. CVMP ensures that veterinary medicines available in Europe are safe, effective and of good quality when appropriately used.
CVMP meaning in Veterinary in Medical
CVMP mostly used in an acronym Veterinary in Category Medical that means Committee on Veterinary Medical Products
Shorthand: CVMP,
Full Form: Committee on Veterinary Medical Products
For more information of "Committee on Veterinary Medical Products", see the section below.
» Medical » Veterinary
Essential Questions and Answers on Committee on Veterinary Medical Products in "MEDICAL»VET"
What is the Committee on Veterinary Medical Products?
What does CVMP do?
CVMP evaluates the data related to veterinary medicinal products submitted by the medicine’s sponsors to ensure they meet safety requirements before authorisation is granted. After authorisation, CVMP continuously monitors their use by means of pharmacovigilance activities as well as medical literature reviews.
How does CVMP regulate veterinary medicines in Europe?
The committee carries out risk/benefit assessment of each application for marketing authorisation of a new medicine or modification to an already authorised product before granting approval. This includes evaluating clinical trial data and other relevant information submitted by the applicant.
What types of veterinary medicine does CVMP regulate?
The committee regulates all types of veterinary medicines, including those intended for treatment and prevention of diseases in animals, vaccines, medicated feed additives and immunostimulants.
What criteria must a veterinary medicine meet in order to be approved by CVMP?
The criteria established by the committee cover areas such as quality control standards, safety for humans, animals and the environment; efficacy; shelf life; labelling; packaging characteristics; stability studies; clinical trials involving animals and/or humans and preclinical studies.
Does CVMP review applications for marketing authorization changes (Variations)?
Yes, once a product has been authorised by CVMP any modifications made to its marketing authorization will also require evaluation before being granted approval. This includes changes concerning manufacturing or storage conditions or addition or removal of indications, routes of administration or excipients.
Can I apply directly to CVMP for marketing authorization for a new veterinary medicinal product?
No, you cannot directly submit an application to CVMPU applications must be made through one of the national regulatory authorities within the European Economic Area (EEA). However, you can ask them to refer it to the committee if appropriate once submitted.
Are there penalties if I don't follow EU regulations on veterinary medicines set out by CVMP?
Yes, failure comply with EU regulations may lead court action prosecutions resulting fines imprisonment.
CVMP also stands for: |
|
| All stands for CVMP |