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Committee for Veterinary Medicinal Products CVMP

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). [Pg.138]

Table 3 Comparison of US FDA, US EPA, and EU Committee for Veterinary Medicinal Products (CVMP) method validation requirements... Table 3 Comparison of US FDA, US EPA, and EU Committee for Veterinary Medicinal Products (CVMP) method validation requirements...
The principal scientific bodies of the EMEA are the Committee for Proprietary Medicinal Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP). These committees have two members from each member state as well as from Norway and Iceland which are appointed to give independent scientific advice to the EMEA. [Pg.64]

The Committee for Human Medicinal Products (CHMP), Committee for Veterinary Medicinal Products (CVMP) and Committee for Orphan Medicinal Products (COMP) are the major committees run by this agency to ensure the above objectives. Additional support comes from more than 90 Working Parties (e.g., on efficacy, safety, quality, biotechnology, pharmacovigilance, blood and plasma, etc.) as well as ad-hoc Expert Groups (on subjects like pediatric use, bioterrorism, oncology, anti-HIV drugs, etc.) and also approximately 2500 European experts from competent national authorities. [Pg.1678]

Committee for Veterinary Medicinal Products (CVMP) 203, 204 complement activation 270, 273 complex PK/PD model 169 Contract Research Organisations (CROs) 129 Coomassie 49 copegus 136 Coptis japonica 29 copyright 187 corapporteur 204 com 37 COS-1 260 cosmetics 206 Creutzfeld-Jacob 120 Crohn s disease 132 crop cultivation 35 cross-presentation 82 cross-reactivity 106 CSF 225 CVM 207 cydohexamide 13 cydosporin 25 cydosporine A 12 cystic fibrosis 183, 250 cytochrome P450 17, 151... [Pg.301]

The institution responsible for the common (supranational) registration of veterinary drugs in the EU is the Committee for Veterinary Medicinal Products (CVMP), which is organisationally subordinate to the European Medicines Evaluation Agency (EMEA). The basic principle is that no new veterinary preparation can be registered for use if the manufacturer cannot demonstrate that the drug is not safe to the treated animal (patient), the consumer, the attending person and the environment. [Pg.906]


See other pages where Committee for Veterinary Medicinal Products CVMP is mentioned: [Pg.300]    [Pg.645]    [Pg.86]    [Pg.346]    [Pg.115]    [Pg.285]    [Pg.447]    [Pg.398]    [Pg.167]    [Pg.1849]    [Pg.27]    [Pg.203]    [Pg.41]   
See also in sourсe #XX -- [ Pg.30 , Pg.138 ]

See also in sourсe #XX -- [ Pg.86 ]

See also in sourсe #XX -- [ Pg.1595 , Pg.1597 ]




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CVMP (

Committee for Medicinal Products

Medicines Committee

Medicines products

Veterinary Products Committee

Veterinary products

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