Article 30(3) opinions
Table of contents
- Dapsone as an impurity in veterinary medicinal products containing sulphamethoxazole or other sulphonamides
- Histamine residues in veterinary medicinal products containing gentamicin for parental administration to horses
- Potential risk for the consumer resulting from the use of lidocaine in food producing species
- Retrovirus RD114 in live attenuated vaccines for use in animals
- Risk for the consumer resulting from the use of diethanolamine as an excipient in veterinary medicinal products for food-producing species
- Risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac
This pages lists the opinions drawn up by the Committee for Medicinal Products for Veterinary Use (CVMP) on any scientific matter related to the evaluation of medicines for use in animals. The Committee must draw up such an opinion at the request of the Executive Director of the European Medicines Agency or of the European Commission. It may also draw up an opinion following a request from a Member State.
Where the scientific issue concerns both human and veterinary medicines, the Committee may adopt a common opinion with the Committee for Medicinal Products for Human Use (CHMP).
Requests for this type of scientific opinion fall under Article 30(3) of Regulation (EC) No 726/2004.
Dapsone as an impurity in veterinary medicinal products containing sulphamethoxazole or other sulphonamides
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Opinion of the CVMP pursuant to Article 30(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council on dapsone as an impurity in veterinary medicinal products containing sulphamethoxazole or other ... (PDF/130.23 KB)
First published: 04/02/2013
Last updated: 04/02/2013
EMA/CVMP/392253/2012 -
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CVMP assessment report under Article 30(3) of Regulation (EC) No 726/2004 for dapsone as an impurity in veterinary medicinal products containing sulphamethoxazole or other sulphonamides (PDF/292.98 KB)
Adopted
First published: 04/02/2013
Last updated: 04/02/2013
EMA/CVMP/392271/2012
Histamine residues in veterinary medicinal products containing gentamicin for parental administration to horses
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CVMP assessment report regarding the request for an opinion under Article 30(3) of Regulation (EC) No. 726/2004 (PDF/315.93 KB)
First published: 30/11/2018
EMA/CVMP/766265/2018 -
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Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004 (PDF/95.88 KB)
First published: 30/11/2018
EMA/CVMP/727329/2018
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CVMP assessment report regarding the request for an opinion under Article-30(3) of Regulation (EC) No 726/2004 in relation to the potential risk for the consumer resulting from the use of lidocaine in food producing spec... (PDF/557.49 KB)
Adopted
First published: 22/04/2015
Last updated: 22/04/2015
EMA/CVMP/118717/2015 -
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Opinion of the Committee for Medicinal Products for Veterinary Use regarding a request pursuant to Article-30(3) of Regulation (EC) No 726/2004 in relation to the potential risk for the consumer resulting from the use of... (PDF/107.01 KB)
First published: 22/04/2015
Last updated: 22/04/2015
EMA/CVMP/124059/2015 -
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Request for an opinion regarding a request pursuant to Article-30(3) of Regulation (EC) No 726/2004 in relation to the potential risk for the consumer resulting from the use of lidocaine in food producing species (PDF/42.08 KB)
First published: 22/04/2015
Last updated: 22/04/2015
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Public statement on the evaluation of the compliance of marketing authorisation holders with CVMP Risk Management Strategy with respect to potential presence of RD114 in feline and canine vaccines (PDF/78.01 KB)
First published: 11/12/2018
EMA/CVMP/814776/2018 -
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CVMP Risk Management Strategy - Managing the risk of the potential presence of replication competent endogenous retrovirus RD114 in starting materials and final products of feline and canine vaccines (PDF/239.91 KB)
First published: 24/02/2017
Last updated: 24/02/2017
EMA/CVMP/IWP/592652/2014 -
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Opinion of the CVMP pursuant to Article 30(3) of Regulation (EC) No 716/2004 of the European Parliament and of the Council on retrovirus RD114 in live attenuated vaccines for use in animals (PDF/55.59 KB)
First published: 14/10/2010
Last updated: 14/10/2010
EMA/CVMP/433418/2010 -
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CVMP assessment report: feline endogenous retrovirus RD114 in some live attenuated vaccines commercially available in the EU for use in animals (PDF/121.35 KB)
First published: 14/10/2010
Last updated: 14/10/2010
EMA/CVMP/300321/2010
Risk for the consumer resulting from the use of diethanolamine as an excipient in veterinary medicinal products for food-producing species
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CVMP assessment report regarding the request for an opinion under Article 30(3) of Regulation (EC) No. 726/2004 in relation to the potential risk for the consumer resulting from the use of diethanolamine as an excipient ... (PDF/477.44 KB)
Adopted
First published: 25/07/2018
Last updated: 25/07/2018
EMA/CVMP/468348/2018 -
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Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004 on the potential risk for the consumer resulting from the use of diethanolamine as an excipient ... (PDF/86.56 KB)
First published: 25/07/2018
Last updated: 25/07/2018
EMA/CVMP/473059/2018 -
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Public consultation concerning a request for CVMP opinion under Article 30(3) of Regulation (EC) No 726/2004 on the risk for the consumer resulting from the use of diethanolamine as an excipient in veterinary medicinal p... (PDF/84.49 KB)
Draft: consultation closed
First published: 16/03/2018
Last updated: 16/03/2018
Consultation dates: 16/03/2018 to 14/05/2018
EMA/CVMP/157690/2018
Risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac
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CVMP assessment report under Article 30(3) of Regulation (EC) No 726/2004 on the risk to vultures and other necrophagous bird populations in the European Union in connection with the use of veterinary medicinal products ... (PDF/889.58 KB)
Adopted
First published: 12/12/2014
Last updated: 12/12/2014
EMA/CVMP/721170/2014 -
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Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004 - On the risk to vultures and other necrophagous bird populations in the European Union in conne... (PDF/127.7 KB)
First published: 12/12/2014
Last updated: 12/12/2014
EMA/CVMP/761582/2014 -
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Overview of comments received on public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bir... (PDF/806.01 KB)
First published: 12/12/2014
Last updated: 12/12/2014
EMA/715812/2014 -
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Consultation procedure - Public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird popula... (PDF/87.37 KB)
Draft: consultation closed
First published: 12/09/2014
Last updated: 12/09/2014
Consultation dates: 12/09/2014 to 10/10/2014
EMA/545597/2014 -
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Request for an opinion regarding the risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac (PDF/27.4 KB)
First published: 12/09/2014
Last updated: 12/09/2014 -
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Template for comments - Public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird populat... (DOC/170 KB)
First published: 12/09/2014
Last updated: 12/09/2014