Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022

News 09/12/2022

CVMP opinions on veterinary medicinal products

Under Regulation (EU) 2019/6

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Brucellin Aquilon (Brucella abortus), from Aquilon Cyl S.L., a new product for in vivo diagnosis of Brucella infected pigs (skin test) to discriminate false positive results by Brucella serological tests.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Porcilis PCV ID (subject to worksharing procedure), concerning the update of the product information of Porcilis PCV ID to include new associated use combinations of Porcilis PCV ID, Porcilis Lawsonia ID, Porcilis M Hyo ID ONCE and Porcilis PRRS.

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Simparica Trio, concerning the addition of three new therapeutic indications: for the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis), for the treatment of demodicosis (caused by Demodex canis), and for the prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection).

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Credelio Plus, concerning the addition of a new therapeutic indication for the treatment of demodicosis (caused by Demodex canis).

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for NexGard and Nexgard Spectra, subject to worksharing procedure, concerning the addition of two new therapeutic indications for the treatment of tick infestations with Hyalomma marginatum and for the treatment of ear mite infestations (caused by Otodectes cynotis), and to amend the product information to allow the use of the products in breeding, pregnant and lactating female dogs.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Prevomax to align the product information with version 9.0 of the QRD template.

The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for :

Locatim
Solensia
Purevax RC, Purevax RCP FeLV, Purevax RCPCh FeLV, BTVPUR, Eurican Herpes 205, Purevax RCPCh and Purevax RCP (subject to worksharing procedure)
Suvaxyn CSF Marker, Fevaxyn Pentofel and Suvaxyn PRRS MLV (subject to worksharing procedure)
Mirataz
Imoxat
Panacur Aquasol (subject to worksharing procedure)
Procox (2 procedures)
Bluevac BTV

Union referrals and related procedures

The Committee concluded the referral procedure for veterinary medicinal products containing N-methyl pyrrolidone as an excipient. The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns relating to the appropriateness of user and target animal safety warnings in view of the teratogenic potential of N-methyl pyrrolidone. The Committee concluded that user and/or target animal safety warnings should be added to the product information of the vast majority of veterinary medicinal products concerned. Furthermore, the Committee agreed that no changes need to be made in the product information for the remaining veterinary medicinal products concerned by this referral. The Committee adopted by consensus an opinion concluding that the benefit-risk balance of the concerned products remains favourable and that the marketing authorisations should be varied or maintained, as applicable.*

Scientific advice

The Committee adopted two scientific advice reports further to requests for initial advice concerning one immunological product for piglets and a substance intended for inclusion in the list of substances considered as not falling within the scope of Regulation No 470/2009.

The Committee endorsed one clarification of a scientific advice concerning a pharmaceutical product for mice, rats, hamsters, gerbils, guinea pigs, chinchillas and rabbits.

Pharmacovigilance

Under Regulation (EU) 2019/6

The Committee adopted recommendations for changes to the summary of product characteristics for Bravecto, Proteq West Nile, Procox, Zuprevo, Felpreva and Improvac as outcome of signal detection activities.

Concept papers, guidelines and SOPs

Environmental Risk Assessment

The Committee adopted a draft reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs (EMA/CVMP/ERA/31905/2022) for a 3-month period of public consultation. This reflection paper has been developed to communicate the CVMP's view on the scientific discussion regarding the potential environmental impact(s) of ectoparasiticidal veterinary medicinal products used in cats and dogs, and provides an opportunity for stakeholders to contribute their views.

Efficacy

The Committee adopted a Questions and answers document on the ‘Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products' (EMA/CVMP/EWP/799840/2022).

Quality

The Committee adopted a draft concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products (EMA/CVMP/637041/2022) for a 3-month period of public consultation.

The Committee adopted a revised reflection paper on the definition of new active substance status - Veterinary (EMA/CVMP/QWP/3629/2016). This reflection paper has been revised to align to Regulation (EU) 2019/6.

The Committee adopted the following revised guidelines (GL) to align to Regulation (EU) 2019/6:

GL on development pharmaceutics for veterinary medicinal products (EMA/CVMP/QWP/684556/2022)
GL on chemistry of active substance veterinary (EMA/CVMP/QWP/707366/2017)
GL on control of impurities of pharmacopoeial substances (EMA/CVMP/QWP/907965/2022)
GL on parametric release (EMA/CVMP/QWP/339588/2005)
GL on declaration of storage conditions (EMA/CVMP/QWP/857608/2022)
GL on stability of existing active substance and related finished product (EMA/CVMP/QWP/709423/2022)
GL on additional quality requirements for products intended for incorporation into animal feed (EMA/CVMP/QWP/711629/2022)
GL on quality of single-dose spot-on products (EMA/CVMP/QWP/544461/2007)
GL on quality of modified release oral dosage forms - veterinary (EMA/CVMP/QWP/908160/2022).

Working parties

The Committee adopted the work plans for 2023 for the CVMP Working Parties on Antimicrobials (EMA/CVMP/AWP/715896/2022), Environmental Risk Assessment (EMA/CVMP/ERA/828487/2022), Efficacy (EMA/CVMP/EWP/817611/2022), Novel Therapies and Technologies (EMA/CVMP/NTWP/701391/2022), Pharmacovigilance (EMA/CVMP/PhVWP/593990/2022), Scientific Advice (EMA/CVMP/SAWP/827784/2022), and Joint CHMP/CVMP Quality Working Party, which will be published on the Agency’s website.

Cooperation with other EU agencies

The Committee adopted a report, prepared in collaboration with EFSA, on the development of a harmonised approach on exposure assessment methodologies for residues from VMPs, feed additives and pesticides in food of animal origin following close of public consultation.

Organisational matters

The Committee adopted the CVMP work plan for 2023 (EMA/CVMP/617330/2022).

More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.

*The information on the referral procedure for veterinary medicinal products containing N-methyl pyrrolidone as an excipient was corrected on 15 March 2023 to better clarify the different outcomes of the procedure, highlighting that the Committee did recommend changes to the product information for the vast majority of veterinary medicinal products concerned.