Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 June 2022

The Committee elected Dr Frida Hasslung Wikström from Sweden as its new Vice-Chair for a
3-year mandate.

CVMP opinions on veterinary medicinal products

Under Regulation (EU) 2019/6

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Circovac (adjuvanted inactivated vaccine against porcine circovirus type 2) to extend the duration of immunity and to extend the duration of lethargy observed after mixed use with Hyogen

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Nobilis IB 4-91 (avian infectious bronchitis vaccine (live, attenuated)) to add the claim for associated non-mixed use with Innovax-ND-ILT in the product information.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Credelio (lotilaner) 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:

Onsior
Suprelorin
Loxicom
Felpreva

Under Regulation (EC) No 726/2004

The Committee adopted by consensus a positive opinion for a marketing authorisation for Evanovo (coccidiosis vaccine live for chickens) from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of chickens to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima and Eimeria praecox, and for the reduction of clinical signs, intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria tenella.

The Committee adopted by consensus a positive opinion for a marketing authorisation for DogStem (equine umbilical cord mesenchymal stem cells) from EquiCord, S.L., a new product for reduction of pain and lameness associated with osteoarthritis in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation for Cortaderm (hydrocortisone aceponate), from Alfasan Nederland B.V., a new product for the symptomatic treatment of inflammatory and pruritic dermatoses in dogs and for alleviation of clinical signs associated with atopic dermatitis in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation for Coxatab (firocoxib), from CP-Pharma Handelsgesellschaft mbH, a new product for the relief of pain and inflammation associated with osteoarthritis and for the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.

Under Regulation (EC) No 1234/2008

The Committee adopted by consensus a positive opinion for a grouped type II variation for Bravecto (fluralaner) chewable tablets for dogs concerning the addition of two new therapeutic indications, for persistent tick killing activity from 7 days to 12 weeks after treatment for Ixodes hexagonus and for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for up to 12 weeks.

Maximum residue limits

The Committee agreed to include benzethonium chloride as a new entry in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, under the heading of excipients. This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.

The Committee adopted the updated list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 – Rev.52.

Scientific advice

The Committee adopted three scientific advice reports further to requests for initial advice. One request concerned an immunological product and two requests concerned pharmaceutical products. The respective target species were cattle, goats, pigs and sheep (one product), dairy cows (one product) and salmon.

Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6

Following three requests, the CVMP classified:

A product (ATCvet classification: Immunologicals) for turkeys as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
A product (ATCvet classification: Immunologicals) for Atlantic salmon as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
A product (ATCvet classification: Alimentary tract and metabolism) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

The Committee reviewed an updated request for classification of a veterinary medicinal product (ATCvet classification: Alimentary tract and metabolism) for horses. The Committee confirmed its previous considerations and classified the product as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Pharmacovigilance

Under Regulation (EU) 2019/6

The Committee endorsed a recommendation for changes to the product information for Cardalis as an outcome of signal detection activities.

Under Regulation (EC) No 726/2004

The Committee endorsed a recommendation for changes to the product information for Suprelorin as an outcome of signal detection activities.

Concept papers, guidelines and SOPs

Efficacy

The Committee adopted a guideline on data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats (EMA/CVMP/EWP/278031/2015), following the close of the public consultation. The comments received during the consultation procedure have been taken into account. Changes introduced mainly concern clarifications regarding data requirements (e.g. number and type of studies, adherence to acceptable quality standards), study design, welfare of animals used in studies, but also other sections as requested by stakeholders. The guideline has also been updated in line with the currently applicable legislation and terminology. The guideline will come into effect on 1 January 2023.

Immunologicals

The Committee adopted a revised guideline on requirements for the production and control of immunological veterinary medicinal products (EMA/CVMP/IWP/206555/2010 – Rev.2), following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the revision of the guideline. Changes introduced following the public consultation mainly include the addition of references to 3R’s aspects and several minor editorial amendments. The revised guideline will come into effect on 16 December 2022.

Pharmacovigilance

The Committee adopted the following lists used for electronic reporting of suspected adverse reactions following the yearly review and update:

CVMP combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA/CVMP/PhVWP/10418/2009 - Rev.13).
List of changes to combined VeDDRA list of clinical terms (EMA/CVMP/PhVWP/237953/2022).

The Committee adopted the revised guidance notes on the use ofVeDDRA terminology for reporting suspected adverse reactions in animals and humans (EMA/CVMP/PhVWP/288284/2007 - Rev. 14), and the non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) terms and codes (EMA/CVMP/PhVWP/360871/2010). The implementation of the standard lists in EudraVigilance Veterinary is provisionally scheduled for 1 October 2022.

Quality

The Committee adopted a list of questions and answers on titanium dioxide. The document aims to provide technical and procedural guidance to replace/remove titanium dioxide in medicines and it will be published on the Agency’s website after its adoption by the CHMP, CMDh and CMDv which is foreseen for their June 2022 meetings.

International harmonisation

The Committee adopted nine revised VICH guidelines on efficacy of anthelmintics for consultation in the EU following the sign-off by the VICH Steering Committee at step-4 of the VICH process:

VICH GL07(R) – Anthelmintics – General requirements (EMA/CVMP/VICH/832/1999-Rev.1)
VICH GL12(R) – Anthelmintics – Bovines (EMA/CVMP/VICH/839/1999-Rev.1)
VICH GL13(R) – Anthelmintics – Ovines (EMA/CVMP/VICH/840/1999-Rev.1)
VICH GL14(R) – Anthelmintics – Caprines (EMA/CVMP/VICH/841/1999-Rev.1)
VICH GL15(R) – Anthelmintics – Equines (EMA/CVMP/VICH/833/1999-Rev.1)
VICH GL16(R) – Anthelmintics – Porcines (EMA/CVMP/VICH/834/1999-Rev.1)
VICH GL19(R) – Anthelmintics – Canines (EMA/CVMP/VICH/835/1999-Rev.1)
VICH GL20(R) – Anthelmintics – Felines (EMA/CVMP/VICH/545/2000-Rev.1)
VICH GL21(R) – Anthelmintics – Chickens (EMA/CVMP/VICH/546/2000-Rev.1)

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”.