EMA European Medicines Agency : Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021, CVMP, 18/06/2021

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Tessie (tasipimidine), from Orion Corporation, a new product for the short-term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure.

The Committee adopted by consensus a positive opinion for a marketing authorisationapplication for Fatrovax RHD, from Fatro S.p.A, a new vaccine for the active immunisation of rabbits from 28 days of age against rabbit haemorrhagic disease caused by RHDV and RHDV2.

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Strangvac, from Intervacc A.B., a new vaccine for the active immunisation of horses from 8 months of age to reduce clinical signs of disease in the acute stage of infection with Streptococcus equi and reduction in number of abscesses within submandibular and retropharyngeal lymph nodes.

The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:

• Baycox Iron
• Eryseng and Eryseng Parvo (worksharing grouped procedure)
• Locatim (grouped)
• Porcilis ColiClos

The Committee also adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure) for BTVPUR and other related nationally authorised products concerning quality-related changes.

Community referrals and related procedures

The Committee concluded the referral procedure for Ronaxan and its associated names (doxycycline) for which Boehringer Ingelheim is the marketing authorisation holder. The matter was referred to the Committee by Germany under Article 34 of Directive 2001/82/EC due to divergent decisions taken by Member States resulting in differences in the product information, mainly with respect to e.g. target species, indications and posology. The Committee agreed harmonised product information for the concerned products and adopted by consensus an opinion concluding that the marketing authorisations of the concerned products should be varied in order to amend the product information accordingly.

Scientific advice

The Committee adopted two separate scientific advice reports further to requests for initial advice for two immunological products. The respective target species were pigs (one product) and cats (one product).

The Committee also endorsed one clarification report relating to scientific advice previously provided for a pharmaceutical product for horses.

Pharmacovigilance

The Committee adopted a recommendation for changes to the summary of product characteristics for Bravecto spot-on as outcome of signal detection activities.

The Committee reviewed the PSURs for Cerenia, Prevomax and Vectra Felis and concluded that changes to their product information were required. The Committee also reviewed the PSURs for Aservo EquiHaler, Credelio, Equilis Te, Evicto, Halagon, HorStem, Isemid, Nasym, Neptra, Nobivac Myxo RHD Plus, Sedadex, Stelfonta, Stronghold, SyvazulBTV, Ubac, Ypozane and Zactran and concluded that no further action was required.

Concept papers, guidelines and SOPs

Safety

The Committee adopted a new concept paper (EMA/CVMP /SWP/265238/2021) for the revision of guidelines related to residues to align with the new definition for withdrawal periods provided in Regulation (EU) 2019/6 for a six-weeks period of public consultation.

Antimicrobials

The Committee adopted a revised guideline on the SPC for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1) following the close of the public consultation. The guideline has been amended to take into account comments received during public consultation. The revised guideline will come into effect on 28 January 2022.

Immunologicals

The Committee adopted a draft revised guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines (EMA/CVMP/IWP/258685/2021) for a three-month period of public consultation. The guideline has been amended to align with the provisions for multi-strain dossiers in Regulation (EU) 2019/6. The comments received during the consultation of the concept paper were considered.

The Committee adopted a draft guideline on data requirements for vaccine antigen master files (EMA/CVMP< /a>/IWP/258755/2021) for a three-month period of public consultation. The comments received during the consultation of the concept paper were considered.

The Committee adopted a concept paper for the revision of the 'Guideline on requirements for the production and control of immunological veterinary medicinal products ' (EMA/CVM P/IWP/284316/2021) for a three-month period of public consultation. The concept paper discusses the changes to be introduced to the existing guideline to bring it in line with the provisions in Regulation (EU) 2019/6.

Pharmacovigilance

The Committee adopted the combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA/CV MP/PhVWP/10418/2009-Rev.12); list of changes to combined VeDDRA list of clinical terms (EMA/C VMP/PhVWP/214371/2021) and non-current VeDDRA Low Level Terms and codes (EMA/102082/2021- Rev.5) following the yearly review and update. The Committee also 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.13). Implementation of the revised VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for 1 October 2021.

Legislation

The Committee adopted the draft veterinary good pharmacovigilance practice (VGVP) modules on collection and recording of suspected adverse events for veterinary medicinal products (EMA/635856/2020), on signal management (EMA/307620/2021), on veterinary pharmacovigilance communication (EMA/63454/2021), on controls and pharmacovigilance inspections (EMA/264458/2021), on pharmacovigilance systems, their quality management systems and pharmacovigilance system master files (EMA/257136/2021) and Annex Glossary (EMA/118227/2021) for a two-month period of public consultation.

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'.