Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021

News 19/02/2021

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Credelio Plus (lotilaner and milbemycin oxime combination) from Elanco GmbH, a new antiparasitic product for oral use in dogs with, or at risk from, mixed infestations/infections of ticks, fleas, gastrointestinal nematodes, heartworm and/or lungworm.

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Daxocox (enflicoxib) from Ecuphar NV, a new product for the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs. 

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Ultifend ND IBD from Ceva-Phylaxia Veterinary Biologicals Co. Ltd, a new vaccine for the active immunisation of chickens or chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by Newcastle disease virus and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent of infectious bursal disease virus (IBDV); to reduce mortality, clinical signs and lesions caused by classical Marek’s disease virus.

The Committee adopted by consensus positive opinions for extensions of the existing authorisation for Emdocam (meloxicam) from Emdoka BVBA concerning:

  • the addition of a new strength of 5 mg/ml solution for injection and to add cats and dogs as new target species;
  • the addition of a new strength of 15 mg/ml and new pharmaceutical form (oral suspension) for horses.

The Committee adopted by consensus a positive opinion for a type II variation application for Equioxx to introduce a new pharmacovigilance system.

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

The Committee also adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure) for Eurican Herpes 205 and other related nationally authorised products concerning quality-related changes.

Renewals of marketing authorisations

The Committee adopted by consensus a positive opinion for the renewal of the marketing authorisation for Sevohale. The Committee, having re-assessed the benefit-risk balance of the product, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewal of the marketing authorisation.

Scientific advice

The Committee adopted five separate scientific advice reports further to requests for initial advice of which two concerned immunological and three pharmaceutical products. The respective target species were dogs (three products), cattle and pigs.

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of one request for classification under the MUMS/limited market policy, the CVMP classified a product (ATCvet classification: Antiparasitic products, insecticides and repellents) for cats as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.

The Committee also reclassified a product (ATCvet classification: Alimentary tract and metabolism) for dogs as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.

Pharmacovigilance

The Committee reviewed the PSURs for Stronghold Plus and Felisecto Plus and concluded that changes to their product information were required.

The Committee reviewed the PSURs for Aivlosin, Coliprotec F4/F18, Cortacare, Eurican Herpes 205, Fortekor Plus, Leucofeligen FeLV RCP and Pexion, and concluded that no further action was required.

Concept papers, guidelines and SOPs

Antimicrobials

The Committee adopted a revised reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/AWP/842786/2015), following the close of the public consultation. The reflection paper has been developed to critically review the current knowledge on the usage of aminopenicillins, resistance development and the potential impact of this resistance on animal and human health.

Environmental Risk Assessment

The Committee adopted a revised reflection paper on antimicrobial resistance in the environment (EMA/CVMP/ERA/632109/2014) following the close of the public consultation. This reflection paper has been developed to address the impact veterinary medicinal products may have on the development of antimicrobial resistance in the environment and whether potential effects should be considered for the current and future risk assessment of such products. The comments received during the consultation procedure have been taken into account in the revision of the reflection paper.

Maximum Residue Limits

The Committee adopted a revised draft guideline on safety and residue data requirements for the establishment of maximum residue limits in minor species (EMA/CVMP/345236/2020) for publication for a 3-month period of public consultation. The guideline defines the data requirements for MRL applications for pharmacologically active substances intended for use in minor species as referred to in Commission Regulation (EU) 2018/782.

Regulation (EU) 2019/6

The Committee adopted a new draft reflection paper on eligibility criteria for limited markets (EMA/CVMP/235292/2020) for publication for a 3-month period of public consultation.
Regulation (EU) 2019/6 introduces a legal basis for granting marketing authorisations intended for limited markets with specific provisions (Articles 4(29), 23 and 24) and replaces the current EMA policy for veterinary medicinal products indicated for minor use minor species (MUMS)/limited market. This reflection paper has been developed to define criteria for classification of a product as intended for a limited market (Article 4(29)) and eligible for consideration in accordance with Article 23 by CVMP.

The Committee adopted a draft guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets and submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/345237/2020) for publication for a 3-month period of public consultation. 

The Committee adopted a new draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/52665/2020) for a 3-month period of public consultation.

The Committee adopted a new draft guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/59531/2020) for a 3-month period of public consultation.

Procedural announcement

For marketing authorisation applications with a validation date on or after 28 January 2022, eligibility for the centralised procedure should be requested in accordance with Article 42 of
Regulation (EU) 2019/6. The Agency is currently revising the pre-submission request form used by applicants to request eligibility and an updated version will be made available on the website as soon as possible. In the meantime, for marketing authorisation applications intended to be submitted on the recommended submission date of 28 January 2022 or onwards, applicants should complete the currently published version of the pre-submission request form and additionally include information in relation to eligibility for the centralised procedure under Article 42 of Regulation (EU) 2019/6. This information should be included in the free-text field within the eligibility section of the form, ‘Additional information on the request’. Similarly, applicants should indicate the legal basis of the intended marketing authorisation application according to Regulation (EU) 2019/6 in the free-text field, ‘Additional relevant information on the future MAA’, e.g. Articles 8, 18, 19, 20, 21, 22, 23 or 25.

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

How useful was this page?

Add your rating
Average
1 rating