The Committee adopted by consensus a positive opinion for a marketing authorisation Nobivac LoVo L4 (a duplicate of Nobivac L4), from Intervet International B.V., a vaccine for the active immunisation of of dogs against Leptospira interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion, L. interrogans serogroup Australis serovar Bratislava to reduce infection and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang to reduce infection and urinary excretion.

The Committee adopted by consensus a positive opinion for a marketing authorisation application for Senvelgo (velagliflozin), from Boehringer Ingelheim Vetmedica GmbH, a product intended for the reduction of hyperglycaemia in cats with non-insulin-dependent diabetes mellitus.

The Committee adopted by consensus a positive opinion for a marketing authorisation Bovilis Cryptium, from Intervet International B.V., a new vaccine for the active immunisation of pregnant cows to raise antibodies in colostrum against glycoprotein Gp40 of Cryptosporidium parvum.

The Committee adopted by consensus a positive opinion for a variation requiring assessment (subject to a worksharing procedure) for Suiseng Diff/A (Clostridioides difficile and Clostridium perfringens vaccine (inactivated)) to add the associated use of the vaccine Suiseng Diff/A with another related nationally authorised product.

The Committee adopted by consensus a positive opinion for a variation requiring assessment (subject to a worksharing procedure) for CircoMax, CircoMax Myco to add the option of administering CircoMax Myco and CircoMax intramuscularly, using needle-free devices.

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

• Clomicalm (grouped)
• Fortekor Plus (grouped)
• Porcilis ColiClos / Porcilis PCV ID / Porcilis PCV / Porcilis PCV M Hyo / Porcilis Porcoli DF (subject to a worksharing procedure)

The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:

• Suvaxyn CSF Marker
• Tulinovet

Union referrals and related procedures

The Committee started a procedure for Procactive 300 mg/ml suspension for injection for cattle, sheep and pigs (procaine benzylpenicillin) from Laboratorios Syva, S.A.U. The matter was referred to the Committee by the European Commission under Article 54(8) of Regulation (EU) 2019/6 due to lack of consensus between Member States in the CMDv review procedure on a variation requiring assessment, on grounds of environmental safety.

Maximum residue limits

The Committee adopted by consensus a positive opinion recommending the establishment of the maximum residue limits status for sodium salicylate in poultry other than turkeys. Sodium salicylate is currently included in Table 1 (allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with numerical MRLs established for turkeys and a “No MRL required” entry in all food producing species except fin fish.

Scientific advice

The Committee adopted one scientific advice report further to a request for initial advice concerning a pharmaceutical product for horses.

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

Following two requests, the CVMP classified:

• A product (ATCvet classification: Nervous system) for freely moving large zoo animals (lions, leopards, cheetahs, tigers, bears, great apes, others) as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
• A product (ATCvet classification: Dermatologicals) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines and SOPs

Antimicrobials

The Committee adopted a guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators (EMA/CVMP/882931/2022) following the close of the public consultation. The document outlines the animal population data that should be reported by Member States and the necessary adjustments, according to so-called denominators, to be made by the Agency for the calculation of population-adjusted volume of sales and of the use of antimicrobials. The comments received during the consultation procedure were taken into account for the revision of the guideline. 

Novel Therapies & Technologies

The Committee adopted a revised guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy (EMA/CVMP/NTWP/32862/2022) following the close of the public consultation. This guideline has been developed to address the regulatory, technical and scientific basis applicable to the quality, safety and efficacy of phage therapy veterinary medicinal products where a variable composition of the final product is expected. The comments received during the consultation procedure were taken into account for the revision of the reflection paper.

Pharmacovigilance

The Committee adopted a guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD) for release for a 1-month period of public consultation. This guideline has been developed to provide specific guidance on the considerations and calculations related to the dose factor which alongside de submission of the yearly sales data will allow to calculate and publish the yearly reported incidences of adverse reactions for each veterinary medicinal product.

Quality

The Committee adopted a concept paper on a guideline on stability testing for variations for veterinary medicinal products (EMA/CVMP/QWP/348098/2023) for release for a 2-month period of public consultation. This concept paper has been developed to address the need for a new guideline on stability testing for variations to a marketing authorisation for veterinary medicinal products in which the new classification system for variations under Regulation (EC) 2019/6 will be used.

The Committee adopted a draft joint (human and veterinary) guideline on development and manufacture of synthetic peptides for release for a 6-month period of public consultation. This guideline has been developed to address specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to medicinal product development, to synthetic peptide development using biological peptides as European reference medicinal product, and to clinical trial applications (human products only). The guideline will be published on the Agency’s website after its adoption by the CHMP which is foreseen for their October 2023 meeting next week.

The Committee adopted a Question and Answer (Q&A) document on the use of X-ray sterilisation processes for Single Use Systems (SUS) used in pharmaceutical manufacturing. The Q&A addresses GMP when using X-ray sterilisation process for SUS, data to be provided to change from gamma irradiation sterilisation process and when this change would trigger a variation. The Q&A document will be published on the Agency’s website after its adoption by the CHMP which is foreseen for their October 2023 meeting next week.

Working parties

The Committee elected Anita Bottger as Vice-chair of the Pharmacovigilance Working Party (PhVWP-V) for a 3-year mandate.

International harmonisation

The Committee adopted a draft VICH quality guideline for release for public consultation in the EU following the sign-off by the VICH Steering Committee:

 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”.