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

9 September 2022

Under Regulation (EU) 2019/6, 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:

• Exzolt – grouped procedure including a change in the pack size and addition of a primary packaging container.
• Porcilis PCV ID
• Solensia
• Improvac - grouped procedure including extension of the inter-dose interval from 4 to 8 weeks and reduction of the minimum age of vaccination accordingly (from 14 to 10 weeks of age) in female pigs.

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

• Clynav
• Evicto (grouped)
• Improvac
• Poulvac E. coli (worksharing procedure with other related nationally authorised products)
• Tulinovet
• Vaxxitek HVT+IBD, Prevexxion RN+HVT+IBD and Prevexxion RN (worksharing procedure)

Union referrals and related procedures

The Committee started two parallel procedures for Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats (Butafosfan, Cyanocobalamin (vitamin B12))and Vey Tosal 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats (Butafosfan, Cyanocobalamin (vitamin B12))from CP-Pharma Handelsgesellschaft mbH and Veyx-Pharma GmbH, respectively. The matters were referred to the Committee by Czechia as the reference Member State in the decentralised procedures, under Article 33(4) of Directive 2001/82/EC, due to concerns raised by Germany relating to the granting of a waiver of bioequivalence study requirements for the intramuscular and subcutaneous routes of administration.

Maximum residue limits

The Committee adopted by consensus a positive opinion recommending the extension of maximum residue limits for praziquantel to fin fish. Furthermore, the CVMP recommended that the “no MRL required” entry established in ovine species be extrapolated to other ruminants except cattle. Praziquantel is currently included in Table 1 (allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with a “No MRL required” entry for ovine and Equidae.

The Committee agreed to include mannosylated chitosan as a new entry in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients and adopted a revised list (EMA/CVMP/519714/2009-Rev. 54). This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.

Scientific advice

The Committee adopted two scientific advice reports further to requests for initial advice concerning two pharmaceutical products. The respective target species were dogs (one product), and mice, rats, hamsters, gerbils, guinea pigs, chinchillas and rabbits (one product).

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

Following two 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: Blood and blood forming organs) for horses as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines and SOPs

Antimicrobials

The Committee adopted a draft concept paper on the development of a guideline on data requirements for post-authorisation studies for antimicrobial veterinary medicinal products under Article 36(2) of Regulation (EU) 2019/6 (EMA/CVMP/AWP/201064/2022) for a 4-month period of public consultation. This concept paper has been developed to address requirements for post-authorisation studies for antimicrobial veterinary medicinal products in order to ensure the benefit-risk balance remains positive in case of development of antimicrobial resistance, as laid out in Article 36(2) of the Regulation.

Pharmacovigilance

The Committee adopted revised questions and answers on describing adverse events in the product information (summary of product characteristics and package leaflet).

Quality

The Committee adopted a draft concept paper on the development of a guideline on synthetic peptides (EMA/CHMP/CVMP/QWP/603822/2022) for public consultation. Development of guidance on this topic is considered appropriate due to the number of clinical trial applications for human products and marketing authorisation applications for synthetic peptides for both human and veterinary medicinal products having significantly increased over the last few years.

The Committee adopted a draft concept paper on the development of a guideline on synthetic oligonucleotides (EMA/CHMP/CVMP/QWP/603963/2022) for public consultation. Development of guidance on this topic is considered appropriate due to the number of clinical trial applications for human products and marketing authorisation applications for synthetic oligonucleotides for both human and veterinary medicinal products having significantly increased over the last few years.

The documents above will be published on the Agency’s website after its adoption by the CHMP which is foreseen for their September meeting next week.

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'.