The Committee adopted by consensus a positive opinion for a type II variation application for Credelio concerning the addition of a new therapeutic indication for the treatment of demodicosis (caused by Demodex canis) in dogs.

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

  • VarroMed
  • Purevax RC, Purevax RCPCh, Purevax RCPCh FeLV, Purevax RC and Purevax RCP FeLV (grouped, subject to a worksharing procedure)
  • Evant (grouped)

Community referrals and related procedures

The Committee started a referral procedure for veterinary medicinal products containing toltrazuril to be administered orally to chickens. The matter was referred to the Committee by the Netherlands under Article 35 of Directive 2001/82/EC due to concerns relating to consumer safety. This referral concerns the appropriateness of current restriction periods before the onset of lay.

Maximum residue limits

The Committee agreed to include Alcohols, C11-14 iso, C13 rich (CAS No: 68526-86-3), Neodecanoic acid, zinc salt (CAS No: 27253-29-8), and Phosphorous acid, tris(iso-tridecyl) ester (CAS No: 77745-66-5) as new entries 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. 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. 50.

Scientific advice

The Committee adopted two separate scientific advice reports further to requests for one initial advice and one follow-up advice, of which one concerned an immunological and the other one a pharmaceutical product. The respective target species were chickens and cats.

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

Following three requests for classification relating to four veterinary medicinal products as intended for a limited market according to Article 4(29), and for eligibility for authorisation under Article 23 (applications for limited market) of Regulation (EU) 2019/6, the CVMP classified:

  • a product (ATCvet classification: antiparasitic products, insecticides and repellents) for honeybees (Apis mellifera) as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6;
  • a product (ATCvet classification: immunologicals) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6;
  • a product (ATCvet classification: immunologicals) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

The Committee reviewed an appeal request for classification of a veterinary medicinal product (ATCvet classification: immunologicals) for rabbits, as intended for a limited market according to Article 4(29), and for eligibility for authorisation under Article 23  under Regulation 2019/6, the Committee confirmed its previous considerations and classified the product as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Pharmacovigilance

The Committee reviewed the PSURs for Cimalgex, Hiprabovis IBR Marker Live, Ingelvac CircoFLEX, Isemid, NexGard & Frontpro, Solensia, Stronghold Plus & Felisecto Plus, and Syvazul BTV and concluded that no further action was required.

The Committee reviewed the PSURs for Stelfonta and Suvaxyn Circo and concluded that changes to their respective product information were required.

Concept papers, guidelines and SOPs

Quality

The Committee adopted the revised guideline on quality of herbal medicinal products/traditional herbal medicinal products, and the revised Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products following the close of the public consultations. The comments received during the consultation procedure have been taken into account for the revision of the two guidelines. These guidelines have been revised to take into account new and revised guidelines, questions and answers and European Pharmacopoeia (Ph. Eur.) revised monographs. The revised guidelines will be published on the Agency’s website after their adoption by the CHMP which is foreseen for its January meeting (24-27 January 2022).

The Committee adopted a concept paper for the revision of the guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMEA/CVMP/540/03 Rev.1) to develop an annex on the concomitant use of veterinary medicinal products and biocides (EMA/CVMP/QWP/697426/2021). This concept paper has been developed to address the need to complement the guideline with information relating to the use of biocides in water used to administer veterinary medicinal products via drinking water. The concept paper will be published for a 3-month period of public consultation on the Agency’s website.

Safety

The Committee adopted a draft guideline on determination of the need for an MRL evaluation for biological substances (EMA/CVMP/SWP/591282/2021) for a 3-month period of public consultation. This guideline has been developed to clarify the data requirements and rules for determination of the need for an MRL evaluation for biological non-immunological substances used in VMPs intended for use in food-producing species.

Efficacy and Antimicrobials

The Committee adopted a draft reflection paper on prophylactic use of antimicrobials in animals in the context of Article 107(3) of Regulation (EU) 2019/6 (EMA/CVMP/AWP/387275/2020) for a 3-month period of public consultation. This reflection paper has been developed to establish an understanding of the term ‘prophylaxis’ as defined in Article 4(16) of the above-mentioned Regulation and to develop high level principles to guide the implementation of the restrictions on prophylactic use as required by the provisions of Article 107(3) of Regulation (EU) 2019/6.

Immunologicals

The Committee adopted a revised guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines (EMA/CVMP/IWP/105506/2007 - 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. The guideline has been amended to align with the provisions for multi-strain dossiers in Regulation (EU) 2019/6, which extends the multi-strain approach to viral diseases, in addition to avian influenza, bluetongue and foot-and-mouth disease, and to bacterial diseases requiring a need for rapid or frequent change in the strains included in the final product. The main aim of the guideline is to address the use of a multi-strain dossier for inactivated vaccines against antigenically variable viruses or bacteria and to provide information on criteria for eligibility to use the multi-strain approach and on data to be included in a multi-strain dossier. The revised guideline will come into effect on 28 January 2022.

The Committee adopted a new guideline on data requirements for vaccine antigen master files (VAMF) (EMA/CVMP/IWP/258755/2021) following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the drafting of the guideline. This guideline has been developed to address the data to be included in a VAMF for veterinary vaccines. The guideline will come into effect on 28 January 2022.

The Committee adopted a new guideline on data requirements for vaccine platform technology master files (vPTMF) (EMA/CVMP/IWP/283631/2021) following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the drafting of the guideline. This guideline has been developed to address the type of data to be included in vPTMF and also the data requirements for subsequent dossier submissions for marketing authorisations based on a vPTMF after its first evaluation and certification. The guideline will come into effect on 28 January 2022.

The Committee adopted a new guideline on data requirements for authorisation of immunological veterinary medicinal products (IVMPs) in exceptional circumstances (EMA/CVMP/IWP/251947/2021), following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the drafting of the guideline. This guideline has been developed to define the minimum data requirements for applications in exceptional circumstances for all relevant parts of the dossier to support applications for authorisation of IVMPs under Article 25 of Regulation (EU) 2019/6. The guideline will come into effect on 28 January 2022.

The Committee adopted a new guideline on clinical trials with immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/260956/2021), following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the drafting of the guideline. This guideline has been developed to advise on how to perform clinical trials (also called field trials) with IVMPs and to address the requirements of the Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council regarding clinical trials for IVMPs. The guideline will come into effect on 28 January 2022.

The Committee adopted a draft revised guideline on requirements for the production and control of immunological veterinary medicinal products (EMA/CVMP/IWP/206555/2010) for a 2-month period of public consultation. This revised guideline has been developed to outline important aspects related to the quality, safety and efficacy parts of the marketing authorisation dossier that are not sufficiently defined in the requirements of Annex I of Regulation (EU) 2019/6 on veterinary medicinal products and in the Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) 2019/6 and in the European Pharmacopoeia (Ph. Eur.).

Novel Therapies & Technologies

The Committee adopted a concept paper on quality, safety and efficacy of bacteriophages as veterinary medicines (EMA/CVMP/NTWP/438290/2021). While Annex II of Regulation (EU) 2019/6 lays down some requirements for veterinary medicinal products specifically designed for bacteriophage therapy, this concept paper has been developed to address the need for a more specific guidance applicable to these products, i.e. containing bacteriophages, by considering their particularities, the new legal basis, and the provisions in Regulation (EU) 2019/6. The concept paper will be published, for a 3-month period of public consultation, on the Agency’s website.

The Committee adopted a concept paper on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy (EMA/CVMP/NTWP/470741/2021). This concept paper has been developed to address the need for clear advice to applicants and assessors on the development and data requirements of potency tests for cell therapy products as well as validation of analytical methods used for the potency assay. The concept paper will be published, for a 3-month period of public consultation, on the Agency’s website.

Regulation (EU) 2019/6

The Committee adopted the following documents related to Regulation (EU) 2019/6:

  • A question and answer document on GLP/GCP requirements for pre-clinical studies (EMA/CVMP/565615/2021), which will be published on the Agency’s website.

Working parties

The Committee adopted the work plans for 2022 for the CVMP Working Parties on Antimicrobials, Efficacy, Environmental Risk Assessment, Immunologicals, Pharmacovigilance, Safety, and Scientific Advice, which will be published on the Agency’s website.

International harmonisation

The Committee adopted the revised guideline VICH GL18(R2) on impurities: residual solvents in new veterinary medicinal products, active substances and excipients, at step 4, for release in the EU following the sign-off by the VICH Steering Committee, for a 5-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”.

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