Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 July 2021
News
Veterinary
Medicines
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a type II variation application (subject to a worksharing procedure) for Ingelvac CircoFLEX to change the product information to add the associated mixed use with other related nationally authorised products.
The Committee adopted by consensus a positive opinion for a type II variation application for Suvaxyn CSF Marker to amend the therapeutic indication by adding the indication “for active immunisation of breeding females to reduce transplacental infection caused by CSFV”.
The Committee also adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
- Apoquel
- Ecoporc Shiga
- Librela
- Locatim (grouped)
- Nobilis Influenza H5N2
- Porcilis PCV (grouped)
- Stelfonta (grouped)
- Vectormune ND (grouped)
Renewals of marketing authorisations
The Committee adopted by consensus a positive opinion for the renewal of the marketing authorisation for Halagon. The Committee, having re-assessed the benefit-risk balance of this product, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewal of the marketing authorisation.
Maximum residue limits
Further to a request from the European Commission, the Committee adopted by consensus a revised opinion on the extension of maximum residue limits for bambermycin to chickens, recommending numerical MRLs.
Scientific advice
The Committee adopted two separate scientific advice reports further to requests for one initial and one follow-up advice, of which one concerned a biological and the other one a pharmaceutical product. The respective target species were dogs.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of two request for classification under the MUMS/limited market policy, the CVMP classified as follows:
- A product (ATCvet classification: immunologicals) for minks and zoo animal species (to be determined) 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.
- A product (ATCvet classification: immunologicals) for sheep and goats as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species.
Following the Committee’s review of two requests for reclassification under the MUMS/limited market policy, the CVMP reclassified two products (ATCvet classification: antiparasitic products, insecticides and repellents) for honey bees as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The products are not eligible for financial incentives as the market is not considered to be limited and authorised products already exist for the indication.
Pharmacovigilance
The Committee adopted recommendations for changes to the summary of product characteristics for Advocate and Kriptazen as an outcome of signal detection activities.
The Committee reviewed the PSUR for Vectra 3D and concluded that changes to the product information were required. The Committee also reviewed the PSURs for Acticam, Bravecto Plus, Chanhold, Evant, Exzolt, Innovax ND-IBD, Suvaxyn PRRS MLV and Vepured and concluded that no further action was required.
Concept papers, guidelines, and SOPs
Quality
The Committee adopted a new guideline on manufacture of the veterinary finished dosage form (EMA/CVMP/QWP/798401/2015) following the close of the public consultation. The guideline replaces the veterinary note for guidance on the manufacture of the finished dosage form (EMEA/CVMP/126/95) and was developed to provide clarification on the type and level of information that should be included in the quality part of the marketing authorisation application dossier with respect to the manufacturing process description addressing also current manufacturing practices. The guideline has been amended to take account of comments received during public consultation (EMA/CVMP/QWP/485008/2019) and of the requirements of Regulation (EU) 2019/6. The guideline will come into effect 6 months after publication but not before 28 January 2022.
The documents above will be published on the Agency’s website in due course.
Safety
The Committee adopted a new concept paper on the development of a guideline on determination of the need for an MRL evaluation for biological substances (EMA/CVMP/SWP/207500/2021) for a
2-month period of public consultation.
Efficacy
The Committee adopted a draft revised guideline on the summary of product characteristics for antiparasitic veterinary medicinal products (EMA/CVMP/EWP/170208/2005) for a 2-month period of public consultation.
The Committee adopted revised guidelines aligned with the terminology and definitions provided by Regulation (EU) 2019/6 on:
- conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/EWP/16/2000);
- demonstration of palatability of veterinary medicinal products (EMA/CVMP/EWP/206024/2011);
- statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010);
- conduct of efficacy studies for non-steroidal anti-inflammatory drugs (EMA/CVMP/EWP/1061/2001);
- demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish (EMA/CVMP/EWP/459868/2008);
- dossier requirements for anticancer medicinal products for dogs and cats (EMA/CVMP/28510/2008);
- veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/459883/2008);
- testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats (EMA/CVMP/EWP/5/2000);
- pharmaceutical fixed combination products (EMA/CVMP/83804/2005);
- specific efficacy requirements for ectoparasiticides in cattle (EMA/CVMP/625/2003), and
- specific efficacy requirements for ectoparasiticides in sheep (EMA/CVMP/411/2001).
These revisions consist of administrative changes made in order to align the aforementioned guidelines with the new definitions and terminology provided by Article 4 of Regulation (EU) 2019/6. The references to the applicable legislation and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept papers and no public consultation were deemed necessary. The revised guidelines will come into effect on 28 January 2022.
Environmental Risk Assessment
The Committee adopted a new concept paper on the development of a guideline on the environmental risk assessment of veterinary medicinal products intended to be used in aquaculture (EMA/CVMP/ERA/173026/2021) for a 3-month period of public consultation.
Immunologicals
The Committee adopted a revised guideline on data requirements for adjuvants in vaccines for veterinary use (EMA/CVMP/IWP/315887/2017) following the close of the public consultation. The guideline has been amended to take into account comments received during public consultation (EMA/CVMP/IWP/30398/2019) and changes were introduced mainly to address the data to be submitted in the marketing authorisation dossiers concerning adjuvant(s) used in veterinary vaccines to meet the requirements of Regulation (EU) 2019/6. The revised guideline will come into effect on 28 January 2022.
The Committee adopted a draft guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances (EMA/CVMP/IWP/299554/2021) for a 3-month period of public consultation. The guideline has been developed to define minimum data requirements for the demonstration of quality, safety, and efficacy of immunological veterinary medicinal products for applications in exceptional circumstances submitted under Article 25 of Regulation (EU) 2019/6.
The Committee adopted a draft guideline on data requirements for vaccine platform technology master files (vPTMF) (EMA/CVMP/IWP/283631/2021) for a 3-month period of public consultation. The guideline has been developed to address the data requirements to support applications for vPTMF. Guidance is also provided on data requirements for subsequent marketing authorisation applications using approved vPTMF.
The Committee adopted a draft guideline on clinical trials with immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/260956/2021) for a 3-month period of public consultation. The guideline has been developed to address the requirements of Regulation (EU) 2019/6 concerning the provision of data from clinical trials for IVMPs and to provide guidance on when omission of clinical efficacy data may be acceptable.
Antimicrobials*
The Committee adopted a reflection paper on promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU (EMA/CVMP/143258/2021) following the close of the public consultation. The reflection paper has been amended to take into account comments received during public consultation (EMA/200935/2021). The reflection paper has been developed to perform a gap analysis of the measures currently in place and identify additional actions that could be implemented to promote the authorisation of alternatives to antimicrobials in the EU. Recommendations to address identified needs are presented.
Regulation (EU) 2019/6
The Committee adopted the English version of the revised QRD product information template v.9. The translated versions will be published in October 2021. QRD template v.9 reflects the requirements of Regulation (EU) 2019/6 for the summary of product characteristics and packaging, as well as taking into account the outcome of the public consultation. Further information is provided on the EMA’s webpage for the veterinary product information templates.
The Committee adopted several documents related to limited markets under Regulation (EU) 2019/6:
- A reflection paper on eligibility criteria for limited markets (EMA/CVMP/235292/2020) following the close of the public consultation. The reflection paper has been amended to take into account comments received during public consultation (EMA/CVMP/147858/2021). The reflection paper has been developed to address criteria for classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 of Regulation (EU) 2019/6 (applications for limited markets).
- The procedural form for requests to CVMP for classification of a veterinary medicinal product intended for a limited market according to Article 4 (29) and for eligibility for authorisation according to Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/272194/2021).
- A guideline on safety and residue 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/345237/2020) following the close of the public consultation. The guideline has been amended to take into account comments received during public consultation.
- A 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) following the close of the public consultation. The guideline has been amended to take into account comments received during public consultation.
- A guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets applications submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/59531/2020) following the close of the public consultation. The guideline has been amended to take into account comments received during 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”.
* The meeting highlights have been updated on 29 July 2021 to include information on the adoption of the reflection paper on promoting the authorisation of alternatives to antimicrobial veterinary medicinal products.