Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023

News 21/04/2023

CVMP opinions on veterinary medicinal products

Under Regulation (EU) 2019/6

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Gumbohatch (live Avian infectious bursal disease vaccine) concerning the amendment of the indication by adding its use in future layer chickens.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Vaxxitek HVT+IBD, Prevexxion RN+HVT+IBD, Prevexxion RN (subject to a worksharing procedure) concerning the update of the approved marketing authorisation dossier of each vaccine with a new clinical efficacy study studying the interaction between RN1250 and vHVT013-69 vaccine strains on infectious bursal disease protection.

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

  • Melovem - to add a new strength and pharmaceutical form - a 15 mg/ml oral suspension for horses
  • Purevax RCPCh , Purevax RCP FeLV, Purevax RCP, Purevax RCPCh FeLV (subject to a workshare 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:

  • Cerenia
  • Contacera
  • Onsior
  • Proteq West Nile – including the update of the product information to implement the outcome of signal detection activities

Maximum residue limits

The Committee adopted by consensus a positive opinion recommending the extrapolation of maximum residue limits for rafoxanide to milk in bovine and ovine species. Furthermore, the CVMP recommended that the maximum residue limits in bovine tissues and milk be extrapolated to all ruminants except ovine. Rafoxanide is currently included in Table 1 (allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with entries for bovine and ovine.

Scientific advice

The Committee adopted 2 scientific advice reports further to requests for initial advice concerning a biological product and a pharmaceutical product, both indicated for dogs.

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

Following 3 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: Musculo-skeletal system) for horses as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
  • A product (ATCvet classification: Alimentary tract and metabolism) for dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Pharmacovigilance

Under Regulation (EU) 2019/6

The Committee adopted a recommendation for changes to the product information sections on special precautions for use, for Neptra as the outcome of signal management activities.

Regulation (EU) 2019/6

The Committee endorsed a survey to be used by stakeholders to provide input into the development of scientific advice requested by the European Commission with regard to the review of the list of substances which are essential for the treatment of equine species, in accordance with article 115(5) of Regulation (EU) 2019/6. The survey will be published on the EMA website with a deadline for completion on of 30 June 2023.

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

Procedural announcement

Handling of variations to centralised marketing authorisations for veterinary medicinal products

Variations requiring assessment

For variations requiring assessment (VRAs) receiving an opinion from the May 2023 meeting of the Committee onwards, the process for adopting Commission Decisions under Article 67 of Regulation (EU) 2019/6 (‘the Regulation’) will change as follows:

Where a VRA affects the terms of the Commission Decision granting the marketing authorisation (including Annexes), marketing authorisation holders are required to wait for the adoption of the Commission Decision before implementing the relevant changes. In accordance with Article 68(1) of the Regulation, the Commission Decision shall also set a time limit for the implementation thereof.

  • When a variation does not have an impact on the terms of the Commission Decision granting the marketing authorisation (including Annexes) and the CVMP issues a favourable opinion, a Commission Decision will not be issued.

The positive opinion of the CVMP will be communicated to the marketing authorisation holder by the Agency and the marketing authorisation holder may implement the changes immediately after receiving the notification by Agency.

Variations not requiring assessment

Pursuant to Article 61 of the Regulation, for variations not requiring assessment, the marketing authorisation holder shall record the change in the Union Product Database, including, as applicable, the summary of product characteristics, labelling or package leaflet in languages referred to in Article 7, within 30 days following the implementation of that variation.

For variations not requiring assessment (VNRAs) recorded in the Union Product Database from
15 May 2023 onwards, marketing authorisation holders should take note of the following:

  • The adoption of a Commission Decision is not necessary if the concerned variation does not affect the terms of the Commission Decision granting the marketing authorisation (including the Annexes thereto).
  • When the terms of the Commission Decision are affected, the concerned changes will be reflected in the next Commission Decision amending the terms of the marketing authorisation following the assessment of a VRA or following another regulatory procedure (e.g., referral, pharmacovigilance activity, etc). The adoption of a stand-alone Commission Decision to reflect a VNRA will only take place in exceptional and duly justified cases. Marketing authorisation holders are required to provide justification to this effect.

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