European Committee for Medicinal Products for Veterinary Use Meeting Took Place

| By | EU Approved, European Union, Veterinary drugs
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The Committee adopted by consensus a positive opinion for a grouped type II variation application for Suvaxyn PRRS MLV to reduce the onset of immunity and implement changes to the product information.The Committee adopted by consensus a positive opinion for a type II variation application for Broadline concerning quality changes.

The Committee adopted by consensus positive opinions for the following type II variation applications (subject to worksharing procedures):

– Porcilis PCV M Hyo and nationally authorised products, to change the product information to allow concurrent administration with Porcilis PRRS.

– LeucogenLeucofeligen FeLV-RCP and Nobivac LeuFeL, to amend the product information to reflect that a beneficial effect of the feline leukaemia virus (FeLV) vaccination is observed 3 weeks after the first injection of the primary vaccination.

Renewals of marketing authorisations

The Committee adopted by consensus a positive opinion for the renewal of the marketing authorisation for Osurnia. The Committee, having re-assessed the benefit-risk balance of the product, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the indefinite renewal of the marketing authorisation.

Maximum residue limits

The Committee adopted by consensus a positive opinion recommending the establishment of maximum residue limits for bambermycin in rabbits.

More information about the above recommendation will be published on the Agency’s website.

Scientific advice

The Committee adopted two separate scientific advice reports further to requests for:

  • Initial advice on quality, safety and efficacy issues for a new veterinary medicinal product for a musculoskeletal disorder indication in horses; and
  • Initial advice on safety and efficacy issues for a new antiparasitic veterinary medicinal product for dogs.

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of three requests for classification under the MUMS/limited market policy, the CVMP classified:

  • An immunological product for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as according to the MUMS policy, products for horses are generally not eligible for fee incentives.
  • A product (cardiovascular system) for cats 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 a non-food-producing species.
  • An immunological product for cattle as indicated for MUMS/limited market and eligible for both reduced data requirements, where applicable, and financial incentives.

Pharmacovigilance

The Committee reviewed the PSURs for Respiporc FLUpan H1N1SevoFloSuvaxyn Circo MH+RTUVirbagen Omega and Zeleris, and concluded that no further action or changes to their product information were required.

The Committee also reviewed the PSUR for Cytopoint and recommended amendments to the product information.

Organisational matters

The Committee finalised the preparation of the CVMP and CVMP/CMDv Presidency meetings to be held under the Romanian Presidency of the EU, on 6-8 May 2019. The discussions will focus on:

  • New Veterinary Regulation: Impact on the CVMP;
  • Functioning of CVMP Working Parties;
  • SPC harmonisation: approach to prioritising of products
  • Veterinary medicinal products for honey bees.
SOURCE: ema.europa.eu
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