First Meeting of CVMP at the Permanent Office of EMA in Amsterdam

| By | EMA, Veterinary drugs
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The Committee adopted by consensus a positive opinion for a type II variation application for Innovax-ND-IBD to add a new indication for mixed use with Nobilis Rismavac for the subcutaneous route of administration. The Committee also adopted by consensus a positive opinion for a type II variation application for Rabitec to extend the duration of immunity from 6 to 12 months.

The Committee also adopted by consensus positive opinions for a type II variation application for Bravecto and for a grouped type II variation application for Clevor, both concerning quality-related changes.

Minor use, minor species (MUMS)/limited market

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

  • A product (musculo-skeletal system) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives in line with the guidance on the classification of veterinary medicinal products indicated for minor use minor species/limited market (EMA/CVMP/388694/2014), which considers products for horses as generally not eligible.
  • A product (blood and blood forming organs) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives in line with the guidance on the classification of veterinary medicinal products indicated for minor use minor species/limited market (EMA/CVMP/388694/2014), which considers products for horses as generally not eligible.

Pharmacovigilance

The Committee reviewed the PSURs for Advocate, Credelio, Metacam and Novem, and recommended amendments to the product information.

The Committee reviewed the PSURs for Activyl, Clomicalm, Evant, Loxicom, Neocolipor, Oxybee, Semintra, Startvac, Suvaxyn Circo, Syvazul BTV, Vepured, Versican Plus DHPPI L4 and Zulvac SBV, and concluded that no further action or changes to their product information were required.

Quality

The Committee adopted a reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018) following the close of the public consultation. This reflection paper was developed to provide industry with guidance on the requirements to control elemental impurities in veterinary medicinal products, as a result of updates in two European Pharmacopoeia monographs. The Committee also adopted a revised version of the document addressing the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/631010/2017-Rev.2).

The reflection paper together with the overview of comments (EMA/CVMP/QWP/434956/2019) as well as the revised document addressing implementation of the reflection paper will be published on the Agency’s website.

SOURCE: EMA
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