Re-examination of the CVMP opinion for veterinary medicinal products containing zinc oxide

Friday March 17, 2017
EMA/ European Union. http://www.ema.europa.eu
Veterinary Medicines Directorate/ United Kingdom. https://www.gov.uk

22-Mar-2017 (6 months 28 days ago)

The Committee considered the grounds for re-examination of the CVMP opinion for veterinary medicinal products containing zinc oxide to be administered orally to food producing species, adopted on December 2016, in the context of a referral procedure initiated under Article 35 of Directive 2001/82/EC.

The Committee concluded that the recommendations included in their initial opinion should be maintained.

The European Commission will now make the final decision on these products. It will consider the CVMP’s recommendation and the evidence submitted by Member States. The Commission’s decision is expected some time after June this year.

Background

The matter had been referred to the Committee by the Netherlands and France under Article 35 of Directive 2001/82/EC due to concerns related to potential risk to the environment and increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide. The Committee concluded that overall the benefit-risk balance for the products concerned by this referral is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment. The CVMP acknowledged that there is a risk of co-selection for resistance associated with the use of zinc oxide but, at the present time, that such risk is not quantifiable. The Committee adopted by consensus a final opinion recommending the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.