New recommendation for phasing out zinc oxide for young pigs

21 March 2017

The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

In December 2016, the CVMP decided to withdraw all medicinal products containing zinc oxide for young pigs from the market. A number of companies holding marketing authorisations for zinc oxide requested a re-examination of the decision, and the case had to be re-examined. After this re-examination, the CVMP concluded at its meeting held on 14-16 March 2017 that the recommendations included in their initial opinion should be maintained. Consequently, medicinal products containing zinc oxide for young pigs must be withdrawn from the market.

The CVMP’s conclusion is a recommendation to the European Commission that will make the final decision. The European Commission will also decide on the length of a phasing-out period for the use of medicinal zinc.

At present, the Danish Medicines Agency cannot predict the length of a phasing-out period. The European Commission has asked the national competent authorities for an opinion on the length of the phasing-out period. The Danish Medicines Agency has assessed that a period of three to five years would be suitable as farmers, veterinarians and industry need time to make the required changes and develop alternatives. The European Commission expects to make a decision at a meeting of the Standing Committee on Medicinal Products for Veterinary Use in June.

Link

The CVMP’s decision in the EMA’s press release about the CVMP meeting

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.