In 2017, the European Medicines Agency (EMA) concluded that the benefit-risk balance of veterinary medicines containing zinc oxide that are administered orally to pigs is negative. The assessment, which was conducted by the EMA expert group, the Committee for Medicinal Products for Veterinary Use (CVMP).
The CVMP recommended to the EU Commission that all existing marketing authorisations for products concerned by this procedure be withdrawn in a phased basis, to allow farmers and other stakeholders to adapt to the new situation. The EU Commission took such a decision on 26 June 2017, meaning that the products concerned must be withdrawn from the European Union, within 5 years, i.e. before 26 June 2022. The decision is binding on all Member States.
Marketing authorisation holders as well as veterinary practitioners and farmers were informed of the decision at the time.
Serial Or Batch Number And Expiry Date:
In Ireland, the following products containing zinc oxide have been authorised by the HPRA for use in pigs:
- Gutal premix, VPA 10782/16/1 (Huvepharma Ltd)
- Pigzin premix, VPA 10443/1/1 (DSM Nutritional Products Ltd)
- Zincotec premix, VPA 10446/1/1 (Provimi Ltd)
Problem Or Issue:
Although authorised for the control of diarrhoea in piglets by the HPRA only since 2013, zinc oxide was prescribed by veterinary practitioners as an alternative to antibiotics.
The premix was normally incorporated into finished piglet feed and fed for up to 14 days during the high risk weaning period.
A number of advisory notices and other media have been used to raise awareness of Veterinary Practitioners and Farmers to this matter since the issue broke in 2017. It is expected that veterinary practitioners have already reviewed disease control options for post-weaning pigs to manage the situation.
Actions To Be Taken:
Veterinary medicines containing zinc oxide have now been withdrawn from the market in Ireland as since June 2022 they are no longer authorised. Veterinary medicines containing zinc oxide may no longer be prescribed or supplied in this country. However, stocks of products that were prescribed before June 2022 and which were supplied to farmers and which are still in date may continue to be used under the responsibility of the veterinary practitioner. Batches of stock that might exist in wholesalers or retailers are now prohibited from supply and should be returned to the marketing authorisation holder for proper disposal.
For the control of diarrhoea in piglets there are a range of potential therapeutics and vaccines authorised for use. Users should discuss their needs with their veterinary practitioners, who will also advise on other disease control measures including biosecurity measures, hygiene, husbandry and nutrition.