Veterinary medicines containing Zinc oxide – Withdrawal of marketing authorisation

24/11/2022

Medicines for animal use Caution-in-use notification (CIUN)

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recommended to the EU Commission that all existing marketing authorisations for products concerned by this procedure be withdrawn in a phased basis, to allow farmers and other stakeholders to adapt to the new situation. The EU Commission took such a decision on 26 June 2017, meaning that the products concerned must be withdrawn from the European Union, within 5 years, i.e. before 26 June 2022.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.

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.

Product information

Active substance: Zinc Oxide
Authorisation holder: Huvepharma Ltd, Gutal premix, VPA 10782/16/1 - DSM Nutritional Products Ltd
Authorisation number: VPA 10782/16/1
VPA 10443/1/1
VPA 10446/1/1
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)
Human or veterinary medicine: Veterinary medicine
Target audience: Veterinary practitioners

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Veterinary medicines containing zinc oxide have now been withdrawn from the market in Ireland as since June 2022 they are no longer authorised.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.

Reference

Background Information Or Related Documents:

The opinion of the CVMP is contained in the CVMP press release March 2017 . The original referral procedure was initiated by France and the Netherlands in February 2016, due to concerns relating to the potential risk to the environment and increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide in food-producing animals. More information of the scientific background to the decision of the CVMP is available here.

Pigzin and ZInctotec were first authorised in Ireland in 2013, while Gutal was authorised in December 2015. Before this time zinc oxide was imported into Ireland under a special Department of Agriculture licence.

Further Information:

The HPRA wishes to stress that the issue does NOT raise any issues of consumer safety or animal safety. Zinc is an essential trace element for humans. Zinc use in animals contributes negligibly to concentrations in edible tissues and is therefore biologically insignificant for the consumer. Zinc oxide has a ‘no MRL required’ status in food-producing animals in the EU.