On 26 June, the European Commission adopted a decision to withdraw the marketing authorisations (MAs) for veterinary medicines containing zinc oxide administered orally to food producing species. Member states have been given up to five years, from the date of adoption of the Commission Decision, to withdraw existing national MAs for these products.
This decision follows a meeting of the Commission’s Standing Committee (attended by representatives of the VMD) on 19 June.
There are 3 veterinary medicines authorised for oral administration to food producing animals in the UK that contain zinc oxide as their active substance; these are authorised for use in piglets for the prevention, or treatment and control, of diarrhoea.
Refer to the Product Information Database for details of authorised products.
The VMD will give the maximum period of 5 years prior to expiry of these MAs to support the adoption of, and transition to, alternative management strategies. We strongly encourage the responsible use of these medicines during this time. The VMD will propose the publication of annual sales data for these medicines to monitor progression in reducing their use.
The VMD recognises the challenge that the withdrawal presents and is committed to finding ways to assist with the transition. We will invite representatives of the pig industry to meet with us in the coming weeks to discuss implementation of the Commission Decision.
In February 2016, France and the Netherlands submitted an Article 35 referral to the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA). The CVMP conducted a scientific review of the data provided by the MA holders and concluded in March 2016 that the risks to the environment, associated with use of these medicines, was not outweighed by the demonstrated clinical benefit to pigs. A hazard associated with antimicrobial resistance was identified but the risk could not be quantified. The CVMP recommended that the European Commission (EC) withdraw these products from the market.
Member states were invited to submit evidence to the EC to demonstrate the length of transition period required for withdrawal of the products, if the CVMP recommendation was adopted. The VMD, in consultation with the pig industry, submitted evidence to request a 10 year transition period.
The EC called a meeting of the Standing Committee in June 2017 to adopt a draft Commission decision including a 5 year maximum period prior to the withdrawal of the products from the market.
Veterinary medicines containing zinc oxide: European referral outcome
European referral of veterinary medicines containing zinc oxide: Call for evidence
Veterinary medicines containing zinc oxide: European referral process
Vaccines to prevent and antibiotics to treat diarrhoea in piglets
There are a limited number of vaccines authorised within the EU for the prevention of diarrhoea in piglets, these are indicated for specific pathogens. There are also a number of antibiotics that are authorised either for treatment, or for prevention and treatment, of specific causes of diarrhoea in piglets.
Refer to the Product Information Database.