VMD confirms maximum five years for zinc oxide

The Veterinary Medicines Directorate (VMD) has confirmed the UK pig industry will be granted the maximum five year period to withdraw zinc oxide from piglet diets.

The VMD has promised to support the industry in the transition and is urging ‘responsible use’ of zinc oxide during the phase-out period. It is planning to publish sales data to highlight progress.

On June 26, 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 were given up to five years, from the date of adoption, to withdraw existing national MAs for these products.

There are three veterinary medicines authorised for oral administration to food producing animals in the UK that contain zinc oxide as their active substance. They are authorised for use in piglets for the prevention, or treatment and control, of diarrhoea.

The VMD, which will invite the NPA and other representatives of the pig industry to meet it in the coming weeks to discuss implementation of the decision, said: “The VMD will give the maximum period of five 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.”

The VMD gave no indication, however, that it would reconsider the use of zinc oxide in the UK once we are out of the EU, despite suggestions from, among others, the National Pig Association and pig medicine specialist David Burch that Brexit presented an opportunity to do so.

Background

In February 2016, France and the Netherlands submitted an Article 35 referral to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP).

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.

In June, the committee adopted a draft Commission decision including a five year maximum period prior to the withdrawal of the products from the market.

Vaccine and antibiotic alternatives

The VMD said there were 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. See the Product Information Database.