European referral of veterinary medicines containing zinc oxide: Call for evidence
The EMA Veterinary Committee has concluded that the benefit:risk balance for veterinary medicines containing zinc oxide is negative and that this class of products should be withdrawn.
The deadline for submission of responses is: 11:59pm 21 February
The EMA’s Committee for Veterinary Medicinal Products (CVMP) concluded in December 2016 that veterinary medicines containing zinc oxide, used to prevent post weaning diarrhoea in piglets, should be withdrawn from the market. This recommendation was based on a conclusion that the risk these products were considered to present to the environment has not been outweighed by the demonstrated benefits.
The CVMP have now been requested to re-examine this conclusion; their final position is expected in March.
The CVMP provide scientific advice to the EU Commission on the benefits and risks relating to authorised veterinary medicines. It is for the EU Commission to decide what action to take as a result.
EU Member States have now been invited by the EU Commission to provide written comments by,13 March 2017, regarding a proposed transitional period before the withdrawal of these products is implemented.
The comments from the Member States should propose a duration for this transitional period, supported by concrete evidence. The EU Commission has also requested information on measures that have already been taken at a national level to reduce the use of zinc oxide and the use of antibiotics in pig production, for example through changes to animal husbandry practices or use of alternatives, including vaccines.
- be concise
- be written in English
- be limited to 2000 words, excluding references; submissions must reference the source of any data provided (provide weblinks to any data that are already in the public domain)
- be specific to proposals for the duration of a transitional period
- be supported by evidence related to:
- the impact of product withdrawal on pig health and welfare and/or pig productivity
- husbandry and/or production system changes that will be necessary to mitigate this impact, and the economic cost of these changes
- effective alternatives to zinc oxide, either currently available or in development
Published: 6 February 2017