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Veterinary referral procedures

A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.

The medicine, or the class of medicines, is 'referred' to the European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP), so that it can make a recommendation for a harmonised position across the European Union (EU). The European Commission then issues a decision to all Member States reflecting the measures they need to take to implement the CVMP recommendation.

Referrals can be started by the European Commission, any Member State or by the company that markets or intends to market the medicine.

Types of referral

EU pharmaceutical legislation on veterinary medicines (Directive 2001/82/EC, as amended) lays down a binding mechanism that can be initiated on the basis of the following articles:

Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure

Article 34

Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States

Article 35

Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment

Article 39Follow-up referral
Article 40Follow-up referral
Article 78

Pharmacovigilance urgent measures: initiated when, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure

Referrals can also be triggered for veterinary medicines under the EU legislation on variations (Commission Regulation EC No 1234/2008):

Article 13This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II).

The Agency's Executive Director, the European Commission or a Member State can also ask the CVMP draw up an opinion on any scientific matter related to the evaluation of medicines for veterinary use.

Publication of referral outcomes

The Agency publishes the outcomes of referrals for veterinary medicines under European Commission decisions on referrals.

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