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:
Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States
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 39||Follow-up referral|
|Article 40||Follow-up referral|
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of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure
|Article 13||This 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.
- For more information, see Article 30(3) opinions.