Referral procedures: veterinary medicines
VeterinaryReferrals
A veterinary 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 for veterinary use. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU).
The medicine, or the class of medicines, is 'referred' to EMA so that it can make a recommendation for a harmonised position across the EU.
The European Commission, any Member State or the company that markets or intends to market the medicine can start a referral. The reasons range from safety concerns over a class of medicines to disagreements among Member States on the use of the medicine.
All referrals on veterinary medicines are assessed by the Committee for Veterinary Medicinal Products (CVMP).
For most referrals, the European Commission issues a decision to all Member States reflecting the measures they need to take to implement EMA's recommendation.
Types of referral
Regulation (EU) 2019/6 describes all types of veterinary referrals. This legislation governs the authorisation and monitoring of veterinary medicines in the EU.
Safety, quality, manufacturing or efficacy issues
| Type of referral / procedure | Trigger |
|---|---|
| Article 82 referral | Concerns about the quality, safety or efficacy of a medicine or a class of medicines that affect the interests of the European Union, related in particular to public or animal health or to the environment. |
| Article 130(4) procedure | Issues related to the quality, compliance, safety or efficacy of medicines authorised via the centralised procedure. Information for marketing-authorisation holders on this type of procedure will be available in due course. |
Safety issues
| Type of referral | Trigger |
|---|---|
| Article 82 referral, based on Article 129(3) | A Member State or the European Commission takes urgent action due to safety issue, in the event of a risk to public or animal health or to the environment. This urgent action may include:
This procedure also applies to safety issues with a class of medicines. Information for marketing-authorisation holders on this type of referral will be available in due course. |
Harmonisation, mutual-recognition procedure and decentralised procedure
| Type of referral / procedure | Trigger |
|---|---|
| Article 70(11) referral | Disagreement between Member States in the summary of product characteristics harmonisation procedure of medicines authorised via the national procedure or by mutual recognition. Information for marketing-authorisation holders on this type of referral will be available in due course. |
| Article 54(8) procedure | The European Commission requests clarifications following a disagreement between Member States regarding an application for marketing authorisation being evaluated in a mutual-recognition or decentralised procedure. The disagreement between Member States relates to a potential serious risk to public or animal health,or to the environment. This procedure can also be triggered when Member States disagree on a variation requiring assessment. Information for marketing-authorisation holders / applicants on this type of procedure will be available in due course. |
EMA's Executive Director, the European Commission or a Member State can also ask the CVMP to draw up an opinion on any scientific matter related to the evaluation of medicines for veterinary use. For more information, see Article 141(1) opinions.
Historical referral types
A number of referral types are no longer applicable because of changes in European law. The outcomes of a number of these historical referral types are available on this website.
| Type of referral procedure | Trigger | Applicable until |
|---|---|---|
| Article 13 referral | Disagreement between Member States on variations (type-II) for medicines authorised via mutual recognition or the decentralised procedure. | January 2022 |
| Article 33(4) referral | Disagreement between Member States about an application for marketing authorisation being evaluated in a mutual-recognition or decentralised procedure when there is a potential serious risk to public or animal health or to the environment. | January 2022 |
| Article 34 referral | Need for EU harmonisation of Member States' decisions related to certain medicines (e.g. different indications, contraindications or posology). | January 2022 |
| Article 35 referral | Issues related to the quality, safety or efficacy of a medicine or a class of medicines that affect the interests of the European Union. This referral has been replaced by Article 82 referrals. | January 2022 |
| Article 39 referral | Disagreement between Member States on a variation for medicines authorised by mutual recognition or via the decentralised procedure. This referral has been replaced by Article 13 referrals. | January 2010 |
| Article 40 referral | A Member State seeking action (variation, suspension or withdrawal) to protect public or animal health or the environment. This referral applied to medicines with a marketing authorisation granted via the mutual-recognition or decentralised procedure. | January 2022 |
| Article 45 procedure | Issues related to the quality, safety or efficacy of medicines authorised via the centralised procedure. This procedure has been replaced by Article 130(4) procedures. | January 2022 |
| Article 78 referral | A Member State varying, suspending, or revoking the marketing authorisation for a medicine in its territory because of safety issue. This referral has been replaced by Article 82 referrals based on Article 129(3). | January 2022 |
| Article 30(3) procedure | The Agency's Executive Director, the European Commission or a Member State asking the CVMP to draw up an opinion on any scientific matter related to the evaluation of medicines for use in animals. This procedure has been replaced by Article 141(1)(c) or (e) procedures. | January 2022 |
Public information on referrals
You can find information on veterinary medicines referrals by name and type at:
On these webpages, EMA publishes information in plain language under the 'Overview' and 'Key facts' sections. This includes:
- medicines under review;
- reason to start a referral;
- outcomes of the procedure.
It is also possible to consult all documents related to the referral. EMA provides a brief description of the information contained on each type of document.
For Union-interest referrals (referrals under Article 82), the Agency makes information available on how the public can submit data to be considered as part of the assessment.
EMA announces the start and the conclusion of all referrals in the CVMP meeting highlights.