Application in exceptional circumstances

This is subject to the condition that the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain quality, safety and efficacy data have not been provided. This type of application is referred to as an ‘application in exceptional circumstances’.

An application in exceptional circumstances is intended for crisis situations, for example, in the event of an outbreak of a new or re-emerging infectious disease that could have serious implications for animal or public health.

Whether or not an application in exceptional circumstances is justified, will be determined on a case-by-case basis. It will be considered whether prompt treatment or vaccination is critical for controlling the outbreak and/or eradicating a disease.

If a marketing authorisation has been granted based on an application in exceptional circumstances, the Summary of Product Characteristics (SPC) will clearly state that only a limited assessment of quality, safety or efficacy has been conducted due to the lack of comprehensive quality, safety or efficacy data.

Submission of applications

If you are required to apply for an application in exceptional circumstances,  this product likely falls under Article 42(2) of the Veterinary Medicinal Products Regulation. This Article states that a centralised application must be submitted for biotechnology products or for products containing a new active ingredient. In such cases, you must contact the EMA. If a centralised application is not required, you may follow the procedure described in the ‘Best Practice Guide for handling applications for marketing authorisations for veterinary medicinal products in exceptional circumstances (national, mutual recognition and decentralised procedures)’. You can find this here on the website of the HMA. In addition, you must also contact the Veterinary Medicinal Products Unit in advance via our Contact Form.

Conditions

If you want to apply for an application in exceptional circumstances, you must fulfil these obligations:

• You must demonstrate that, for objective and verifiable reasons, the quality, safety or efficacy data required under Annex II cannot be provided; 
• You must introduce conditions or restrictions, especially with regard to the safety of the veterinary medicinal product;
• You must notify the competent authorities or the Unit, as appropriate, of any adverse effects associated with the use of the veterinary medicinal product;
• You must conduct studies after the authorisation has been issued.

Required documents

Often an application in exceptional circumstances involves an immunological veterinary medicinal product (IVMP). For this, the EMA has drawn up the Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances. This sets out the minimum information required to demonstrate the quality, safety and efficacy of IVMPs for applications submitted pursuant to Article 25 of Regulation (EU) 2019/6. The required documentation is described further in brief in Annex II of the Veterinary Medicinal Products Regulation under Section IV.7 entitled ‘Applications in exceptional circumstances’.

Extension of marketing authorisation for an application in exceptional circumstances

A marketing authorisation for exceptional circumstances is valid for one year. If you want to extend this period of validity, you must submit a new application at least three months before the expiry of the validity period. The authorisation for exceptional circumstances will then remain valid until a decision has been taken. If the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain quality, safety and efficacy data have not been provided, the period of validity of the marketing authorisation for exceptional circumstances will be extended by a period of five years. If you submit all the missing data on quality, safety and efficacy, an authorisation for exceptional circumstances may be replaced by a marketing authorisation for an unlimited period.   

The legal basis for an application in exceptional circumstances is set out in Articles 25, 26 and 27 of the Veterinary Medicinal Products Regulation.