Special Marketing Authorisations

In order to improve the availability of veterinary medicinal products in the European Union (EU) for smaller markets, in some cases it should be possible to grant marketing authorisations without submitting all described documents in the dossier for the application. This shall be based on a risk-benefit assessment of the situation and, if necessary, special obligations. Such marketing authorisations shall in particular be granted for veterinary medicinal products intended for animal species of lesser economic importance or for the treatment or prevention of diseases that are rare or geographically limited.

Therefore, the possibility of a marketing authorisation for limited markets and in exceptional circumstances was created in Regulation (EU) 2019/6.

Marketing Authorisation for Limited Markets

According to Article 23 of Regulation (EU) 2019/6, the applicant shall not be required to provide certain information and documents on safety and efficacy with the application for marketing authorisation, provided that:

1. 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 documentation on safety and efficacy has not been provided;
2. the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

The lack of comprehensive safety and efficacy data and documents shall be clearly stated in the package leaflet (instructions for use).

The marketing authorisation for limited markets is valid for a period of five years. Before the expiry of this period, the authorisation is re-examined and the risk-benefit ratio of the veterinary medicinal product is updated. The marketing authorisation holder shall submit an application for re-examination of the marketing authorisation six months before the expiry of the period of validity. After re-examination, the validity of the marketing authorisation is extended by an additional period of five years.

Provided that all missing documents required for a complete authorisation have been submitted, the obligation for re-examination may be waived and an unlimited marketing authorisation be granted.

Requirements for applications for marketing authorisations intended for limited markets were developed and compiled in a guideline.

Marketing Authorisation in Exception Circumstances

Pursuant to Article 25 of Regulation (EU) 2019/6, it is permitted that certain data and documents on quality, safety and efficacy are not provided, if the benefit of the immediate availability on the market of the veterinary medicinal product concerned to the animal or public health outweighs the risk inherent in the fact that certain documents have not been provided. In this case, however, the applicant shall demonstrate that this documentation cannot be provided for objective and verifiable reasons.

The lack of comprehensive quality, safety and efficacy data and documents shall be stated in the package leaflet (instructions for use).

The marketing authorisation in exception circumstances is valid for a period of one year. Before the expiry of this period, the authorisation is re-examined and the risk-benefit ratio of the veterinary medicinal product is updated. The marketing authorisation holder shall submit an application for re-examination of the marketing authorisation three months before the expiry of the period of validity. After re-examination, the validity of the marketing authorisation is extended by an additional period of one years.

Provided that all missing documents required for a complete authorisation have been submitted, the obligation for re-examination may be waived and an unlimited marketing authorisation be granted.

For applications for marketing authorisations in exceptional circumstances, corresponding requirements were developed and compiled in a guideline.

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