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23/02/2022

MA renewal

For veterinary medicinal products with limited marketing authorisation, the original MA has a validity of 5 years. For marketing authorisations in exceptional circumstances, they shall be reviewed annually.

Before the expiry of that period, it is for the holder to apply for the renewal of his authorisation. Otherwise, the MA is considered abandoned and the medicinal product can no longer be marketed.

The limited market definition includes the treatment and prevention of an infrequent disease and/or in a limited geographical area or target species other than bovine, sheep reared for meat, pigs, chickens, dogs and cats.

A marketing authorisation for a limited market may be sought if the benefit of the availability on the market of the veterinary medicinal product for animal or public health outweighs the risks inherent in the absence of part of the required technical documentation and the applicant provides evidence that the veterinary medicinal product is intended for a limited market.

The documentation provided may not be exhaustive in terms of safety or efficacy, but may be complete in terms of quality.

The period of validity is limited to 5 years with a review to ensure that the market remains limited and that the profit is always higher. The MA may become unlimited when the holder provides all the required documentation.

The MA for exceptional circumstances is requested for animal or public health reasons. The documentation provided may not be exhaustive in terms of quality, safety or efficacy. This MA is granted for only 1 year and needs to be reviewed.

The MA is issued with conditions or restrictions in particular on safety, the obligation to report any adverse reactions and the obligation to carry out post-authorisation studies.

To apply for a renewal of the MA