Price
Free
Execution deadline in working days
15
Recipient
Any person
Receiving restrictions
-

The Marketing Authorisation Holder should submit a periodic safety report (periodic safety reports) on the side effects of the veterinary medicinal product. The veterinarian or pharmacist shall be required to report non-foreseeable adverse reactions which have become known to him when administering veterinary or medicinal products for human use to animals or under professional duties.

Process description

  1. Service requests
    The Marketing Authorisation Holder shall submit periodic safety reports to the Food and Veterinary Service:
    1. not less than once every six months after receipt of the registration certificate for veterinary medicinal products and until the placing on the market thereof (if it is not specified otherwise in the regulatory enactments regarding the registration of veterinary medicinal products or in the instructions of the European Commission);
    2. not less than every six months during the first two years following the initial placing on the market of the veterinary medicinal product and annually over the next two years;
    3. every three years thereafter;
    4. At the request of a special Food and Veterinary Service, periodic safety reports shall be submitted without delay.

    A message signed with an e-signature may be submitted using an e-mail or an e-address of the institution.

  2. Receipt of services
    Receipt of services according to the application of choice.