Cascade system for the use of medicinal products by the veterinarian outside the terms of the marketing authorisation

The cascade system allows the veterinarian to deviate from the strict use of veterinary medicinal products authorised and marketed in Belgium.

The veterinarian may apply the cascade, exceptionally and under their own responsibility, for the treatment of the animals concerned, to avoid unacceptable suffering.

If no veterinary medicinal product authorised in Belgium exists or is available for the animal species concerned and for that particular indication, the veterinarian in charge may apply the cascade under specific conditions which differ depending on the species treated.

There are three different cascade systems

  1. For non-food-producing animals
  2. For food-producing terrestrial animals
  3. For food-producing aquatic animals

 

  1. Treating a non-food-producing animal with a medicinal product outside the terms of the marketing authorisation

Legal framework: Article 112 of Regulation 2019/6

  • Level 1: a veterinary medicinal product authorised in Belgium or in another Member State for use in the same species or another animal species for the same indication or for another indication.

If the medicinal product under level 1 does not exist.

  • Level 2: a medicinal product for human use authorised in a Member State of the European Union.

If the medicinal product under level 2 does not exist.

  • Level 3: a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

If the medicinal product under level 3 does not exist.

  1. Treating a food-producing terrestrial animal with a medicinal product outside the terms of the marketing authorisation

Legal framework: Article 113 of Regulation 2019/6

  • Level 1: a veterinary medicinal product authorised in Belgium or in another Member State for use in the same or in another food-producing terrestrial animal species, for the same indication or for another indication.

If the medicinal product under level 1 does not exist.

  • Level 2: a veterinary medicinal product authorised in Belgium for use in a non-food-producing animal species for the same indication.

If the medicinal product under level 2 does not exist.

  • Level 3: a medicinal product for human use authorised in a Member State of the European Union.

If the medicinal product under level 3 does not exist.

  • Level 4: a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

If the medicinal product under level 4 does not exist.

For food-producing animals, active substances are subject to a maximum residue limit (MRL).

  1. Treating a food-producing aquatic animal with a medicinal product outside the terms of the marketing authorisation

Legal framework: Article 114 of Regulation 2019/6

  • Level 1: a veterinary medicinal product authorised in Belgium or in another Member State of the European Union for use in the same or in another food-producing aquatic animal species, for the same indication or for another indication.

If the medicinal product under level 1 does not exist.

  • Level 2: a veterinary medicinal product authorised in Belgium or in another Member State for use in a food-producing terrestrial animal species.     

 If the medicinal product under level 2 does not exist.

  • Level 3: a medicinal product for human use authorised in a Member State of the European Union.

If the medicinal product under level 3 does not exist.

  • Level 4: a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

If the medicinal product under level 4 does not exist.

  • Level 5: except for immunological veterinary medicinal products, a veterinary medicinal product authorised in a third country for use in the same animal species and for the same indication.
  • With regards to levels 2 and 3, following publication of the implementing act by the Commission establishing a list of active substances for use in food-producing aquatic species, the veterinarian's choice will be limited to these substances when using level 2 or 3 medicines.

For all food-producing animals, active substances are subject to a maximum residue limit (MRL).

In practice

  1. The veterinarian keeps a record of the medicinal products they administered or supplied through the cascade system.
  2. The veterinarian keeps these data for at least five years.
  3. The veterinarian who prescribes medicinal products through the cascade system ticks the relevant box on the prescription.
  4. Import from a third country: the veterinarian in charge of a depot emails this form (FR-NL) to infovet@fagg-afmps.be to notify the FAMHP of the import of a veterinary medicinal product from a third country.
    The notification takes place no later than the day after the veterinary medicinal product is ordered.
    The FAMHP sends an acknowledgement of receipt of the notification to the veterinarian in charge of a depot.
    The veterinarian in charge of a depot keeps for a period of five years:
    • a copy of the notification;
    • the acknowledgement of receipt;
    • the import documents;
    • the Summary of Product Characteristics (SPC).

Useful links 

The Union Product Database (UPD) allows to access information about veterinary medicinal products authorised in all EU Member States.

Legislation 

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