Cascade

Are you a veterinarian? Then you have the option of treating animals with other veterinary medicinal products or medicines for conditions for which no veterinary medicine is available in the Netherlands, in order to prevent unacceptable suffering in the animals you are treating. This is referred to as ‘Use of medicinal products outside the terms of the marketing authorisation’, but is more commonly known as the cascade. This type of use is subject to various requirements and falls entirely under your responsibility as a veterinarian.

Use in non-food-producing animal species (Article 112)

If you are a veterinarian, you may treat non-food-producing animal species with the following medicines in the absence of a suitable veterinary medicinal product:

  • First and foremost, with a veterinary medicinal product with marketing authorisation issued in the Netherlands or in another Member State for use in:
    • the same species or;
    • another animal species for the same indication or;
    • another indication.
  • If a veterinary medicinal product referred to in the above is not available or cannot be used, then you may use medicine authorised in the Netherlands or in another Member State.
  •  If the veterinary or other medicines listed in the above are likewise unavailable, then, as a veterinarian, you have the option of preparing the veterinary medicinal product yourself. You may also have the product prepared by a pharmacist. This is referred to as compounding or extemporaneous preparation.

In cases where none of the foregoing options are available, you may: in exceptional cases, as a veterinarian, treat an animal with a veterinary medicinal product that is authorised in a third country for the same animal species and the same indication. This does not apply to immunological veterinary medicinal products. In such cases, as a veterinarian or as the wholesaler acting at the request of the veterinarian, you must report the intended import from a third country.

Please note! You must apply for an import declaration. You can do so here. The declaration is needed to inform the authorities of the exporting country and the importing country (the Netherlands) of the legal basis of the activity.

In the case of horses, there is an option of having the equine passport state that the horse in question is not intended for slaughter for human consumption if the animal has been treated with an active substance that does not comply with Regulation (EC) No 470/2009.

Use in food-producing animal species (Article 113)

If you are a veterinarian, you may treat food-producing animal species with the following medicines in the absence of a suitable veterinary medicinal product:

  • First of all, with a veterinary medicinal product with marketing authorisation issued in the Netherlands or in another Member State that has been approved for the same or a similar indication for the same or a different food-producing animal species.
  • Secondly, a veterinary medicinal product that is authorised in the Netherlands for use in a non-food-producing animal species for the same indication.
  • If a veterinary medicinal product referred to in the above is not available or cannot be used, you may use medicine authorised in the Netherlands or in another Member State.
  •  If the veterinary or other medicines listed in the above are likewise unavailable, then, as a veterinarian, you have the option of preparing the veterinary medicinal product yourself. You may also have the product prepared by a pharmacist. This is referred to compounding or extemporaneous preparation.

In cases where none of the foregoing options are available, you may: in exceptional cases, as a veterinarian, treat an animal with a veterinary medicinal product that is authorised in a third country for the same animal species and the same indication. This does not apply to immunological veterinary medicinal products. In such cases, as a veterinarian or as the wholesaler acting at the request of the veterinarian, you must report the intended import from a third country.

Please note! You must apply for an import declaration. Please apply for an import declaration here. The declaration is needed to inform the authorities of the exporting country and the importing country (the Netherlands) of the legal basis of the activity.

For food-producing animal species, the pharmacologically active substances in a medicinal product must be authorised in accordance with Regulation (EC) No 470/2009.

Use in food-producing fish and other aquatic species (Article 114)

The requirements for food-producing aquatic species are approximately comparable to those described in the foregoing for food-producing terrestrial animals. However, a number of specific provisions apply to food-producing aquatic species. These are set out in Article 114 of the Veterinary Medicinal Products Regulation.

For food-producing animal species, the pharmacologically active substances in a medicinal product must be authorised in accordance with Regulation (EC) No 470/2009.

Withdrawal period

If the SPC of a veterinary medicinal product already states a withdrawal period for the relevant animal species, this period can be applied.

Meat and slaughterhouse waste
If no withdrawal period has been specified for meat/slaughterhouse waste from the relevant animal species, then:

  • multiply the longest withdrawal period from the SPC for meat and slaughterhouse waste by a factor of 1.5;
  • observe a withdrawal period of at least one day if the SPC for meat and slaughterhouse waste specifies a withdrawal period of zero days;
  • the withdrawal period is at least 28 days for meat and slaughterhouse waste for a veterinary or other medicinal product that has not been licenced for food-producing animals.

Milk
If no withdrawal period has been specified for milk from the relevant animal species, then:

  • multiply the longest withdrawal period from the SPC for milk by a factor of 1.5;
  • observe a withdrawal period of at least one day if the SPC for milk specifies a withdrawal period of zero days;
  • the withdrawal period is at least seven days for milk for a veterinary or other medicinal product that has not been licenced for food-producing animals.

Eggs
If no withdrawal period has been specified for eggs from the relevant animal species, then:

  • multiply the longest withdrawal period from the SPC for eggs by a factor of 1.5;
  • observe a withdrawal period of at least one day if the SPC for eggs specifies a withdrawal period of zero days;
  • the withdrawal period is at least ten days for eggs for a veterinary or other medicinal product that has not been licenced for food-producing animals.

Use in the event of a (temporary) shortage of a veterinary medicinal product

The foregoing provisions likewise apply if an authorised veterinary medicinal product is (temporarily) unavailable in the Netherlands.

Additional rules

As a veterinarian, you may:

  • obtain a medicine (listed in the above) authorised in the Netherlands through a licenced wholesaler of medicines in the Netherlands; or
  • obtain a veterinary medicinal product (listed in the above) in another EEA Member State through a wholesaler of veterinary medicinal products in the Netherlands or in another EEA Member State.

As a veterinarian, you may administer the medicine personally. You may also have it administered by someone else under your own responsibility (if this is permitted for the relevant veterinary or other medicinal product).

As a veterinarian, you are responsible for ensuring correct labelling in respect of the user.

As a veterinarian, you must keep records of the use of veterinary medicinal products that are used outside the terms of the marketing authorisation.

As a veterinarian or wholesaler, you are not permitted to advertise veterinary medicinal products that are used outside the terms of the marketing authorisation.

Legal basis

The administrative requirements for veterinarians are set out in the Section 5.1 – 5.4 of the Veterinarians Decree.

Article 112 of the Veterinary Medicinal Products Regulation sets out the ‘Use of medicinal products outside the terms of the marketing authorisation’ for non-food-producing animal species.

Article 113 describes the ‘Use of medicinal products outside the terms of the marketing authorisation’ for food-producing terrestrial animal species.

Article 114 describes the ‘Use of medicinal products outside the terms of the marketing authorisation’ for food-producing aquatic species.

Additional information

Please find more information in the newsletters of the Ministry of Agriculture, Nature and Food Quality about the cascade. In the event you have any additional questions about the cascade or about applying for an import declaration, please submit your enquiries to the Veterinary Medicinal Products Unit using our contact form.