Legislation

Question 1

European legislation establishes (2)

Answer 1

regulations & directives

Regulations – come into force in all member states after adoption.

Directives – obligatory to member states, harmonized in the national legislation, minor differences between countries may occur.

Question 2

Define withdrawal period.

Answer 2

The necessary period from the last administration of a veterinary medicinal product administered to animals, under normal conditions of use and in accordance with the provisions of this Directive, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to Regulation (EEC) 37/2010.

Question 3

What is the cascade system for veterinary medicines?

Answer 3

The Cascade is a risk based decision-tree to help veterinary surgeons decide which product to use when there is no authorised veterinary medicine available.

Without the Cascade, veterinary surgeons would only be allowed to prescribe veterinary medicines that are authorised for a given species and for a given condition.

Question 4

Regulation 37/2010

Answer 4

List of substances allowed to be used in food producing animals.

If the substance is not listed in Table 1, it is not allowed to be used in that animal species.

Table 1: allowed substances
Table 2: prohibited substances

Question 5

Regulation 1950/2006

Answer 5

list of substances allowed for use in horses

„By means of the derogation provided for in Directive 2001/82/EC, equidae intended for slaughter for human consumption may be administered substances essential for their treatment, hereinafter ‘essential substances’, subject to a withdrawal period of at least six months.“

Question 6

MRL =

Answer 6

maximum residual level

is the maximum concentration of a substance residue in or on food stuffs that is legally tolerated

Question 7

Define allopathic medicine.

Answer 7

a system of medical practice that emphasizes diagnosing and treating disease and the use of conventional, evidence-based therapeutic measures (such as drugs or surgery)

essentially the opposite of homeopathic