COUNCIL REGULATION (EEC) N°2377/90

laying down a Community procedure for
the establishment of maximum residue limits of
veterinary medicinal products in foodstuffs of animal origin

ANNEX V

Information and particulars to be included in an application for the establishment of a maximum residue limit
for a pharmacologically active substance used in veterinary medicinal products

[Administrative particulars

1.1. Name or corporate name and permanent address of the applicant.

1.2. Name of the veterinary medicinal product.

1.3. Qualitative and quantitative composition in terms of active principles, with mention of the international non-proprietary name recommended by the World Health Organization, where such name exists.

1.4. Manufacturing authorization, if any.

1.5. Marketing authorizations, if any.

1.6. Summary of the characteristics of the veterinary medicinal product(s) prepared in accordance with Article 5a of Directive 81/851/EEC.

A. Safety documentation

A.0. Expert report

A.1. Precise identification of the substance concerned by the application

1.1. International non-proprietary name (INN).

 

1.2. International Union of Pure and Applied Chemistry (IUPAC) name.

 

1.3. Chemical Abstract Service (CAS) name.

 

1.4. Classification:

- therapeutic ;
- pharmacological.

1.5. Synonyms and abbreviations.

 

1.6. Structural formula.

 

1.7. Molecular formula.

 

1.8. Molecular weight.

 

1.9. Degree of impurity.

 

1.10. Qualitative and quantitative composition of impurities.

 

1.11. Description of physical properties:

- melting point ;
- boiling point ;
- vapour pressure ;
- solubility in water and organic solvents, expressed in grams per litre, with indication of temperature ;
- density ;
- refractive index, rotation, etc.

A.2. Relevant pharmacological studies

2.1. Pharmacodynamics.

 

2.2. Pharmacokinetics.

A.3. Toxicological studies

3.1. Single dose toxicity.

 

3.2. Repeated dose toxicity.

 

3.3. Tolerance in the target species of animal.

 

3.4. Reproductive toxicity, including teratogenicity.

 

3.4.1. Study of the effetcs on reproduction.

 

3.4.2. Embryotoxicity/fetotoxicity, including teratogenicity.

 

3.5. Mutagenicity.

 

3.6. Carcinogenicity.

A.4. Studies of other effects

4.1. Immunotoxicity.

 

4.2. Microbiological properties of residues.

 

4.2.1. On the human gut flora ;

 

4.2.2. On the organisms and microorganisms used for industrial food-processing.

 

4.3. Observations in humans.

B. Residue documentation

B.0. Expert report

B.1. Precise identification of the substance concerned by the application

The substance concerned should be identified in accordance with point A.1. However, where the application relates to one or more veterinary medical products, the product itself should be identified in detail, including:

- qualitative and quantitative composition ;
- purity
- identification of the manufacturer's batch used in the studies ; relationship to the final product ;
- specific activity and radio-purity of labelled substances ;
- position of labelled atoms on the molecule.

B.2. Residue studies

2.1. Pharmacokinetics (absorption, distribution, biotransformation, excretion).

 

2.2. Depletion of residues.

 

2.3. Elaboration of maximum residue limits (MRLs).

B.3. Routine analytical method for the detection of residues

3.1. Description of the method.

 

3.2. Validation of the method.

 

3.2.1. specificity ;

 

3.2.2. accuracy, including sensitivity ;

 

3.2.3. precision ;

 

3.2.4. limit of detection ;

 

3.2.5. limit of quantitation ;

 

3.2.6. practicability and applicability under normal laboratory conditions ;

 

3.2.7. susceptibility to interference.]

 

 

Commision Regulation (EEC) N° 762/92 of 27 March 1992 (OJ N° L 83, 28.3.1992)