F1ANNEX ICHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS
Annotations:
Amendments (Textual)
TITLE IREQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
PART 3:SAFETY AND RESIDUES TESTS
A.Safety tests
CHAPTER I:PERFORMANCE OF TESTS
1.Precise identification of the product and of its active substance(s)
international non-proprietary name (INN),
International Union of Pure and Applied Chemistry Name (IUPAC),
Chemical Abstract Service (CAS) number,
therapeutic, pharmacological and chemical classification,
synonyms and abbreviations,
structural formula,
molecular formula,
molecular weight,
degree of impurity,
qualitative and quantitative composition of impurities,
description of physical properties,
melting point,
boiling point,
vapour pressure,
solubility in water and organic solvents expressed in g/l, with indication of temperature,
density,
spectra of refraction, rotation, etc,
formulation of the product.
Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).