F1ANNEX IANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
Annotations:
Amendments (Textual)
PART IIIPARTICULAR MEDICINAL PRODUCTS
2.RADIO-PHARMACEUTICALS AND PRECURSORS
2.2.Radio-pharmaceutical precursors for radio-labelling purposes
Module 4
Concerning single dose and repeat dose toxicity, the results of studies carried out in conformity with the provisions related to good laboratory practice laid down in Council Directives 87/18/EEC and 88/320/EEC shall be provided, unless otherwise justified.
Mutagenicity studies on the radio-nuclide are not considered to be useful in this particular case.
Information relating to the chemical toxicity and disposition of the relevant ‘cold’ nuclide shall be presented.
Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).