Division IntroductionF1

United Kingdom

1. (i)Division (i)
2. (ii)In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it shall be sufficient to:
3. (iii)A detailed description (specification) of the material used, as provided for under point 1.11 must be provided. Where testing is done using active substance the material used shall be of that specification that will be used in the manufacture of preparations to be authorised except where radio-labelled material is used.
4. (iv)Division (iv)
5. (v)Division (v)
6. (vi)Where relevant, tests shall be designed and data analysed using appropriate statistical methods.