Division Introduction

The provisions of this Section cover analytical methods used for the generation of pre-approval data and required for post-approval control and monitoring purposes.

Descriptions of methods shall be provided and include details of equipment, materials and conditions used.

On request, the following shall be provided:

1. (a)

   analytical standards of the purified active substance;

2. (b)

   samples of the active substance as manufactured;

3. (c)

   analytical standards of relevant metabolites and all other components included in all monitoring residue definitions;

4. (d)

   samples of reference substances for the relevant impurities.

Where possible, the standards referred to in points (a) and (c) shall be made commercially available and, on request, the distributing company shall be named.