Division IntroductionF1

The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.

For analytical methods used for generation of data as required in this Regulation or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.

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

As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.

For this Section the following applies:

On request the following samples must be provided:

1. (i)

   analytical standards of the pure active substance;

2. (ii)

   samples of the active substance as manufactured;

3. (iii)

   analytical standards of relevant metabolites and all other components included in the residue definition;

4. (iv)

   if available, samples of reference substances for the relevant impurities.