Division Introduction
United Kingdom
- (i)Active substances are defined in Article 2(2) of Regulation (EC) No 1107/2009 and include chemical substances and micro-organisms including viruses.
- (ii)For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.
- (iii)Division (iii)
- (iv)Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with point 1.4, must be provided. The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.
- (v)Division (v)
- (vi)Division (vi)
- (vii)In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.
- (viii)Division (viii)