The Medicines (Products for Animal Use—Fees) Regulations 1998

Interpretation

1.—(1) In this Schedule–

• “biological product” has the same meaning as set out in Part I of Schedule 1;

• “dormant biological product” means a biological product which is not currently being manufactured or sold and in respect of which there is no current intention to recommence the manufacture or sale;

• “immunological Veterinary Medicinal Product” has the same meaning as in Part I of Schedule 1;

• “major inspection” means an inspection at a site at which 60 or more, but fewer than 250, relevant persons are employed;

• “minor inspection” means an inspection at a site at which fewer than 10 relevant persons are employed;

• “relevant person” means any person directly or indirectly engaged in, or assisting in, the activity of manufacturing or assembling products and also includes any person whose connection with that activity involves management, quality control, site maintenance, packing, storage or distribution;

• “standard inspection” means an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed; and

• “supersite inspection” means an inspection at a site at which 250 or more relevant persons are employed;

(2) In calculating the number of relevant persons for the purposes of this Schedule, any person operating partly as a relevant person (whether as a part-time employee or by virtue of being only partly employed in such work) shall be included in the calculation but only as a fraction calculated by reference to the amount of time spent by that person in so operating or, where such a calculation is inappropriate, by reference to the proportion of his job which can otherwise be reasonably attributed to so operating and, in either case, by comparison with the average working week of a relevant person engaged in full-time employment at the same site.