The Medicines (Products for Animal Use—Fees) Regulations 2004

1.—(1) In this Schedule—

“biological product” has the same meaning as set out in Part 1 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 Directive 2001/82/EC;

“major”, in relation to an inspection, describes an inspection at a site at which 60 or more, but fewer than 250, relevant persons are employed;

“minor”, in relation to an inspection, describes an inspection at a site at which fewer than 10 relevant persons are employed;

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

“standard”, in relation to an inspection, describes an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed; and

“supersite”, in relation to an inspection, describes 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 relevant work) shall be included in the calculation pro rata.