Regulation 8
SCHEDULE 2U.K.Fees relating to site inspections
InterpretationU.K.
1.—(1) In this Schedule—U.K.
“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.
FeesU.K.
2.—(1) The fee for an inspection is that specified in the table below.U.K.
| Type of inspection | Fee (£) |
|---|---|
| Supersite | 10,300 |
| Major | 5,420 |
| Standard | 3,885 |
| Minor | 2,095 |
(2) Sub-paragraph (1) does not apply where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products in which case the fee payable is that specified in the table below.
| Type of inspection | Fee (£) |
|---|---|
| Supersite | 17,085 |
| Major | 9,440 |
| Standard, covering immunological veterinary medicinal products | 6,160 |
| Other standard | 4,640 |
| Minor, covering immunological veterinary medicinal products | 3,105 |
| Other minor | 3,105 |
(3) Sub-paragraph (1) does not apply where the site inspected is concerned only with the assembly of products, in which case the fee payable is that specified in the table below.
| Type of inspection | Fee (£) |
|---|---|
| Supersite | 7,485 |
| Major | 5,055 |
| Standard | 2,480 |
| Minor | 1,280 |
(4) Sub-paragraph (1) does not apply where the site inspected is limited solely to the manufacture or assembly of—
(a)products the sale or supply of which would require a product licence but for article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, in which case the fee payable is £105;
(b)emergency vaccines, in which case the fee payable is £115;
(c)products covered by paragraph (a) above and vaccines covered by paragraph (b), in which case the fee payable is £200.
3. Paragraph 2 does not apply to a biological product (not being a dormant biological product), for which—U.K.
(a)a marketing authorisation or product licence was granted because it was identical to an existing product, in which case the inspection fee is £65;
(b)the fee for any inspection limited to either or both of the premises where it is manufactured or assembled and the procedures for its quality control is £1,480.
4.—(1) The fee payable for an inspection at a site outside the United Kingdom shall be increased by an amount equal to the travelling and subsistence costs of one or more inspectors and any additional costs reasonably incurred by them on account of it being outside the United Kingdom.U.K.
(2) For the purposes of sub-paragraph (1), the fees of an interpreter shall be regarded as an additional cost capable of being reasonably incurred.