SCHEDULE 2FEES RELATING TO SITE INSPECTIONS
Interpretation1
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.
Fees
2
1
Subject to paragraphs 3 and 4, except in the case of an inspection falling within sub-paragraphs (2) to (4) below, the fee payable in respect of an inspection of a kind described in an entry in column (1) of Table A is that specified in the corresponding entry in column (2) of that Table.
Column (1) | Column (2) |
|---|---|
Kind of inspection | Fee |
Supersite inspection | £8,390 |
Major inspection | £4,415 |
Standard inspection | £3,155 |
Minor inspection | £1,705 |
2
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 the fee payable for an inspection of a kind described in an entry in column (1) of Table B of such a site shall be that specified in the corresponding entry in column (2) of that Table.
Column (1) | Column (2) |
|---|---|
Kind of inspection | Fee |
Supersite inspection | £13,905 |
Major inspection | £7,680 |
Standard inspection covering immunological Veterinary Medicinal Products | £5,010 |
Other standard inspection | £3,775 |
Minor inspection covering immunological Veterinary Medicinal Products | £2,580 |
Other minor inspection | £2,525 |
3
Except in the case of an inspection falling within sub-paragraph (4) below, where the site inspected is concerned only with the assembly of products the fee payable for an inspection of the kind described in an entry in column (1) of Table C of such a site shall be that specified in the corresponding entry in column (2) of that Table.
Column (1) | Column (2) |
|---|---|
Kind of inspection | Fee |
Supersite inspection | £6,090 |
Major inspection | £4,115 |
Standard inspection | £2,015 |
Minor inspection | £1,035 |
4
Where the site inspected is limited solely to the manufacture or assembly of–
a
products, the sale or supply of which do not require a marketing authorisation or product licence and to which article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, the fee payable shall be £100;
b
emergency vaccines, the fee payable shall be £100; or
c
products covered by paragraph (a) above and vaccines covered by paragraph (b) above, the fee payable shall be £200.
3
1
The fee payable for any inspection of either or both of the premises and the procedures for the quality control of a biological product, in respect of which a marketing authorisation or product licence has been granted or applied for, is £1,210 for each such product which is not a dormant biological product.
2
A fee of £55 is payable for any such inspection in connection with such an authorised or licensed biological product (not being a dormant biological product) for which a marketing authorisation or product licence was granted because it was identical to an existing product.
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 relating to the inspection and any additional costs reasonably incurred by him in respect of that inspection as a result of it being at a site outside the United Kingdom.
2
The fee payable for an inspection pursuant to paragraph 4 at a site, whether or not outside the United Kingdom, shall be increased by an amount equal to the travelling and subsistence costs of one or more inspectors relating to the inspection and any additional costs reasonably incurred by him in respect of that inspection in the case of its being at a site outside the United Kingdom (such as interpreter’s fees).
3
For the purposes of sub-paragraphs (1) and (2) above, the fees of an interpreter shall be regarded as included among additional costs capable of being reasonably incurred.