The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004

Amendment of Schedule 2 to the General Fees Regulations

10.  In Schedule 2 to the General Fees Regulations (fees for inspections) after paragraph 6 insert the following paragraphs—

“7.— (1) Subject to paragraph 8, the fee payable under regulation 13A(1) by a person in respect of any inspection of one or more sites for the purpose of ascertaining whether that person—

(a) is—

(i) conducting, or has conducted, a clinical trial, or

(ii) performing, or has performed, the functions of a sponsor of a clinical trial,

in accordance with the conditions and principles of good clinical practice, pursuant to regulation 28(1) of the Clinical Trials Regulations; or

(b) has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the conditions and principles of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations,

shall be calculated as specified in sub-paragraphs (2) to (4).

(2) For each category of activity relevant to compliance with good clinical practice described in column (1) of the following Table which is assessed for compliance at a site inspected as part of that inspection, the points specified in the corresponding entry in column 2 of that Table shall be allocated.

Table

Column 1	Column 2
Category of GCP activity	Points
Archiving	1
Project management	3
Quality system	2
Essential documents	3
Contracts and agreements	2
Training	2
Computer systems	3
Data management	3
Statistics	2
Regulatory affairs	1
Investigational medicinal product management	2
Monitoring	3
Pharmacovigilance	2
Reporting	1

(3) The points allocated for each category of activity assessed at a site shall be added to give a total for that site and the points for each site visited as part of that inspection shall be added to give a total for that inspection.

(4) The fee payable shall be—

(a) where the total points for an inspection are less than 10, £3,000,

(b) where the total points for an inspection are more than 9 and less than 16, £5,000,

(c) where the total points for an inspection are more than 15 and less than 26, £10,000, and

(d) where the total points for an inspection are more than 25, £15,000,

except that where more than 2 sites are visited as part of an inspection an additional fee of £3,000 shall be payable for each extra site visited.

8.   The fee payable in respect of an inspection where a site inspected is outside the United Kingdom shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs (such as interpreters' fees) reasonably incurred by him in respect of that inspection as a result of its being at a site outside the United Kingdom.”.