SCHEDULES

SCHEDULE 2Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

F1PART 6BCapital Fee for Testing of Samples by the Appropriate Authority

Annotations:
Amendments (Textual)

57B

1

Unless sub-paragraph (2) applies, the fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of a medicinal product of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

2

This sub-paragraph applies where—

a

the holder of the marketing authorisation submits, with a sample of a batch of medicinal product, a certificate issued by a laboratory in a designated country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted; and

b

on the basis of the documentation submitted with the sample, the appropriate authority considers that it is only necessary to carry out a paper based assessment of the sample.

3

Where sub-paragraph (2) applies, the fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of medicinal product of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 3 of that table.

4

Where a product falls within more than one of the Bands referred to in the following table, the product is to be treated as if it only falls within the Band which attracts the highest fee.

Fees for testing of samples

Column 1Product Type

Column 2Fee payable where the licensing authority carries out a full assessment

Column 3Fee payable where the licensing authority carries out a paper-based assessment

1. Plasma pools which require—

(a)

three or fewer tests

£180

£90

(b)

four or five tests

£215

£90

(c)

six or more tests

£230

£90

2. Band A

£1,660

£305

3. Band B

£1,910

£305

4. Band C

£2,340

£305

5. Band D

£3,690

£677

6. Band E

£6,410

£677

7. Band F

£10,350

£677

5

In this paragraph—

  • “Band A” means a single component product, other than Botulinum toxin, requiring five or fewer in vitro tests;

  • “Band B” means Factor VIII, Factor IX or intravenous Immunoglobulin;

  • “Band C” means a multi-component product, or Botulinum toxin, requiring five or fewer in vitro tests;

  • “Band D” means a product requiring six to nine in vitro tests;

  • “Band E” means a product requiring—

    1. a

      ten or more in vitro tests, or

    2. b

      one or more in vivo tests;

  • “Band F” means a product—

    1. a

      which requires one or more tests that must be carried out under containment measures applicable to hazard Group 3 or 4 biological agents under the Control of Substances Hazardous to Health Regulations 2002 ; or

    2. b

      requires the use of human cells or tissues as part of its testing;

  • “Multi-component product” means a product containing two or more analytes that require testing; and

  • “Single component product” means a product containing a single analyte that requires testing.