PART 3AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

Amendments by the sponsor24

1

A sponsor may make an amendment to a clinical trial authorisation, other than a substantial amendment, at any time.

2

A sponsor shall—

a

keep records of the amendments made in accordance with paragraph (1); and

b

send those records, or copies of such records, to the licensing authority, where the authority send him a notice in writing requiring him to provide those records, or copies of such records.

3

If the sponsor proposes to make a substantial amendment to a clinical trial authorisation which consists of, or includes, an amendment to—

a

the terms of the request for authorisation of the clinical trial; or

b

the particulars or documents that accompanied that request,

he shall send a valid notice of amendment to the licensing authority, whether or not he is also required to send a notice in accordance with paragraph (4).

4

If the sponsor proposes to make a substantial amendment to a clinical trial authorisation which consists of, or includes, an amendment to—

a

the terms of the application for an ethics committee opinion in relation to the clinical trial; or

b

the particulars or documents that accompanied that application,

he shall send a valid notice of amendment to the relevant ethics committee, whether or not he is also required to send a notice in accordance with paragraph (3).

5

The licensing authority may, within the period of 35 days from the date of receipt of a valid notice of amendment, give written notice to the sponsor—

a

setting out the licensing authority’s grounds for not accepting the proposed amendment; or

b

stating that the licensing authority accepts the application for amendment, subject to any conditions which may be specified in the notice.

6

A relevant ethics committee shall, within the period of 35 days from the date of receipt of a valid notice of amendment, give an opinion to the sponsor.

7

Subject to paragraph (8), if the sponsor has sent a notice in accordance with paragraph (3), he may make the amendment only if—

a

the licensing authority have given him a notice in accordance with paragraph (5)(b); or

b

no notice has been given by the licensing authority in accordance with paragraph (5).

8

If the sponsor has been given a notice in accordance with paragraph (5)(b), he may make the amendment subject to the conditions, if any, specified in the notice.

9

If the sponsor has sent a notice in accordance with paragraph (4), he may make the amendment only if the relevant ethics committee has given a favourable opinion.

10

In this regulation—

  • “valid notice of amendment” means a notice that is—

    1. a

      in writing; and

    2. b

      accompanied by—

      1. i

        the particulars specified in Part 3 of Schedule 3, and

      2. ii

        any fee which may be payable in connection with that notice under the Medicines (Products for Human Use—Fees) Regulations 199535.