Regulation 7 Variations of authorizations, licences and certificates

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

reg 7 am by Medicines for Human Use (Fees Amendments) 2005 reg 6(1), (2)
reg. 7(1)(c) substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 4(2)
reg. 7(1) words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 8(a)
reg. 7(3) inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 8(b)

(1)

Subject to regulations 8, 9, 19 and 23, a person who makes an application—

(a)

under regulation 4 of the 1994 Regulations for the variation of a United Kingdom marketing authorization;

(b)

under section 30 of the Act for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; and

(c)

under section 39(4) of the Act for the variation of a provision of a clinical trial certificate,

shall pay the fees mentioned in paragraph (2).

(2)

The fees referred to in paragraph (1) are—

(a)

the fee prescribed in Part III of Schedule 1 in connection with the application; and

(b)

in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with the application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.