Regulation 5 Inspections in connection with multiple applications for authorizations or licences

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

regs 4, 5 am by Medicines for Human Use (Fees Amendments) 2005 reg 4(1)–(3)
reg. 5(a) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 3(3)(a)
reg. 5(b) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 3(3)(b)
reg. 5 words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 7

Where an inspection mentioned in regulation 4(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product, by more than one applicant for—

(a)

a marketing authorization and that site is located outside the United Kingdom; or

(b)

a manufacturer’s licence and that site is located in the United Kingdom,

the fee in respect of that inspection shall be payable in equal proportions by each of those applicants.