OpenLegislation

Regulation 8 Inspections in connection with multiple applications for variations of licences

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

Where an inspection mentioned in regulation 7(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product by more than one applicant for a variation to—

(a)

a product licence 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.