Regulation 7 Amendment of regulation 6 of, and additional regulation 6A to, the principal Regualtions

In regulation 6 of the principal Regulations (variations of licences) for “Subject to regulations 9, 16 and 20” there shall be substituted “Subject to regulations 6A, 9, 16 and 20”.

After regulation 6 to the principal Regulations there shall be inserted the following regulation—

“Inspections in connection with multiple applications for variations of licences

6A

Where an inspection mentioned at regulation 6(b) of these Regulations is made at a site which has been named as a possible site for manufacture 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 applicant for such variation.”.