Regulation 4 Amendment of regulation 3 of, and additional regulation 3A to, the principal Regulations

In regulation 3 of the principal Regulations (applications for licences) for the words “Subject to regulations 16 and 20”, there shall be substituted “Subject to regulations 3A, 16 and 20”.

After regulation 3 there shall be inserted the following regulation—

“Inspections in connection with multiple applications for licences

3A

Where an inspection mentioned at regulation 3(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)

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 licence.”.