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4.—(1) 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”.
(2) After regulation 3 there shall be inserted the following regulation—
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.”.
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