Paragraph 2 Fees

Subject to paragraphs 3 to 5 below, the fee payable in respect of an inspection under these Regulations shall be —

(a)

except in the case of an inspection falling within sub-paragraphs (b) to (d) below —

(i)

in respect of a minor inspection, £750;

(ii)

in respect of a standard inspection, £1,500;

(iii)

in respect of a major inspection, £3,000;

(b)

where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products —

(i)

in respect of a minor inspection, £1,250;

(ii)

in respect of a standard inspection, £2,500;

(iii)

in respect of a major inspection, £5,000;

(c)

except in the case of an inspection falling within sub-paragraph (b) above or sub-paragraph (d) below, where the site inspected is concerned only with the assembly of medicinal products —

(i)

in respect of a minor inspection, £500;

(ii)

in respect of a standard inspection, £1,000;

(iii)

in respect of a major inspection, £2,000;

(d)

where the site inspected is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which does not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, £50.