Paragraph 2 Fees

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

Sch.2, para 1(3) added by Medicines (Products for Human Use—Fees) 1994 reg.8(2)
Sch.2, para 2(a)(i)-(iv) (b)(i)-(iv)(c)(i)-(iv)(d) amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.2, para 2A(1) amended by Medicines (Products for Human Use—Fees) 1994 reg.8(3)
Sch.2, para 4(a)-(c) amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.2, para 2 amended by Medicines (Products for Human Use– Fees) 1992 reg.9(2)
Sch.2, paras 2(a)(i)(ii)(iii)(iv) (b)(i)(ii)(iii)(iv)(c)(i)(ii)(iii) (iv)(d), 4(a)(b)(c) amended by Medicines (Products for Human Use– Fees) 1992 Sch
Sch.2, para 2(b) amended by Medicines (Products for Human Use– Fees) 1992 reg.9(2)
Sch.2, para 2A added by Medicines (Products for Human Use– Fees) 1992 reg.9(3)

Subject to paragraphs 3 to 5, 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, £1,350;

(ii)

in respect of a standard inspection, £2,700;

(iii)

in respect of a major inspection, £5,100;

(iv)

in respect of a supersite inspection, £10,200;

(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, £1,500;

(ii)

in respect of a standard inspection, £5,500;

(iii)

in respect of a major inspection, £8,500;

(iv)

in respect of a supersite inspection, £17,000;

(c)

except in the case of an inspection falling within sub-paragraph (b) above or subparagraph (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, £1,350;

(iii)

in respect of a major inspection, £2,700;

(iv)

in respect of a supersite inspection, £5,400;

(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, £100.