The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Regulation 10(2)(a)

SCHEDULE 4 MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT

1.  In section 107 of the Act (validity of decisions and proceedings relating thereto)—

(a) in subsection (1), the reference to Part II of the Act shall include a reference to these Regulations and the reference to a licence shall include a reference to a marketing authorization;

(b) in subsections (2)(a) and (3)(b), any reference to the Act shall include a reference to these Regulations; and

(c) in subsection (4), any reference to a licence shall include a reference to a marketing authorization.

2.  In section 108 of the Act (enforcement in England and Wales)—

(a) in subsection (1), the reference to the Act shall include a reference to these Regulations and the relevant Community provisions; and

(b) in subsection (2)(c), the reference to sections 93 and 94 of the Act shall include a reference to these Regulations and those provisions.

3.  In section 109 of the Act (enforcement in Scotland), in subsection (1), the reference to the Act shall include a reference to these Regulations and the relevant Community provisions.

4.  In section 110 of the Act (enforcement in Northern Ireland), in subsection (1), the reference to the Act shall include a reference to these Regulations and the relevant Community provisions.

5.  In section 111 of the Act (rights of entry)—

(a) in subsection (1), the first reference to the Act shall include a reference to these Regulations and the relevant Community provisions;

(b) in subsection (2), the first reference to the Act shall include a reference to these Regulations and Council Regulation (EEC) No. 2309/93; and

(c) in subsection (3), any reference to a licence under Part II of the Act shall include a reference to a marketing authorization.

6.  In section 112 of the Act (power to inspect, take samples and seize goods and documents)—

(a) in subsection (1), the first reference to the Act shall include a reference to these Regulations and Council Regulation (EEC) No. 2309/93;

(b) in subsection (4), any reference to the Act shall include a reference to these Regulations;

(c) in subsections (5) and (9), any reference to the Act shall include a reference to these Regulations and Council Regulation (EEC) No. 2309/93; and

(d) in subsection (7), any reference to a licence under Part II of the Act shall include a reference to a marketing authorization.

7.  In section 118 of the Act (restrictions on disclosure of information), in subsection (1), the second reference to the Act shall include a reference to these Regulations and Council Regulation (EEC) No. 2309/93.

8.  In section 119 of the Act (protection for officers of enforcement authorities), any reference to the Act shall include a reference to these Regulations and Council Regulations (EEC) No. 2309/93.

9.  In section 121 of the Act (contravention due to default of other person)—

(a) in subsections (1) and (2), any reference to the Act shall include a reference to these Regulations; and

(b) in subsection (4), the reference to sections 63 to 65, 85 to 90 and 93 to 96 of the Act shall include a reference to paragraphs 11 and 12 of Schedule 3 to these Regulations.

10.  In section 122 of the Act (warranty as a defence)—

(a) in subsection (1), the reference to the Act shall include a reference to these Regulations; and

(b) in subsection (2), the reference to sections 63(b), sections 64 and 65, sections 85 to 88 and section 90 of the Act shall include a reference to paragraphs 11 and 12 of Schedule 3 to these Regulations.

11.  In section 124 of the Act (offences by bodies corporate), in subsection (1), the reference to the Act shall include a reference to these Regulations.

12.  In section 125 of the Act (prosecutions)—

(a) in subsections (1) to (3), any reference to the Act shall include a reference to these Regulations; and

(b) in subsections (4) and (6), the second reference to the Act shall include a reference to these Regulations.

13.  In section 127 of the Act (service of documents), the reference to the Act shall include a reference to these Regulations and Council Regulation (EEC) No. 2309/93.

14.  In Schedule 3 to the Act (sampling), in paragraph 1(1), the first reference to the Act shall include a reference to these Regulations and Council Regulation (EEC) No. 2309/93.