PART IGENERAL

Application3

1

These Regulations shall not apply to a biocidal product where and to the extent that the biocidal product is placed on the market or used for a purpose over which control is exercised under—

a

any of the Regulations set out in Schedule 2;

b

Council Regulation (EEC) No. 2309/939, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products; or

c

sections 32 to 39 or section 58B of the Medicines Act 196810.

2

Subject to Schedule 13, these Regulations, except regulation 29, shall not apply to a biocidal product which contains an existing active substance.

3

These Regulations shall not apply to a biocidal product which is a relevant plant protection product where and to the extent that that biocidal product is placed on the market or used for a purpose over which, but for the provisions of Schedule 3 to the 1995 Regulations, control under the 1995 Regulations would otherwise be exercisable.

4

These Regulations shall not apply to a biocidal product which, by virtue of regulation 19(1) of the Marketing Authorisations for Veterinary Medicinal Products Regulations 199411, continues to have a product licence under section 7 of the Medicines Act 1968 so long as that licence remains in force.

5

These Regulations shall not apply to the placing on the market of a biocidal product prepared extemporaneously in the circumstances described in regulation 5(1)(c) of the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 199412.

6

Regulations 30 to 32 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.

7

These Regulations shall not extend to Northern Ireland.

8

In this regulation—

a

“the 1995 Regulations” means the Plant Protection Products Regulations 199513; and

b

“relevant plant protection product” shall have the meaning assigned to it in paragraph 8 of Schedule 3 to the 1995 Regulations.