Regulation 93 New Part 2A and Part 2B

After Part 2 (as substituted by the previous regulation) insert—

“PART 2A

Active Substances

Prohibition on manufacture, importation or distribution of active substances unless registered

26.

(1)

No person may manufacture, import or distribute an active substance unless the person is registered in the register maintained under sub-paragraph (2).

(2)

The Secretary of State must establish and maintain a register of manufacturers, importers and distributors of active substances and the sites occupied by them for the purposes of manufacturing or holding active substances.

Application for registration

27.

(1)

An applicant for registration under paragraph 26 must, at least two months before commencing an activity mentioned in paragraph 26(1) or, in the case of an existing manufacturer, within two months of the date on which this provision comes into force, submit the following to the Secretary of State—

(a)

the name and address of the proposed registration holder;

(b)

the name of the relevant active substance;

(c)

a description of the activity proposed to be engaged in in relation to the relevant active substance; and

(d)

particulars in relation to the site at which the relevant active substance is to be manufactured or held (as the case may be).

(2)

Information may be submitted to the Secretary of State pursuant to sub-paragraph (1) prior to the date on which this provision comes into force, and in such a case—

(a)

as regards an applicant for registration who is not an existing manufacturer, the relevant period of two months is to be treated as having started on the date of submission;

(b)

as regards an applicant for registration who is an existing manufacturer, the information is to be treated as having been submitted within the relevant period of two months.

Good manufacturing or distribution practice

28.

A manufacturer, importer or distributor of active substances must comply with good manufacturing practice or good distribution practice, as applicable.

Supply of information

29.

(1)

A person registered under paragraph 26 must immediately inform the Secretary of State on receipt of any new information that might adversely affect the quality and safety of the active substance.

(2)

A person registered under paragraph 26 must immediately inform the Secretary of State of any prohibition or restriction in relation to the active substance imposed by the competent authorities of any country other than the United Kingdom in which the active substance is authorised.

Inspection of sites

30.

The Secretary of State may, from time to time, inspect sites registered under paragraph 26, basing the frequency of the inspections on the risks associated with each site’s history and the nature of the substances handled at the site.

Report following inspection

31.

(1)

After each inspection of a site for the purposes of this Part, the inspector must make a written report to the Secretary of State on whether the requirements in this Part are being complied with.

(2)

The Secretary of State must inform the inspected registered person of the content of such reports.

PART 2B

Schedule 2 Offences

Offences

32.

It is an offence to fail to comply with—

(a)

paragraph 1;

(b)

paragraph 4(3);

(c)

paragraph 8;

(d)

paragraph 11;

(e)

paragraph 15;

(f)

paragraph 18;

(g)

paragraph 19;

(h)

paragraph 20(1), (3) or (4);

(i)

paragraph 22;

(j)

paragraph 23;

(k)

paragraph 24;

(l)

paragraph 26;

(m)

paragraph 28;

(n)

paragraph 29.”.