OpenLegislation

Regulation 2

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

(1)

Where any of the conditions set out in paragraph (2) is satisfied, something which would otherwise fall within section 58(4)(a) of the Act is not to be regarded as a dangerous substance.

(2)

Those conditions are:

(a)

that it exists in the form of, or is included in, a medicinal product; or

(b)

that it is an immunological product intended to diagnose whether a state of immunity to certain diseases exists in human beings or animals; or

(c)

that it is for use in medicinal tests on animals in accordance with a valid animal test certificate; or

(d)

that it is modified for use to be administered to one or more human beings or animals for a medicinal purpose; or

(e)

that it is kept in such a way that it is no longer in a state that will allow it to be propagated; or

(f)

that it is kept—

(i)

as part of a clinical specimen for diagnostic purposes, and

(ii)

for no longer than is reasonably practicable for its disposal after the time when the diagnosis has been made.

(3)

In this regulation—

  • “administer” has the same meaning as in section 130(9) of the Medicines Act 1968f1;

  • “medicinal product” means any substance or article which is held in a form which is ready to be administered to one or more human beings or animals for a medicinal purpose; and

  • “medicinal purpose” has the same meaning as in section 130(2) of the Medicines Act 1968.

Annotations

Footnotes

f1

1968 c.67; section 130(9) was amended by paragraph 3(9) of Schedule 1 to the Animal Health and Welfare Act 1984 (c.40).