Citation and commencement

1. This order may be cited as the Medicines (Importation of Medicinal Products for Re-exportation) Order 1971 and shall come into operation on 1st September 1971.

Interpretation

2.-(1) In this order, unless the context otherwise requires-

"the Act" means the Medicines Act 1968;

"antigens" are substances which on administration to a human being or animal are capable of eliciting a specific immunological response;

"antisera" are substances which consist wholly or partly of sera derived from animals which have been immunised against one or more micro-organisms, viruses or other antigens;

"antitoxins" are substances which consist wholly or partly of immunoglobulins of antisera derived from animals which have been immunised against one or more toxins whether detoxified or not;

"corticotrophin" is a substance obtained from the anterior lobe of the pituitary gland and which contains the peptide hormone that increases the rate at which corticoid hormones are secreted by the adrenal gland;

"heparin" is a substance containing the sodium salt of a sulphated poly-saccharide obtained from mammalian tissues which has the property of prolonging the clotting time of blood in human beings or animals;

"hyaluronidase" is a substance prepared from mammalian testicles or sperm or from other sources of the enzymes which diminish the viscosity of the hyaluronic acid present in mammalian tissues;

"insulin" is a preparation of the specific antidiabetic principle of the pancreas;

"plasma" means the fluid element of uncoagulated blood;

"preparations of the pituitary (posterior lobe)" include the active principles thereof (whether obtained by fractionation of the gland or by synthesis) and derivatives of those principles with the same specific biological action;

"sera" means the fluid element of coagulated blood;

"toxins" are substances used in the diagnosis, prevention or treatment of disease and consisting wholly or partly of poisonous substances derived from specific micro-organisms, plants or animals;

"vaccines" are substances which consist wholly or partly of-

being substances which, when administered to human beings or animals, are used for the prevention or treatment of specific diseases;

and other expressions have the same meaning as in the Act.

(2) The Interpretation Act 1889 shall apply to the interpretation of this order as it applies to the interpretation of an Act of Parliament.

Removal of restriction on importation of certain medicinal products

3.-(1) The restriction imposed by section 7(3) of the Act (which prohibits the importation, except in accordance with a product licence, of medicinal products and of articles and substances in relation to which that subsection has effect) shall, subject to paragraph (2) of this article, not apply to the importation of the medicinal products, articles and substances referred to in Part I of the Schedule to this order, not being medicinal products or substances specified in Part II of the said Schedule.

(2) The exemption conferred by paragraph (1) of this article shall take effect only in relation to medicinal products, articles and substances which, having been imported, are to be exported-

(a)in the form in which they were imported, and

(b)without being assembled in a way different from the way in which they were assembled on being imported.

SCHEDULE

Article 3

PART I

Medicinal products, articles and substances (other than those specified in Part II of this Schedule) to the importation of which section 7(3) of the Act does not apply.

1. All medicinal products.

2. The substances to which the Medicines (Control of Substances for Manufacture) Order 1971(2) applies.

3. The articles and substances to which the Medicines (Surgical Materials) Order 1971(3) applies.

PART II

Medicinal products and substances to the importation of which section 7(3) of the Act continues to apply.

Medicinal products and substances, for use other than for human beings, and consisting wholly or partly of antigens, antisera, antitoxins, corticotrophin, heparin, hyaluronidase, insulin, plasma, preparations of the pituitary (posterior lobe), sera, toxins, vaccines or other medicinal products or substances derived from animals.

EXPLANATORY NOTE

Section 7(3) of the Medicines Act 1968 prohibits the importation of medicinal products except in accordance with a product licence. The subsection also has effect in relation to such articles and substances to which it has been applied by orders made under sections 104 or 105 of the Act.

This order, made under section 13(2) of the Act, exempts from such prohibition the importation of medicinal products and the articles and substances which are the subject of orders under sections 104 and 105, other than certain specified medicinal products and substances for veterinary use. The exemption only takes effect where the medicinal products, articles and substances are to be re-exported without any change in their form or their manner of assembly.