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The Medicines (Importation of Medicinal Products for Re-exportation) Order 1971

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Statutory Instruments

1971 No. 1326

MEDICINES

The Medicines (Importation of Medicinal Products for Re-Exportation) Order 1971

Made

9th August 1971

Laid before Parliament

18th August 1971

Coming into Operation

1st September 1971

The Secretary of State for Social Services and the Secretary of State for Wales (being the Secretaries of State respectively concerned with health in England and in Wales), the Minister of Agriculture, Fisheries and Food, the Secretary of State for Scotland (being the Secretary of State concerned with health and with agriculture in Scotland), the Minister of Health and Social Services for Northern Ireland and the Minister of Agriculture for Northern Ireland, acting jointly, in exercise of their powers under section 13(2) and 13(3) of the Medicines Act 1968 as having effect subject to the provisions of article 2(2) of and Schedule 1 to the Transfer of Functions (Wales) Order 1969(1), and of all other powers enabling them in that behalf, and after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this order, hereby make the following order:—

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;

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

antiseraare 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;

antitoxinsare 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;

corticotrophinis 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;

heparinis 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;

hyaluronidaseis 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;

insulinis 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;

toxinsare 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;

vaccinesare substances which consist wholly or partly of—

(a)

any micro-organisms, viruses or other organisms in any state,

(b)

any toxins of microbial origin which have been detoxified, or

(c)

any extracts or derivatives of any micro-organisms or of any viruses,

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.

Keith Joseph

Secretary of State for Social Services

4th August 1971

Given under my hand on 5th August 1971.

Peter Thomas

Secretary of State for Wales

In Witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 2nd August 1971.

L.S.

J. M. L. Prior

Minister of Agriculture, Fisheries and Food

Gordon Campbell

Secretary of State for Scotland

3rd August 1971

Given under my hand on 9th August 1971.

W. K. Fitzsimmons

Minister of Health and Social Services for Northern Ireland

Given under my hand on 6th August 1971.

H. W. West

Minister of Agriculture for Northern Ireland

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.

(1)

(1969 I, p. 1070)

(2)

(1971 II, p. 3506).

(3)

(1971 II, p. 3632).

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