Therapeutic Substances Act, 1932

• Jurisdiction: Ireland
• Citation: IR No. 25/1932
• Year: 1932

Number 25 of 1932.
THERAPEUTIC SUBSTANCES ACT, 1932.
ARRANGEMENT OF SECTIONS
Section 1. Definitions. 2. Advisory Committee. 3. Therapeutic substances to which Act applies. 4. Regulations as to standards of therapeutic substances. 5. General regulations. 6. Manufacturer's licences. 7. Prohibition of manufacture of therapeutic substances without licence. 8. Prohibition of manufacture of therapeutic substances not complying with standards of strength, purity, etc. 9. Import licences. 10. Research licences. 11. Import permits. 12. Restriction on import of therapeutic substances. 13. Application of Customs Acts. 14. Fees on grant of licences. 15. Revocation and suspension of licences. 16. Powers of inspectors. 17. Breach of licence conditions. 18. Sale of proprietary medicine consisting of or containing therapeutic substances. 19. Sale of therapeutic substances unlawfully manufactured or imported. 20. Penalty for offences. 21. Expenses. 22. Short title and commencement.
SCHEDULE .
THERAPEUTIC SUBSTANCES TO WHICH THIS ACT APPLIES.
Number 25 of 1932.
THERAPEUTIC SUBSTANCES ACT, 1932.
AN ACT TO REGULATE THE MANUFACTURE, IMPORT AND SALE OF THERAPEUTIC (INCLUDING PROPHYLACTIC AND DIAGNOSTIC) SUBSTANCES. [10th December, 1932.]
BE IT ENACTED BY THE OIREACHTAS OF SAORSTÁT EIREANN AS FOLLOWS:—
	Definitions.	1.—In this Act—
	the expression “the Minister” means the Minister for Local Government and Public Health;
	the expression “prescribed” means prescribed by regulations made by the Minister under this Act;
	the expression “therapeutic” includes prophylactic and diagnostic.
	Advisory Committee.	2.—(1) For the purpose of advising and assisting the Minister in the making of orders and regulations under this Act there shall be established a committee to be called and known as the Therapeutic Substances Advisory Committee (in this Act referred to as the Advisory Committee).
	(2) The Advisory Committee shall consist of ten members appointed from time to time as follows, that is to say:—
	(a) one shall be appointed by the Minister for Local Government and Public Health;
	(b) one shall be appointed by the Minister for Agriculture; and
	(c) one shall be appointed by each of the following bodies, that is to say, the University of Dublin, the National University of Ireland, the Medical Registration Council, the Royal College of Physicians of Ireland, the Irish Medical Association, the Veterinary Council, the Pharmaceutical Society of Ireland, and the Institute of Chemists.
	(3) Every member of the Advisory Committee shall, unless he previously dies or resigns hold office for a period of three years from the date of his appointment, but shall be eligible for re-appointment.
	(4) Subject to the provisions of this section, the Minister may by rules made under this section regulate the times of appointment of members of the Advisory Committee, the time and mode of filling casual vacancies in the Advisory Committee, the period of office of persons appointed to fill such vacancies, the quorum at meetings of the Advisory Committee, and the procedure of the Advisory Committee.
	(5) The Advisory Committee shall meet whenever summoned by the Minister.
	(6) Subject to rules made by the Minister under this section the Advisory Committee shall regulate their proceedings in such manner as they think fit.
	Therapeutic substances to which Act applies.	3.—(1) This Act applies to—
	(a) every therapeutic substance specified in the Schedule to this Act;
	(b) such other therapeutic substances as may from time to time be declared by order for the time being in force made under this section to be therapeutic substances to which this Act applies.
	(2) The Minister may, after consultation with the Advisory Committee, by order made under this section—
	(a) declare any therapeutic substance, the purity or potency of which cannot in the opinion of the Minister be adequately tested by chemical means, to be a therapeutic substance to which this Act applies;
	(b) revoke any order previously made by him under this section.
	(3) Every order made by the Minister under this section shall be laid before each House of the Oireachtas as soon as may be after it is made, and if either such House shall, within twenty-one days on which such House has sat after such order is laid before it, pass a resolution annulling such order, such order shall be annulled accordingly but without prejudice to the validity of anything previously done thereunder.
	Regulations as to standards of therapeutic substances.	4.—The Minister may, after consultation with the Advisory Committee, by order make regulations (in this Act referred to as regulations as to the standards of therapeutic substances) in relation to the following matters, that is to say:—
	(a) the standard of strength, quality and purity of any therapeutic substance to which this Act applies;
	(b) the tests to be used for determining whether such standard has been attained;
	(c) units of standardisation.
	General regulations.	5.—(1) The Minister may, after consultation with the Advisory Committee, by order make regulations prescribing any matter or thing which is referred to in this Act as prescribed or to be prescribed.
	(2) Any regulations made by the Minister under this Act may relate to the several matters in respect of which the power to make regulations is conferred by different sections of this Act.
	(3) Every regulation made under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made, and if either such House shall, within twenty-one days on which such House has sat after such regulation is laid before it, pass a resolution annulling such regulation, such regulation shall be annulled accordingly but without prejudice to the validity of anything previously done thereunder.
	Manufacturer's licences.	6.—(1) The Minister may grant a licence (in this Act referred to as a manufacturer's licence) to manufacture for sale any therapeutic substance to which this Act applies on the premises specified in such licence to any person who—
	(a) applies in the prescribed form and manner to the Minister for such licence; and
	(b) satisfies the Minister that the conditions under which such therapeutic substance is to be manufactured by him and the premises on which such substance is to be manufactured are such as to comply with any regulations made under this Act prescribing the conditions subject to which such licence is to be granted.
	(2) Every manufacturer's licence shall—
	(a) be in the prescribed form, and
	(b) be expressed and operate to licence the person to whom it is granted to manufacture for sale all the therapeutic substances to which this Act applies or such one or more of them as may be specified in such licence on the premises specified in such licence, and
	(c) be granted subject to the conditions prescribed in respect thereof.
	(3) Every manufacturer's licence shall, unless sooner revoked or suspended under this Act, remain in force for the prescribed period from the date thereof and shall then expire.
	Prohibition of manufacture of therapeutic substances without licence.	7.—(1) Subject to the provisions of this section, it shall not be lawful—
	(a) for any person to manufacture for sale any therapeutic substance to which this Act applies unless such person holds a manufacturer's licence for the time being in force to manufacture for sale such therapeutic substance, or
	(b) for any person to whom a manufacturer's licence has been granted to manufacture for sale any such therapeutic substance elsewhere than on the premises specified in such licence.
	(2) Every person who acts in contravention of this section shall be guilty of an offence under this Act.
	(3) This section shall not apply to—
	(a) the preparation by a registered medical practitioner for any of his own patients or for and at the request of another such practitioner of a therapeutic substance to which this Act applies, if it is specially prepared with reference to the condition, and for the use, of an individual patient, or
	(b) the preparation by a registered veterinary surgeon for any animals under his care or for and at the request of another such surgeon of a therapeutic substance to which this Act applies, if it is specially prepared with reference to the condition, and for the use, of an individual animal.
	Prohibition of manufacture of therapeutic substances not complying with standards of strength, purity, etc.	8.—(1) It shall not be lawful for a person to whom a manufacturer's licence has been granted to manufacture for sale any therapeutic substance to which this Act applies unless such therapeutic substance complies with the standards of strength, quality and purity prescribed in respect of such...