Therapeutic Substances Act 1925
| Jurisdiction | UK Non-devolved |
Therapeutic Substances Act, 1925
(15 & 16 Geo. 5.) CHAPTER 60.
An Act to provide for the regulation of the manufacture, sale, and importation of vaccines, sera, and other therapeutic substances.
[7th August 1925]
Be it enacted by the King's most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—
1 Therapeutic substances to which Act applies.
1. This Act applies to the therapeutic substances specified in the Schedule to this Act and any other therapeutic substances which may from time to time be added to that Schedule by regulations made under this Act as being substances the purity or potency of which cannot be adequately tested by chemical means.
2 Restrictions on manufacture of therapeutic substances.
(1) No person shall manufacture for sale any therapeutic substance to which this Act applies unless he he holds a licence for the purpose from the licensing authority, or elsewhere than on the premises in respect of which such a licence is in force.
(2) A licence under this section shall continue in force for such period as may be prescribed, but may from time to time be renewed for a like period, and may extend to all the therapeutic substances to which this Act applies, or to such one or more of them as may be specified in the licence, and shall be issued subject to such conditions as may be prescribed.
(3) An applicant for a licence or the renewal of a licence must satisfy the licensing authority that the conditions under which the therapeutic substances are to be manufactured by him and the premises in which they are to be manufactured are such as to comply with any regulations made under this Act, and an applicant who so satisfies the licensing authority shall be entitled to the grant or renewal of the licence.
(4) The licensing authority may revoke a licence or suspend it for such period as he thinks fit if in his opinion the licensee has failed to comply with the conditions subject to which the licence was issued or with the regulations made under this Act as to the prescribed standards of strength, quality and purity, and such revocation or suspension may apply to all the therapeutic substances to which the licence applies or to some one or more of them:
Provided that a person who is aggrieved by the revocation or suspension of his licence may, subject to rules of court, appeal to the court, whose decision shall be final.
(5) Nothing in this section shall apply to 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.
3 Restrictions on importation of therapeutic substances.
(1) It shall not be lawful to import into Great Britain or Northern Ireland any therapeutic substance to which this Act applies unless the substance—
(a ) is proved to the satisfaction of the licensing authority to comply with the standard of strength, quality and purity prescribed in the case of that substance, if the substance is one the manufacture of which is carried on in Great Britain or Northern Ireland, or, if such manufacture is not so carried on, with such standards (if any) of strength, quality and purity, as may be prescribed for that substance, or, if no such standards are so prescribed, with such standards of quality and purity as are prescribed in the case of therapeutic substances of a similar class, the manufacture of which is carried on in Great Britain or Northern Ireland, and is consigned to a person licensed by the licensing authority to import it; or
(b ) is consigned to a person engaged in scientific research holding a special licence to import it for the purpose of such research issued by the licensing authority.
(2) The issue of any licence under this section shall be subject to such conditions, including conditions as to suspension and revocation, as may be prescribed.
(3) Therapeutic substances prohibited to be imported by this section shall be deemed to be included among the goods enumerated and described in the table of prohibitions and restrictions inwards contained in section forty-two of the Customs Consolidation Act, 1876 ,...
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