Therapeutic Substances Regulations, 1952
| Jurisdiction | UK Non-devolved |
| Citation | SI 1952/1937 |
| Year | 1952 |
1952 No. 1937
THERAPEUTIC SUBSTANCES
The Therapeutic Substances Regulations, 19527thNovember 1952
8thNovember 1952
1stJanuary 1953
ARRANGEMENT OF REGULATIONS
PART I—General Regulations 1—3
PART II—Licences for manufacture of therapeutic substances Regulations 4 & 5
PART III—Provisions with regard to containers, labelling
and sale of therapeutic substances Regulations 6—8
PART IV—Standards of strength, quality and purity and
tests for determining whether those standards have been
attained Regulations 9—15
PART V—Licences for import of therapeutic substances Regulations 16 & 17
PART VI—Research licences Regulation 18
PART VII—Therapeutic substances manufactured or imported
for export only Regulation 19
PART VIII—Therapeutic substances intended for veterinary
purposes only Regulation 20
PART IX—Non-sterile surgical ligature and suture Regulation 21
PART X—Addition of substances to Schedule to Act Regulation 22
PART XI—Supplementary Regulations 23 & 24
FIRST SCHEDULE—Regulations revoked Page 3432
SECOND SCHEDULE—Forms of application for and the granting
of licences Page 3432
THIRD SCHEDULE—Vaccines, toxins and antigens Page 3435
FOURTH SCHEDULE—Sera and antitoxins Page 3449
FIFTH SCHEDULE—Arsphenamine (commonly known as salvarsan)
its derivatives and analogous substances Page 3455
SIXTH SCHEDULE—Insulin Page 3459
SEVENTH SCHEDULE—Pituitary (posterior lobe) extract Page 3460
EIGHTH SCHEDULE—Surgical ligature and surgical suture Page 3461
NINTH SCHEDULE—Antibiotics Page 3462
TENTH SCHEDULE—Preparations of human blood Page 3465
ELEVENTH SCHEDULE—Organic substances having the specific
biological action of curare on neuromuscular
transmission and preparations thereof Page 3470
TWELFTH SCHEDULE—Dimercaprol Page 3472
The Joint Committee constituted by subsection (1) of section 4 of the Therapeutic Substances Act, 1925(a), in exercise of the powers conferred on them by sections 1 and 5 of the said Act, after consultation with the Advisory Committee constituted under subsection (2) of section 4 aforesaid, hereby make the following regulations:—
PART I
GENERAL
Citation
1. These regulations may be cited as the Therapeutic Substances Regulations, 1952, and shall come into operation on the first day of January, 1953.
Interpretation
2.—(1) In these regulations, unless the context otherwise requires,—
"the Act" means the Therapeutic Substances Act, 1925;
"the existing regulations" means the regulations specified in the first schedule to these regulations;
"import licence" means a licence to import a therapeutic substance for purposes other than those of scientific research;
"licence" means a licence under the Act;
"the licensing authority" means the Minister of Health in the application of the regulations to England and Wales, the Secretary of State for Scotland in the application of the regulations to Scotland and the Minister of Health and Local Government for Northern Ireland in the application of the regulations to Northern Ireland;
"manufacturing licence" means a licence to manufacture a therapeutic substance for sale;
"proper name" in relation to a therapeutic substance, means the name prescribed in or approved in accordance with the relative schedule as the proper name of the substance;
"relative schedule", in relation to a therapeutic substance, means such of the provisions of any of the schedules to these regulations as are applicable to that substance;
"research licence" means a licence to import a therapeutic substance for the purpose of scientific research;
"therapeutic substance" or "substance" means one of the therapeutic substances specified in the Schedule to the Act or added to that Schedule by these regulations or by any regulations revoked by these regulations.
(2) References in these regulations to a substance of which there is a definition in the relative schedule shall be construed as references to the substance so defined.
(3) For the purposes of these regulations the cubic centimetre may be used wherever the millilitre is indicated.
(4) The Interpretation Act, 1889(b), applies to the interpretation of these regulations as it applies to the interpretation of an Act of Parliament.
Licences and Applications for Licences
3.—(1) The form of application to the licensing authority for a licence or the renewal of a licence under these regulations, and the form of licence to be granted by the licensing authority, shall be the appropriate form set out in the second schedule hereto or a form substantially to the like effect.
(2) Licences granted under these regulations shall, unless sooner suspended or revoked, continue in force for a period of two years.
(a) 15 & 16 Geo. 5. c. 60.
(b) 52 & 53 Vict. c. 63.
PART II
LICENCES FOR MANUFACTURE OF THERAPEUTIC SUBSTANCES
Licensing authority to be satisfied that conditions will be observed
4. Before a manufacturing licence is issued or renewed, the applicant shall satisfy the licensing authority that upon the issue or renewal of the licence the conditions set out in regulation 5 of these regulations will be observed.
Conditions
5. Every manufacturing licence shall be subject to the following conditions:—
(a) the licensee shall provide and maintain an adequate staff and adequate premises and plant for the proper manufacture of the substance in respect of which the licence is issued;
(b) without prejudice to the generality of the foregoing requirement the licensee, if he for any purpose engages in the culture or manipulation of pathogenic spore-bearing micro-organisms, shall provide to the satisfaction of the licensing authority separate laboratories, utensils and apparatus required for the culture or manipulation of such microorganisms; and the separate laboratories, utensils and apparatus so provided shall not be used for the manufacture of any other therapeutic substance;
(c) the licensee shall either:—
(i) provide and maintain an adequate staff and adequate premises and plant for carrying out such tests of the strength, quality and purity of the substance as, pursuant to part IV of these regulations, he may be required to carry out; and where animals are used for such tests they shall be suitably housed; or
(ii) make arrangements with some institution approved by the licensing authority for such tests to be regularly carried out on his behalf by that institution;
(d) the licensee shall keep readily available for inspection durable records (which shall not be destroyed without the permission of the licensing authority) of the details of manufacture of each batch of the substance and the tests carried out thereon in such a form that the records will be easily identifiable with the substance issued for sale by reference to the number of the batch as shown on the label of each container under the provisions of sub-paragraph (c) of paragraph (1) of regulation 7 of these regulations;
(e) the licensee shall allow an inspector authorised by the licensing authority in that behalf to enter, with or without prior notice, any premises where the manufacture is carried on and to inspect the premises and plant, the process of manufacture and the means employed for standardising and testing the substance and to take samples thereof;
(f) the licensee shall forthwith report to the licensing authority any changes in the expert staff responsible for the manufacture or testing of the substance and any material alterations in the premises or plant used for that purpose;
(g) the licensee shall on request furnish to the licensing authority from every batch of the substance, or from such batch or batches as the licensing authority may from time to time specify, a sample of such amount as the authority may, consider adequate, for any examination required to be made; and the licensee shall, if required by the licensing authority, furnish full protocols of the tests which have been applied;
(h) if the licensing authority so direct, the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sale of the batch has been issued to him by the licensing authority;
(i) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality or purity specified in these regulations and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may be practicable, recall all issues already made from that batch;
(j) the licensee shall comply with the provisions of parts III and IV of these regulations, and, as respects each therapeutic substance which he is licensed to manufacture, with the requirements of the relative schedule, and with such further requirements, if any, as may be specified in any regulations which may be made under the Act, and of which the licensing authority has given the licensee not less than one month's notice.
PART III
PROVISIONS WITH REGARD TO CONTAINERS, LABELLING AND SALE OF THERAPEUTIC SUBSTANCES
Containers
6.—(1) No therapeutic substance shall be sold or offered for sale unless it has been sealed, in such manner as will in the opinion of the licensing authority suffice to preclude the access of micro-organisms, in a previously sterilised container of a material inert towards the substance:
Provided that in the case of a preparation of a vaccine intended for administration by any means other than injection into the tissues which is in a solid form or is to be administered in a solid vehicle, the container in which it is packed need not be sterile but the ordinary standards of pharmaceutical cleanliness shall be observed in the packing of the preparation.
(2) When any therapeutic substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be withdrawn for use on different occasions, the liquid shall...
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