Therapeutic Substances (Saorstát Eireann) Regulations, 1934.

• Statutory Instrument No.: 365/1934

THE THERAPEUTIC SUBSTANCES (SAORSTÁT EIREANN) REGULATIONS, 1934.
The Minister for Local Government and Public Health in exercise of the powers conferred on him by the Therapeutic Substances Act, 1932 , does by this his order after consultation with the Therapeutic Substances Advisory Committee make the following Regulations, that is to say:—
PART I.GENERAL.
	1 Interpretation.	1.—(1) These Regulations may be cited as the Therapeutic Substances (Saorstát Eireann) Regulations, 1934.
(2) The provisions relating to labelling other than that contained in paragraph (e) of Article 8 (1) of these Regulations shall come into operation on the 1st day of March, 1935, but save as aforesaid these Regulations shall come into operation on the 1st day of June, 1935.
	2 ..	2.—(1) In these Regulations, unless the context otherwise requires—
"the Act" means the Therapeutic Substances Act, 1932 ;
"the Minister" means the Minister for Local Government and Public Health;
"therapeutic substance" or "substance" means one of the therapeutic substances specified in the Schedule to the Act, or such other substance or substances as may from time to time be declared by any Order of the Minister for the time being in force to be therapeutic substances to which the Act applies.
(2) For the purposes of these Regulations the millilitre may be used wherever the cubic centimetre is indicated.
(3) The Interpretation Act, 1923 , applies to the interpretation of these Regulations, as it applies to the interpretation of an Act of the Oireachtas.
	3 Licences and Applications for Licences.	3.—(1) Such of the forms set out in the First Schedule to these Regulations as is applicable to the case (or a form substantially to the like effect) shall be used whenever a licence under these Regulations is granted by the Minister or an application for such a licence is made to the Minister.
(2) Licences granted under these Regulations shall, unless sooner suspended or revoked under the Act, continue in force for a period of two years from the date thereof.
PART II.LICENCES FOR MANUFACTURE OF THERAPEUTIC SUBSTANCES.
	4 ..	4.—Before a licence to manufacture a therapeutic substance for sale (in this Part of these Regulations referred to as "a manufacturer's licence") is issued, the applicant shall satisfy the Minister that upon the issue of the licence the conditions set out in Article 5 of these Regulations will be observed.
	5 ..	5.—Every manufacturer's licence shall be subject to the special conditions, if any, set out in the Schedule to these Regulations which relates to the therapeutic substance in respect of which the licence is granted (in these Regulations referred to as "the relative Schedule"), and to the following general 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) 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, may be required to be carried out by him, including proper housing for animals used for the purpose of such tests, or
(ii) make arrangements with some institution approved by the Minister for such tests to be regularly carried out on his behalf by that institution;
(c) the licensee shall not manufacture for sale the therapeutic substance in respect of which the licence is granted elsewhere than on the premises specified in the licence;
(d) the licensee shall keep permanent records of the details of manufacture of each batch of the substance which is issued for sale and of the application of the tests thereto in such form as to be available for inspection and to be easily identified by reference to the number of the batch as shown on the label of each container;
(e) the licensee shall from time to time report to the Minister 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 which have been made since the date of the last inspection made on behalf of the licensing authority before the issue of the licence;
(f) the licensee shall on request furnish to the Minister from every batch of the substance or from such batch or batches as the Minister may from time to time specify a sample of such amount as the Minister may consider adequate for any examination required to be made; and the licensee shall, if so required, furnish full protocols of the tests which have been applied;
(g) if the Minister so directs, 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 or on behalf of the Minister;
(h) the licensee shall, on being informed by the Minister that any part of any batch of the substance has been found by the Minister 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 in the particular circumstances of the case be practicable, recall all issues already made from that batch;
(i) the licensee shall comply with the provisions of Parts III and IV of these Regulations, and of the Schedules referred to therein, 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 Minister has given the licensee not less than one month's notice.
PART III.PROVISIONS WITH REGARD TO THE NAMES OF THERAPEUTIC SUBSTANCES AND TO CONTAINERS, LABELS, ETC.
	6 Name of Substance.	6.—If any therapeutic substance is advertised or sold as a proprietary medicine or is contained in a medicine so advertised or sold, the name stated in the relative Schedule as being the accepted scientific name or name descriptive of the true nature and origin (hereinafter referred to as the "proper name") of the substance shall appear on the label in the manner prescribed in this Part of these Regulations.
	7 Containers.	7.—(1) No therapeutic substance intended for injection shall be sold or offered for sale unless it has been sealed in a previously sterilized glass container in such manner as will in the opinion of the Minister suffice to preclude the access of bacteria:
(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 contain a sufficient proportion of some antiseptic to prevent the growth of any organism which may be accidentally introduced in the process of removing a portion of the contents of the container.
(3) The container shall comply with such further requirements, if any, as are specified in the relative Schedule.
(4) The Minister may in the case of any particular preparation of any therapeutic substance dispense with any of the requirements of this Article or of the relative Schedule, and may make such additional requirements as, having regard to the nature of the preparation, he may deem necessary.
	8 Labelling.	8.—(1) Every phial, ampoule or other sealed container of a therapeutic substance shall bear a label on which is printed or written in indelible ink the following particulars and such further particulars, if any, as may be specified in the relative Schedule:—
(a) the proper name of the substance in letters not less conspicuous than those in which the proprietary name, if any, is printed or written, and following immediately after or under such proprietary name;
(b) the number of every licence under which the substance or any of its constituents is manufactured or if imported, the name of the manufacturer;
(c) a distinctive batch number, that is to say, the number by reference to which the prescribed tests and details of manufacture of the particular batch from which the substance in the container is taken are permanently recorded and available for inspection;
(d) where a test for potency in units is required by these Regulations in respect of a substance other than vaccine lymph a statement of the potency in units defined in terms of relation to the standard preparation specified in the relative Schedule:
(e) if the substance is intended to be used solely for veterinary purposes, the words "to be used solely for veterinary purposes."
(2) The particulars prescribed in sub-paragraphs (a), (b) and (c) of the preceding paragraph shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale.
(3) The following particulars and such further particulars, if any, as may be specified in the relative Schedule shall be printed or written in indelible ink either on the label borne by the container of any therapeutic substance or on a label or wrapper affixed to any package in which any such container is issued for sale:—
(a) the name and address of the manufacturer of the final product;
(b) the number of the manufacture or import licence;
(c) the date on which the manufacture of the particular batch from which the substance in the container is taken was completed, as defined in the relative Schedule, or if there is no definition in the relative Schedule as hereafter defined in this Article;
(d) where a test for maximum toxicity is required by these Regulations, a statement that the substance has passed such test;
(e) where a test for potency or maximum toxicity is required, the date up to which the substance, if kept under suitable conditions, may be...