S.I. No. 253/1939 - The Therapeutic Substances (Amendment) Regulations, 1939.

STATUTORY RULES AND ORDERS. 1939. No. 253.

THE THERAPEUTIC SUBSTANCES (AMENDMENT) REGULATIONS, 1939.

DEPARTMENT OF LOCAL GOVERNMENT AND PUBLIC HEALTH.

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, order as follows, that is to say :—

1. —(1) This Order may be cited as the Therapeutic Substances (Amendment) Regulations, 1939, and shall be read and construed as one with the Therapeutic Substances Regulations, 1934 to 1938, and may be cited collectively together therewith as the Therapeutic Substances Regulations, 1934 to 1939.

(2) The provisions of Article 5 of these Regulations relating to surgical catgut shall come into operation on the 1st day of November, 1939, but save as aforesaid these Regulations shall come into operation on the 1st day of April, 1940.

(3) In this Order, the expression " the Principal Regulations " means the Therapeutic Substances (Saorstát Éireann) Regulations, 1934.

2. Every therapeutic substance of animal origin intended for injection which is not a therapeutic substance specified in the Schedule to the Therapeutic Substances Act, 1932 , is hereby declared to be a therapeutic substance to which the said Act applies and the Therapeutic Substances Regulations, 1934 to 1938, as amended by this Order, shall apply accordingly to any such substance.

3. The following amendments shall be made in the Principal Regulations :—

(i) To Article 13 there shall be added the following paragraph immediately after paragraph (f) thereof ;

(g) any other therapeutic substance of animal origin intended for injection.

(ii) The following schedule shall be appended as a Sixth Schedule.

SIXTH SCHEDULE.

Provisions applicable to therapeutic substances of animal origin intended for injection, to which no relative Schedule relates.

Every therapeutic substance of animal origin intended for injection to which no relative Schedule relates, and which has not been sterilised or does not contain an effective disinfectant, shall, in addition to being tested for sterility in accordance with the Regulations, be tested in such manner as the Minister shall approve in each particular case for the purpose of determining that the substance does not contain any living virus, unless the manufacturer satisfies the Minister that adequate precautions are taken by him to ensure the absence from the substance of any living virus.

(iii) For paragraph (2) of Article 1 of Part II (c) of the Second Schedule there shall be substituted the following paragraph :

(2) for the purposes of this Schedule, tuberculins are classified in three groups (a) Old Tuberculin, (b) Tuberculin Bouillon Filtrate and (c) Other Tuberculins or Derivates thereof.

(iv) The following heading and article shall be inserted immediately before Article 4 of Part II (c) of the Second Schedule :

Other Tuberculins and Derivates thereof.

3A. Tuberculins and derivates thereof other than Old Tuberculin and Tuberculin Bouillon Filtrate shall be prepared by such methods as may be approved by the Minister.

4. Article 3 relating to Schick Toxin (diluted for use) of Part II (A) of the Second Schedule of the Principal Regulations, as amended by paragraph (c) of Article 10 of the Therapeutic Substances (Saorstát Eireann) (Amendment) Regulations, 1935, is hereby revoked.

5. Article 5 of the Therapeutic Substances (Saorstát Éireann) (Amendment) Regulations, 1935, as substituted by the Therapeutic Substances (Amendment) Regulations, 1937, shall be revoked and the following article shall be substituted in its place :

5.—(1) If any surgical catgut is advertised or sold as such, and as sterile and ready for use, the name " sterilised surgical catgut " shall be indelibly marked on the sealed container of surgical catgut or printed or written in indelible ink on a label enclosed therein, and there shall also be indelibly marked on such container or printed or written in indelible ink on such label :—

(a) the name " sterilised surgical catgut " 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 surgical catgut 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 surgical catgut in the container is taken are permanently recorded and available for inspection ; and

(d) the name and address of the manufacturer of the surgical catgut.

(2) The date of completion of the manufacture of the particular batch from which the surgical catgut in the container was taken shall also be printed or written in indelible ink on the label or wrapper affixed to any package in which such container is offered for sale. For this purpose the date of completion of the manufacture shall be deemed to be the date on which the test for sterility hereinafter prescribed in these Regulations was completed.

Given under the Official Seal of the Minister for Local Government and Public Health, this Ninth day of September One Thousand Nine Hundred and Thirty-nine.

(Signed) SEÁN T. O'KELLY,

Minister for Local Government and Public Health.