S.I. No. 555/1942 - Therapeutic Substances (Emergency Amendment) Order, 1942


STATUTORY RULES AND ORDERS. 1942. No. 555.

THERAPEUTIC SUBSTANCES (EMERGENCY AMENDMENT) ORDER, 1942

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 , after consultation with the Therapeutic Substances Advisory Committee, hereby orders as follows, that is to say :—

1. This Order shall continue in force until the expiration of two years from the date on which the Emergency Powers Act, 1939 , ceases to be in force and shall then expire.

2. This order shall apply to the substances mentioned in the Schedule to this order and to no other therapeutic substances.

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

the expression " the prescribed conditions " means, in relation to any substance to which this order applies, the conditions of storage specified for such substance in the schedule hereto ;

the expression " the licensee " in relation to a substance to which this order applies means the holder of the manufacturer's license or the importer's license (as the case may be) relating to such substance.

4. —(1) At the expiration of six months after the date of this order the proviso to Article 9 of the Principal Order shall cease to have effect in relation to any substance to which this order applies.

(2) For the purpose of the application of this order to a sale taking place not more than six months after the date of this order the word " sell " means to sell otherwise than in accordance with the proviso to Article 9 of the Principal Order.

5. If and so long as between the manufacture in Eire or the importation into Éire (as the case may be) of any substance to which this order applies and the sale of such substance, such substance has not been stored for a total number of days exceeding 183 otherwise than by the licensee under the prescribed conditions, the period within which under Article 9 of the Principal Order a person may sell such substance shall be extended by a further period of two years.

6. —(1) The licensee shall, in relation to any substance to which this order applies, keep available for inspection records sufficient to enable it to be determined whether the period within which such substance may be sold is extended by this order and, if so, the date to which it is so extended.

(2) The records to be kept in pursuance of this article in relation to any substance shall show the following matters, that is to say :—

(a) the periods of storage of such substance under the prescribed conditions ;

(b) in the case of a substance imported into Éire, the date of such importation ;

(c) whenever any such substance leaves the possession of the licensee the date when the transfer occurred and the name and address of the person to whom possession was transferred ;

(d) the date (if any) marked on any phial, capsule or sealed container as the emergency expiry date for any such substance.

7. If it appears from the records kept by a licensee under Article 5 immediately before he parts with the possession of any substance to which this order applies (except for the purposes of test) that the period within which such substance may be sold has been extended by virtue of this order he shall mark in indelible ink on every phial, capsule or sealed container in which such substance is, the date to which such period is so extended under the words " emergency expiry date ".

8. In a prosecution of any person other than the licensee for the sale of a substance to which this order applies in contravention of Article 9 of the Principal Order as amended by this order it shall be a good defence for such person to prove that on the phial, capsule, or sealed container in which such person received such substance from the licensee a date not before the date of such sale was marked by the licensee as the emergency expiry date.

9. —(1) This order may be cited as the Therapeutic Substances (Emergency Amendment) Order, 1942.

(2) This Order and the Therapeutic Substances Regulations 1934 to 1941 shall be read and construed as one order and may be collectively cited as the Therapeutic Substances Regulations, 1934 to 1942.

SCHEDULE.

Substance

Conditions of Storage

1. Anti-sera and anti-toxins prepared from the following micro-organisms :—

(i) The substance shall be kept in the dark at a temperature of not more than 5° nor less than 2° Centigrade;

B. diphtheriae.

Meningococcus.

(ii) Containers in which a rubber cap or stopper is used shall be stored in such a position as to prevent the substance from remaining in contact with the rubber.

C. tetani.

Gas gangrene organisms.

Pneumococcus.

B. typhosus.

II. Diphtheria prophylactics.

III. Insulin

The substance shall be kept in the dark at a temperature of not more than 5° nor less than 2° Centrigrade.

GIVEN under the Official Seal of the Minister for Local Government and Public Health this Thirty-first day of December, One Thousand Nine Hundred and Forty-two.

(Signed) SEÁN MAC ENTEE,

Minister for Local Government and

Public Health.