S.I. No. 365/1934 - The Therapeutic Substances (Saorstát Eireann) Regulations, 1934.

1. Pituitary extract is the watery extract prepared from the separate posterior lobe of the pituitary body, or the watery solution of one or more of the separated active principles of that lobe. The proper name of the complete watery extract is "Pituitary (posterior lobe) Extract." The proper name of a solution containing one of the separated active principles is "Oxytocic principle of the pituitary posterior lobe" or "Pressor principle of the pituitary posterior lobe" or such other name descriptive of such a solution as the Minister may in any particular case approve in writing.

Standard preparation.

2. The standard preparation is a quantity of dried acetone-extracted substance obtained from the posterior lobes of fresh pituitary bodies of oxen. This standard is kept in an institution approved by the Minister.

Unit of standardisation.

3.—(1) The unit of pituitary extracts for the purposes of these Regulations is the specific activity corresponding to that yielded by 0.5 milligramme of the standard preparation when extracted by the method approved by the Minister under this Schedule.

(2) When the preparation is a solution of a separated active principle, the unit employed in indicating the strength shall be the amount of that active principle yielded to extraction by 0.5 mgm. of the standard preparation as determined by the appropriate biological test.

Quality.

3. The standard preparation is a quantity of dry soluble insulin hydrochloride prepared and kept in an institution approved by the Minister.

Unit of standardisation.

4. The acidity of the prepared watery extract shall be such that the hydrogen-ion concentration is not less than that corresponding to pH = 4, or greater than that corresponding to pH = 3.

Tests.

5.—(1) The method used for preparing the extract from the standard preparation and for its use in a comparative biological test and the biological methods employed in making the test shall be such as the Minister may from time to time approve.

(2) Samples from each batch of the finished product shall be tested for sterility in accordance with the methods set forth in Part IV of these Regulations, unless the finished product has been sterilized by heat in a manner satisfactory to the Minister after being sealed in the containers.

Container.

5. The acidity of the prepared watery solution, as determined by a suitable indicator, shall be such that the hydrogen-ion concentration is not less than that corresponding to pH=4, or greater than that corresponding to pH=3.

Tests.

6.—(1) The methods used for testing the potency of preparations in comparison with the standard preparation shall be such as the Minister may from time to time approve.

(2) In addition, samples from each batch shall be tested in such manner as the Minister may direct for the purpose of ascertaining its stability under ordinary conditions of storage.

Container.

6. The glass of the container shall be non-alkaline resistance glass.

Labelling.

7. The label on the container shall indicate the strength of the extract as the number of units per c.c.

8. The date to be specified in compliance with the requirements of Article (8) (3) (

e

) of these Regulations shall be such date as the Minister shall in any particular case have approved in writing.

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 expected to retain a potency not less than that stated on the label to the container, or not to acquire a toxicity greater than that permitted by the test, as the case may be;

(

f

) where an antiseptic substance has been added, the nature and the percentage proportion introduced;

(

g

) the precautions necessary for preserving the properties of the contents to the date indicated in sub-paragraph (

e

) of this paragraph.

(4) For the purposes of sub-paragraph (

c

) of the last preceding paragraph the date on which the manufacture of a batch is completed shall be—

(

a

) in cases where a test for potency or toxicity is required by these Regulations, or not being so required, is accepted by the Minister as sufficient for the purpose of fixing the date of completion of manufacture, the date on which the test was completed, or the date on which the substance was removed from cold storage after having there been kept at a temperature not exceeding 5°C. continuously for a period not exceeding two years from the time when the last test was completed;

(

b

) in cases where no such test is required or accepted—

(i) if the substance is a serum obtained from living animals, the earliest date on which any material contributing to the batch was removed from the animal, and

(ii) if the substance was obtained by the growth of organisms on artificial media, the earliest date on which growth was terminated in any of the material contributing to the batch

Provided that, in cases where no such test is required or accepted, if a batch of the substance (including all materials contributing to the batch) has for a period of not more than three years been kept in cold storage at a temperature not exceeding 5°C. continuously from the earliest practicable date after that on which the material was removed from the animal or on which growth was terminated in the material, as the case may be, the date of removal from cold storage shall be treated as the date on which the manufacture of the batch is completed.

9 Prohibition of sale of Substance after prescribed date.

9.

—No person shall sell any therapeutic substance after the date recorded on the container, label or wrapper as the date up to which the substance may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required or permitted by the test, as the case may be

Provided that a person may at the request of a registered medical practitioner or registered veterinary surgeon sell after the date aforesaid any therapeutic substance (except one that is required to be tested for maximum toxicity) which loses its potency, if he has previously drawn the practitioner's or surgeon's attention to the dates recorded on the container, label or wrapper, and the practitioner or surgeon certifies in writing that the sale is required owing to the urgency of the case.

PART IV.STANDARDS OF STRENGTH, QUALITY AND PURITY AND TESTS FOR DETERMINING WHETHER THOSE STANDARDS HAVE BEEN ATTAINED, UNITS OF STANDARDISATION.

10 Standards.

10.

—Every therapeutic substance intended for sale shall conform with the standards of strength, quality and purity specified in these Regulations, and the tests for determining such conformity shall be applied to samples taken from the final product after every manufacturing process has been completed.

11 Tests for Strength and Quality.

11.

—The tests, if any, required for determining the strength and quality of each of the therapeutic substances shall be those set out in the relative Schedule to these Regulations.

12 Units of Standardisation.

12.

—The unit of standardisation in relation to a therapeutic substance shall be such unit, if any, as is prescribed by the relative Schedule.

13 Tests for Sterility.

13.

—The following tests for the presence of living aerobic or anaerobic bacteria shall be made by the manufacturer or by some institution approved by the Minister for the purpose of carrying out tests on his behalf in the case of—

(

a

) sera and solutions of serum proteins intended for injection;

(

b

) the vaccines to which Part I (A) of the Second Schedule to these Regulations applies;

(

c

) toxins, toxoids, and other antigens or mixtures of these or any one of these with serum which are intended to be used in medical or veterinary practice for diagnosis, prophylaxis or treatment by inoculation of the patient or animal;

(

d

) solutions of insulin;

(

e

) dry preparations of insulin intended for therapeutic use; and

(

f

) preparations of the posterior lobe of the pituitary body intended for use by injection, except preparations which, after being sealed in the containers, have been sterilised by heat in a manner satisfactory to the Minister

Provided that—

(i) in the case of dry preparations of insulin the tests shall be applied with such modifications as the Minister considers appropriate; and

(ii) if a manufacturer satisfies the Minister that he has already in use tests for the presence of living aerobic or anaerobic bacteria, in any of above-named substances, and that these tests, as applied by him, will detect the presence of such bacteria in the substance as ready for issue with a certainty at least equal to that afforded by the application of the tests prescribed by this Part of these Regulations, the Minister may approve the use of such tests in the place of the prescribed tests, but in such a case the Minister may at any time withdraw such approval and require the manufacturer to carry out the prescribed tests.

14 Application of Tests for Sterility.

14.

—The tests shall be applied—

(

a

) to samples taken from each batch of the substance before the operation of filling and sealing the containers in which it is to be issued has commenced; and

(

b

) to the contents of sample containers when ready for issue.

15 Amount of Samples.

15.

—The samples required to be taken under the last preceding Article shall be taken in the following proportions:—

(

a

) in the case of samples taken from the batch, the quantity taken shall be not less than 0·1 per cent. of the total volume of the batch if the volume is not more than 10 litres, and not less than 10 c.c. if the volume is 10 litres or more, but shall in no case be less than 1 c.c.

Provided that if, at the time when the test is made, the batch is contained in a number of bulk containers, samples in the foregoing proportions shall be taken from each of such bulk containers and be separately tested;

(

b

) in the case of the contents of sample containers the number of containers taken for test shall be not less than 1 per cent. of the total number filled from the batch if this number is not more than 1,000, and not less than 10 containers if the total number is more than 1,000.

16 Method of preparing and using Media.

16.

—(1) The tests shall be made in fluid media, the quantity of medium contained in each tube or other vessel used in the test being such as to secure that any antiseptic present in the sample is so diluted that the growth of micro-organisms would not be inhibited.

(2) In the case of a test for aerobic organisms the medium shall consist either of a meat extract with the addition of 1 per cent. of peptone, or of such an equivalent as can be prepared by the tryptic digestion of muscle. After the final sterilisation the hydrogen-ion concentration of the medium shall be between the limits represented by pH = 7·2 and pH = 7·8.

(3) In the case of a test for anaerobic organisms the medium shall consist of a nutrient broth similar to that used in testing for aerobic organisms with the addition of heat coagulated tissue. The tissue shall occupy a depth of not less than 1 centimetre at the bottom of the tube and the broth a depth of not less than 5 centimetres. After the final sterilization the hydrogen-ion concentration of the medium shall be between the limits represented by pH. = 7·2 and pH. = 7·8. In the case of tests of sera, unless the cultures are to be incubated in an apparatus in which the contained atmosphere is devoid of oxygen, the broth shall have above it a layer not less than 1 centimetre in depth of liquid paraffin, vaseline or other suitable material to act as a barrier to the absorption of oxygen. In every case before the test inoculation the medium shall be heated to 100° C for a period sufficient to free it completely from dissolved oxygen and then be cooled to 37° C or lower.

(4) The Minister may, at the request of any licensee, authorise the use, for the test prescribed under either paragraph (2) or (3) of this Article, of any other specified medium or method of using a specified medium, on being satisfied that its use affords equal certainty in the detection of the presence of living aerobic or anaerobic organisms, as the ease may be.

17 Method of Testing.

17.

—(1) In the case of sample taken from the batch each sample shall be inoculated into tubes or other vessels containing the media, one-half of the total volume of the sample being used for the aerobic and one-half for the anaerobic test.

(2) In the case of the contents of sample containers the contents of each container shall be subjected to the test for aerobic and the test for anaerobic organisms. When the volume in the container is 2 c.c. or more, 1 c.c. shall be used for each test. When the volume in the container is less than 2 c.c., the contents shall be divided into two approximately equal parts, one part being used for the aerobic and the other for the anaerobic test.

(3) The inoculated tubes shall be incubated at 37° C. for five days and be examined after incubation, permanent records being kept of the examination of each tube.

18 ..

18.

—(1) If at the examination referred to in the last preceding Article no growth of micro-organisms is found in any tube, the sample may be treated as having passed the test.

(2) If at such examination a growth of micro-organisms is visible, further samples may be taken and the tests may be repeated on the further samples so taken; but no container the contents of which form part of the batch shall be issued until such further samples have passed the test. The process of taking samples from the batch for a test may, if necessary, be repeated twice

Provided that if the same organism is visible in more than one test, the batch shall be treated as not sterile and the material contained in the batch shall not be issued or used as part of a further batch unless and until it has been re-sterilised and has passed the tests.

19 ..

19.

—Notwithstanding anything contained in the last preceding Article, in any case where—

(

a

) a substance is certified in writing by a medical practitioner or a registered veterinary surgeon as being required in an emergency, but the licensee has no filled containers in stock; or

(

b

) a substance which in the opinion of the Minister is so unstable that the delay occasioned by the completion of the sterility test on filled containers would render its issue in active form impossible,

the licensee may issue the substance from a batch which has already passed the tests for sterility and freedom from abnormal toxicity, without completing the sterility test on the filled containers, provided that he complies with the following conditions:—

(i) the licensee shall before the issue take samples in the required proportions from the containers into which the batch is filled, and after the required inoculation and incubation shall examine the tubes every day for five days;

(ii) if at any examination any growth is visible in any of the tubes, he shall immediately notify the licensing authority;

(iii) he shall keep available for inspection a record of all issues made under this Article containing such particulars of the circumstances in which the issue is made as the Minister may require.

20 Tests for Freedom from Abnormal Toxicity.

20.

—The following tests for freedom from abnormal toxicity shall, in the case of each batch of serum, be made by the licensee or by some institution approved by the Minister for the purpose of carrying out the tests on his behalf:—

(

a

) a dose of 0·5 c.c. of the serum shall be injected subcutaneously into a normal mouse and the serum may be treated as having passed the test for freedom from an excess of antiseptic if the injection does not produce death or serious symptoms; and

(

b

) a dose of not less than 5 c.c. of the serum shall be injected subcutaneously or intraperitioneally into a normal guinea pig and the serum shall be treated as having passed the test for freedom from other abnormal toxic constituents if the injection does not produce death or serious symptoms.

PART V.LICENCES FOR IMPORT OF THERAPEUTIC SUBSTANCES.

21 ..

21.

—Every applicant for a licence to import a therapeutic substance or substances for purposes other than those of scientific research (in this Part of these Regulations referred to as an "import licence") shall furnish to the Minister a written undertaking with the Minister in a form approved by the Minister, signed by or on behalf of the person who manufactures the therapeutic substance or substances to which the application relates (hereinafter referred to as the "manufacturer"), that he will in the event of such licence being granted during the continuance of the licence comply with the following conditions:—

(

a

) the applicant shall be the sole accredited agent of the manufacturer for the import of the substance;

(

b

) the manufacturer will comply with the conditions imposed on a licensee by paragraphs (

a

), (

b

), (

d

) and (

e

) inclusive of Article 5 of these Regulations;

(

c

) the manufacturer will allow any inspector authorised by the Minister in that behalf to enter, with or without prior notice, any premises where the manufacture of the therapeutic substance is carried on and to inspect the premises and plant and the process of manufacture and the means employed for standardising and testing the substance and to take samples thereof;

(

d

) the manufacturer will from time to time report to the Minister any proposal to carry on the manufacture of the therapeutic substance in premises other than those in which it was carried on when the licence was issued and every such change of premises if and when effected and in a case in which the manufacture is carried on in more than one factory any proposal for redistributing functions between factories and every such redistribution if and when effected;

(

e

) the manufacturer will comply with the provisions of Part III of these Regulations;

(

f

) every substance manufactured by the manufacturer for import under licence will as regards strength, quality, and purity conform with the provisions of Part IV of these Regulations and of the relative Schedule, or, with such standards of strength, quality and purity as may be prescribed for that substance by any Regulations made under the Act and for the time being in operation, or, if no such standards are so prescribed, with such standards of strength, quality and purity as are prescribed in the case of therapeutic substances of a similar class;

(

g

) the manufacturer will comply with such further requirements, if any, applicable to manufacturers of therapeutic substances as may be specified in any Regulations which may be made under the Act and of which the Minister has given to the licensee not less than one month's notice.

22 ..

22.

—(1) Every import licence shall be subject to the observance by the manufacturer of the undertaking signed by him in respect of such licence.

(2) Every import licence shall, in addition, be subject to the following conditions:—

(

a

) 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;

(

b

) 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 authorising the sale of the batch has been issued to him by or on behalf of the Minister;

(

c

) 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 and 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 the issues already made from that batch;

(

d

) the licensee shall comply with such further requirements, if any, applicable to the holders of import licences, as may be specified in any Regulations which may be made under the Act and of which the Minister has given to him not less than one month's notice.

PART VI.RESEARCH LICENCES.

23 ..

23.

—Every licence granted to a person engaged in scientific research to import therapeutic substances for the purpose of scientific research (in this Part of these Regulations referred to as a "research licence") shall be subject to the following conditions:—

(

a

) the licensee shall use the substances imported under the licence for purposes of scientific research exclusively, and shall carry on such research in the place or places specified in the licence or in such other place or places as the Minister may from time to time authorize;

(

b

) the licensee shall keep a record of the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer;

(

c

) the licensee shall comply with such further requirements, if any, applicable to the holders of research licences, as may be specified in any Regulations which may be made under the Act, and of which the Minister has given to the licensee not less than one month's notice.

PART VII.THERAPEUTIC SUBSTANCES MANUFACTURED OR IMPORTED FOR EXPORT ONLY.

24 ..

24.

—The Minister may in the case of any particular substance dispense with any of the requirements of these Regulations if he is satisfied that the substance is being manufactured exclusively for sale outside Saorstát Eireann or is being imported exclusively for re-export, and that such dispensation is desirable, regard being had to the nature of any arrangements for regulating the manufacture and sale of the substance in operation in the country to which the substance is to be exported.

Given under the Official Seal of the Minister for Local

Government and Public Health this 23rd day of

November, One Thousand Nine Hundred and

Thirty-Four.

(Sighnithe) SEÁN T. O CEALLAIGH,

Minister for Local Government and Public Health.

FIRST SCHEDULE.

FORM 1.

Form of Application for a Licence to Manufacture Therapeutic Substances for Sale.

Therapeutic Substances Act, 1932

.

To Minister for Local Government and Public Health.

, of

hereby apply for a licence to manufacture on premises at the undermentioned therapeutic substances for sale:—

The names and qualifications of the expert staff responsible for the manufacture or testing of the above-mentioned substances are as follow:—

Names.

Qualifications.

Signature

Date

FORM 2.

Form of Manufacturer's Licence.

Therapeutic Substances Act,

1932.

Licence No.

The Minister for Local Government and Public Health in exercise of the powers conferred on him by the above-mentioned Act hereby licenses of to manufacture on premises at the undermentioned therapeutic substance(s) for sale:—

This licence is granted subject to the conditions applicable to manufacturers' licences and to the conditions pertaining to the manufacture of the above-named substance(s) set out in any Regulations made under the said Act and for the time being in force, and may be suspended or revoked by the said Minister under the said Act if the licensee is convicted of an offence under the said Act.

This licence will, unless previously suspended or revoked by the said Minister, continue in force for a period of two years from the date hereof.

Given under the Official Seal of the Minister for Local Government and Public Health this day of in the year One thousand nine hundred and

FORM 3.

Form of Application for a Licence to Import a Therapeutic Substance.

Therapeutic Substances Act, 1932.

To Minister for Local Government and Public Health.

of

hereby apply for a licence to import the undermentioned Therapeutic substance(s) from

of being the manufacturer thereof, that is to say:—

enclose with this application an undertaking signed by or on behalf of such manufacturer in accordance with Article 21 of the Therapeutic Substances (Saorstát Eireann) Regulations, 1934.

Signature

Date

FORM 4.

Form of Import Licence.

Therapeutic Substances Act,

1932.

Licence No.

The Minister for Local Government and Public Health in exercise of the powers conferred on him by the above-mentioned Act hereby licenses of to import the undermentioned therapeutic substance(s) from of , being the manufacturer thereof, that is to say:—

This licence is granted subject to the conditions pertaining to the importation of the above-mentioned substance(s) set out in any Regulations made under the said Act and for the time being in force and to the observance by such manufacturer of the undertaking signed by him in respect of this licence.

This licence may be suspended or revoked by the said Minister under the said Act if the licensee is convicted of an offence under the said Act or if there has in the opinion of the said Minister been a breach of the said undertaking.

This licence will, unless previously suspended or revoked by the said Minister, continue in force for a period of two years from the date hereof.

Given under the Official Seal of the Minister for Local Government and Public Health this day of One Thousand Nine Hundred and

FORM 5.

Form of Application for a research licence to import therapeutic substances for the purpose of scientific research.

Therapeutic Substances Act,

1932.

To The Minister for Local Government and Public Health.

I † of being a person engaged in scientific research, hereby apply for a licence to import the undermentioned therapeutic substances for the purpose of scientific research at the following place or places

† The application should be signed by the individual person desiring to import the substances.

This application is supported by the recommendations appearing below.

Signature

Date

‡recommend that the above application be granted.

1

of

President [Principal, Chairman

Provost or Vice-Chancellor] of

2

of

Professor of

FORM 6.

Form of Research Licence.

Therapeutic Substances Act,

1932.

Licence No.

The Minister for Local Government and Public Health in exercise of the powers conferred on him by the above mentioned Act, hereby licenses of being a person engaged in scientific research, to import for the purpose of scientific research at

or in such other place or places as the said Minister may from time to time authorise, the under-mentioned therapeutic substance(s)

‡The recommendation must be signed by one of the persons named at (

a

) below and also by a person holding one of the offices named at (

b

) below:—

(

a

) The President of the General Medical Council.

The President of the Medical Registration Council of Saorstát Eireann.

The President of the Irish Free State Veterinary Council.

The Chairman of the Medical Research Council.

The Provost of Trinity College, Dublin.

The President of University College, Cork.

The President of University College, Dublin.

The President of University College, Galway.

The Vice-Chancellor, Queen's University, Belfast.

The President of the Royal College of Physicians, London.

The President of the Royal College of Physicians of Ireland.

The President of the Royal College of Physicians, Edinburgh.

The President of the Royal College of Surgeons of England.

The President of the Royal College of Surgeons, Edinburgh.

The President of the Royal College of Surgeons in Ireland.

The President of the Royal College of Veterinary Surgeons.

The Principal of the Veterinary College of Ireland, Dublin.

The President of the Royal Society.

The President of the Royal Dublin Society.

The President of the Royal Irish Academy.

The President of the Royal Academy of Medicine in Ireland.

The President of the Pharmaceutical Society of Ireland.

(

b

) A Professor of Anatomy, Bacteriology, Biochemistry, Hygiene, Materia Medica, Medical Jurisprudence, Medicine, Pathology, Pharmacology, Physiology, Surgery or Therapeutics in a University in the Irish Free State or in a College in the Irish Free State which is incorporated by Charter.

This licence is granted subject to the conditions pertaining to the importation of therapeutic substances for the purpose of scientific research set out in any Regulations made under the said Act and for the time being in force and may be suspended or revoked by the said Minister if the licensee is convicted of an offence under the said Act.

This licence will, unless previously suspended or revoked by the said Minister, continue in force for a period of two years from the date hereof.

Given under the Official Seal of the Minister for Local Government and Public Health this

day of in the year One thousand nine hundred and

SECOND SCHEDULE.

VACCINES, TOXINS, TOXOIDS, ANTIGENS, SERA AND ANTITOXINS.

PART I.

Vaccines.

(A.)

PROVISIONS APPLICABLE TO THE PRODUCTION OF VACCINES.

Definition.

1.—(1) This Part of this Schedule applies to vaccines made from any micro-organism pathogenic to man or other animal and to vaccines made from other micro-organisms which have any antigenic value.

(2) For the purposes of this Part of this Schedule a vaccine means a sterile suspension of a killed culture of the micro-organism from which the vaccine derives its name or a sterile extract or derivative of a micro-organism which has been prepared from a genuine culture of the micro-organism.

Staff of Establishment.