S.I. No. 77/1937 -- Dangerous Drugs (Methylmorphine and Ethylmorphine) Regulations, 1937.
No. 77/1937: DANGEROUS DRUGS (METHYLMORPHINE AND ETHYLMORPHINE) REGULATIONS, 1937. | ||||||||||||||||||||||
DANGEROUS DRUGS (METHYLMORPHINE AND ETHYLMORPHINE) REGULATIONS, 1937. | ||||||||||||||||||||||
WHEREAS by virtue of the Dangerous Drugs Act, 1934 (Commencement) Order, 1937 (Statutory Rules and Orders No. 40 of 1937), the dangerous Drugs Act, 1934 (No. 1 of 1934), came into operation on the 1st day of April, 1937: | ||||||||||||||||||||||
AND WHEREAS it is enacted by section 5 of the said Act that the Minister for Justice may by Order make regulations in relation to any matter or thing referred to in the said Act as prescribed: | ||||||||||||||||||||||
AND WHEREAS it is enacted by sub-section (3) of section 18 of the said Act that every import permit in respect of a drug to which Part IV of the said Act applies shall be in the prescribed form and contain the prescribed particulars: | ||||||||||||||||||||||
AND WHEREAS it is enacted by sub-section (2) of section 19 of the said Act that the Minister for Justice may, if he so thinks fit, grant to any person who complies with the prescribed conditions, an export permit to export any drug to which Part IV of the said Act applies, and it is enacted by sub-section (3) of the said section that every export permit in respect of any such drug shall be in the prescribed form and shall contain the prescribed particulars: | ||||||||||||||||||||||
AND WHEREAS it is enacted by sub-section (1) of section 20 of the said Act that for the purpose of preventing the improper use of drugs to which Part IV of the said Act applies, the Minister for Justice may by order make regulations under the said section for controlling or restricting the manufacture, sale, possession and distribution of such drugs, and in particular, but without prejudice to the generality of the foregoing power for— | ||||||||||||||||||||||
(a) prohibiting the manufacture of any such drugs except on premises licensed for the purpose and subject to any conditions specified in the licence; and | ||||||||||||||||||||||
(b) prohibiting the manufacture, sale, or distribution of any such drug except by persons licensed or otherwise authorised under such regulations and subject to any conditions specified in the licence or authority; and | ||||||||||||||||||||||
(c) regulating the issue by registered medical practitioners of prescriptions containing any such drug and the dispensing of any such prescriptions; and | ||||||||||||||||||||||
(d) requiring persons engaged in the manufacture, sale, or distribution of any such drug to keep such books and furnish such information either in writing or otherwise as may be prescribed by such regulations; | ||||||||||||||||||||||
AND WHEREAS it is enacted by section 21 of the said Act, that Part V of the said Act applies to the following drugs, that is to say:— | ||||||||||||||||||||||
(a) methylmorphine (commonly known as codeine) and its salts; | ||||||||||||||||||||||
(b) ethylmorphine (commonly known as dionin) and its salts | ||||||||||||||||||||||
AND WHEREAS it is enacted by sub-section (1) of section 22 of the said Act that the Executive Council may at any time by order under the said sub-section declare that Part IV (that is to say sections 17, 18, 19 and 20) of the said Act shall, with such modifications as may be specified in such order, apply to any drug to which Part V of the said Act applies, and whenever any such order is made in relation to a drug to which the said Part V applies, the said Part IV shall, so long as such order is in force, apply with such modifications as are specified in such order to such drug: | ||||||||||||||||||||||
AND WHEREAS by order entitled the Dangerous Drugs Act, 1934 , (Application of Part IV to Methylmorphine and Ethylmorphine) Order, 1937 (Statutory Rules and Orders No. 66 of 1937) made on the 9th day of April, 1937, under sub-section (1) of the said section 22 of the said Act, it was declared that Part IV of the said Act shall apply to drugs to which Part V of the said Act applies, subject to the following modifications, that is to say:— | ||||||||||||||||||||||
(a) section 17 of the said Act shall not apply; | ||||||||||||||||||||||
(b) the power conferred on the Minister for Justice by sub-section (1) of section 20 of the said Act to make regulations for controlling or restricting the manufacture, sale, possession and distribution of drugs to which the said Part IV applies shall be exercisable— | ||||||||||||||||||||||
(i) in relation to sale or distribution of any drug to which the said Part V applies only as respects sale or distribution by a wholesale druggist (within the meaning of the said Order) and, in the case of a wholesale druggist who is also a person entitled, under the Pharmacy Act (Ireland) 1875, as amended by the Pharmacy Act (Ireland) 1875, Amendment Act, 1890, to keep open shop for the sale of poisons, only as respects sale or distribution otherwise than in the course of any retail business (within the meaning of the said Order) carried on by him, | ||||||||||||||||||||||
(ii) in relation to possession of any of the drugs to which the said Part V applies only as respects possession thereof in a quantity exceeding one pound avoirdupois; | ||||||||||||||||||||||
(c) sub-section (2) of section 20 of the Act shall not apply: | ||||||||||||||||||||||
NOW, THEREFORE, I, P. J. Ruttledge, Minister for Justice, in exercise of the powers conferred on me by the Dangerous Drugs Act, 1934 (No. 1 of 1934), and of every and any other power me in this behalf enabling do hereby order and make the following regulations, that is to say:— | ||||||||||||||||||||||
PART I. PRELIMINARY AND GENERAL. | ||||||||||||||||||||||
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Short title and commencement. | ||||||||||||||||||||||
1. (1) These Regulations may be cited as the Dangerous Drugs (Methylmorphine and Ethlymorphine) Regulations, 1937. | ||||||||||||||||||||||
(2) These Regulations shall come into operation on the 1st day of June, 1937. | ||||||||||||||||||||||
Application of Interpretation Act, 1923 . | ||||||||||||||||||||||
2. The Interpretation Act, 1923 (No. 46 of 1923), applies to the interpretation of these Regulations in like manner as it applies to the Interpretation of an Act of the Oireachtas. | ||||||||||||||||||||||
Definitions. | ||||||||||||||||||||||
3. (1) In these Regulations— | ||||||||||||||||||||||
the expression "the Act" means the Dangerous Drugs Act, 1934 (No. 1 of 1934); | ||||||||||||||||||||||
the expression "the Minister" means the Minister for Justice; | ||||||||||||||||||||||
the word "drug" means any drug to which Part V of the Act applies; | ||||||||||||||||||||||
the word "licence" means a licence granted by the Minister under sub-section (4) of section 20 of the Act, and the word "licensed" shall be construed accordingly; | ||||||||||||||||||||||
the expression "retail business" means the business of retailing or dispensing or compounding drugs carried on at a shop; | ||||||||||||||||||||||
the expression "wholesale druggist" means a person who carries on the business of selling drugs to persons who buy to sell again; | ||||||||||||||||||||||
the word "register" means a bound book and does not include any form of loose-leaf register or card index. | ||||||||||||||||||||||
(2) For the purposes of these Regulations but subject in each case to any limitation attached to his licence— | ||||||||||||||||||||||
(a) a wholesale druggist licensed to manufacture a drug shall be deemed to be licensed to supply that drug; | ||||||||||||||||||||||
(b) a wholesale druggist licensed to supply a drug shall be deemed to be a person licensed to be in possession of more than one pound avoirdupois of such drug. | ||||||||||||||||||||||
(3) For the purposes of these Regulations a person shall be deemed to be in possession of a drug if it is in his actual custody or is held by any other person subject to his control or for him or on his behalf. | ||||||||||||||||||||||
Non-application of regulations to certain types of sales. | ||||||||||||||||||||||
4. Nothing in these Regulations shall apply to any sale or distribution of any drug by a person other than a wholesale druggist nor to any sale or distribution, in the course of any retail business, by a person entitled, under the Pharmacy Act (Ireland), 1875, as amended by the Pharmacy Act (Ireland), 1875, Amendment Act, 1890, to keep open shop for the sale of poisons. | ||||||||||||||||||||||
PART II. PERMITS TO IMPORT AND EXPORT METHYLMORPHINE AND ETHYLMORPHINE. | ||||||||||||||||||||||
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Form of import permit. | ||||||||||||||||||||||
5. Every import permit under section 18 of the Act in respect of a drug shall be in the Form set out in the First Schedule to these Regulations and shall contain the particulars indicated in such Form. | ||||||||||||||||||||||
Conditions to be complied with by applicants for export permits. | ||||||||||||||||||||||
6. The following shall be the conditions to be complied with by an applicant for an export permit to export from Saorstát Eireann to another country a quantity of any drug, that is to say:— | ||||||||||||||||||||||
(a) that he is licensed to supply or have in his possession, such drug; | ||||||||||||||||||||||
(b) that he produces to the Minister the appropriate import certificate mentioned in paragraph 2 of Article 13 of the Geneva Convention, 1925, or, where applicable, the appropriate special certificate mentioned in paragraph 7 of the said Article 13. | ||||||||||||||||||||||
Form of export permit. | ||||||||||||||||||||||
7. Every export permit under section 19 of the Act in respect of a drug shall be in the Form set out in the Second Schedule to these Regulations and shall contain the particulars indicated in such Form. | ||||||||||||||||||||||
PART III. MANUFACTURE, SALE, POSSESSION AND DISTRIBUTION OF METHYLMORPHINE AND ETHYLMORPHINE. | ||||||||||||||||||||||
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Manufacture of drugs. | ||||||||||||||||||||||
8. A person shall not manufacture, or carry on any process in the manufacture of a drug unless he is duly licensed so to do, and in so doing complies with the terms and conditions of his licence. | ||||||||||||||||||||||
Supplying of drugs. | ||||||||||||||||||||||
9. A wholesale druggist shall not supply a drug to any person, whether in Saorstát Eireann or elsewhere unless— | ||||||||||||||||||||||
(a) he is fully licensed so to do, and in so doing complies with the terms and conditions of his licence, and | ||||||||||||||||||||||
(b) in case the drug is to be supplied in any one transaction in a quantity exceeding one pound avoirdupois, the person to whom it is to be supplied is licensed to be in possession of more than one pound avoirdupois of the drug. | ||||||||||||||||||||||
Possession of drugs. | ||||||||||||||||||||||
10. No person shall be in possession of a drug in any quantity exceeding one pound avoirdupois unless he is duly so licensed. | ||||||||||||||||||||||
Marking of packages of bottles. | ||||||||||||||||||||||
11. No wholesale druggist licensed to supply a drug shall supply the drug unless the package or bottle in which it is contained is plainly marked with the amount of the drug contained therein. | ||||||||||||||||||||||
Records in relation to drugs. | ||||||||||||||||||||||
12. Every wholesale druggist who is licensed to supply drugs shall, in accordance with the following provisions, keep registers and enter therein true particulars in relation to all drugs obtained or supplied (whether to a person within or outside Saorstát Eireann) by him, that is to say:— | ||||||||||||||||||||||
(a) either one register or two registers may be kept and in the former case a separate part of such register and in the latter case a separate register shall be reserved for entries in respect of each of the following classes of drugs, that is to say:— | ||||||||||||||||||||||
(i) methylmorphine and salts of methylmorphine, | ||||||||||||||||||||||
(ii) ethylmorphine and salts of ethylmorphine; | ||||||||||||||||||||||
(b) in the case of a business carried on at more than one set of premises, a separate register (or a separate set of registers) shall be kept in respect of each such set of premises and in the case of a business made up of different departments, a separate register (or a separate set of registers) may, with the approval of the Minister be kept in respect of each department; | ||||||||||||||||||||||
(c) each separate part of a register (or, as the case may be, each separate register) shall be divided into two sub-parts for entries respectively of drugs obtained and drugs supplied, and the said sub-parts shall be in the forms respectively set out in Parts I and II of the Third Schedule to these Regulations; | ||||||||||||||||||||||
(d) an entry in respect of any drug obtained or supplied shall be made in the appropriate sub-part of the appropriate register and shall consist of the particulars indicated by the form of such sub-part of such register; | ||||||||||||||||||||||
(e) every such entry shall be made, in the case of obtaining a drug, on the day such drug is received or, if that is not reasonably practicable, on the next following day and, in the case of supplying a drug, on the day on which the transaction in question is effected or, if that is not reasonably practicable, on the next following day; | ||||||||||||||||||||||
(f) no cancellation obliteration or alteration shall be made of an entry in a register, and any correction of an entry shall be made by way of marginal or foot note specifying the date thereof; | ||||||||||||||||||||||
(g) a register shall not be used for any purpose save for the purposes of these Regulations or for the purpose of complying with section 2 of the Poisons (Ireland) Act, 1870; | ||||||||||||||||||||||
(h) every entry made in a register and every correction of such an entry shall be made in ink or otherwise so as to be indelible; | ||||||||||||||||||||||
(i) each register shall be kept on the premises to which it relates, and shall be kept at all times available for inspection. | ||||||||||||||||||||||
Particulars to be furnished by licensed wholesale druggists. | ||||||||||||||||||||||
13. Every licensed wholesale druggist shall, on demand by the Minister or any person empowered in that behalf by order in writing by the Minister, furnish to the Minister or that person, as the case may be, such particulars as the Minister or that person may require with respect to the obtaining or supplying by such licensed wholesale druggist of any drug or with respect to any stocks of drugs in the possession of such licensed wholesale druggist. | ||||||||||||||||||||||
Preservation of registers. | ||||||||||||||||||||||
14. All registers which are kept in pursuance of the requirements of these Regulations shall be preserved for a period of two years from the date on which the last entry is made therein. | ||||||||||||||||||||||
FIRST SCHEDULE. | ||||||||||||||||||||||
FORM OF IMPORT PERMIT UNDER SECTION 18 OF THE DANGEROUS DRUGS | ||||||||||||||||||||||
ACT, 1934. | ||||||||||||||||||||||
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IMPORT PERMIT. | ||||||||||||||||||||||
In pursuance of sub-section (2) of Section 18 of the Dangerous Drugs Act, 1934 (No. 1 of 1934), the Minister for Justice hereby grants to (a) ........... | ||||||||||||||||||||||
............................................................ ..................................................... | ||||||||||||||||||||||
this permit to import into Saorstát Eireann from (b) ....................................... | ||||||||||||||||||||||
............................................................ ..................................................... | ||||||||||||||||||||||
from (c) ............................................................ ........................................ | ||||||||||||||||||||||
through (d) ............................................................ .................................... | ||||||||||||||||||||||
before the..............day of .........................., 19..., the consignment specified | ||||||||||||||||||||||
in the Schedule hereto, subject to the following conditions:— | ||||||||||||||||||||||
1. The permit does not authorise the importer to be in possession of or to supply the drugs specified in the said Schedule. | ||||||||||||||||||||||
2. The permit does not relieve the importer from compliance with any Customs regulations in force for the time being relating to the importation of goods into or transhipment of goods in Saorstát Eireann, or any Post Office regulations for the time being in force in Saorstát Eireann. | ||||||||||||||||||||||
3. The permit is valid only for the importer and may be revoked at any time by the Minister for Justice. It shall be produced for inspection when required by any person duly authorised under the said Act. | ||||||||||||||||||||||
4. The permit shall be surrendered to the Customs Officer at the time of importation, or, if the importation is not effected before the..............day of ..............................................., 19..........., shall immediately after that date be surrendered to the Minister for Justice. | ||||||||||||||||||||||
(a) Name and address of importer. | ||||||||||||||||||||||
(b) Name and address of exporter. | ||||||||||||||||||||||
(c) Country from which the consignment is to be imported. | ||||||||||||||||||||||
(d) Name of port or place in Saorstát Eireann through which the consignment is to imported. | ||||||||||||||||||||||
SCHEDULE. | ||||||||||||||||||||||
(Quantity and description of drugs to be imported). | ||||||||||||||||||||||
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ENDORSEMENT BY CUSTOMS OFFICER | ||||||||||||||||||||||
AT THE TIME OF IMPORTATION. | ||||||||||||||||||||||
I hereby certify that the person named overleaf has to-day imported the | ||||||||||||||||||||||
*consignment thereon specified................................. ‡ ex †..................... under Customs | ||||||||||||||||||||||
Entry No........................... ‡ by registered parcel post or insured box post (Parcel No.....................................dated......................................................) | ||||||||||||||||||||||
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If the whole consignment for which the permit has been granted is not imported, the Customs Officer should suitably amend the certificate above, and insert below the actual amount of items imported. | ||||||||||||||||||||||
* See note below. | ||||||||||||||||||||||
† Insert name of ship. | ||||||||||||||||||||||
‡ Strike out all words inapplicable. | ||||||||||||||||||||||
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This permit must be endorsed by the Customs Officer and returned immediately to:— | ||||||||||||||||||||||
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SECOND SCHEDULE. | ||||||||||||||||||||||
FORM OF EXPORT PERMIT UNDER SECTION 19 of THE DANGEROUS DRUGS ACT, 1934 . | ||||||||||||||||||||||
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EXPORT PERMIT. | ||||||||||||||||||||||
In pursuance of subsection (2) of Section 19 of the Dangerous Drugs Act, 1934 (No. 1 of 1934), the Minister for Justice hereby grants to (a) ............... | ||||||||||||||||||||||
............................................................ .................................................... | ||||||||||||||||||||||
this permit export from (b) ............................................................ ............. | ||||||||||||||||||||||
............................................................ ..................................................... | ||||||||||||||||||||||
to (c) ............................................................ ..................................................... | ||||||||||||||||||||||
to (d) ............................................................ ..................................................... | ||||||||||||||||||||||
before the............day of......................, 19........., the consignment specified in the Schedule hereto, subject to the following conditions:— | ||||||||||||||||||||||
1. The permit does not relieve the exporter from compliance with any Customs regulations in force for the time being relating to the exportation of goods from Saorstát Eireann or from any provision of the Post Office Acts, 1908 and 1920, or Post Office Regulations for the time being in force, or from any rules or regulations respecting the transmission of articles by post which may for the time being be in force whether within Saorstát Eireann or in the countries or places to which such goods may be addressed. | ||||||||||||||||||||||
2. The permit does not authorise the exporter to be supplied with, or be in possession of, the drugs specified in the Schedule. | ||||||||||||||||||||||
3. The exporter, if so required by the Revenue Commissioners, shall produce to them, within such time as they may allow, proof to their satisfaction that the said goods were duly delivered at the destination named in this permit; and in the event of non-compliance with this condition, the permit shall be deemed void and of no effect. | ||||||||||||||||||||||
4. The exporter shall make, on the form provided for the purpose, a return at the end of each quarter to the Secretary, Department of Justice, Dublin, of all exports by him during the quarter of any of such drugs whether in pursuance of this or any other permit granted to him. | ||||||||||||||||||||||
5. This permit shall be produced for inspection when required by any person duly authorised under the said Act. | ||||||||||||||||||||||
6. This permit, if not used or if used for the export of a part only of the quantity authorised, shall be returned to the Secretary, Department of Justice, Dublin, within seven days of the date of its expiry. | ||||||||||||||||||||||
(a) Name and address of exporter. | ||||||||||||||||||||||
(b) Port or place in Saorstát Eireann from which the consignment is to be exported. | ||||||||||||||||||||||
(c) Name and address of importer. | ||||||||||||||||||||||
(d) Country to which the consignment is to be exported. | ||||||||||||||||||||||
SCHEDULE. | ||||||||||||||||||||||
(Quantity and description of drugs to be exported). | ||||||||||||||||||||||
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DEPARTMENT OF JUSTICE, | ||||||||||||||||||||||
UPPER MERRION STREET, DUBLIN. | ||||||||||||||||||||||
Date............................... | ||||||||||||||||||||||
THIRD SCHEDULE. | ||||||||||||||||||||||
FORM OF REGISTER. | ||||||||||||||||||||||
PART I. | ||||||||||||||||||||||
DRUGS OBTAINED. | ||||||||||||||||||||||
(The class of drugs to which the entries relate to be specified at the head of each page in the Register.) | ||||||||||||||||||||||
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PART II. | ||||||||||||||||||||||
DRUGS SUPPLIED. | ||||||||||||||||||||||
(The class of drugs to which the entries relate to be specified at the head of each page in the Register.) | ||||||||||||||||||||||
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Given under my Seal of Office this 16th day of | ||||||||||||||||||||||
April, 1937. | ||||||||||||||||||||||
(Signed) P. J. RUTTLEDGE, | ||||||||||||||||||||||
Minister for Justice. | ||||||||||||||||||||||
(Signed) M. O CUINNEAIN. | ||||||||||||||||||||||