The Minister for Health, in exercise of the powers conferred on him by sections 4 , 5 and 38 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), hereby makes the following Regulations.

PART I

1 Citation.

1. These Regulations may be cited as the Misuse of Drugs (Scheduled substances) Regulations, 1993.

2 Interpretation.

2. (1) In these Regulations:—

"the Act" means the Misuse of Drugs Act, 1977 ;

"animal remedy" has the same meaning as in the Animal Remedies Act, 1993 (No. 23 of 1993);

"the EC Council Regulation" means Council Regulation (EEC) No 3677/90⁽¹⁾, as amended by Council Regulation (EEC) No 900/92^(2),laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances;

"import" means any physical introduction of a scheduled substance into the State from a territory which is not part of the customs territory of the European Community;

"export" means any physical departure of a scheduled substance from the State to a territory which is not part of the customs territory of the European Community;

"medical preparation" has the same meaning as in section 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and by section 7 of the Health (Family Planning) Act, 1992 (No. 20 of 1992);

⁽¹⁾ Official Journal of the European Communities, No. L357, 20.12.1990 (pages 1-4).

⁽²⁾ Official Journal of the European Communities, No. L96, 10.4.1992 (pages 1-6),

"the Minister" means the Minister for Health;

"officer of customs and excise" means an officer within the meaning of the Customs Acts;

"operator" means any person engaged in the manufacture, processing, trade or distribution of scheduled substances or involved in other related activities such as the brokering or storage of scheduled substances;

"person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons" means a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts 1875 to 1977;

"produce", where the reference is to producing a scheduled substance, means producing it by cultivation, manufacture, synthesis or by any other method;

"scheduled substance" means any controlled drug specified in the First Schedule;

"the State Chemist" means the head of the State Laboratory;

"supply" includes supply notwithstanding that the person supplied may be in another Member State of the European Community;

"transit" means any transport of a scheduled substance between third countries through the customs territory of the State and any trans-shipment in that territory;

"ultimate consignee" means the person, who may or may not be the end-user, to whom a scheduled substance is to be delivered in the country of destination.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article; and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule.

3 Saver.

3. (1) Nothing in these Regulations shall be construed as affecting any provision of the Misuse of Drugs Regulations, 1988 ( S.I. No. 328 of 1988 ).

(2) These Regulations shall not apply to animal remedies, medical preparations, or to any preparation or other product containing a scheduled substance compounded in such a way that such substance cannot be easily used or recovered by readily applicable means.

PART II PRODUCTION, SUPPLY, IMPORTATION AND EXPORTATION OF SCHEDULED SUBSTANCES

4 General Prohibition.

4. (1) Subject to the provisions of these Regulations a person shall not—

( a ) produce a scheduled substance;

( b ) supply or offer to supply a scheduled substance;

( c ) import a scheduled substance; or

( d ) export a scheduled substance.

(2) Sub-article (1) shall not apply to any scheduled substance specified in Category 3 of the First Schedule.

(3) Sub-article (1) (d) shall not apply to any scheduled substance in respect of which an export authorisation has been granted pursuant to the provisions of the EC Council Regulation.

5 Licences.

5. A person so authorised by a licence granted by the Minister under Section 14 of the Act and for the time being in force may, under and in compliance with any conditions attached thereto, produce, supply, offer to supply, import, export or have in his possession any scheduled substance to which the licence relates.

6 Specific Authorities.

6. (1) A person may supply or offer to supply any scheduled substance specified in Category 1 of the First Schedule to any person who may lawfully supply or have that substance in his possession where the person so supplying or offering to supply the scheduled substance is a person acting in his capacity as—

( a ) a pharmacist;

( b ) a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons;

( c ) a person in charge of a laboratory the recognised activities of which consist of, or include, the conduct of scientific education or research and which is attached to a university or a hospital, or a person in charge of any other laboratory engaged in the conduct of scientific education or research and which is attached to any other institution approved for the purpose by the Minister;

( d ) the State Chemist;

( e ) the Director of the Forensic Science Laboratory in the Department of Justice;

( f ) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875;

( g ) a person employed or engaged as an inspector in connection with a scheme for the licensing of manufacturers or wholesalers of animal remedies or medical preparations.

( h ) an operator licensed under Article 2 (a) of the EC Council Regulation.

(2) A person whose name is for the time being entered in a register kept for the purpose of this sub-article by the Minister may, at the premises in respect of which his name is entered in the register and in compliance with any conditions subject to which his name is so entered, produce any scheduled substance in Category 2 of the First Schedule and may supply or offer to supply any such scheduled substance to any person who may lawfully supply that substance.

(3) A person, being a person specified in any of paragraphs (a), (b), (c), (d), (e) or (f) of sub-article (1) may, when acting in his capacity as such, for the purpose of his business or profession:

( a ) supply any scheduled substance in Category 2 of the First Schedule to any person who may lawfully supply that substance;

( b ) produce any preparation or other product containing any scheduled substance in Category 1 or Category 2 of the First Schedule.

(4) Where the supply of a scheduled substance under this article is to be made to a person in another Member State of the European Community, such supply shall not be made except to an operator authorised under the laws of that State, to supply or to possess the said scheduled substance, in accordance with article 4(3) of Council Directive 92/109/EEC⁽³⁾ on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances.

PART III POSSESSION OF SCHEDULED SUBSTANCES

7 General authorities.

7. A person who, by virtue of these Regulations, is authorised to produce, supply or offer to supply any scheduled substance may in accordance with the provisions of the Regulations have such substance in his possession.

8 Specific general authorities.

8. (1) Any of the following persons may have a scheduled substance in his possession, that is to say—

( a ) a member of the Garda Síochána when acting in the course of his duty as such;

( b ) an officer of customs and excise when acting in the course of his duty as such;

( c ) a person authorised in writing by the Minister in accordance with section 24 of the Act, when acting in the course of his duty as such;

( d ) a person engaged in connection with the postal services provided by An Post when acting in the course of his duty as a person so engaged;

⁽³⁾ Official Journal of the European Communities, No. L370, 19.12.1992 (pages 76-82).

( e ) person engaged in the work of any laboratory to which the substance has been sent for forensic examination when acting in the course of his duty as a person so engaged;

(f) a person engaged in the work of a customs agent when acting in the course of his duty as a person so engaged;

( g ) a person engaged in the business of a carrier when acting bona fide in the course of that business;

( h ) a person engaged in conveying the substance to a person authorised by these Regulations to have it in his possession.

(2) A person who is lawfully in possession of a scheduled substance may supply that substance to a person from whom he obtained it.

PART IV LABELLING OF SCHEDULED SUBSTANCES

9 ..

9. An operator shall not supply or offer to supply a scheduled substance specified in Category 1 or Category 2 of the First Schedule otherwise than in a bottle, package or other container unless it is clearly marked with the name of the substance as specified in the said Schedule.

PART V DOCUMENTATION AND RECORD KEEPING

10 ..

10. (1) Subject to sub-articles (2) and (4), where an operator proposes to supply a scheduled substance specified in Category 1 or Category 2 of the First Schedule, he shall not deliver the substance:

( a ) until he obtains a requisition in writing which—

(i) is signed by or on behalf of the person to whom the substance is to be supplied (in this part referred to as "the recipient"),

(ii) states the name and address of the recipient, and

(iii) specifies the name of the substance, the purpose for which it is required and the total quantity to be supplied.

(2) Sub-article (1) shall not apply—

( a ) in respect of the supply of a scheduled substance in Category 2 of the First Schedule to a person who is a regular customer of the supplier and who has within the previous twelve months already furnished to the operator a requisition in accordance with sub-article (1), or

( b ) to any supply made by a carrier in the ordinary course of transporting a scheduled substance from the operator to the recipient.

(3) Subject to sub-article (4), an operator shall not import, export, supply or offer to supply any scheduled substance specified in Category 1 or Category 2 of the First Schedule or participate in the broking or transit of such substance unless all transactions relating thereto are properly documented and any invoices, cargo manifests, customs, administrative, transport and other commercial or shipping documentation relating to the transaction contain sufficient information to positively identify—

( a ) the name of the scheduled substance as specified in the First Schedule;

( b ) the amount of the scheduled substance in the consignment;

( c ) in the case of a mixture, the total amount of the mixture in the consignment and the amount or percentage of each of its components which is a scheduled substance; and

( d ) the name and address (not being a post office box number or other such reference) of the supplier and of the recipient whether or not either such person is the importer, exporter, distributor or ultimate consignee.

(4) Sub-articles (1) and (3) shall not apply to transactions concerning a scheduled substance in Category 2 of the First Schedule where the quantity involved does not exceed that specified for that substance in the Second Schedule.

(5) An operator shall keep such detailed records of his activities as are required to comply with his obligations under sub-articles (1) and (3).

(6) The documents and records referred to in this article shall be retained for a period of not less than three years from the end of the calendar year in which the relevant transaction took place. Such documents and records shall be readily available for inspection by an officer of Customs and Excise, a member of the Garda Síochána or a person duly authorised under section 24 of the Act.

11 Furnishing of information with respect to Schedule Substances.

11. (1) An operator shall on demand made by the Minister or by any person authorised in writing by the Minister in that behalf—

( a ) furnish such particulars as may be requested in respect of the importation, producing, obtaining, exporting, broking, transit or supplying by him of any scheduled substance or in respect of any stock of such substance in his possession;

( b ) for the purpose of confirming any such particulars, produce any stock of such substance in his possession;

( c ) produce any register, book, requisition, invoice, cargo manifest or other document in his possession which is required to be kept under these Regulations in respect of any dealings in scheduled substances.

(2) Where the demand referred to in sub-article (1) is made in writing the particulars, or confirmation thereof, shall be furnished not later than fourteen days from the date of the said demand.

FIRST SCHEDULE

Category 1

1. The following substances, namely:—

Acetylanthranilic acid

Ephedrine

Ergometrine

Ergotamine

Isosafrole (cis isomer)

Isosafrole (trans isomer)

Lysergic acid

3, 4-Methylenedioxyphenylpropan-2-one

1-Phenyl-2-propanone (otherwise known as phenylacetone)

Piperonal

Pseudoephedrine

Safrole.

2. Any sale of a substance specified in paragraph 1.

3. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1 or 2.

Category 2

4. The following substances, namely:—

Acetic anhydride

Anthranilic acid

Phenylacetic acid

Piperidine

5. Any sale of a substance specified in paragraph 4.

6. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 4 or 5.

Category 3

7. The following substances, namely:—

Acetone

Ethyl ether

Methylethylketone

Potassium permanganate

Toluene.

8. Any salt of a substance specified in paragraph 7.

9. The following substances, namely:—

Hydrochloric acid.

Sulphuric acid.

10. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 7, 8 or 9.

SECOND SCHEDULE

(article 10 (4))

Substance	Threshold
Acetic anhydride	20 Litres
Anthranilic acid and its salts	1 Kilogramme
Phenylacetic acid and its salts	1 Kilogramme
Piperidine and its salts	0.5 kilogramme

GIVEN under the Official Seal of the Minister for Health this 22nd day of November, 1993.

BRENDAN HOWLIN,

Minister for Health.

EXPLANATORY NOTE.

These Regulations implement Council Directive 92/109/EEC on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances. These controls have their origin in the United Nations Convention against illicit traffic in Narcotic Drugs and Psychotropic Substances, 1988.

These Regulations apply controls to the Scheduled Substances specified in Categories 1 to 3 in Schedule 1 to the Regulations (being drugs to which the Misuse of Drugs Acts, 1977 and 1984 apply).

The effect of these Regulations is to impose restrictions on the production, supply, importation and exportation of the substances concerned, which vary according to the extent to which those substances are likely to be used for the illicit manufacture of Narcotic Drugs and Psychotropic Substances. The importation and exportation controls only apply to Category 1 and Category 2 substances and in respect of consignments destined for or originating in countries which are not Member States of the European Community. The export controls operating under Council Regulation (EEC) No. 3677/90 (as amended) are not affected by these Regulations.

In addition the Regulations specify the classes of persons who may possess and/or supply scheduled substances and the circumstances in which such possession or supply would not be in contravention of the Act. Requirements are also laid down in regard to the labelling of scheduled substances and in respect of documentation, record keeping and the furnishing of information on scheduled substances.