S.I. No. 558/2009 - European Communities (Control of Drug Precursors) Regulations 2009

Type Statutory Instrument
Publication 2010-01-05
Last updated 2022-11-11
State In force superseded text
Text As published
articles 38

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

2 amending acts · 2022-11-11, S.I. No. 555/2022 - European Communities (Control of Drug Precursors) (Amendment) Regulat…

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S.I. No. 558 of 2009

EUROPEAN COMMUNITIES (CONTROL OF DRUG PRECURSORS) REGULATIONS 2009

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 5th January, 2010.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving full effect to Regulation (EC) No. 273/2004 1 of the European Parliament and of the Council of 11 February 2004 on drug precursors, Council Regulation (EC) No. 111/2005 2 of22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors and Commission Regulation (EC) No. 1277/2005 3 of 27 July 2005 laying down implementing rules for Regulation (EC) No. 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No. 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, as amended by Commission Regulation (EC) No. 297/2009 4 of 8 April 2009, hereby make the following regulations:

PART 1 Preliminary

1.

1.

These Regulations may be cited as the European Communities (Control of Drug Precursors) Regulations 2009.

2.

2.

(1) In these Regulations—

“Act of 1977” means the Misuse of Drugs Act 1977 (No. 12 of 1977), as amended by the Act of 1984 and the Act of 2006;

“Act of 1984” means the Misuse of Drugs Act 1984 (No. 18 of 1984);

“Act of 1995” means the Irish Medicines Board Act 1995 (No. 29 of 1995), as amended by the Act of 2006;

“Act of 2006” means Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006);

“approved examiner” means:

“authorised officer” means an officer (including an officer of customs and excise) appointed in accordance with Regulation 23 of these Regulations;

“Board” means the Irish Medicines Board established by section 3 of the Act of 1995;

“Commissioners” means the Revenue Commissioners;

“EC Regulations” means Regulation 273/2004, Regulation 111/2005 and Regulation 1277/2005;

“Minister” means the Minister for Health and Children;

“official laboratory” means the State Laboratory, or a Public Analyst Laboratory, or the Forensic Science Laboratory, or such other laboratory as has been approved by the Minister for the purposes of these Regulations;

“Regulation 273/2004” means Regulation (EC) No. 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors;

“Regulation 111/2005” means Council Regulation (EC) No. 111/2005 of22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors;

“Regulation 1277/2005” means Commission Regulation (EC) No. 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No. 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No. 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, as amended by Commission Regulation (EC) No. 297/2009 of 8 April 2009;

“special licensed operators” means pharmacies, dispensaries of veterinary medicine, universities, public authorities (as defined by Article 12(2) of Regulation 1277/2005) or armed forces, having a valid and operative special licence issued in accordance with Article 3(2) of Regulation 273/2004;

“special registered operators” means pharmacies, dispensaries of veterinary medicine, universities, public authorities (as defined by Article 12(2) of Regulation 1277/2005) or armed forces, having a valid and operative registration in accordance with Article 3(6) of Regulation 273/2004.

3.

3.

(1) The Commissioners shall be a competent authority for the purposes of the following provisions of the EC Regulations:

PART 2 Regulation 273/2004

4.

4.

(1) An operator who fails to comply with Article 3(1) of Regulation 273/2004 shall be guilty of an offence.

5.

5.

(1) An operator applying for a licence in accordance with Article 3(2) of Regulation 273/2004 and Article 5 of Regulation 1277/2005 shall be guilty of an offence, if the operator knowingly or recklessly provides false information in making such application.

6.

6.

(1) An operator who fails to comply with Article 3(6) of Regulation 273/2004 shall be guilty of an offence.

7.

7.

(1) An operator applying for a licence in accordance with Article 3 of Regulation 273/2004 and Article 5 of Regulation 1277/2005 shall pay a fee of €63.50 in respect of each class of substance to which the application relates.

8.

8.

(1) An operator who fails to comply with Article 4 of Regulation 273/2004 shall be guilty of an offence.

9.

9.

An operator shall be guilty of an offence if the operator fails to ensure that all transactions are documented, and all necessary records kept, in accordance with Article 5 of Regulation 273/2004.

10.

10.

An operator shall be guilty of an offence if the operator fails to ensure that labels, complying with Article 7 of Regulation 273/2004, are affixed to scheduled substances of categories 1 and 2 of Annex I to Regulation 273/2004 in accordance with Article 7 of Regulation 273/2004, before they are supplied.

11.

11.

(1) An operator shall be guilty of an offence if the operator fails to inform the competent authority of any unusual orders or transactions, or any other suspicious circumstances, in accordance with Article 8(1) of Regulation 273/2004.

PART 3 Regulation 111/2005

12.

12.

(1) An operator who fails to comply with Article 3 of Regulation 1277/2005 shall be guilty of an offence.

13.

13.

(1) An operator shall be guilty of an offence if the operator fails to ensure that all transactions are documented, and all necessary records kept, in accordance with Articles 3 and 4 of Regulation 111/2005.

14.

14.

(1) An operator applying for a licence in accordance with Article 6 of Regulation 111/2005 and Article 5 of Regulation 1277/2005 shall be guilty of an offence, if the operator knowingly or recklessly provides false information in making such application.

15.

15.

(1) An operator who fails to comply with Article 7 of Regulation 111/2005 shall be guilty of an offence.

16.

16.

(1) An operator shall be guilty of an offence if the operator fails, upon request, to demonstrate licit purposes in accordance with Article 8 of Regulation 111/2005 and Article 16 of Regulation 1277/2005.

17.

17.

(1) An operator shall be guilty of an offence if the operator fails to inform the competent authority (or another competent authority) of any unusual orders or transactions, or any other suspicious circumstances, in accordance with Article 9(1) of Regulation 111/2005.

18.

18.

(1) An operator shall be guilty of an offence if the operator exports, or seeks or attempts to export, scheduled substances without having a valid operative export authorisation for the substances and quantities in question, where such an authorisation is required pursuant to Article 12 of Regulation 111/2005 and Article 22 of Regulation 1277/2005.

in circumstances where Article 14 of Regulation 111/2005 and Article 23 of Regulation 1277/2005 apply.

19.

19.

(1) An operator having a valid operative export authorisation by simplified procedure in accordance with Article 19 of Regulation 111/2005 and Articles 25, 26 and 27 of Regulation 1277/2005, shall be guilty of an offence if the operator fails to comply with the procedure set down in Article 27 of Regulation 1277/2005, or if he fails to comply with a requirement set down in Article 27 of Regulation 1277/2005.

20.

20.

(1) An operator shall be guilty of an offence if the operator imports, or seeks or attempts to import, scheduled substances without having a valid operative import authorisation for the substances and quantities in question, where such an authorisation is required pursuant to Article 20 of Regulation 111/2005.

in circumstances where Article 22 of Regulation 111/2005 and Article 23 of Regulation 1277/2005 apply.

21.

21.

(1) An operator, applying for a licence in accordance with Article 6 of Regulation 111/2005 and Article 5 of Regulation 1277/2005, shall pay a fee of €63.50 in respect of each class of substance to which the application relates.

22.

22.

(1) Scheduled substances, which are prohibited from being imported or exported or are subject to any restriction on importation or exportation, are deemed to be so prohibited or restricted for the purposes of the Customs Consolidation Act 1876, the Customs Act 1956 and the Customs and Excise (Miscellaneous Provisions) Act 1988 .

PART 4 Regulation 1277/2005

23.

23.

(1) An operator who fails to take adequate security measures in accordance with Article 6 of Regulation 1277/2005, shall be guilty of an offence.

PART 5 Enforcement

24.

24.

(1) The enforcement of these Regulations and of the EC Regulations, shall be carried out in accordance with the provisions of these Regulations and the EC Regulations.

25.

25.

(1) An authorised officer, or a member of the Garda Síochána, may, for the purposes of these Regulations and for the purposes of enforcing the EC Regulations, take without payment a sample of any relevant substance in the possession of an operator.

26.

26.

(1) Where a sample is taken pursuant to these Regulations for the purpose of official analysis, and where the division of the sample is reasonably practicable, the authorised officer or member of the Garda Síochána concerned may divide the sample into three approximately equal parts each of which he or she shall mark in such a way as to identify it as a part of the sample taken by the officer or member. The authorised officer or member shall mark, seal and fasten each part in such a manner as its nature will permit, forward one part to the approved examiner in an official laboratory for analysis, give or send one part to the relevant operator and retain the third part.

the provisions of paragraph (1) of this Regulation as regards the division of samples into parts shall be deemed to be complied with if the authorised officer or member of the Garda Síochána divides the containers into three lots and deals with each lot as if it were a sample as specified under paragraph (1) of this Regulation.

27.

27.

(1) The approved examiner or a person under his or her direction shall analyse as soon as possible any sample submitted to him or her in pursuance of these Regulations and the approved examiner shall certify to the person who submitted the sample to him or her the result of such analysis. The form of certificate set out in the Schedule to these Regulations or a certificate in like form shall be used.

28.

28.

Where a sample is taken by an authorised officer or a member of the Garda Síochána in pursuance of these Regulations for analysis by an approved examiner, and where the operator requests in writing the results of such analysis the request shall be made to—

and the Board, or the Commissioners, or the Garda Síochána (as the case may be) shall comply with such request.

29.

29.

(1) An authorised officer or a member of the Garda Síochána may, for the purposes of these Regulations, seize, remove, detain or direct the withdrawal from the market of any relevant substances where the operator is suspected by him or her to be in breach of the operator’s obligations pursuant to the EC Regulations.

order that the substances be destroyed or otherwise disposed of, after such period, not exceeding 14 days, as may be specified in such order, and the authorised officer or a member of the Garda Síochána shall destroy or dispose of them accordingly.

30.

30.

(1) A person who fails to comply with these Regulations shall be guilty of an offence.

31.

31.

Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate shall be guilty of an offence and shall be liable to be proceeded against and punished as if he or she was guilty of the firstmentioned offence.

32.

32.

(1) Any person who forges, or utters knowing it to be forged, a certificate of analysis or other document purporting to be issued, granted or given under these Regulations, or required for the purposes of these Regulations or the EC Regulations, (hereafter in this Regulation referred to as “a forged document”), is guilty of an offence.

is guilty of an offence.

33.

33.

(1) For the purposes of these Regulations, every contravention of a Regulation shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Regulation of these Regulations.

34.

34.

An offence under these Regulations may be prosecuted by—

35.

35.

In any proceedings for an offence under these Regulations and/or the EC Regulations, it shall be a good defence for a person charged to show that he or she reasonably believed that he or she had complied with these Regulations and the EC Regulations.

PART 6 Revocations, Qualifications and Transitional Arrangements

36.

36.

(1) The validity of any licences issued before the coming into force of these Regulations shall not be affected by these Regulations. Such licensees shall not be obliged to apply for new licences pursuant to the provisions of these Regulations until the earlier licences have expired according to the terms of the licences, the provisions of the legislation under which the licences were granted or pursuant to Article 10(2) of Regulation 1277/2005.

37.

37.

(1) Subject to Regulation 36, the following instruments are hereby revoked-

38.

38.

(1) The Misuse of Drugs Act, 1977 (Controlled Drugs) (Declaration) Order, 1987 ( S.I. No. 251 of 1987 ) is amended by the removal of “phenylacetone” from subparagraph (a) of paragraph 2 of the schedule to that instrument.

“5. Any salt of a substance specified in any of paragraphs 1 to 4 of this Schedule.”;

“6. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1 to 5 of this Schedule.”; and

SCHEDULE Form of official certificate to be given by an approved examiner to an authorised officer or member of the Garda Síochána.

European Communities

(Control of Drug Precursors) Regulations 2009

Certificate of Analysis

To (1)

I, the undersigned (2)

being an Approved Examiner for the purpose of the above Regulations certify that on

the.................day of.................................................. 20......

a sample marked (3)

Date.........................................................

Number...................................................

Weight or Measure

was submitted to me by you and I certify that the sample was prepared and analysed/examined by me or under my direction (4)

and as a result I am of the opinion that (5)

Observations: (6)

I further certify that the sample has undergone no change which would affect my opinion/observations expressed above.

Certified by me this..................... day of................................................. 20.....

at (7)

Name in BLOCK LETTERS

Status.....................................................................

Signature...............................................................

................................................................................

Official Stamp

NOTES

(1)Insert the name and address of the person submitting the sample for analysis.

(2)Insert description (e.g. Public Analyst located at a Public Analyst Laboratory).

(3)Insert particulars of marking (e.g. name, date etc.) and the weight or measure (this may be left unanswered if the sample cannot be conveniently weighed or measured or if the weight or measurement is not material to the result of analysis).

(4)Indicate whether the approved examiner carried out the analysis himself or herself or whether it was carried out by another under the direction of the approved examiner.

(5)Here the approved examiner should specify the result of the analysis having regard to the provisions of the EC Regulations.

(6)Here the approved examiner may insert, at his or her discretion, his or her opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he or she may add any other observations as he or she may consider relevant.

(7)Insert the name and address of the laboratory carrying out the analysis/examination.

GIVEN under my Official Seal,

22 December 2009.

MARY HARNEY,

Minister for Health and Children.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation).

These Regulations are intended to give full effect to Regulation (EC) No. 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, Council Regulation (EC) No. 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors and Commission Regulation (EC) No. 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No. 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No. 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, as amended by Commission Regulation (EC) No. 297/2009 of 8 April 2009.

These Regulations may be cited as the European Communities (Control of Drug Precursors) Regulations 2009.

Footnotes

1

OJ L 47, 18.2.2004, p. 1.

2

OJ L 22, 26.1.2005, p. 1.

3

OJ L 202, 3.8.2005, p. 7.

4

OJ L 95, 9.4.2009, p.13.

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