European Communities (Control of Drug Precursors) Regulations, 2009

• Jurisdiction: Ireland

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

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:

(a) the State Chemist, or

(b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 (38 & 39 Vic., c.63), or

(c) a chemist or analyst appointed by the Minister as an approved examiner for the purposes of these Regulations;

“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.

(2) A word or expression which is used in these Regulations and which is also used in the EC Regulations has, unless the context otherwise requires, the same meaning in these Regulations as it has in the EC Regulations.

(3) (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.

(b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

(c) A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.

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

(a) Articles 4(3), 5, 8 and 10 of Regulation 273/2004,

(b) Articles 4, 8, 9, 14, 26(1), 26(2) and 26(3) of Regulation 111/2005, and

(c) Articles 16, 17, 18, 19 and 23 of Regulation 1277/2005.

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

(a) Articles 3, 5, 8, 9, 10 and 13 of Regulation 273/2004,

(b) Articles 4, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 20, 21, 24, 26(5) and 32 of Regulation 111/2005, and

(c) Articles 3, 5, 7, 8, 9, 10, 11, 17, 18, 19, 21, 23, 25 and 26 of Regulation 1277/2005.

(3) The Garda Síochána shall be a competent authority for the purposes of the following provisions of the EC Regulations:

(a) Articles 4(3), 5, 8 and 10 of Regulation 273/2004,

(b) Articles 4, 9, 26(2) and 26(3) of Regulation 111/2005, and

(c) Articles 16, 17 and 19 of Regulation 1277/2005.

PART 2 Regulation 273/2004

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

(2) An officer, appointed in accordance with Article 3(1) of Regulation 273/2004, shall be guilty of an offence if he or she fails to comply with Article 3(1) of Regulation 273/2004.

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.

(2) An operator shall be guilty of an offence if the operator possesses or places on the market scheduled substances of category 1 of Annex I to Regulation 273/2004 unless a licence has been granted to that operator in respect of the substance or substances, and the operation or operations, in question in accordance with Article 3 of Regulation 273/2004 and Article 7 of Regulation 1277/2005, and that licence is still valid and operative.

(3) An operator holding a valid operative licence issued in accordance with Article 3 of Regulation 273/2004 and Article 7 of Regulation 1277/2005, shall be guilty of an offence if the operator supplies scheduled substances of category 1 of Annex I to Regulation 273/2004 to a person—

(a) who does not hold a valid operative licence, issued in accordance with Article 3 of Regulation 273/2004 and Article 7 of Regulation 1277/2005, in respect of such substances, or a valid operative special licence, or

(b) who has not signed a customer declaration as provided for in Article 4(1) of Regulation 273/2004.

(4) A person applying for a special licence in accordance with Article 3(2) of Regulation 273/2004 shall be guilty of an offence, if the operator knowingly or recklessly provides false information in making such application.

(5) A special licensed operator shall be guilty of an offence if the operator uses precursors in a manner inconsistent with Article 3 of Regulation 273/2004 or in breach of the terms and conditions of the special licence issued.

(6) A person who may be entitled to become a special licensed operator in accordance with Article 3 of Regulation 273/2004 shall be guilty of an offence if it, he or she carries out activities for which a licence or special licence is required in accordance with Article 3, without such a licence.

(7) An operator, holding a licence issued in accordance with Regulation 273/2004, or a licence issued before the date of application of Regulation 273/2004, shall be guilty of an offence, if the operator fails to comply with Article 10(2) of Regulation 1277/2005.

(8) An operator, holding a licence issued in accordance with Regulation 273/2004, shall be guilty of an offence if the operator fails to inform the competent authority of any changes in information in accordance with Article 10(3) of Regulation 1277/2005.

(9) An operator, holding a licence issued in accordance with Regulation 273/2004, shall be guilty of an offence if the operator fails to return the licence, when it is no longer valid, to the competent authority, as is required pursuant to Article 10(4) of Regulation 1277/2005.

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

(2) A special registered operator shall be guilty of an offence if that operator uses precursors in a manner inconsistent with Article 3(6) of Regulation 273/2004.

(3) A person who may be entitled to become a special registered operator, in accordance with Article 3 of Regulation 273/2004, shall be guilty of an offence if it, he or she carries out activities for which a registration or special registration is required in accordance with Article 3, without having effected such registration.

(4) An operator or special registered operator purporting to register in accordance with Article 3(6) of Regulation 273/2004, shall be guilty of an offence, if that operator knowingly or recklessly provides false information in making such registration.

7. (1) An operator applying for a licence in accordance with Article 3 of Regulation 273/2004...