Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 11th November, 2022. | ||
I, STEPHEN DONNELLY, Minister for Health, 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 Commission Delegated Regulation (EU) 2015/1011 of 24 April 20151 and Commission Implementing Regulation (EU) 2015/1013 of 25 June 20152 , hereby make the following regulations: | ||
1. (1) These Regulations may be cited as the European Communities (Control of Drug Precursors) (Amendment) Regulations 2022. | ||
(2) The Principal Regulations and these Regulations may be cited together as the European Communities (Control of Drug Precursors) Regulations 2009 and 2022. | ||
2. In these Regulations “Principal Regulations” means the European Communities (Control of Drug Precursors) Regulations 2009 ( S.I. No. 558 of 2009 ). | ||
3. Regulation 2(1) of the Principal Regulations is amended— | ||
(a) in the definition of “authorised officer”, by substituting “Regulation 24” for “Regulation 23”, | ||
(b) by substituting for the definition of “Board” the following definition: | ||
“‘Authority’ means the Health Products Regulatory Authority”, | ||
(c) in the definition of “EC Regulations”, by substituting “Regulation 2015/1011 and Regulation 2015/1013” for “and Regulation 1277/2005”, | ||
(d) in the definition of “Regulation 273/2004”, by inserting “as amended from time to time” after “drug precursors”, | ||
(e) in the definition of “Regulation 111/2005”, by inserting “as amended from time to time” after “drug precursors”, | ||
(f) by substituting for the definition of “Regulation 1277/2005” the following definitions: | ||
“‘Regulation 2015/1011’ means Commission Delegated Regulation (EU) 2015/1011 of 24 April 20151 ; | ||
‘Regulation 2015/1013’ means Commission Implementing Regulation (EU) 2015/1013 of 25 June 20152 ;”, | ||
(g) in the definition of “special licensed operators”, by substituting “Article 3(12) of Regulation 2015/1011” for “Article 12(2) of Regulation 1277/2005”, and | ||
(h) in the definition of “special registered operators”, by substituting “Article 3(12) of Regulation 2015/1011” for “Article 12(2) of Regulation 1277/2005”. | ||
4. Regulation 3 of the Principal Regulations is amended— | ||
(a) in paragraph (1)— | ||
(i) in subparagraph (b), by substituting “Regulation 111/2005,” for “Regulation 111/2005, and”, and | ||
(ii) by substituting for subparagraph (c) the following subparagraphs: | ||
“(c) Articles 8 and 9 of Regulation 2015/1011, and | ||
(d) Article 11 of Regulation 2015/1013.”, | ||
(b) in paragraph (2)— | ||
(i) by substituting “Authority” for “Board”, | ||
(ii) in subparagraph (b), by substituting “Regulation 111/2005,” for “Regulation 111/2005, and”, and | ||
(iii) by substituting for subparagraph (c) the following subparagraphs: | ||
“(c) Articles 3, 9, 11 and 12 of Regulation 2015/1011, and | ||
(d) Articles 3, 4, 5, 6, 7, 10 and 11 of Regulation 2015/1013.”, and | ||
(c) in paragraph (3), by substituting for subparagraph (c) the following: | ||
“(c) Articles 8 and 9 of Regulation 2015/1011.”. | ||
5. Regulation 5 of the Principal Regulations is amended— | ||
(a) in paragraph (1), by substituting “Article 3 of Regulation 2015/1011” for “Article 5 of Regulation 1277/2005”, | ||
(b) in paragraph (2), by substituting “Article 3 of Regulation 2015/1013” for “Article 7 of Regulation 1277/2005”, | ||
(c) in paragraph (3), by substituting “Article 3 of Regulation 2015/1013” for “Article 7 of Regulation 1277/2005” in both places it occurs, | ||
(d) in paragraph (7), by substituting “Article 3(9) of Regulation 2015/1011” for “Article 10(2) of Regulation 1277/2005”, | ||
(e) in paragraph (8), by substituting “Article 6 of Regulation 2015/1013” for “Article 10(3) of Regulation 1277/2005”, and | ||
(f) in paragraph (9), by substituting “Article 7(1) of Regulation 2015/1013” for “Article 10(4) of Regulation 1277/2005”. | ||
6. Regulation 7 of the Principal Regulations is amended— | ||
(a) in paragraph (1), by substituting “Article 3 of Regulation 2015/1011 shall pay such fee as may be levied by the Authority in accordance with Article 3(6c) of Regulation 273/2004” for “Article 5 of Regulation 1277/2005 shall pay a fee of €63.50”, and | ||
(b) in paragraph (2), by substituting “such fee as may be levied by the Authority in accordance with Article 3(6c) of Regulation 273/2004” for “a fee of €63.50”. | ||
7. Regulation 8(5) of the Principal Regulations is amended by substituting “Article 7 of Regulation 2015/1011” for “Article 15 of Regulation 1277/2005”. | ||
8. Regulation 11 of the Principal Regulations is amended— | ||
(a) in paragraph (2), by substituting “Article 9(1) of Regulation 2015/1011 within the timeframe specified in Article 10 of Regulation 2015/1013” for “Article 17 of Regulation 1277/2005 within the timeframe specified in Article 19 of Regulation 1277/2005”, and | ||
(b) in paragraph (3), by substituting “Article 10 of Regulation 2015/1013” for “Article 19 of Regulation 1277/2005”. | ||
9. Regulation 12(2) of the Principal Regulations is amended— | ||
(a) by substituting “Article 3(1) of Regulation 2015/1011” for “Article 3 of Regulation 1277/2005”, and | ||
(b) by substituting “the second subparagraph of that provision” for “Article 4 of Regulation 1277/2005”. | ||
10. Regulation 14 of the Principal Regulations is amended— | ||
(a) in paragraph (1), by substituting “Article 3 of Regulation 2015/1011” for “Article 5 of Regulation 1277/2005”, | ||
(b) in paragraph (3), by substituting “Article 3(9) of Regulation 2015/1011” for “Article 10(2) of Regulation 1277/2005”, | ||
(c) in paragraph (4), by substituting “Article 6 of Regulation 2015/1013” for “Article 10(3) of Regulation 1277/2005”, and | ||
(d) in paragraph (5), by substituting “Article 7 of Regulation 2015/1013” for “Article 10(4) of Regulation 1277/2005”. | ||
11. Regulation 16 of the Principal Regulations is amended by substituting “Article 8 of Regulation 2015/1011” for “Article 16 of Regulation 1277/2005” in both places it occurs. | ||
12. Regulation 17 of the Principal Regulations is amended— | ||
(a) in paragraph (2), by substituting “Article 9(1) of Regulation 2015/1011 within the timeframe specified in Article 10 of Regulation 2015/1013” for “Article 18 of Regulation 1277/2005 within the timeframe specified in Article 19 of Regulation 1277/2005”, and | ||
(b) in paragraph (3), by substituting “Article 10 of Regulation 2015/1013” for “Article 19 of Regulation 1277/2005”. | ||
13. Regulation 18 of the Principal Regulations is amended— | ||
(a) in paragraph (1), by substituting “Article 10 of Regulation 2015/1011” for “Article 22 of Regulation 1277/2005”, and | ||
(b) in paragraph (2), by substituting “Article 11(2) and (4) of Regulation 2015/1013” for “Article 23 of Regulation 1277/2005” in each place it occurs. | ||
14. Regulation 19 of the Principal Regulations is amended— | ||
(a) by substituting for paragraph (1) the following: | ||
“19. (1) An operator having a valid operative export authorisation by simplified procedure in accordance with Article 19 of Regulation 111/2005 and Article 12 of Regulation 2015/1011 shall be guilty of an offence if the operator fails to comply with the requirements of Article 11(8), (9) and (10) of Regulation 2015/1013 when establishing such authorisation.”, and | ||
(b) in paragraph (2), by substituting “Article 12(2) of Regulation 2015/1011” for “Article 26 of Regulation 1277/2005”. | ||
15. Regulation 20 of the Principal Regulations is amended by substituting for paragraph (2) the following: | ||
“(2) An operator importing or attempting or seeking to import, scheduled substances shall be guilty of an offence if the operator fails to comply with Article 22 of Regulation 111/2005 or Article 11(3) or (4) of Regulation 2015/1013.”. | ||
16. Regulation 21 of the Principal Regulations is amended— | ||
(a) in paragraph (1), by substituting “Article 3 of Regulation 2015/1011, shall pay such fee as may be levied by the Authority in accordance with Article 3(6c) of Regulation 273/2004” for “Article 5 of Regulation 1277/2005, shall pay a fee of €63.50”, | ||
(b) in paragraph (2), by substituting “such fee as may be levied by the Authority in accordance with Article 3(6c) of Regulation 273/2004” for “a fee of €63.50”, and | ||
(c) in paragraph (3), by substituting “such fee as may be levied by the Authority in accordance with Article 3(6c) of Regulation 273/2004” for “a fee of €63.50”. | ||
17. Regulation 22(1) of the Principal Regulation is amended by substituting “ section 50 of the Customs Act 2015 ” for “the Customs Consolidation Act 1876 , the Customs Act 1956 and the Customs and Excise (Miscellaneous Provisions) Act 1988 ”. | ||
18. The Principal Regulations are amended by substituting for Part 4 the following: | ||
“PART 4 | ||
REGULATION 2015/1011 | ||
23. (1) An operator who fails to take adequate security measures in accordance with Article 3(2)(a) of Regulation 2015/1011, shall be guilty of an offence. | ||
(2) An operator who attempts to transfer a licence issued in accordance with the EC Regulations, in breach of Article 3(8) of Regulation 2015/1011, shall be guilty of an offence.”. | ||
19. Regulation 36(1) of the Principal Regulations is amended by substituting “Article 3(9) of Regulation 2015/1011” for “Article 10(2) of Regulation 1277/2005”. | ||
| ||
GIVEN under my Official Seal, | ||
28 October, 2022. | ||
STEPHEN DONNELLY, | ||
Minister for Health. | ||
EXPLANATORY NOTE | ||
(This note is not part of the instrument and does not purport to be a legal interpretation.) | ||
These Regulations amend the European Communities (Control of Drug Precursors) Regulations 2009 to take account of the replacement of Commission Regulation (EC) No. 1277/2005 of 26 July 2005 with Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 and Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015. | ||
These Regulations may be cited as the European Communities (Control of Drug Precursors) (Amendment) Regulations 2022. | ||
1 OJ No. L 162, 27.6.2015, p. 12. 2 OJ No. L 162, 27.6.2015, p. 33. |