The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 34 U.K. Amendments to existing law

PART 6 U.K. Northern Ireland statutory rules

Control of Pesticides Regulations (Northern Ireland) 1987 U.K.

102.  For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern Ireland) 1987 M1 substitute— U.K.

“(i) the Human Medicines Regulations 2012;”.

Marginal Citations

M1 S.R. (NI) 1987 No 414, as amended by S.R. (NI) 1997 No 469.

Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995 U.K.

103.  In rule 4 of the Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995 M2 — U.K.

(a) omit the definition “the 1997 Order”;

(b) in the definitions “nurse independent prescriber” and “pharmacist independent prescriber” for “article 1(2) of the 1997 Order” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”; and

(c) in the definition “prescription only medicine” for “article 1(2) of the 1997 Order” substitute “ regulation 5(3) of the Human Medicines Regulations 2012 ”.

Marginal Citations

M2 S.R. (NI) 1995 No 8, as amended by S.R. (NI) 2009 No 429. There are other amendments, but none is relevant.

Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996 U.K.

104.  In the Schedule to the Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996 M3 for “Medicines Act 1968” substitute “ Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M3 S.R. (NI) 1996 No 81.

Pharmaceutical Services Regulations (Northern Ireland) 1997 U.K.

105.  In Part 2 of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997 M4 , in paragraph 2(12) for the words from “Articles” to the end of the paragraph substitute regulation 224 of the Human Medicines Regulations 2012”. U.K.

Marginal Citations

M4 S.R. (NI) 1997 No 381, as amended by S.R. (NI) 1999 No 405. There are other amendments, but none is relevant.

Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998 U.K.

106.  In Schedule 1, Chapter 4, Section 4.8, Part C of the Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998 M5 , for the words from “means” to the end of the Part substitute “ has the meaning given in regulation 2 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M5 S.R. (NI) 1998 No 28.

Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998 U.K.

107.  The Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998 M6 are amended as follows— U.K.

(a) in regulation 10(1)(a) for “section 8 of the Medicines Act 1968” substitute “ regulation 17 of the Human Medicines Regulations 2012 ”; and

(b) in regulation 11(1) for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

Marginal Citations

M6 S.R. (NI) 1998 No 45, as amended by S.R. (NI) 2011 No 124.

Importation of Animal Pathogens Order (Northern Ireland) 1999 U.K.

108.  In article 5(a) of the Importation of Animal Pathogens Order (Northern Ireland) 1999 M7 for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M7 S.R. (NI) 1999 No 433.

Biocidal Products Regulations (Northern Ireland) 2001 U.K.

109.  In Schedule 2 to the Biocidal Products Regulations (Northern Ireland) 2001 M8 — U.K.

(a) omit entry (f); and

(b) for entry (i) substitute—

“(i) the Human Medicines Regulations 2012;”.

Marginal Citations

M8 S.R. (NI) 2001 No 422.

Misuse of Drugs Regulations (Northern Ireland) 2002 U.K.

110.—(1) The Misuse of Drugs Regulations (Northern Ireland) 2002 M9 are amended as follows. U.K.

(2) In regulation 2(2)—

(a) in the definitions “clinical management plan”, “nurse independent prescriber”, “patient group direction”, “registered chiropodist”, “registered midwife”, “registered nurse”, “registered occupational therapist”, “registered optometrist”, “registered orthoptist”, “registered orthotist and prosthetist”, “registered paramedic”, “registered physiotherapist”, “registered radiographer” and “supplementary prescriber”, for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”; and

(b) in the definition “medicinal product” for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”

(3) In regulation 6A(1)(e) for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

(4) In regulation 8(2)—

(a) in sub-paragraph (h) after the first occurrence of “the Medicines Act 1968” insert “ or of Schedule 31 to the Human Medicines Regulations 2012 ”; and

(b) in sub-paragraph (j) after “the Medicines Act 1968” insert “ or of regulation 324 of the Human Medicines Regulations 2012 ”.

(5) In regulation 9(2)—

(a) in sub-paragraph (f) after “the Medicines Act 1968” insert “ or of Schedule 31 to the Human Medicines Regulations 2012 ”; and

(b) in sub-paragraph (h) after “the Medicines Act 1968” insert “ or of regulation 324 of the Human Medicines Regulations 2012 ”.

(6) In regulation 11(1) for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

(7) In regulation 17—

(a) after “the Medicines Act 1968” insert “ or of the Human Medicines Regulations 2012 ”; and

(b) after “that Act” insert “ or of those Regulations ”.

(8) In regulation 18 for paragraph (3) substitute—

“(3) In this regulation, “clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2004.”.

Marginal Citations

M9 S.R. (NI) 2002 No 1, as amended by S.R. (NI) 2003 No 324, S.R. (NI) 2003 No 420, S.R. (NI) 2005 No 119, S.R. (NI) 2005 No 564, S.R. (NI) 2006 No 214, S.R. (NI) 2006 No 264, and S.R. (NI) 2007 No 348.

Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003 U.K.

111.  In regulation 5(2)(c) of the Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003 M10 for “section 58 of the Medicines Act 1968” substitute “ regulation 214 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M10 S.R. (NI) 2003 No 34.

Waste Management Licensing Regulations (Northern Ireland) 2003 U.K.

112.  In paragraph 2 of Schedule 1 to the Waste Management Licensing Regulations (Northern Ireland) 2003 M11 , in the definition “hazardous waste” for the words following “ “medicinal product” means” to the end of the definition substitute “ a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M11 S.R. (NI) 2003 No 493.

Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 U.K.

113.—(1) The Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 M12 are amended as follows. U.K.

(2) In regulation 2—

(a) in the definition “licensing authority” for “section 6(3) of the Medicines Act 1968” substitute “ regulation 6 of the Human Medicines Regulations 2012 ”;

(b) omit the definition “the POM Order” and

(c) in the definition “prescription only medicine” for the words from “referred” to the end of the definition substitute “ within the meaning of regulation 5(3) of the Human Medicines Regulations 2012 ”.

(3) In regulation 47(2) for the words from “Part 3” to the end of the regulation substitute “ Part 12 of the Human Medicines Regulations 2012 ”.

(4) In Schedule 5—

(a) in paragraph 11A(1) in the definition “Patient Group Direction” for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”; and

(b) in paragraph 41(2)(a)—

(i) for “article 3B(3) of the POM Order” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(ii) for “that Order” substitute “ those Regulations ”.

Marginal Citations

M12 S.R. (NI) 2004 No 140, as amended by S.R. (NI) 2005 No 368.

Nursing Homes Regulations (Northern Ireland) 2005 U.K.

114.  In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland) 2005 M13 for “section 58 of the Medicines Act 1968” substitute “ regulation 214 or 215 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M13 S.R. (NI) 2005 No 160.

Residential Care Homes Regulations (Northern Ireland) 2005 U.K.

115.  In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland) 2005 M14 for “section 58 of the Medicines Act 1968” substitute “ regulation 214 or 215 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M14 S.R. (NI) 2005 No 161.

Children's Homes Regulations (Northern Ireland) 2005 U.K.

116.  In regulation 20(4)(b) of the Children's Homes Regulations (Northern Ireland) 2005 M15 , for “section 58 of the Medicines Act 1968” substitute “ regulations 214 or 215 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M15 S.R. (NI) 2005 No 176.

Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006 U.K.

117.  In regulation 3(1) of the Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006 M16 in the definition “Pharmacist” for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M16 S.R. (NI) 2006 No 478.

Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007 U.K.

118.  In regulation 71(3)(a) of the Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007 M17 , for “section 8(2) of the Medicines Act 1968” substitute “ regulation 17 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M17 S.R. (NI) 2007 No 68.

Day Care Setting Regulations (Northern Ireland) 2007 U.K.

119.  In regulation 13(6)(b) of the Day Care Setting Regulations (Northern Ireland) 2007 M18 for “section 58 of the Medicines Act 1968” substitute “ regulations 214 or 215 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M18 S.R. (NI) 2007 No 234.

Residential Family Centres Regulations (Northern Ireland) 2007 U.K.

120.  In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern Ireland) 2007 M19 for “section 58 of the Medicines Act 1968” substitute “ regulations 214 or 215 of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M19 S.R. (NI) 2007 No 236.

Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007 U.K.

121.  In regulation 3(1)(a) of the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007 M20 for “the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M20 S.R. (NI) 2007 No 420.

Specified Animal Pathogens Order (Northern Ireland) 2008 U.K.

122.  In article 5(2)(b) of the Specified Animal Pathogens Order (Northern Ireland) 2008 M21 for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M21 S.R. (NI) 2008 No 336.

Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 U.K.

123.  In regulation 2(2) of the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 M22 , in the definition “retail pharmacy business” for “section 132 of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M22 S.R. (NI) 2009 No 225.

Private Water Supplies Regulations (Northern Ireland) 2009 U.K.

124.  In regulation 4(b) of the Private Water Supplies Regulations (Northern Ireland) 2009 M23 for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”. U.K.

Marginal Citations

M23 S.R. (NI) 2009 No 413.