The Human Medicines Regulations 2012

PART 6Northern Ireland statutory rules

Control of Pesticides Regulations (Northern Ireland) 1987

102.  For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern Ireland) 1987(1) substitute—

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

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

103.  In rule 4 of the Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995(2)—

(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”.

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

104.  In the Schedule to the Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996(3) for “Medicines Act 1968” substitute “Human Medicines Regulations 2012”.

Pharmaceutical Services Regulations (Northern Ireland) 1997

105.  In Part 2 of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997(4), in paragraph 2(12) for the words from “Articles” to the end of the paragraph substitute regulation 224 of the Human Medicines Regulations 2012”.

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

106.  In Schedule 1, Chapter 4, Section 4.8, Part C of the Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998(5), 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”.

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

107.  The Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998(6) are amended as follows—

(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”.

Importation of Animal Pathogens Order (Northern Ireland) 1999

108.  In article 5(a) of the Importation of Animal Pathogens Order (Northern Ireland) 1999(7) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “the Human Medicines Regulations 2012”.

Biocidal Products Regulations (Northern Ireland) 2001

109.  In Schedule 2 to the Biocidal Products Regulations (Northern Ireland) 2001(8)—

(a)omit entry (f); and

(b)for entry (i) substitute—

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

Misuse of Drugs Regulations (Northern Ireland) 2002

110.—(1) The Misuse of Drugs Regulations (Northern Ireland) 2002(9) are amended as follows.

(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.”.

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

111.  In regulation 5(2)(c) of the Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003(10) for “section 58 of the Medicines Act 1968” substitute “regulation 214 of the Human Medicines Regulations 2012”.

Waste Management Licensing Regulations (Northern Ireland) 2003

112.  In paragraph 2 of Schedule 1 to the Waste Management Licensing Regulations (Northern Ireland) 2003(11), 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”.

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

113.—(1) The Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004(12) are amended as follows.

(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”.

Nursing Homes Regulations (Northern Ireland) 2005

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

Residential Care Homes Regulations (Northern Ireland) 2005

115.  In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland) 2005(14) for “section 58 of the Medicines Act 1968” substitute “regulation 214 or 215 of the Human Medicines Regulations 2012”.

Children’s Homes Regulations (Northern Ireland) 2005

116.  In regulation 20(4)(b) of the Children’s Homes Regulations (Northern Ireland) 2005(15), for “section 58 of the Medicines Act 1968” substitute “regulations 214 or 215 of the Human Medicines Regulations 2012”.

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

117.  In regulation 3(1) of the Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006(16) in the definition “Pharmacist” for “the Medicines Act 1968” substitute “the Human Medicines Regulations 2012”.

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

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

Day Care Setting Regulations (Northern Ireland) 2007

119.  In regulation 13(6)(b) of the Day Care Setting Regulations (Northern Ireland) 2007(18) for “section 58 of the Medicines Act 1968” substitute “regulations 214 or 215 of the Human Medicines Regulations 2012”.

Residential Family Centres Regulations (Northern Ireland) 2007

120.  In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern Ireland) 2007(19) for “section 58 of the Medicines Act 1968” substitute “regulations 214 or 215 of the Human Medicines Regulations 2012”.

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

121.  In regulation 3(1)(a) of the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007(20) for “the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994” substitute “the Human Medicines Regulations 2012”.

Specified Animal Pathogens Order (Northern Ireland) 2008

122.  In article 5(2)(b) of the Specified Animal Pathogens Order (Northern Ireland) 2008(21) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “the Human Medicines Regulations 2012”.

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

123.  In regulation 2(2) of the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009(22), in the definition “retail pharmacy business” for “section 132 of the Medicines Act 1968” substitute “regulation 8(1) of the Human Medicines Regulations 2012”.

Private Water Supplies Regulations (Northern Ireland) 2009

124.  In regulation 4(b) of the Private Water Supplies Regulations (Northern Ireland) 2009(23) for “the Medicines Act 1968” substitute “the Human Medicines Regulations 2012”.