The Human Medicines Regulations 2012

Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

; and

• (b) add the entry—

Human Medicines Regulations 2012, in relation to Part 7 (traditional herbal registrations) of those Regulations

Single Use Carrier Bags Charge (Wales) Regulations 2010

101

In Schedule 1(3) to the Single Use Carrier Bags Charge (Wales) Regulations 2010 —

• (a) in the definition “EEA health professional” for the words from “1(2)” to the end of the definition substitute “ 213(1) of the Human Medicines Regulations 2012 ”;

• (b) in the definition “pharmacy medicine” for the words from “means” to the end of the definition substitute “ has the meaning given in regulation 5(5) of the Human Medicines Regulations 2012 ”;

• (c) in the definition “prescription only medicine” for the words from “means” to the end of the definition substitute “ has the meaning given in regulation 5(3) of the Human Medicines Regulations 2012 ”; and

• (d) in the definition beginning “supplementary prescriber” for “article 1(2) of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

PART 6 — Northern 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 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 —

• (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 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 , 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 , 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 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 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 —

• (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 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 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 , 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 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 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 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 , 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 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 , 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 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 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 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 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 , 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 for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

SCHEDULE 35 — Repeals and revocations

Enactment or instrument	Extent of repeal or revocation
Medicines Act 1968 (c. 67)	Sections 2A to 9. Section 10(7). Sections 11 to 14. Section 15(1) and (2). Sections 16 to 57. Section 58(1A), (2) and (3). Sections 59 to 61. Sections 65 and 66. Section 67(3A), (5) and (6). Section 68. Sections 85 and 86. Section 89. Section 91(1). Sections 92 to 103. Section 108(3) to (5) and (7). Section 109(3). Section 110(3). Section 111(3). Section 112(7). Sections 115 and 116. Section 126(4). Section 130(2) to (8) and (10). Section 132(2), (3) and (5). Schedules 1A and 2. In Schedule 3, paragraphs 5 to 7.
Medicines (Extension to Antimicrobial Substances) Order 1973 (S.I. 1973/367)	The whole Order.
Medicines (Specified Articles and Substances) Order 1976 (S.I. 1976/968)	The whole Order.
Medicines (Fluted Bottles) Regulations 1978 (S.I. 1978/40)	The whole of the Regulations.
Medicines (Medicines Act 1968 Amendment) Regulations 1983 (S.I. 1983/1724)	The whole of the Regulations.
Medicines (Products Other than Veterinary Drugs) (General Sale List) Amendment Order 1990 (S.I. 1990/1129)	The whole Order.
Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 (S.I. 1992/605)	The whole of the Regulations.
Medicines Act 1968 (Amendment) Regulations 1993 (S.I. 1993/834)	The whole of the Regulations.
Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S.I. 1994/105)	The whole of the Regulations.
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994 (S.I. 1994/899)	The whole of the Regulations.
Medicines (Advertising) Regulations 1994 (S.I. 1994/1932)	The whole of the Regulations.
Medicines (Monitoring of Advertising) Regulations 1994 (S.I. 1994/1933)	The whole of the Regulations.
Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144)	The whole of the Regulations.
Medicines Act 1968 (Amendment) Regulations 1995 (S.I. 1995/2321)	The whole of the Regulations.
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996 (S.I. 1996/482)	The whole of the Regulations.
Prescription Only Medicines (Human Use) Order 1997 (S.I. 1997/1830)	The whole of the Order except articles 1(1) to (5), 5 and 10 and Schedules 1 and 2.
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 1998 (S.I. 1998/3105)	The whole of the Regulations.
Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/267)	The whole of the Regulations.
Medicines (Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/784)	The whole of the Regulations.
Medicines (Codification Amendments Etc.) Regulations 2002 (S.I. 2002/236)	The whole of the Regulations
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003 (S.I. 2003/1618)	The whole of the Regulations.
Medicines (Child Safety) Regulations 2003 (S.I. 2003/2317)	The whole of the Regulations.
Medicines (Advertising) Amendment Regulations 2004 (S.I. 2004/1480)	The whole of the Regulations.
Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765)	The whole Order.
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/768)	The whole of the Regulations.
Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094)	The whole of the Regulations except paragraph 12(1), (4) and (5) of Schedule 1, and regulation 8 as it relates to those paragraphs.
Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1520)	The whole of the Regulations.
Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1710)	The whole of the Regulations.
Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750)	The whole of the Regulations except paragraph 8(a)(i) and (b) of Schedule 7, and regulation 12 as it relates to those paragraphs.
Medicines (Advisory Bodies) (No 2) Regulations 2005 (S.I. 2005/2754)	The whole of the Regulations, except Schedule 3, and regulation 4 as it relates to that Schedule, and paragraphs 3 and 7(1) and (3) of Schedule 4, and regulation 5 as it relates to those paragraphs.
Medicines (Advertising Amendments) Regulations 2005 (S.I. 2005/2787)	The whole of the Regulations.
Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789)	The whole of the Regulations.
Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006 (S.I. 2006/395)	The whole of the Regulations.
Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 (S.I. 2006/1952)	The whole of the Regulations.
Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 (S.I. 2008/1692)	The whole of the Regulations.
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (S.I. 2008/3097)	The whole of the Regulations.
Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 (S.I. 2009/1164)	The whole of the Regulations, except regulation 3.
Medicines (Exemptions and Miscellaneous Amendments) Order 2009 (S.I. 2009/3062)	The whole Order.
Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)	The whole of the Regulations.

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State — 2012-07-09

Edwin Poots — Minister for Health, Social Services and Public Safety — 2012-07-19

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c,51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).

[^f00002]: S.I. 1972/1811.

[^f00003]: S.I. 1999/2027.

[^f00004]: 1968 c.67.

[^f00005]: Section 10(1) was amended by paragraph 10(a) of Part 1 of Schedule 8 to S.I. 2006/2407, paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001, and article 3 of S.I. 1971/1445. Section 10(2) was repealed by paragraph 10(b) and (3)(b) was repealed by paragraph 10(c) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(4) was amended and section 10(5) and (6) inserted by article 3 of S.I. 1971/1445. Section 10(6A) was repealed by paragraph 10(d) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(7) was inserted by article 3 of S.I. 1971/1445, and amended by regulation 3 of S.I. 1993/834. Section 10(7A) to (7C) was inserted by the Health Act 2006 section 26(1), and section 10(7A) was amended by paragraph 10(e) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(8) was inserted by S.I. 1971/1445 article 3. Section 10(9) was inserted by paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001.

[^f00006]: OJ No L 311, 28.11.2001, p.67. Directive 2001/83/EC was last amended by Directive 2010/84/EU (OJ No L 348, 31.12.2010, p.74).

[^f00007]: 2006 c.41.

[^f00008]: S.I. 1972/1265 (N.I. 14).

[^f00009]: 2009 c.1 (N.I.).

[^f00010]: 2006 c.42.

[^f00011]: 1978 c.29.

[^f00012]: OJ No L 121, 1.5.2001, p.34. Directive 2001/20/EC was last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14).

[^f00013]: S.I. 2004/1031, to which there are amendments not relevant to these Regulations.

[^f00014]: 1984 c.24. Section 14 was substituted by the Dentists Act 1984 (Amendment) Order 2005 (S.I. 2005/2011) articles 2 and 6 and further amended by the European Qualifications (Health and Social Care Professions) Regulations 2007 (S.I. 2007/3101), regulations 109 and 111. Other amendments of the Dentists Act are not relevant to these Regulations.

[^f00015]: OJ No L 33, 8.2.2003, p. 30.

[^f00016]: OJ No L 102, 7.4.2004, p. 48.

[^f00017]: 2003 c.21.

[^f00018]: OJ L 91, 30.3.2004, p.25.

[^f00019]: S.I. 2002/254, as amended by S.I. 2009/1182. There are other amendments that are not relevant.

[^f00020]: S.I. 2010/231.

[^f00021]: 1993 c.21. Section 41 was amended by S.I. 2007/3101 regulations 206 and 214.

[^f00022]: 1994 c.17.

[^f00023]: S.I. 2002/254. Relevant amendments were made by S.I. 2004/2033, S.I. 2009/1182, S.I. 2010/233 and the Health and the Social Care Act 2012 (2012 c.7).

[^f00024]: 1984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

[^f00025]: S.I. 2006/1440, Schedule.

[^f00026]: 2006 c.41.

[^f00027]: 2006 c.42.

[^f00028]: 1978 c.29. Concurrent functions under section 36(1) were transferred to the National Waiting Times Board by article 4(2)(c) and (4) of S.S.I. 2002/305.

[^f00029]: S.I. 1972/1265 (N.I. 14), as amended by S.I. 1984/1158 (N.I. 8), S.I. 1986/595 ( N.I. 4) and 2004/311 (N.I. 2).

[^f00030]: 1997 c.46.

[^f00031]: S.I. 1997/1177 (N.I. 7).

[^f00032]: OJ No L 378, 27.12.2006, p.1. Regulation (EC) No 1901/2006, as amended by Regulation (EC) No 1902/2006 (OJ No L 378, 27.12.2006, p.20) .

[^f00033]: S.I. 2010/231.

[^f00034]: S.I. 1976/1213 (N.I. 22), as amended by S.R. 2008 No. 192.

[^f00035]: S.I. 2002/253, as amended by S.I. 2009/1182.

[^f00036]: 1989 c.44; section 7(a) was amended by S.I. 2005/848, articles 2 and 7(1).

[^f00037]: Section 8B was inserted by S.I. 2007/3101, regulations 178 and 180.

[^f00038]: 1968 c.67. Sections 74A and 74J were inserted by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231.

[^f00039]: Section 75 was amended by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231

[^f00040]: OJ No L 136, 30.4.2004, p.1. Regulation (EC) No 726/2004 was last amended by Regulation (EU) No 1235/2010 (OJ No L348, 31.12.2010, p.1).

[^f00041]: OJ No L 324, 10.12.2007, p.121.

[^f00042]: OJ No L 334, 12.12.2008, p.7.

[^f00043]: OJ L 91, 30.3.2004, p.25.

[^f00044]: OJ No L 136, 30.4.2004, p. 34.

[^f00045]: OJ No L 15, 17.1.1987. p.38.

[^f00046]: S.I. 1978/1006, as amended by S.I. 1995/2147 and S.I. 2006/2806; there are other amendments not relevant to these Regulations.

[^f00047]: Article 16(4), second paragraph, of Regulation (EC) No 726/2004 (“the Regulation”) imposes an obligation identical to that set out in Article 23(4), second paragraph, of the 2001 Directive; Article 23(4), second paragraph, of the 2001 Directive is transposed at regulation 182(5).

[^f00048]: Article 20(8) of the Regulation applies Article 107i of the 2001 Directive, which in turn applies Articles 107j and 107k of the 2001 Directive; Article 107k(2) second paragraph is implemented in regulation 197(3).

[^f00049]: Article 21(1) of the Regulation, first paragraph, cross-refers to obligations set out in Article 104 of the 2001 Directive, implemented in regulation 182 and 185; Article 21(1), second paragraph, and 21(2) of the Regulation are similar in effect to Article 104a of the 2001 Directive, implemented in regulation 183.

[^f00050]: Article 22 of the Regulation cross-refers to obligations set out in Article 106a(1) of the 2001 Directive; Article 106a(1) is implemented in regulation 205.

[^f00051]: Article 28(1) and (2) of the Regulation cross-refers to obligations set out in Articles 107, 107a, 107b and 107c of the 2001 Directive; those Articles are implemented in regulations 185, 186, 187, 188, 191, 192 and 193; Article 28(5) of the Regulation applies Articles 107e to 107g of the 2001 Directive; Article 107g of the 2001 Directive is implemented in regulation 194.

[^f00052]: Article 28a(3) of the Regulation imposes an obligation identical to that set out in the first sentence of Article 107h(3) of the 2001 Directive; Article 107h(3) first sentence is implemented in regulation 190.

[^f00053]: Article 28b(1) of the Regulation cross-refers to prohibitions and obligations set out in Articles 107m, 107n, 107o, 107p and 107q of the 2001 Directive; those Articles are implemented in regulations 198, 199, 200, 201 and 202; Article 107n(1) and the first paragraph of Article 107n(3), implemented in regulation 199(2) and (6), are excluded as they are enforced otherwise than by way of criminal offence.

[^f00054]: 1978 c.29. Section 10(1) was amended by the Health Services Act 1980 (1980 c.53), Schedule 6 paragraph 2. There are other amendments not relevant to these Regulations.

[^f00055]: S.I. 2001/3998. Schedule 1 has been amended by S.I. 2005/1653, 2009/3136, 2010/1144 and 1799. Schedule 2 has been amended by S.I. 2003/1432 and 2009/3136. Schedule 3 has been amended by S.I. 2007/2154.

[^f00056]: S.R. 2002 No. 1. Schedule 1 has been amended by S.R. 2005 No. 360 and S.R. 2010 Nos. 148 and 247. Schedule 2 has been amended by S.R. 2003 No. 314 and S.R. 2009 No. 390. Schedule 3 has been amended by S.R. 2007 No. 348.

[^f00057]: 1984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

[^f00058]: OJ No L 255, 30.9.2005, p.22, as last amended by Commission Regulation (EU) No 213/2011 (OJ No L 59, 4.3.2011, p.4).

[^f00059]: 2006 c.41.

[^f00060]: 2006 c.42.

[^f00061]: 1978 c.29. Section 2(1)(a) was amended by section 28(a)(i) of the National Health Service and Community Care Act 1990 (1990 c.19) and section 14(2) of, and paragraph 1 of Schedule 7 to, the Health and Social Services and Social Security Adjudications Act 1983 (1983 c.41).

[^f00062]: 2009 c.1 (N.I.).

[^f00063]: S.I. 1972/1265 (N.I. 14).

[^f00064]: 2004 c.17.

[^f00065]: 1983 c.20.

[^f00066]: 2000 c.14.

[^f00067]: 1978 c.29. Section 10F was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

[^f00068]: S.I. 2003/431 (N.I. 9).

[^f00069]: 1978 c.29. Section 12A was inserted by section 31 of the National Health Service and Community Care Act 1990 (1990 c.19), and amended by section 46(1)(a) of the Health Act 1999 (1999 c.8).

[^f00070]: S.I. 1991/194 (N.I. 1), Health and Social Services trusts were renamed Health and Social Care trusts by section 1(3) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)). There are other amendments not relevant to this regulation.

[^f00071]: References to a nursing home in these Regulations concern Northern Ireland only.

[^f00072]: 1952 c.52.

[^f00073]: 1989 c.45.

[^f00074]: 1953 c.18 (N.I.). Functions transferred by article 6(1) of, and Schedule 4 to, S.I. 2010/976.

[^f00075]: 1989 c.44; section 7 was amended by S.I. 2005/848, articles 2 and 7(1).

[^f00076]: Section 8B was inserted by S.I. 2007/3101, regulations 178 and 180.

[^f00077]: 2008 c.14.

[^f00078]: 1978 c.29. Section 10P was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

[^f00079]: Section 2(1)(b) was inserted by section 28(a) of the National Health Service and Community Care Act 1990 (1990 c.19).

[^f00080]: S.I. 1990/247 (N.I. 3). Special Health and Social Services Agencies were renamed Special Health and Social Care Agencies by section 1(4) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)).

[^f00081]: 1998 c.29.

[^f00082]: 1978 c.29.

[^f00083]: 2008 c.14.

[^f00084]: Regulated activities for the purposes of section 10 are defined in section 8 of that Act and set out in regulation 3 of, and Schedule 1 to, S.I. 2010/781.

[^f00085]: 2008 No. 1976 (W. 185).

[^f00086]: S.I. 2000/1059, as amended by S.I. 2006/2523.

[^f00087]: S.I. 1978/1006.

[^f00088]: S.S.I. 2004/115

[^f00089]: S.R. (NI) 2004 No. 140.

[^f00090]: OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

[^f00091]: 2003 c.21.

[^f00092]: 2003 c.21.

[^f00093]: 1990 c.42.

[^f00094]: 1996 c.55.

[^f00095]: Section 56(1) was amended by section 406(7) of and Schedule 19(1) to the Communications Act 2003.

[^f00096]: 1994 c.39. There is an amendment to section 2(1) that is not relevant to this regulation.

[^f00097]: 1972 c.9 (N.I.).

[^f00098]: 1990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

[^f00099]: 1991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

[^f00100]: 2000 c.36.

[^f00101]: 1995 c. 46.

[^f00102]: 1987 c.43. Section 2(4) was repealed in relation to England and Wales by S.I. 2000/2771 article 2(1) and (3) and in relation to Scotland by S.S.I. 2001/265 article 2(1) and (3).

[^f00103]: S.I. 1987/2049 (N.I. 20), as amended by 2001 c.13 (NI).

[^f00104]: OJ No L 348, 31.12.2010, p.74.

[^f00105]: S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696 and S.I. 2006/915 and these Regulations. There are other amendments, but none is relevant.

[^f00106]: OJ No L 38, 9.2.2006, p. 40.

[^f00107]: OJ No L 294, 25.10.2006, p. 32.

[^f00108]: OJ No L 91, 30.3.2004, p. 25, as amended by Commission Directive 2011/38/EU, OJ No L 94, 12.4.2011, p. 28.

[^f00109]: OJ No L 147, 9.6.1975, p.13, no longer in force.

[^f00110]: OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

[^f00111]: OJ No L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p. 14).

[^f00112]: OJ No L 334, 12.12.2008, p.7.

[^f00113]: OJ No L 15, 17.1.1987. p.38.

[^f00114]: 1996 c.16.

[^f00115]: 1967 c.77.

[^f00116]: 1990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

[^f00117]: 1991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

[^f00118]: 1990 c.16.

[^f00119]: 1989 No. 846 (N.I. 6).

[^f00120]: 2006 c. 41.

[^f00121]: 1978 c. 29.

[^f00122]: 2006 c. 42.

[^f00123]: S.I. 1972/1265 (N.I. 14).

[^f00124]: S.I. 2001/3998, to which there are amendments that are not relevant.

[^f00125]: S.R. 2002 No. 1, to which there are amendments that are not relevant.

[^f00126]: S.I. 2001/3998 as amended by S.I. 2007/2154. There are other amendments that are not relevant.

[^f00127]: S.R. 2002 No. 1, as amended by S.R. 2007 No. 348. There are other amendments that are not relevant.

[^f00128]: 1970 c.40: subsection (1) was amended by section 272(1) of and Schedule 30 to the Local Government Act 1972; section 16 of and Schedule 8 paragraph 15 to the Local Government Act 1985, and section 66(6) and (8) of, and Schedule 16 paragraph 38(5) and Schedule 18 to the Local Government (Wales) Act 1994. Subsection (1A) was inserted by section 66(6) of and Schedule 16 paragraph 38(5) to that Act. Subsection 2 was substituted by section 180(1) of and Schedule 13 paragraph 85(2) to the Local Government etc (Scotland) Act 1994, and subsection (7) was repealed by sections 1(1) and 194 of, and Schedule 1 paragraph 8 and Schedule 34 Part 1 to the Local Government, Planning and Land Act 1980.

[^f00129]: 1967 c.80.

[^f00130]: S.I. 1994/3144, as amended by S.I. 2004/3224 and S.I. 2005/2759. There are other amendments to those regulations that are not relevant to this paragraph..

[^f00131]: S.I. 1976/1726, as amended by S.I. 1977/996 and 2168, S.I. 1978/41 and 1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558 and 2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 and 3144, S.I. 2002/236, S.I. 2004/1031 and S.I. 2005/2745 and 2753.

[^f00132]: S.I. 1977/1055, as amended by S.I. 1992/3274, 1994/104 and 3144, and 2005/2753..

[^f00133]: Section 28(3) was amended by Schedule 1 to the Animal Health and Welfare Act 1984 (1984 c.40), regulation 4(5) of S.I. 1977/1050, regulation 2(2) of S.I. 1975/1169, regulation 6(2) of S.I. 1994/276, regulation 2(a)(iii) of S.I. 2002/236 and paragraph 14 of Schedule 8 to S.I. 2006/2407.

[^f00134]: S.I. 1975/1326, as amended by S.I. 1979/1760 and S.I. 1994/1932.

[^f00135]: S.I. 1976/1726, as amended by S.I. 1977/996, S.I. 1977/2168, S.I. 1978/41, S.I. 1978/1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558, S.I. 1985/2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 S.I. 1994/3144, S.I. 2002/236, S.I. 2004/1031, S.I. 2005/2745 and S.I. 2005/2753.

[^f00136]: S.I. 1977/1055, as amended by S.I. 1992/3274, S.I. 1994/104, S.I. 1994/3144, and S.I. 2005/2753.

[^f00137]: S.I. 1978/41, as amended by S.I. 2004/1771.

[^f00138]: S.I. 2010/1882.

[^f00139]: S.I. 1978/1006, as amended by S.I. 1995/2147, S.I. 2005/2754. S.I. 2006/2407 and S.I. 2006/2806.

[^f00140]: 1968 c.67. Schedule 1A was inserted by regulation 7(2) of S.I. 2005/1094.

[^f00141]: 1968, c.67. Section 10(1), 10(3) and 10(7A) were amended and 10(2) repealed by Part 1 paragraphs 1 and 10 of Schedule 8 to S.I. 2006/2407, section 10(1), 10(4) were amended and 10(5) to (7) and 10(8) inserted by article 3 of S.I. 1971/1445, section 10(1) was amended and section 10(9) inserted by paragraph 5 Schedule 1 to the Regulations of Care (Scotland) Act 2001, and section 10(7A) to (7C) were inserted by section 26(1) of the Health Act 2006.

[^f00142]: Section 15(3) was amended by paragraphs 1 and 11(b) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00143]: Section 58((1), (4) and (6) was amended by paragraph 29 of Part 1 of Schedule 8 to S.I. 2006/2407. Section 58(4) was amended by paragraph 2(b) of Schedule 5 to S.I. 2002/53. Section 58(4) was amended by section 63(1 and (4) of, and section 58(4A) and (4C) inserted by section 63(1) and (5) of, the Health and Social Care Act 2001.

[^f00144]: Section 58A was inserted by regulation 2 of S.I. 1992/3271, and the heading substituted by and subsection (1) amended by paragraph 30 Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00145]: Section 62(7) was substituted by paragraph 12(5) of Schedule 1 to S.I. 2005/1094.

[^f00146]: Section 67(1B) was inserted by section 63(7) of the Health and Social Care Act 2001, and section 67(3A) inserted and section 67(4) amended by paragraph 8 of Schedule 5 to S.I. 2005/2789

[^f00147]: Section 72(1)(c) was amended by paragraph 12(a) of Schedule 5 to the Adults with Incapacity (Scotland) Act 2000 and paragraph 14(a) of Schedule 6 to the Mental Capacity Act 2005, and section 72(4)(c) by paragraph 14(d) of Schedule 6 to the Mental Capacity Act 2005.

[^f00148]: S.I. 1986/594 (N.I. 4).

[^f00149]: Section 87(1) was amended by paragraph 44 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00150]: Section 88(1) was amended by paragraph 45 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00151]: Section 91(2) and (3) was amended by paragraph 48(b) and (c) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 91(2) was amended by section 32(2) of the Magistrates’ Courts Act 1980.

[^f00152]: Section 108(2) was amended and 108(12) inserted by paragraph 8 of Schedule 3 to the Food Safety Act 1990, section 108(6A) to (6D) was inserted and section 108(9) and (10) amended by section 31(1) of the Health Act 2006, section 108(9) was amended by paragraph 56(c), section 108(10) by paragraph 56(d) and section 108(11) by paragraph 56(e) of Part 1 of Schedule 8 to S.I. 2006/2407, and section . 108(12) was amended by paragraph 33 of Schedule 16 to the Local Government (Wales) Act 1994.

[^f00153]: Section 109(2)(c) was repealed by paragraph 9(a) of Schedule 3 to the Food Safety Act 1990, and section 109(2)(d) was repealed by paragraph 57 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00154]: Section 110(1) was amended by paragraph 58(a) and section 110(5)(a) was amended by paragraph 58(c)(i) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 110(3A) and (3B) were inserted by section 31(3)(b) and section 110(5)(a) amended by section 31(3)(c) of the Health Act 2006. In relation to Northern Ireland,

[^f00155]: The amendments in paragraph 19(b)(iii) and (iv), (f) and (g) reproduce amendments already made with effect in Northern Ireland by article 2 and the Schedule to S.R. (NI) 1973 No 211.

[^f00156]: 1972 c. 9 (N.I.).

[^f00157]: Section 111(1)(aa) was inserted by paragraph 9 of Schedule 5 to S.I. 2005/2789.

[^f00158]: Section 121(4) was amended by paragraph 61 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00159]: Section 122(2) was amended by paragraph 62 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00160]: Section 125(4) was amended by paragraph 63 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00161]: Section 126(3) was amended by paragraph 64(c) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00162]: Section 129(2) was amended by paragraph 65(a) of and section 129(3) was amended by paragraph 65(b) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00163]: Section 130(1) was amended by paragraph 66(a) of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00164]: Section 131(5) was amended by paragraphs 43 and 44 of Schedule 1 to the National Health Service (Consequential Provisions) Act 2006, paragraph 30 of Schedule 16 to the National Health Service (Scotland) Act 1978 and paragraph 128(2) of Schedule 4 to the National Health Service Reorganisation Act 1973.

[^f00165]: Paragraph 17 of Schedule 3 was amended by paragraph 66 of Part 1 of Schedule 8 to S.I. 2006/2407.

[^f00166]: Paragraphs 2 to 5, 7 and 9(b) and (c) and following words of Schedule 4 were omitted by paragraphs 69(a), (c) and (e)(iii) and (iv) of Part 1 of Schedule 8 to S.I. 2006/2407. Paragraph 6 was amended by paragraph 69(b), paragraph 8 by paragraph 69(d), paragraph 9 by paragraph 69(e) and paragraph 10 by paragraph 69(f) of that Part.

[^f00167]: 1971 c.69.

[^f00168]: 1968 c.29. Paragraph (b) of section 2(5) was inserted by paragraph 16 of Schedule 5 to the Medicines Act 1968.

[^f00169]: 1975 c.24.

[^f00170]: 1975 c.25.

[^f00171]: 1987 c.43. Section 19(1) was amended by paragraph 7 of Part 1 of Schedule 9 to S.I. 2006/2407; there are other amendments to that subsection, but none is relevant.

[^f00172]: 1990 c.43. Section 142(7) was amended by paragraph 8 of Schedule 4 to the Radioactive Substances Act 1993 (1993 c.12), in relation to England and Wales by paragraph 5(1) and (12) of Part 1 of Schedule 26 to S.I. 2010/675, and by paragraph 8 of Part 1 of Schedule 9 to S.I. 2006/2407.

[^f00173]: 1994 c.23. In Part II of Schedule 8, note (2B) to Group 12 was inserted by S.I. 2009/2972, and note (11)(a) to Group 15 was amended by paragraph 10(a), and (11)(d) inserted by paragraph 10(b), of Schedule 9 to S.I. 2006/2407.

[^f00174]: 1999 c.8. Subsection (2A) was inserted by paragraph 1 of Schedule 8 to the Health and Social Care Act 2008 (2008 c.14).

[^f00175]: 2003 c.21. Section 368R was inserted by regulation 2 of S.I. 2009/2979.

[^f00176]: 2007 asp 13.

[^f00177]: S.I. 1972/1265 (N.I. 14). Article 57D was inserted by article 4 of the Primary Medical Services (Northern Ireland) Order 2004 (S.I. 2004/311 (N.I. 2))

[^f00178]: S.I. 1976/1213 (N.I. 22).

[^f00179]: S.I. 1976/1214 (N.I. 23).

[^f00180]: S.I. 1981/1115 (N.I. 22).

[^f00181]: S.I. 1997/2778 (N.I. 19). Article 33(6) was amended by S.R. (NI) 2006 No 45.

[^f00182]: S.I. 1997/2779 (N.I. 20).

[^f00183]: S.I. 2004/1031, as amended by S.I. 2005/2754. There are other amendments, but none is relevant.

[^f00184]: S.I. 1978/1006, as amended by S.I. 1995/2147 and S.I. 2006/2407. There are other amendments, but none is relevant.

[^f00185]: S.I. 1980/14, as amended by S.I. 1994/2920, S.I. 1994/3142 and S.I. 1994/3144.

[^f00186]: S.I. 1986/1700. There are amendments, but none is relevant.

[^f00187]: S.I. 1986/1761, as amended by S.I. 2006/2407. There are other amendments, but none is relevant.

[^f00188]: S.I. 1989/684, as amended by S.I. 1995/871, S.I. 2004/1031 and S.I. 2005/2754. There are other amendments, but none is relevant.

[^f00189]: S.I. 1995/449

[^f00190]: S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696, and S.I. 2006/915. There are other amendments, but none is relevant.

[^f00191]: S.I. 1999/3267, as amended by S.I. 2005/1476. There are other amendments, but none is relevant.

[^f00192]: S.I. 2000/620, as amended by S.I. 2000/3189 and S.I. 2009/1166. There are other amendments, but none is relevant.

[^f00193]: S.I. 2001/880, as amended by S.I. 2010/745. There are other amendments, but none is relevant.

[^f00194]: S.I. 2001/1841, as amended by S.I. 2005/2750 and S.I. 2008/548.

[^f00195]: S.I. 2001/3998, as amended by S.I. 2003/2429, S.I. 2005/271, S.I. 2006/986, S.I. 2006/1450, S.I. 2007/2154 and 2012/973. There are other amendments, but none is relevant.

[^f00196]: S.I. 2002/3170, as amended by S.I. 2005/2750 and S.I. 2008/548.

[^f00197]: S.I. 2003/1076, as amended by S.I. 2005/2061. There are other amendments, but none is relevant.

[^f00198]: S.I. 2003/1374. There are amendments, but none is relevant.

[^f00199]: S.I. 2003/1376. There are amendments, but none is relevant.

[^f00200]: S.I. 2003/1571, as amended by S.I. 2006/1996. There are other amendments, but none is relevant.

[^f00201]: S.I. 2003/1680, as amended by S.I. 2004/3224, S.I. 2005/2750 and S.I. 2005/2754.

[^f00202]: S.S.I. 2004/115, as amended by S.S.I. 2005/337. There are other amendments, but none is relevant.

[^f00203]: S.S.I. 2004/116, as amended by S.S.I. 2005/336. There are other amendments, but none is relevant.

[^f00204]: S.I. 2004/291, as amended by S.I. 2005/893. There are other amendments, but none is relevant.

[^f00205]: S.I. 2004/478, as amended by S.I. 2006/358 and S.I. 2010/1647. There are other amendments, but none is relevant.

[^f00206]: S.I. 2004/627, as amended by S.I 2005/893. There are other amendments, but none is relevant.

[^f00207]: S.I. 2004/1022, as amended by S.I 2005/366 and S.I. 2009/1977. There are other amendments, but none is relevant.

[^f00208]: S.I. 2004/1975.

[^f00209]: S.I. 2005/1478, as amended by S.I. 2008/1940. There are other amendments, but none is relevant.

[^f00210]: S.I. 2007/121, as amended by S.I. 2009/1175 and S.I. 2010/1647. There are other amendments, but none is relevant.

[^f00211]: S.I. 2007/1523.

[^f00212]: S.I. 2007/3544, as amended by S.I. 2009/2981. There are other amendments, but none is relevant.

[^f00213]: S.I. 2008/548.

[^f00214]: S.I. 2008/944. There are amendments, but none is relevant.

[^f00215]: S.I. 2008/1270. There are amendments, but none is relevant.

[^f00216]: S.I. 2008/3258. There are amendments, but none is relevant.

[^f00217]: S.S.I. 2009/45. There are amendments, but none is relevant.

[^f00218]: S.S.I. 2009/183.

[^f00219]: S.I. 2009/669. There are amendments, but none is relevant.

[^f00220]: S.I. 2010/2880. There are amendments, but none is relevant.

[^f00221]: S.R. (NI) 1987 No 414, as amended by S.R. (NI) 1997 No 469.

[^f00222]: S.R. (NI) 1995 No 8, as amended by S.R. (NI) 2009 No 429. There are other amendments, but none is relevant.

[^f00223]: S.R. (NI) 1996 No 81.

[^f00224]: S.R. (NI) 1997 No 381, as amended by S.R. (NI) 1999 No 405. There are other amendments, but none is relevant.

[^f00225]: S.R. (NI) 1998 No 28.

[^f00226]: S.R. (NI) 1998 No 45, as amended by S.R. (NI) 2011 No 124.

[^f00227]: S.R. (NI) 1999 No 433.

[^f00228]: S.R. (NI) 2001 No 422.

[^f00229]: 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.

[^f00230]: S.R. (NI) 2003 No 34.

[^f00231]: S.R. (NI) 2003 No 493.

[^f00232]: S.R. (NI) 2004 No 140, as amended by S.R. (NI) 2005 No 368.

[^f00233]: S.R. (NI) 2005 No 160.

[^f00234]: S.R. (NI) 2005 No 161.

[^f00235]: S.R. (NI) 2005 No 176.

[^f00236]: S.R. (NI) 2006 No 478.

[^f00237]: S.R. (NI) 2007 No 68.

[^f00238]: S.R. (NI) 2007 No 234.

[^f00239]: S.R. (NI) 2007 No 236.

[^f00240]: S.R. (NI) 2007 No 420.

[^f00241]: S.R. (NI) 2008 No 336.

[^f00242]: S.R. (NI) 2009 No 225.

[^f00243]: S.R. (NI) 2009 No 413.

Terms of appointment

Facilities and proceedings

Payment and expenses

Status

Manufacturer's licences

Manufacturers' licence relating to import

Wholesale dealer's licences

All licences

Application of this Schedule

Appointment of reviewers

Procedure before hearing

Procedure at hearing

Procedure following hearing

The summary of the product characteristics must contain the following information in the following order—

• (23) For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the statement “This medicinal product is subject to additional monitoring”.

• (24) The name of the medicinal product followed by its strength and pharmaceutical form.

• (25) The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of—

• (a) the active substances; and

• (b) those excipients of which knowledge is essential for proper administration of the medicinal product.

• (26) The pharmaceutical form of the medicinal product.

• (27) Clinical particulars in relation to the medicinal product, covering—

• (a) therapeutic indications;

• (b) posology and method of administration for adults and, where necessary, for children;

• (c) contra-indications;

• (d) special warnings and precautions for use and, in the case of immunological medicinal products any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient;

• (e) interaction with other medicinal products and other forms of interactions;

• (f) use during pregnancy and lactation;

• (g) effects on ability to drive and to use machines;

• (h) other undesirable effects; and

• (i) information on overdose (including symptoms, emergency procedures and antidotes).

• (28) The pharmacological properties of the medicinal product, covering—

• (a) pharmacodynamic properties;

• (b) pharmacokinetic properties; and

• (c) pre-clinical safety data.

• (29) Pharmaceutical particulars in relation to the medicinal product, covering—

• (a) a list of excipients;

• (b) major incompatibilities;

• (c) shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

• (d) special precautions for storage;

• (e) nature and contents of container; and

• (f) special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

• (30) The holder of the UK marketing authorisation.

• (31) The number of the UK marketing authorisation.

• (32) The date of the first UK marketing authorisation or, where the UK marketing authorisation has been renewed, the date of the last renewal.

• (33) The date of any revisions of the text of the summary of the product characteristics.

• (34) For radiopharmaceuticals, full details of internal radiation dosimetry.

• (35) For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.

Meaning of “national homoeopathic product”

General requirements for application

Requirement to submit safety data

Exceptions to requirement to submit safety data

Requirement to submit efficacy data

The summary of the product characteristics must contain the following information in the following order—

• (21) For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the statement “This medicinal product is subject to additional monitoring”.

• (22) The name of the medicinal product followed by its strength and pharmaceutical form.

• (23) The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of—

• (a) the active substances; and

• (b) those excipients of which knowledge is essential for proper administration of the medicinal product.

• (24) The pharmaceutical form of the medicinal product.

• (25) The pharmacological properties of the medicinal product, covering—

• (a) pharmacodynamic properties;

• (b) pharmacokinetic properties; and

• (c) pre-clinical safety data.

• (26) Pharmaceutical particulars of the medicinal product, covering—

• (a) a list of excipients;

• (b) major incompatibilities;

• (c) shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

• (d) special precautions for storage;

• (e) nature and contents of the container; and

• (f) special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

• (27) The holder of the traditional herbal registration.

• (28) The number of the traditional herbal registration.

• (29) The date of the first traditional herbal registration or, where the traditional herbal registration has been renewed, the date of the last renewal.

• (30) The date of any revisions of the text of the summary of the product characteristics.

• Co-danthramer Capsules NPF

• Co-danthramer Capsules Strong NPF

• Co-danthramer Oral Suspension NPF

• Co-danthramer Oral Suspension Strong NPF

• Co-danthrusate Capsules

• Co-danthrusate Oral Suspension NPF

• Mebendazole Tablets NPF

• Mebendazole Oral Suspension NPF

• Miconazole Oral Gel NPF

• Nystatin Oral Suspension

• Nystatin Pastilles NPF

• Streptokinase and Streptodornase Topical Powder NPF

• Water for injections

• In this Schedule “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.

A clinical management plan must contain the following particulars—

• (a) the name of the patient to whom the plan relates;

• (b) the illnesses or conditions which may be treated by the supplementary prescriber;

• (c) the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan;