Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles 4

Reform history JSON API

If a sample consists of substances or articles in unopened containers, the sampling officer may divide the sample into parts by dividing the containers into three lots without opening them if it appears to the sampling officer that—

(a) it is not reasonably practicable to open the containers and divide the contents into parts; or

(b) opening the containers and dividing the contents into parts might affect the composition or impede the analysis or other examination of the contents.

12

Regulation 343(1)(a) to (d) has effect in relation to supplying a part of a sample in pursuance of the preceding paragraphs as it has effect in relation to the service of a document.

13

If after reasonable inquiry the sampling officer is unable to ascertain the name of a person to whom, or the address at which, a part of a sample should be supplied, the sampling officer may retain that part of the sample.

Notice to person named on container

14

(1) This paragraph applies where the sampling officer has obtained a sample of a substance or article and it appears to the sampling officer that—

(a) the substance or article was manufactured in the United Kingdom by a person (“M”) whose name and address in the United Kingdom are stated on its container or packaging; and

(b) M is not a person to whom a part of the sample must be supplied under the preceding provisions of this Schedule.

(2) Unless the sampling officer decides not to submit the sample for analysis or other examination, the sampling officer must give notice to M—

(a) stating that the sample has been obtained; and

(b) specifying the person from whom the sampling officer purchased it or, if it was obtained otherwise than by purchase, the place from which the sampling officer obtained it.

(3) Notice under sub-paragraph (2) must be given to M within the period of three days beginning immediately after the day on which the sample was obtained.

Analysis or other examination

15

Where the enforcing authority that authorises the sampling officer is the Secretary of State or the Minister for Health, Social Services and Public Safety, if the sampling officer decides to submit the sample for analysis the officer must do so—

(a) to a medicines control laboratory; or

(b) to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

16

Where any other enforcing authority authorises the sampling officer, if the sampling officer decides to submit the sample for analysis the officer must do so to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

17

(1) Arrangements of the kind mentioned in paragraphs 15(b) and 16 made by an enforcement authority in England, Wales or Scotland other than the Secretary of State must be approved by the Secretary of State.

(2) Arrangements of the kind mentioned in paragraph 15(b) made by a district council in Northern Ireland must be approved by the Minister for Health, Social Services and Public Safety.

18

A laboratory to which a sample is submitted under paragraph 15 or 16 must analyse or examine the sample as soon as practicable,

19

A laboratory that has analysed or examined a sample submitted under the preceding provisions of this Schedule must issue and send to the sampling officer a certificate specifying the result of the analysis or examination.

20

A person to whom a part of the sample is to be supplied in accordance with paragraphs 2 to 8 is entitled, on payment of the required fee, to be given a copy of any certificate as to the result of an analysis or examination which is sent to the sampling officer under paragraph 19.

Provisions as to evidence

21

(1) In proceedings for an offence under these Regulations, a document produced by one of the parties to the proceedings and purporting to be a certificate issued under paragraph 19 is to be sufficient evidence of the facts stated in the document unless sub-paragraph (2) applies.

(2) A party to proceedings, other than the party who produced the document mentioned in paragraph (1), may require that the person who issued the certificate be called as a witness.

(3) In proceedings in Scotland, if the person who issued the certificate is called as a witness, that person's evidence is to be sufficient evidence of the facts stated in the certificate.

22

In proceedings for an offence under these Regulations, a document produced by one of the parties to the proceedings which has been supplied by another party to the proceedings as a copy of a certificate issued under paragraph 19 is to be sufficient evidence of the facts stated in the document.

23

(1) If, in proceedings before a magistrates' court for an offence under these Regulations, a defendant intends to produce a certificate issued under paragraph 19, or to require that the person by whom a certificate was issued be called as a witness, the defendant must give notice of that intention and (where a certificate is to be produced) a copy of the certificate to the other party at least three clear days before the day on which the summons is returnable.

(2) If sub-paragraph (1) is not complied with the court may adjourn the hearing on such terms as it thinks fit.

(3) In Scotland, if in proceedings in the sheriff court for an offence under these Regulations the accused intends to produce a certificate under paragraph 19, or to require that the person by whom a certificate was issued be called as a witness, the accused must give notice of that intention and (where a certificate is to be produced) a copy of the certificate to the procurator fiscal at least three clear days before the day on which the case proceeds to trial.

(4) If sub-paragraph (3) is not complied with the sheriff may adjourn the diet on such terms as the sheriff thinks fit.

Analysis under direction of court

24

(1) This paragraph applies where proceedings for an offence under these Regulations relate to a substance or article of which a sample has been taken as mentioned in paragraph 1 of this Schedule.

(2) Where this paragraph applies, the part of the sample retained in pursuance of paragraph 10(a) is to be produced as evidence.

(3) The court must, if requested by a party to the proceedings, and may, in the absence of such a request, cause that part of the sample to be sent for analysis to the Government Chemist (or, in Northern Ireland, to the Government Chemist in Northern Ireland) or to be sent for other examination to a laboratory specified by the court.

(4) If, in a case where an appeal is brought, no action has been taken under sub-paragraph (3), that sub-paragraph applies to the court by which the appeal is heard.

(5) A person or laboratory to whom or to which a part of a sample is sent under this paragraph for analysis or other examination must—

(a) analyse or examine it; and

(b) issue and give to the court a certificate specifying the results of the analysis or examination.

(6) A certificate under sub-paragraph (5)(b) is to be evidence (and, in Scotland, is to be sufficient evidence) of the facts stated in the certificate unless a party to the proceedings requires that the person by whom it was issued be called as a witness.

(7) In Scotland, if the person by whom a certificate is issued is called as a witness that person's evidence is sufficient evidence of the facts stated in the certificate.

25

The costs of analysis or examination under paragraph 24 are to be paid by the prosecutor or the defendant (or, in Scotland, the accused) as the court may order.

Proof by written statement

26

(1) In relation to England and Wales section 9 of the Criminal Justice Act 1967 does not have effect with respect to a document produced as mentioned in paragraph 21 or 22, or with respect to any certificate transmitted to a court under paragraph 24.

(2) In relation to Northern Ireland any enactment corresponding to section 9 of the Criminal Justice Act 1967 does not have effect with respect to a document produced as mentioned in paragraph 21 or 22, or with respect to any certificate transmitted to a court under paragraph 24.

Payment for sample taken under compulsory powers

27

(1) Where a sampling officer takes a sample in the exercise of a power conferred by regulation 327, the officer must, if payment is required, pay the value of the sample to the person to whom a part of the sample is required to be supplied under paragraph 5, 7 or 8 (as the case may be) of this Schedule.

(2) If the sampling officer and the person mentioned in sub-paragraph (1) are unable to agree, the value of the sample is to be determined—

(a) by the arbitration of a single arbitrator appointed by the sampling officer and the other person in question; or

(b) if they are unable to agree on an arbitrator, by the county court for the district (or in Northern Ireland the division) in which the sample was taken.

(3) In the application of this paragraph to Scotland for references to the county court there is to be substituted a reference to the sheriff.

SCHEDULE 32 — Transitional provisions and savings

Continuity of the law

1

(1) This paragraph applies where any provision of these Regulations re-enacts (with or without modification) an enactment or instrument repealed or revoked by these Regulations.

(2) The repeal and re-enactment do not affect the continuity of the law.

(3) Anything done, or having effect as if done, under or for the purposes of the repealed provision that could have been done under or for the purposes of the corresponding provision of these Regulations, if in force or effective immediately before the commencement of that corresponding provision, has effect thereafter as if done under or for the purposes of that corresponding provision.

(4) Any reference (express or implied) in these Regulations or any other enactment, instrument or document to a provision of these Regulations is to be construed (so far as the context permits) as including, as respects times, circumstances or purposes in relation to which the corresponding repealed provision had effect, a reference to that corresponding provision.

(5) Any reference (express or implied) in any enactment, instrument or document to a repealed provision is to be construed (so far as the context permits), as respects times, circumstances and purposes in relation to which the corresponding provision of these Regulations has effect, as being or (according to the context) including a reference to the corresponding provision of these Regulations.

(6) This paragraph has effect subject to any specific transitional provision or saving in this Schedule.

Product licences

2

(1) This paragraph applies to a marketing authorisation that—

(a) became a marketing authorisation on 1st January 1995 by virtue of paragraph 1 of Schedule 6 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (conversion of existing product licences); and

(b) by virtue of paragraph 1 of this Schedule, has effect from the coming into force of these Regulations as a marketing authorisation granted under these Regulations.

(2) The following provisions do not apply in relation to the marketing authorisation—

(a) regulation 68(7) (revocation etc of marketing authorisation because the holder has ceased to be established in the EU); and

(b) regulation 258 (packaging requirements: specific provisions).

(3) Paragraph (4) applies if the marketing authorisation has not been renewed in the period beginning with 1st January 1995 and ending when these Regulations come into force.

(4) The Medicines (Labelling) Regulations 1976 and the Medicines (Leaflets) Regulations 1977 (and subsequent regulations amending those regulations) in so far as they relate to medicinal products continue to have effect in relation to the product to which the marketing authorisation relates until the marketing authorisation is renewed.

Product licences of right

3

(1) This paragraph applies to a product licence of right.

(2) In this paragraph, “product licence of right” means a licence of right within the meaning of section 25(4) of the Medicines Act 1968 that—

(a) has been issued in relation to the requirements to hold a product licence contained in section 7(2) of that Act; and

(b) is in force immediately before the coming into force of these Regulations.

(3) A product licence of right shall continue in force, subject to the following sub-paragraphs.

(4) Parts 4 to 11, 13 and 14 of these Regulations shall not apply in relation to a medicinal product that is the subject of a product licence of right, except as provided in the following sub-paragraphs.

(5) A medicinal product to which a product licence of right relates shall—

(a) continue to be classified as a prescription only medicine, a medicinal product not subject to general sale, or a medicinal product subject to general sale, as the case may be, in accordance with the provisions of the Medicines Act 1968 and any statutory instrument made under that Act that was in force immediately before the coming into force of these regulations; and

(b) shall be treated as a prescription only medicine, a pharmacy medicine not subject to general sale, or a medicine subject to general sale respectively, as the case may be, for the purposes of Part 12 of these Regulations.

(6) The provisions listed in sub-paragraph (7), and any provisions to which they refer, shall continue to have effect as they did immediately before the coming into force of these Regulations in relation to a product licence of right and to the product to which it relates.

(7) Those provisions are—

(a) section 28(1), (2) and (3)(a) to (e) and (g) to (j) (general power to suspend, revoke or vary licences) of the Medicines Act 1968 ;

(b) the Medicines (Advertising of Medicinal Products) (No. 2) Regulations 1975 ;

(d) the Medicines (Leaflets) Regulations 1977 ; and

(e) the Medicines (Labelling and Advertising to the Public) Regulations 1978 .

(8) Part 1 of Schedule 11 (advice and representations) shall have effect where the licensing authority proposes to exercise any power conferred by section 28 of the Medicines Act referred to in sub-paragraph 7(a) in relation to a product licence of right, as if that proposal concerned the suspension, revocation or variation of a UK marketing authorisation, certificate of registration or traditional herbal registration under these Regulations.

(9) Without prejudice to any requirement of Part 1 of Schedule 11 as to the service of notices, where in the exercise of any such power the licensing authority suspends, revokes or varies a product licence of right, it must serve a notice on the holder a notice giving particulars of the suspension, revocation or variation and of the reasons for its decision to suspend, vary or revoke the product licence of right.

(10) Regulations 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons) and 271 (offences: penalties) shall have effect in relation to the provisions in sub-paragraph (7)(d) as if—

(a) references to the holder of a marketing authorisation included reference to the holder of a product licence of right; and

(b) the provisions in sub-paragraph (7)(d) were requirements of Part 13.

(11) A product licence of right shall cease to be in force at the same time that a marketing authorisation, certificate of registration or traditional herbal registration is granted in respect of the product to which the product licence of right relates.

Classification of UK marketing authorisation and certificate of registration

4

(1) Sub-paragraph (3) applies to a UK marketing authorisation granted before 1st April 2002 if—

(a) the authorisation contains a statement that the product to which the authorisation relates is to be available on one or more of the bases set out in paragraph (2); or

(b) the product to which the authorisation relates is to be available on one or more of the bases set out in paragraph (2) by virtue of any enactment in force immediately before the coming into force of these Regulations.

(2) Those bases are that the product is to be available—

(a) only on prescription;

(b) only from a pharmacy; or

(3) It is a condition of the UK marketing authorisation that the product is only to be available on that basis or those bases.

Advanced therapy medicinal products

5

No provision of these Regulations that applies only to advanced therapy medicinal products shall apply until 30th December 2012 to advanced therapy medicinal products which—

(a) are tissue engineered products; and

(b) were legally on the market in the United Kingdom in accordance with United Kingdom or European Union legislation on 30th December 2008.

Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)

6

Regulation 9 (amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004) of the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 remains in force.

Section 60 of the Medicines Act 1968 etc

7

(1) Section 60 of the Medicines Act 1968 (“the Act”) shall continue to have effect insofar as it relates to the making of, and continued operation of, the Medicines (Administration of Radioactive Substances) Regulations 1978 (“the 1978 Regulations”).

(2) The following provisions of the Act shall continue to have effect as they did immediately before the coming into force of these Regulations in relation to the following provisions of the 1978 Regulations—

(a) section 22A(2) to (9) and 10(b) (hearing before person appointed) of the Act, in relation to regulation 7 (hearings and written representations) of the 1978 Regulations;

(b) section 67(2) and (4) (offences under Part III) of the Act, as they relate to section 60 of the Act, in relation to regulation 8 (application of provisions of the Act) of the 1978 Regulations; and

(c) paragraphs 7, 8, 9(3) and 10 to 12 of Schedule 1A (provisions relating to Commission and committees) to the Act , in relation to the committee established under regulation 3 (advisory committee) of the 1978 Regulations.

SCHEDULE 33 — Transitional arrangements: pharmacovigilance

Pharmacovigilance system master file

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Post-authorisation safety studies

3

Regulations 198, 199, 200, 201 and 202 (provisions relating to post authorisation safety studies) do not apply to post authorisation safety studies commenced before 21st July 2012.

4

Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004) does not apply to post authorisation safety studies commenced before 21stJuly 2012.

Reporting obligations

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Periodic safety update reports

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 34 — Amendments to existing law

PART 1 — The Medicines Acts 1968 and 1971

1

The Medicines Act 1968 is amended as follows.

2

For the text of section 1 (Ministers responsible for the administration of Act) substitute—

(1) In this Act, “the Ministers” has the meaning given by regulation 6(6) to (8) of the 2012 Regulations (but as if references in that regulation to those Regulations were references to this Act).

3

In section 10 (exemptions for pharmacists)—

(a) in subsection (1) for “a practitioner” substitute “ an appropriate practitioner ”;

(b) in subsections (1) and (4) for “sections 7 and 8 of this Act” substitute “ regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations ”;

(d) in subsection (6) for “section 8(2) of this Act” substitute “ regulation 17(1) of the 2012 Regulations ”;

(e) omit subsection (7); and

(f) in subsection (8) for the words from “section 92” to the end of the subsection substitute “ regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations ”.

4

In section 15 (provision for extending or modifying exemptions)—

(a) omit subsections (1) and (2); and

(b) in subsection (3) for “sections 9 to 14” substitute “ section 10 ”.

5

In section 58 (medicinal products on prescription only)—

(a) in subsection (1) for the words from the first occurrence of “for the purposes” to the end of the subsection substitute “ as prescription only medicines ”;

(b) omit subsections (1A), (2) and (3);

(c) in the opening words of subsection (4) for “the last preceding subsection” substitute “ regulation 223(1) of the 2012 Regulations ”;

(d) in subsection (4)(a)—

(i) for “paragraph (a) or paragraph (b) of subsection (2) of this section, or both those paragraphs,” substitute “ regulation 214(1) or (2) of the 2012 Regulations ”, and

(ii) for the words from “or, where” to “of this section” substitute “ or, in the case of an appropriate practitioner, other than a doctor or dentist, ”;

(e) in subsection (4)(b) for “paragraph (a) of that subsection” substitute “ regulation 214(1) of the 2012 Regulations ”;

(f) in subsection (4A) for “a person who is an appropriate practitioner by virtue of subsection (1)(d) or (e)” substitute “ an appropriate practitioner, other than a doctor or dentist ”;

(g) in subsection (4C) for “subsection (2)(a) or (b) of this section” substitute “ regulation 214(1) or (2) of the 2012 Regulations ”; and

(h) after subsection (6) insert—

(7) In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of— (a) the Commission; or (b) an expert committee appointed by the Ministers, or by one of them acting alone.

6

In section 58A(1) (requirement to specify certain products as prescription-only products)—

(a) omit paragraphs (a) and (b) and the word “and” following paragraph (b); and

(b) for the words following paragraph (c) to the end of the subsection substitute “is specified as a prescription only medicine”.

7

In section 62 (prohibition of sale or supply, or importation, of medicinal products of specified description), after subsection (7) add—

(8) In this section “the appropriate committee” means whichever the Ministers consider appropriate of— (a) the Commission; or (b) an expert committee appointed by the Ministers, or by one of them acting alone.

8

In section 64(5) (protection for purchasers of medicinal products) for “a practitioner” substitute “ an appropriate practitioner ”.

9

(1) Section 67 (offences under Part III) is amended as follows.

(2) In subsection (1B)(a) for “by virtue of provision made under section 58(1) of this Act” substitute “ within the meaning of regulation 214 of the 2012 Regulations ”;

(3) in subsection (2)—

(a) for “52, 58, 63, 64 and 65”, substitute “ 63 and 64 ”; and

(b) omit “any regulations made under section 60 or section 61 or”.

(4) Omit subsection (3A).

(5) In subsection (4) for “subsection (1A), (1B), (2), (3) or (3A)” substitute “ subsection (1A), (1B), (2) or (3) ”.

(6) Omit subsections (5) and (6).

10

In section 72 (representative of pharmacist in case of death or disability)—

(a) in paragraph (1)(c) , for the words from “a committee” to the end of paragraph (c) substitute “a controller is appointed in his case under the Mental Health (Northern Ireland) Order 1986 ”; and

(b) in paragraph (4)(c) for “committee” substitute “ controller ”.

11

In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical Society” substitute—

(a) in the first place it appears, “General Pharmaceutical Council or, in Northern Ireland, the Pharmaceutical Society of Northern Ireland”; and

(b) in the second place it appears, “Council or the Society”.

12

In section 87 (requirements as to containers)—

(a) in subsection (1) for “section 85(2) of this Act” substitute “ subsection (3) ”; and

(b) after subsection (2) insert—

(3) The purposes mentioned in subsection (1) are— (a) securing that medicinal products are correctly described and readily identifiable; (b) securing that any appropriate warning or other appropriate instruction or information is given, and that false or misleading information is not given, with respect to medicinal products; (c) promoting safety in relation to medicinal products.

13

In section 88(1) (distinctive colours, shapes and markings of medicinal products) for “section 85(2)” substitute “ section 87(3) ”.

14

In section 91 (offences under Part V, and supplementary provisions)—

(a) omit subsection (1);

(b) in subsection (2) omit “section 85(3), section 86(2) or”; and

15

In section 104 (application of Act to certain articles and substances)—

(a) in the heading to the section for “Act” substitute “ the 2012 Regulations ”; and

(b) in paragraph (1) for “this Act” substitute “ the 2012 Regulations ”.

16

In section 105 (application of Act to certain other substances which are not medicinal products)—

(a) in the heading to the section for “Act” substitute “ the 2012 Regulations ”; and

(b) in paragraph (1) for “this Act” substitute “ the 2012 Regulations ”.

17

In section 107 (validity of decisions and proceedings relating thereto)—

(a) in subsection (1)—

(i) omit “of the licensing authority under Part II of this Act or”, and

(ii) for “licence or certificate granted or issued” substitute “ certificate issued ”;

(b) in subsection (4)—

(i) for “grant a licence or certificate” substitute “ issue a certificate ”,

(ii) for “licence or certificate granted” substitute “ certificate issued ”, and

(iii) for “grant of the licence or” substitute “ issue of the ”;

18

(1) Section 108 (enforcement in England and Wales) is amended as follows.

(2) In subsection (2)—

(a) in paragraph (a) for the words from “sections 64” to “and 89(2)” substitute “ section 64 and sections 87(2) and 88(3) ”;

(b) omit paragraphs (b) and (c); and

(i) for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”,

(ii) for “the Society” substitute “ the Council ”,

(iii) for “that Society” substitute “ that Council ”

(iv) for “paragraphs (a) and (b)” substitute “ paragraph (a) ”,

(v) for “those paragraphs” substitute “ that paragraph ”, and

(vi) omit the words from “, and the provisions” to the end of the subsection.

(3) Omit subsections (3) to (5).

(4) In subsection (6)—

(a) for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”;

(b) omit paragraph (a); and

(5) In subsections (6A) and (6B) for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”.

(6) Omit subsection (7).

(7) In subsection (9) for “(7)” substitute “ (6D) ”.

(8) In subsection (10)—

(i) for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”, and

(ii) for the words from “or any” to “that duty” substitute “ has in relation to any matter failed to perform a duty imposed on it by subsections (6A) or (6B) to enforce any provisions mentioned in those subsections ”.

(9) In subsection (12) for paragraphs (a) and (b) substitute—

(a) in relation to an area in England other than the City of London, the council of a non-metropolitan county, metropolitan district or London borough; (b) in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London; and (c) in relation to an area in Wales, the council of a county or county borough.

19

In section 109 (enforcement in Scotland)—

(a) in subsection (2)—

(i) for the words from “(2)” to “(10)” substitute “ (2), (6) to (6D), (9) and (10) ”, and

(ii) in paragraph (a) omit the words from “or” to “jointly”; and

(b) omit subsection (3).

20

In section 110 (enforcement in Northern Ireland)—

(a) in subsection (1), for “Minister of Health and Social Services for Northern Ireland” substitute “ Minister for Health, Social Services and Public Safety ”;

(b) in subsection (2)—

(i) for “paragraphs (a) and (b)” substitute “ paragraph (a) ” in both places where it occurs,

(ii) for the words from “those paragraphs” to “subsection” substitute “ that paragraph ”,

(iii) for “area” substitute “ district ” ,

(iv) for “health authority” in both places where it occurs substitute “ district council ”,

(v) omit the words “and the provisions and regulations specified in the said paragraph (c)”;

(d) in subsections (3A) and (3B), after “the Pharmaceutical Society” insert “ of Northern Ireland ”;

(e) in subsection (5)—

(i) for “Subsections (9) and (10)” substitute “ Subsection (9) ”,

(ii) in paragraph (a) for “(2) to (7)” substitute “ (2) to (6D) ”, and

(iii) omit paragraph (b) and the word “and” preceding that paragraph;

(f) omit subsections (6) and (7); and

(g) for subsection (8) substitute—

(8) In this section “district council” means a council established under the Local Government Act (Northern Ireland) 1972 .

21

In section 111 (rights of entry)—

(a) in subsection (1) omit paragraph (aa) except for the word “or”;

(b) in subsection (2) omit paragraph (a);

(d) in subsection (6) omit—

(i) “aircraft,” in both places where it occurs, and

(ii) “, commander”; and

(e) for subsection (9) substitute—

(9) References in this section to a justice of the peace— (a) in relation to England, include a reference to a district judge (magistrates' courts); (b) in relation to Scotland, are to be read as references to a sheriff, stipendiary magistrate or justice of the peace, and (c) in relation to Northern Ireland, are to be read as references to a lay magistrate or a district judge (magistrates' courts).

22

In section 113(1) (application of sampling procedure to substance or article seized under section 112), omit the words from “(including” to the end of the subsection.

23

In section 114(1) (supplementary provisions as to rights of entry and related rights), omit—

(a) “aircraft,” in both places where it occurs; and

(b) “, commander”.

24

In section 121(4) (contravention due to default of other person), for the words from “63” to “96” substitute “ 63, 64, 87 and 88 ”.

25

In section 122(2) (warranty as defence), for the words “section 63(b), sections 64 and 65, sections 85 to 88” substitute “ sections 63(b), 64, 87 and 88 ”.

26

In section 123(1)(b) (offences in relation to warranties and certificates of analysis), omit “section 115 of this Act, or under”.

27

In section 125 (prosecutions)—

(a) in subsection (4)—

(i) for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”, and

(ii) for “that Society” substitute “ the Council ”;

(b) in subsections (6) and (7) for “Minister of Health and Social Services for Northern Ireland” substitute “ Minister for Health, Social Services and Public Safety ”.

28

In section 126 (presumptions)—

(a) in subsection (1), omit paragraph (b) and the word “or” following it;

(b) in subsection (3), omit “subsections (3) and (5) of section 85,”; and

29

In section 128 (financial provisions)—

(a) in subsection (1), for the words from “any of” to “section 1(1) of this Act” substitute “ either of the Ministers ”;

(b) in subsections (4) and (5), for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council or (as the case may be) the Pharmaceutical Society of Northern Ireland ”;

(d) in subsection (6), for the words from “any of the Ministers” to “Ireland” substitute “ the Secretary of State ”.

30

In section 129 (orders and regulations)—

(a) in subsection (2), omit the words from “or any regulations” to “section 120 of this Act”;

(b) in subsection (3)—

(i) in paragraph (a), for the words from “13” to “and 130(5)(c)” substitute “ 58, 62, 79 and 106 ”, and

(ii) omit paragraph (b);

(d) in subsection (7)—

(i) omit “Part V or Part VI”, and

(ii) for the words “a committee established under section 4 of this Act” substitute “ an expert committee appointed by themselves, or by one of them acting alone ”.

31

In section 130 (meaning of medicinal product and related expressions)—

(a) for subsection (1) substitute—

(1) In this Act, “medicinal product” has the meaning given by regulation 2 of the 2012 Regulations.

; and

(b) omit subsections (2) to (8) and (10).

32

In section 131(5) (meaning of “wholesale dealing”, “retail sale” and related expressions) for “or the Health and Personal Social Services (Northern Ireland) Order1972” substitute “ , the Health and Personal Social Services (Northern Ireland) Order 1972 or the Health and Social Care (Reform) Act (Northern Ireland) 2009 ”.

33

In section 132 (general interpretation provisions)—

(a) for subsection (1) substitute—

(1) In this Act— (a) unless the context otherwise requires, any expression defined by any provision of the 2012 Regulations, and not defined in this Act, has the same meaning as it has for the purposes of those Regulations; and (b) “the 2012 Regulations” means the Human Medicines Regulations 2012.

(b) omit subsections (2) and (3);

(d) omit subsection (5).

34

In Schedule 3 (sampling)—

(a) omit paragraphs 5 to 7;

(b) in paragraph 8 for “3 to 7” substitute “ 3 or 4 ”;

(d) in paragraph 17, in the words following paragraph (c)—

(i) for the words “a health authority” substitute “ the Pharmaceutical Society of Northern Ireland ”, and

(ii) for “the Minister of Health and Social Services for Northern Ireland” substitute “ the Minister for Health, Social Services and Public Safety ”.

35

In Schedule 4 (provisions relating to Northern Ireland)—

(a) for every reference to “the Minister of Health and Social Services for Northern Ireland” substitute “ the Minister for Health, Social Services and Public Safety ”;

(b) in paragraph 6 omit the words from “(except” to “Act)”;

(d) in paragraph 10 for “the Ministry of Health and Social Services for Northern Ireland” substitute “ the Department of Health, Social Services and Public Safety ”.

Medicines Act 1971

36

(1) The Medicines Act 1971 shall have effect as follows.

(2) In section 1 (fees)—

(a) in subsection (1), the reference to any application in pursuance of the Medicines Act 1968 for a licence or certificate under Part II of that Act, or for the variation or renewal of such a licence or certificate, shall have effect as a reference to any application under Parts 3 to 8 of these Regulations for the grant, variation or renewal of—

(i) a manufacturer's licence,

(ii) a wholesale dealer's licence,

(iii) a marketing authorisation,

(iv) a certificate of registration,

(v) a traditional herbal registration, or

(vi) an Article 126a authorisation; and

(b) in subsection (2)(b), the reference to any licence or certificate under the Medicines Act 1968 shall have effect as a reference to a manufacturer's licence, a wholesale dealer's licence, a marketing authorisation, a certificate of registration, a traditional herbal registration, or an Article 126a authorisation under these Regulations.

(3) Paragraph (2) has effect in relation to references of the kind mentioned in that paragraph in regulations made under section 1.

PART 2 — Other primary legislation

Trade Descriptions Act 1968

37

In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act 1968 for the words from “made under Part V” to “that Act)” substitute “ of Chapter 1 of Part 13 of the Human Medicines Regulations 2012 ”.

House of Commons Disqualification Act 1975

38

In Part II (bodies of which all members are disqualified) of Schedule 1 to the House of Commons Disqualification Act 1975 for the entry for the Commission for Human Medicines and any committee established under section 4 of the Medicines Act 1968 substitute—

The Commission on Human Medicines.

Northern Ireland Assembly Disqualification Act 1975

39

In Part II (bodies of which all members are disqualified) of Schedule 1 to the Northern Ireland Assembly Disqualification Act 1975 for the entry for the Commission for Human Medicines and any committee established under section 4 of the Medicines Act 1968 substitute—

The Commission on Human Medicines.

Consumer Protection Act 1987

40

Section 19(1) (interpretation of Part II) of the Consumer Protection Act 1987 shall have effect as if, in the definition “licensed medicinal product”, the reference to any medicinal product within the meaning of the Medicines Act 1968, in respect of which a product licence within the meaning of that Act is for the time being in force, included a reference to a medicinal product, in respect of which a marketing authorisation or a traditional herbal registration within the meaning of these Regulations is for the time being in force.

Environmental Protection Act 1990

41

In section 142(7) (powers to obtain information about potentially hazardous substances) of the Environmental Protection Act 1990 , for the entry relating to the Medicines Act 1968 substitute “ Parts 3 to 8 and 16 of the Human Medicines Regulations 2012 ”.

Value Added Tax Act 1994

42

In Part II of Schedule 8 (zero-rating) to the Value Added Tax Act 1994 —

(a) in note (2B) to Group 12 (drugs, medicines, aids for the handicapped etc) for the words “article 1(2) of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”; and

(b) in note (11) to Group 15 (charities etc)—

(i) for paragraph (a) substitute—

(a) “medicinal product” has the meaning assigned to it by regulation 2(1) of the Human Medicines Regulations 2012;

, and

(ii) omit paragraphs (b) and (c).

Health Act 1999

43

In section 60(2A)(c) (regulation of health care and associated professions) of the Health Act 1999 , after “that Act” insert “ or the Human Medicines Regulations 2012 ”.

Communications Act 2003

44

In section 368R(1) (interpretation of Part 4A) of the Communications Act 2003 , for the definition “prescription-only medicine” substitute the following definition—

“prescription-only medicine” means a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations 2012;

Christmas Day and New Year's Day Trading (Scotland) Act 2007

45

In section 7 (interpretation) of the Christmas Day and New Year's Day Trading (Scotland) Act 2007 —

(a) omit the definition “appropriate person”; and

(b) for the definition “on prescription” substitute the following definition—

“on prescription” means in accordance with a prescription given by an appropriate practitioner, within the meaning of regulation 214(1) and (3) to (6) (sale or supply of prescription only medicines) of the Human Medicines Regulations 2012;

PART 3 — Northern Ireland Orders in Council

46

The Health and Personal Social Services (Northern Ireland) Order 1972 is amended as follows—

(a) in article 2(2), in the definition “pharmacist” for “Medicines Act 1968” substitute “ Human Medicines Regulations 2012 ”; and

(b) in article 57D—

(i) in paragraphs (3) and (5) for “Community” substitute “ EU ”, and

(ii) in paragraph (5) for “regulation 1 of the Medicines for Human Use (Marketing Authorisations etc Regulations 1997” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Pharmacy (Northern Ireland) Order 1976

47

In article 2(2) of the Pharmacy (Northern Ireland) Order 1976 , in the definition “retail pharmacy business” for “section 132(1) of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Poisons (Northern Ireland) Order 1976

48

In article 2(2) of the Pharmacy (Northern Ireland) Order 1976 —

(a) in the definition “pharmacist” after “Medicines Act” insert “ or the Human Medicines Regulations 2012 ”; and

(b) in the definition “retail pharmacy business” for “section 132(1) of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Diseases of Animals (Northern Ireland) Order 1981

49

In article 38 of the Diseases of Animals (Northern Ireland) Order 1981 in the definition “retail pharmacy business” for “section 132(1) of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Waste and Contaminated Land (Northern Ireland) Order 1997

50

In article 33(6) of the Waste and Contaminated Land (Northern Ireland) Order 1997 for the entry relating to the Medicines Act 1968 substitute “ Parts 3 to 8, 12 and 16 of the Human Medicines Regulations 2012 ”.

Shops (Sunday Trading &c.) (Northern Ireland) Order 1997

51

In article 4(3) of the Shops (Sunday Trading &c.) (Northern Ireland) Order 1997 for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

PART 4 — The Medicines for Human Use (Clinical Trials) Regulations 2004

52

The Medicines for Human Use (Clinical Trials) Regulations 2004 are amended as follows.

53

In regulation 2(1) (interpretation)—

(a) before the definition “the Act” insert the following definition—

“the 2012 Regulations” means the Human Medicines Regulations 2012;

(b) for the definition “appropriate committee” substitute—

“appropriate committee” for the purposes of any provision of these Regulations under which a function falls to be performed means whichever the licensing authority considers to be appropriate of— 1. the Commission on Human Medicines; or 2. an expert committee appointed by the licensing authority;

“the Commission on Human Medicines” means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;

(d) in the definition “licensing authority” for “section 6 of the Act” substitute “ regulation 6 of the 2012 Regulations ”;

(e) for sub-paragraph (a) of the definition “marketing authorisation” substitute—

(a) a UK marketing authorisation granted by the licensing authority under the 2012 Regulations,

; and

(f) for the definition “medicinal product” substitute—

“medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.

54

In regulation 4(3) (responsibility for functions under the Directive) for “the Act” substitute “ the 2012 Regulations ”.

55

In regulation 19(10) (authorisation procedure for clinical trials involving medicinal products for gene therapy etc) omit “established by section 2A of the Act”.

56

In regulation 46(2)(c) (labelling) for words from “Schedule 5” to the end of the sub-paragraph substitute “ Part 13 of the 2012 Regulations that apply in relation to medicinal products sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner within the meaning of regulation 214(3) to (6) of those Regulations ”.

57

In regulation 47 (application of enforcement provisions of the Act)—

(a) for “the Act” in the heading substitute “ the 2012 Regulations ”; and

(b) for paragraph (1) substitute—

(1) Regulations 2, 8(1), 322, 323(1), 324(1), 325 to 330, 332 to 339, 343 and Schedule 31 of the 2012 Regulations (“those provisions”) shall apply for the purposes of these Regulations as they apply for the purposes of the 2012 Regulations, but with the modifications specified in Schedule 9, and any reference in those provisions to the 2012 Regulations includes a reference to these Regulations.

; and

(3) In those provisions as applying by virtue of paragraph (1), any reference to, or relating to, a requirement, a power, a function, a right, a duty, an entitlement, or a protection shall be read as a reference to, or relating to, that requirement, power, function, right, duty, entitlement, or protection as applied by this regulation.

58

In regulation 48(5) (infringement notices) for “sections 108 to 110 of the Act” substitute “ regulation 323(1) or 324(1) of the 2012 Regulations ”.

59

In regulation 49(5) (offences) for “the Act” substitute “ the 2012 Regulations ”.

60

In regulation 53(3) (construction of references to specified publications) for “section 103(1) of the Act” substitute “ regulation 321(1) of the 2012 Regulations ”.

61

In paragraph 4(2) of Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials)—

(a) in sub-paragraph (a), for paragraphs (i) to (iii) substitute—

(i) the Commission on Human Medicines, (ii) an expert committee appointed by the licensing authority, (iii) an expert advisory group within the meaning of regulation 14 of the 2012 Regulations, (iv) the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees, (v) the Medicines Commission formerly established under section 2 of the Act, or any of its committees, (vi) the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or (vii) the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and

; and

(b) in sub-paragraph (b) after “Crown” insert “ , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister ”.

62

In Schedule 7 (standard provisions for manufacturing authorisations)—

(a) in Part 2—

(i) in paragraph 5 for “the Act” substitute “ the 2012 Regulations ”,

(ii) in paragraph 9 for “the Act or any regulations under the Act” substitute “ or the 2012 Regulations ”, and

(iii) in paragraph 13—

(aa) for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb) for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”; and

(b) in Part 3—

(i) in paragraph 6 for “the Act” in the first place where it occurs substitute “ the 2012 Regulations ”, and

(ii) in paragraph 8—

(aa) for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb) for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”.

63

In paragraph 5(2) of Schedule 8 (procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations)—

(a) in sub-paragraph (a), for paragraphs (i) to (iii) substitute—

(i) the Commission on Human Medicines, (ii) an expert committee appointed by the licensing authority, (iii) an expert advisory group within the meaning of regulation 14 of the 2012 Regulations, (iv) the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees, (v) the Medicines Commission formerly established under section 2 of the Act, or any of its committees, (vi) the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or (vii) the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and

; and

(b) in sub-paragraph (b) after “Crown” insert “ , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister ”.

64

For Schedule 9 substitute the following Schedule—

SCHEDULE 9 (1) The modifications of the 2012 Regulations mentioned in regulation 47 are as follows. (2) In regulation 2 (medicinal products)— (a) at the beginning of paragraph (1) insert “ Subject to paragraph (3), ”; and (b) after paragraph (2) insert the following paragraph— (3) “Medicinal product” includes any investigational medicinal product. (2) In regulation 8(1) (interpretation)— (a) the definition “assemble” is substituted by the definition of that expression in regulation 2(1) of these Regulations; and (b) there is inserted in the appropriate position in alphabetical order a definition “container” in the same terms as the definition of that expression in regulation 2(1) of these Regulations; and (c) the definition “qualified person” is substituted by the definition of that expression in regulation 2(1) of these Regulations. (3) In regulation 322(1) (validity of decisions and proceedings) omit “or” and insert a comma before “ 8 (Article 126a authorisations) ”, and after those words insert “ or the Clinical Trials Regulations ”. (4) In regulation 325(1) (rights of entry) insert after sub-paragraph (b) the following sub-paragraph— (ba) in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations; (5) (1) Regulation 327 (powers of inspection, sampling and seizure) is amended as follows. (2) In paragraph (1)— (a) after sub-paragraph (b) omit “; or”; (b) after sub-paragraph (c) insert “ ; or ” and the following sub-paragraph— (d) in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations. (3) After paragraph (2)(g) insert the following sub-paragraph— (h) information and documents relating to clinical trials (4) In paragraph (3)— (a) omit “or” following sub-paragraph (a); and (b) following paragraph (b) insert “ ; or ” and the following sub-paragraph— (c) a medicinal product used, or intended to be used, in a clinical trial (5) In paragraph (4)— (a) after “require” insert “ — (a) ”; and (b) after “control” insert “ ; or ” and the following sub-paragraph— (b) a person associated with a clinical trial to produce information or documents relating to the clinical trial which are in the person's possession or under the person's control (6) In paragraph (5)(a) for “(2)(f) or (g)” substitute “ (2)(f), (g) or (h) ”. (7) After paragraph (9) insert the following paragraph— (10) In this regulation, “a person associated with a clinical trial means any of the following— (a) the sponsor of a clinical trial (within the meaning of regulation 3 of the Clinical Trials Regulations); (b) any person who, under arrangements made with the sponsor of a clinical trial, carries out functions of the sponsor of the trial; (c) in investigator for a clinical trial (within the meaning of regulation 2(1) of the Clinical Trials Regulations); (d) any person, other than an investigator, who conducts a clinical trial; (e) any person occupying premises at which a clinical trial is being conducted; or (f) any person who, in the course of employment with a person listed in any of sub-paragraphs (a) to (e), undertakes activities in connection with a clinical trial. (8) In regulation 335(6) (contravention due to fault of another person) omit “and” after sub-paragraph (e) and after sub-paragraph (f) insert “ ; and ” and the following sub-paragraph— (g) any obligation or prohibition under the Clinical Trials Regulations (9) In regulation 336(3) (warranty as defence) omit “and” after sub-paragraph (c) and after sub-paragraph (d) insert “ ; and ” and the following sub-paragraph— (e) regulation 46 of the Clinical Trials Regulations (labelling)

PART 5 — Other United Kingdom, Scotland and Wales Secondary legislation

Medicines (Administration of Radioactive Substances) Regulations 1978

65

In regulation 8(1) of the Medicines (Administration of Radioactive Substances) Regulations 1978 —

(a) for “Section 6(2) of the Act” substitute “Regulation 6(3) of the Human Medicines Regulations 2012 (“the 2012 Regulations”); and

(b) for “by or under the Act” substitute “ by the 2012 Regulations ”.

Importation of Animal Products and Poultry Products Order 1980

66

In the Schedule to the Importation of Animal Products and Poultry Products Order 1980 , for “or the Medicines for Human Use (Marketing Authorisations Etc. Regulations) 1994” substitute “ or the Human Medicines Regulations 2012 ”.

Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986

67

In rule 2 of The Medicines Act (Hearings by Persons Appointed) Rules 1986 —

(a) in the definition “applicant” omit the words “a licence or certificate under Part II or a direction under section 47(6) (application for a direction concerning incorporation of standard conditions into a licence or certificate) or”;

(b) in the definition “person appointed” omit—

(i) sub-paragraphs (i), (ii), (iii), (v) and (vi), and

(ii) the words following sub-paragraph (vii), from “including” until the end of the definition; and

(i) omit sub-paragraph (i), and

(ii) in sub-paragraph (ii) for “the appropriate Ministers as defined in section 1(2)” substitute “ the Ministers as defined in regulation 6(6) and (7) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012 ”.

Medicines Act (Hearings by Persons Appointed) Rules 1986

68

In rule 2 of The Medicines Act (Hearings by Persons Appointed) Rules 1986 —

(a) in the definition “applicant” omit the words “a licence or certificate under Part II or a direction under section 47(6) (application for a direction concerning incorporation of standard conditions into a licence or certificate) or”;

(b) in the definition “person appointed” omit—

(i) sub-paragraphs (i), (ii), (iii), (v) and (vi), and

(ii) the words following sub-paragraph (vii), from “including” until the end of the definition; and

(i) omit sub-paragraph (i), and

(ii) in sub-paragraph (ii) for “section 1(1)” substitute “ regulation 6(6) and (7) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012 ”.

Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989

69

(1) The Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 is amended as follows.

(2) In article 1(2) insert after the definition “ the 1987 Act ” the following definition—

“the 2012 Regulations” means the Human Medicines Regulations 2012;

(3) In Schedule 1—

(a) in paragraph 1 omit “, II” and “, VI”;

(b) after paragraph 1 insert the following paragraph—

(1A) Functions of the Ministers under the 2012 Regulations (except those under Part 15 (British Pharmacopeia) of those Regulations), subject to paragraph 11 below.

(d) for paragraph 3 substitute—

(3) Functions of the Commission on Human Medicines, whose continuation is provided for in regulation 9 of the 2012 Regulations (except those under Part 15 (British Pharmacopoeia) of those Regulations).

(e) for paragraph 4 substitute—

(4) Functions of any expert committee appointed by the licensing authority under the 2012 Regulations.

(f) for paragraph 8 substitute—

(8) Functions of reviewers appointed under the 2012 Regulations.

(g) omit paragraphs 9A, 9C and 9D;

(h) in paragraph 10(c) for “and of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ and of the 2012 Regulations ” and

(i) in paragraph 11—

(i) after “Paragraphs 1” insert “ , 1A ”, and

(ii) after “under it” insert “ or under the 2012 Regulations ”.

Medical Devices (Consultation Requirements) (Fees) Regulations 1995

70

In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 —

(a) in the definition “authorised medicinal product”—

(i) in sub-paragraph (b) before “under” insert “ the Human Medicines Regulations 2012 or ”, and

(ii) in sub-paragraph (c) for “those” substitute “ the latter ”; and

(b) in the definition “product licence of right” for “section 25(4) of that Act” substitute “ paragraph 3(2) of Schedule 32 to the Human Medicines Regulations 2012 ”.

Prescription Only Medicines (Human Use) Order 1997

71

(1) The Prescription Only Medicines (Human Use) Order 1997 is amended as follows.

(2) In article 1—

(a) in paragraph (2) omit all the defined expressions except “inhaler” and “maximum strength”;

(b) for paragraph (2A) substitute—

(2A) In this Order, unless the context otherwise requires, any expression defined by any provision of the Human Medicines Regulations 2012 has the same meaning as it has for the purposes of those Regulations.

(d) omit paragraphs (6) to (9).

(3) In article 5(1) for the words from the beginning of the paragraph until sub-paragraph (a) substitute “A medicinal product that is not the subject of a marketing authorisation is a prescription only medicine for the purposes of the Human Medicines Regulations 2012 if it, or a substance in it, is listed in column 1 of Schedule 1, unless there”.

(4) In paragraphs (1) and (2) of article 10 for the words “The restrictions” to “administration of” substitute “ A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is ”.

General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999

72

In rule 7B(b) of the Schedule to the General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999 , for the words from “article” to the end of the paragraph substitute “ regulation 215 (prescribing and administration by supplementary prescribers) ” of the Human Medicines Regulations 2012.

National Health Service (Charges for Drugs and Appliances) Regulations 2000

73

The National Health Service (Charges for Drugs and Appliances) Regulations 2000 are amended as follows—

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) in regulation 6A(6) for the words from “the Medicines” to the end of the paragraph substitute “ the Human Medicines Regulations 2012 ”.

Biocidal Products Regulations 2001

74

In Schedule 2 to the Biocidal Products Regulations 2001 —

(a) omit entry (f); and

(b) for entry (i) substitute—

(i) the Human Medicines Regulations 2012;

Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001

75

In article 4(4) of the Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001 , for the words following “marketing authorisation” to the end of the paragraph substitute “ , certificate of registration, traditional herbal registration or Article 126a authorisation within the meaning of the Human Medicines Regulations 2012. ”

Misuse of Drugs Regulations 2001

76

In regulation 2(1) of the Misuse of Drugs Regulations 2001 —

(a) in the definitions “clinical management plan”, “nurse independent prescriber”, “patient group direction”, “pharmacist independent prescriber”, “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 definitions “pharmacist” and “registered pharmacy” for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

Medicines for Human Use (Kava-kava) (Prohibition Order) 2002

77

In paragraph (d) of article 3 of the Medicines for Human Use (Kava-kava) (Prohibition Order) 2002 , for the words following “subject” to the end of the article substitute “ of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation within the meaning of the Human Medicines Regulations 2012. ”.

Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003

78

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003

79

In the column “specified UK laws” of the Schedule to the Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003 for “the Medicines (Advertising) Regulations 1994” substitute “ Chapters 1 and 2 of Part 14 (advertising) of the Human Medicines Regulations 2012 ”.

Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003

80

In the Schedule to the Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003 —

(a) in the first column, insert in the appropriate position in alphabetical order “ Human Medicines Regulations 2012 ”;

(b) in the second column, insert adjacent to the entry “ Human Medicines Regulations 2012 ” in the first column “regulation 303 (advertising offences)”; and

(c) omit “Medicines (Advertising) Regulations 1994” in the first column and the adjacent entry “regulation 23 (offences)” in the second column.

Health Professions (Parts of and Entries in the Register) Order of Council 2003

81

In article 6 of the Health Professions (Parts of and Entries in the Register) Order of Council 2003 —

(a) for sub-paragraph (b) of paragraph (2), up to and including the word “analgesics”, substitute—

(b) referred to in the following provisions of Schedule 17 (exemption for sale, supply or administration by certain persons) to the Human Medicines Regulations 2012 — (i) in Part 1 (exemption from restrictions on sale or supply of prescription only medicines), paragraph 11 (certificate of competence in the use of specified medicines), or (ii) in Part 3 (exemptions from the restriction on administration of prescription only medicines), paragraph 1 (certificate in the use of analgesics),

; and

(b) in paragraph (3) for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”.

Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003

82

(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 (interpretation) are amended as follows.

(2) In regulation 1(2)—

(a) omit the following definitions—

(i) “the 1994 Regulations”, and

(ii) “herbal remedy”;

(b) before the definition of “the appropriate committee” insert—

“the 2012 Regulations” means the Human Medicines Regulations 2012;

“the appropriate committee” means whichever the appropriate Minister considers to be the appropriate body of the following— 1. the Commission; or 2. an expert committee appointed by the appropriate Minister, or by the appropriate Ministers for Great Britain and for Northern Ireland acting jointly;

(d) after the definition of “the appropriate Minister” insert—

“the Commission” means the Commission on Human Medicines continued in existence by regulation 9 of the 2012 Regulations;

(e) for the definition of “excluded medicine” substitute—

“excluded medicine” means a medicinal product to which the restrictions in regulation 46 (requirement for authorisation) of the 2012 Regulations do not apply by virtue of regulation 3(6) (scope of these Regulations: special provisions) or 4(1) (special provisions for pharmacies etc) of those Regulations;

(f) in the definition of “market” for the words from “have the same meaning” to the end substitute “ are to be construed in accordance with the 2012 Regulations; ”;

(g) for the definition of “medicinal product” substitute—

“medicinal product” has the meaning given by regulation 2 of the 2012 Regulations;

; and

(h) in the definition of “unlicensed product”—

(i) in paragraph (a)(i), for “the 1994 Regulations” substitute “ the 2012 Regulations ”,

(ii) omit paragraph (b) and the word “or” following it,

(iii) for paragraph (c) substitute—

(c) no traditional herbal registration has been granted by the licensing authority under the 2012 Regulations;

, and

(iv) after that paragraph insert the word “ or ” and the following paragraph —

(d) no Article 126a authorisation has been granted by the licensing authority under those regulations;

National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004

83

(1) The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 are amended as follows.

(2) In regulation 2(1)—

(a) omit the definition “the POM Order”; and

(b) in the definition “prescription only medicine” for the words from “article” to the end of the definition substitute “ regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012 ”.

(3) In paragraph 41(2)(a) of Schedule 5—

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

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

National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004

84

(1) The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 are amended as follows.

(2) In regulation 2(1)—

(a) omit the definition “the POM Order”; and

(b) in the definition “prescription only medicine” for the words from “article” to the end of the definition substitute “ regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012 ”.

(3) In paragraph 13(2)(a) of Schedule 1—

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

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

National Health Service (General Medical Services Contracts) Regulations 2004

85

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

National Health Service (General Medical Services Contracts) (Wales) Regulations 2004

86

(1) The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004 are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i) omit the definition “the POM Order”; and

(ii) in the definition “prescription only medicine” for the words from “article” to the end of the definition substitute “ regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012 ”; and

(b) in paragraph (3) for “the POM Order” substitute “ the Human Medicines Regulations 2012 ”.

(3) In paragraph 43(2)(a) of Schedule 6—

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

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

National Health Service (Personal Medical Services Agreements) Regulations 2004

87

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004

88

In Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004 for “article 12F of the Prescription Only Medicines (Human Use) Order 1997 or article 8 of the Medicines (Pharmacy and General Sale- Exemptions) Order 1980”, in both places where those words occur, substitute “ regulation 247 (exemption for supply in the event or anticipation of pandemic disease) of the Human Medicines Regulations 2012 ”.

Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004

89

(1) The Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004 is amended as follows.

(2) In article 2(1)—

(a) omit the definition “the 1994 Regulations”; and

(b) after the definition “the 2003 Act” insert the following definition—

“the 2012 Regulations” means the Human Medicines Regulations 2012;

(3) In article 7—

(a) in paragraph (1) for “the 1994 Regulations” substitute “ Chapter 3 (monitoring of advertising) of Part 14 of the 2012 Regulations ”; and

(b) in paragraph (2)—

(i) for “the 1994 Regulations” substitute “ the 2012 Regulations ”, and

(ii) for the words from “the following” to the end of the paragraph substitute “ regulation 314 of the 2012 Regulations ”.

(4) In article 8(3)(d) for “the 1994 Regulations” substitute “ Chapter 3 (monitoring of advertising) of Part 14 of the 2012 Regulations ”.

(5) In article 11—

(a) in paragraph (2) for “the 1994 Regulations” substitute “ the 2012 Regulations ”; and

(b) in paragraph (3)—

(i) for “section 1(1)(a) of the Medicines Act 1968” substitute “ regulation 6(6) of the 2012 Regulations ”, and

(ii) for “the 1994 Regulations” substitute “ Chapter 3 (monitoring of advertising) of Part 14 of the 2012 Regulations ”.

General Optical Council (Registration Rules) Order of Council 2005

90

In the Table in rule 10 of the Schedule to the General Optical Council (Registration Rules) Order of Council 2005 —

(a) in entry B column 3—

(i) in paragraph (a) for “paragraph 6A of Schedule 5 to the Prescription Only Medicines (Human Use) Order 1997” substitute “ paragraph 8 of Part 1 of Schedule 17 of the Human Medicines Regulations 2012 ”, and

(ii) in paragraph (b) for “6B” substitute “ 9 ”;

(b) in entry C column 3 for “article 3B of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(c) in entry D column 3 for “article 3 of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 5(3) of the Human Medicines Regulations 2012 ”.

National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007

91

(1) The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007 are amended as follows.

(2) In regulation 2(1) omit the definition of “the POM Order”.

(3) In regulation 2(2A) for “the POM Order” substitute “ the Human Medicines Regulations 2012 ”.

(4) In regulation 7(2) for the words from “the Medicines” to the end of the regulation substitute “ the Human Medicines Regulations 2012 ”.

(5) In regulation 7A(1)(b) for the words from “article 12F” to the end of the regulation substitute “ regulation 247 of the Human Medicines Regulations 2012 ”.

Human Tissue (Quality and Safety for Human Application) Regulations 2007

92

In regulation 2(3) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 —

(a) omit sub-paragraph (a); and

(b) for sub-paragraph (b) substitute—

(b) the Human Medicines Regulations 2012;

Legislative and Regulatory Reform (Regulatory Functions) Order 2007

93

(1) The Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007 is amended as follows.

(2) In Part 2 under the heading “Medicines”—

(a) omit the entries—

Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

Medicines (Advertising) Regulations 1994

Medicines (Monitoring of Advertising) Regulations 1994

Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

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

, and

Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

; and

(b) add the entry—

Human Medicines Regulations 2012

(3) In Part 3 under the heading “Public health and safety”—

(a) omit the entries—

Medicines (Advertising) Amendment Regulations 2004

, and

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

(4) In Part 6—

(a) omit the entry—

Medicines (Advertising) Regulations 2005

; and

(b) add the entry—

Human Medicines Regulations 2012, in relation to Chapters 1 and 2 of Part 14 (advertising) of those Regulations

(5) In Part 8—

(a) omit the entry—

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

(6) In Part 13—

(a) omit the entry—

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

Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008

94

In paragraph (d) of article 3 of the Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008 , for the words following “subject” to the end of the article substitute “ of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation within the meaning of the Human Medicines Regulations 2012. ”.

Specified Animal Pathogens Order 2008

95

In article 5(2) of the Specified Animal Pathogens Order 2008 —

(a) in sub-paragraph (b) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”; and

(b) omit sub-paragraph (c).

Specified Animal Pathogens (Wales) Order 2008

96

In article 5(2) of the Specified Animal Pathogens (Wales) Order 2008 —

(a) in sub-paragraph (b) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”; and

(b) omit sub-paragraph (c).

Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008

97

In regulation 1(2) of the Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008 in the definition “prescription only medicine”, for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”.

Specified Animal Pathogens (Scotland) Order 2009

98

In article 5(2) of the Specified Animal Pathogens (Scotland) Order 2009 —

(a) in sub-paragraph (b) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;” substitute “ the Human Medicines Regulations 2012. ”; and

(b) omit sub-paragraph (c).

National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

99

(1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 are amended as follows.

(2) In regulation 2(1)—

(a) in the definition “clinical management plan” for the words from “article” to the end of the definition substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”;

(b) in the definition “non-proprietary name”—

(i) for “section 103(5) of the 1968 Act” in both places where it occurs substitute “regulation 321(3) of the Human Medicines Regulations 2012, and

(ii) for “section 100 of that Act” substitute “ regulation 318 of those Regulations ”;

(c) in the definition “Patient Group Direction” for the words from “Article” to the end of the definition substitute “ regulation 213 of the Human Medicines Regulations 2012 ”; and

(d) in the definition “supply form” for the words from “Article” to the end of the definition substitute “ regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012 ”.

(3) In Schedule 1—

(a) in paragraph 4—

(i) in sub-paragraph (23) for “Article 12C of the Prescription Only Medicines (Human Use) Order 1997 (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction)” substitute “ regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012 ”; and

(ii) in sub-paragraph (29) for “paragraph (4) of article 8 of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 225 (emergency sale etc by pharmacist: at patient's request) of the Human Medicines Regulations 2012 ”; and

(b) in paragraph 10(8) for “article 12C of the Prescription Only Medicines (Human Use) Order 1997, (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction)” substitute “ regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012, ”.

Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009

100

(1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009 is amended as follows.

(2) In Part 1 of Schedule 1, to the entry “Medicines Act 1968 (section 109)” add “or Human Medicines Regulations 2012 (regulation 323)”.

(3) In Part 2 of Schedule 1—

(a) omit the entry—

Medicines (Advertising) Regulations 1994

; and

(b) add in the appropriate place the entry—

Human Medicines Regulations 2012, in relation to Chapters 1 and 2 of Part 14 (advertising) of those Regulations

(4) In Part 4 of Schedule 1—

(a) omit the entry—

Medicines (Traditional Herbal Medicinal Products for human use) Regulations 2005

; and

(b) add in the appropriate place the entry—

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

(5) In Part 2 of Schedule 2—

(a) omit the entry—

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.