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

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articles 4

Reform history JSON API

(aa) in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(bb) in the case of a broker in Northern Ireland, the licensing authority or by the competent authority of any EEA State, or

(ii) carried out in co-operation with the manufacturer of, or the holder of the marketing authorisation, for the product;

(c) keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with sub-paragraph (b);

(d) record in relation to the brokering of each medicinal product—

(i) the name of the medicinal product,

(ii) the quantity of the product brokered,

(iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv) the name and address of the—

(aa) supplier, or

(bb) consignee, and

(v) the date on which the sale or purchase of the product is brokered;

(e) maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities; and

(f) keep the documents or record required by sub-paragraph (c) or (d) available to the licensing authority for a period of five years; and

(g) comply with regulation 45F(1), (2) and (4).

(4) Where the address at which the plan or records necessary to comply with paragraph (3)(b) to (d) are kept is different from the address notified in accordance with regulation 45B(2)(c)(i), the broker must—

(a) ensure that the plan or records are kept at an address in the United Kingdom; and

(b) inform the licensing authority of the address at which the plan or records are kept.

(5) The broker must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products brokered within the period specified by the licensing authority.

(6) The broker must take all reasonable precautions and exercise all due diligence to ensure that any information provided by that broker to the licensing authority in accordance with regulation 45F is not false or misleading.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the registration, the broker must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any copies, which an inspector may carry out or take under regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure).

Provision of information

45F

(1) A broker registered in the UK must immediately inform—

(a) the licensing authority; and

(b) the UK marketing authorisation holder, or, where applicable—

(i) the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii) the EU marketing authorisation holder,

Power to suspend or vary a broker’s registration or remove a broker from the register

45G

(1) The licensing authority may in accordance with regulation 45H—

(a) suspend a broker’s registration for such period as the authority thinks fit;

(b) vary a broker’s registration; or

(2) The suspension of registration or removal from the register may be—

(a) total;

(b) limited to medicinal products of one or more descriptions; or

(c) limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to a broker’s registration except on one or more of the following grounds—

(a) the information in the application as a result of which the broker’s registration was granted was false or incomplete in a material respect;

(b) a material change of circumstances has occurred in relation to any of the matters stated in the application;

(d) the broker has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the registration relates when required to do so under regulation 45F(6).

Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register

45H

(1) This regulation applies where—

(a) regulation 45I does not apply; and

(b) the licensing authority proposes to exercise the power in regulation 45G(1).

(2) The licensing authority must notify the broker in writing of—

(a) its proposal;

(b) the reasons for it; and

(c) the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or revocation should take effect.

(3) The registered broker may before the date specified in the notice—

(a) make written representations to the licensing authority with respect to the proposal; or

(b) notify the licensing authority that the broker wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the broker makes written representations in accordance with paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) Schedule 5 has effect if the registered broker—

(a) notifies the licensing authority of the proposal to review upon oral representations in accordance with paragraph (3)(b); and

(b) pays the fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend or vary a registration or remove a broker from the register in accordance with the provisions of regulation 45G it must give a notice to the broker.

(7) A notice under paragraph (6) must—

(a) give particulars of the suspension, variation or removal; and

(b) give reasons for the decision to suspend, vary or remove a broker from the register.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of a broker registration in cases of urgency

45I

(1) The licensing authority may immediately suspend a broker’s registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a) a broker’s registration has been suspended under paragraph (1); and

(b) it appears to the licensing authority that it is necessary to consider whether the broker’s registration should be—

(i) further suspended or varied, or

(ii) removed from the brokers’ register.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45H (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45H and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 45H to suspend, vary or revoke the registration is made on an application under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).

Variation of a broker’s registration on the application of the broker

45J

(1) This regulation applies if the person registered as a broker applies to the licensing authority for a variation of the registration.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application;

(e) include the appropriate fee in accordance with the Fees Regulations.

(3) The licensing authority must vary a broker’s registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

(4) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a) beginning with the day on which notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 45G and 45I.

Offences: breach of regulations and false information

45K

(1) A person is guilty of an offence if the person—

(a) contravenes regulation 45A(1); or

(b) brokers a medicinal product otherwise than in accordance with the criteria under regulation 45E relating to that person’s brokering registration.

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a) an application for a broker registration under regulation 45B(2);

(b) a notification to the licensing authority under regulation 45F(4);

(d) response to a notice under regulation 45C(3) or 45J(5).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45F(6) or 45J(5).

Penalties

45L

(1) A person guilty of an offence under regulation 45K(1) or (2) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 45K(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

CHAPTER 4 — Importation, manufacture and distribution of active substances

Criteria for importation, manufacture or distribution of active substances

45M

(1) A person may not—

(a) import;

(b) manufacture; or

Registration in relation to active substances

45N

(1) For registration in relation to active substances, the licensing authority must have received a valid registration form from the applicant for import, manufacture or, as the case may be, distribution of an active substance and—

(a) 60 days have elapsed since receipt and the licensing authority have not notified the applicant that an inspection will be carried out; or

(b) the licensing authority—

(i) notified the applicant within 60 days of receipt of a registration form that an inspection will be carried out; and

(ii) within 90 days of that inspection the licensing authority have issued that person with a certificate of good manufacturing practice or, as the case may be, of good distribution practice; and

(2) The person applying for registration under paragraph (1) must notify the licensing authority of any changes which have taken place as regards the information in the registration form—

(a) immediately where such changes may have an impact on quality or safety of the active substances that are manufactured, imported or distributed;

(b) in any other case, on each anniversary of the receipt of the application form by the licensing authority.

(3) For the purpose of paragraph (2), changes which are notified in accordance with that paragraph shall be treated as incorporated in the application form.

(4) Any notification to the licensing authority under paragraph (2) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(5) A registration form is valid for the purpose of paragraph (1) if—

(a) it is provided to the licensing authority; and

(b) is completed in the way and form specified in Schedule 7A.

(6) Paragraph (1) does not apply until 20th October 2013 in relation to a person who had, before 20th August 2013, commenced the activity for which the person would, apart from this provision, need to send a registration form to the licensing authority.

Requirements for registration as an importer, manufacturer or distributor of an active substance

45O

(1) Where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance manufactured in Great Britain, a manufacturer in Great Britain must comply with the principles and guidelines of good manufacturing practice for active substances.

(1A) Where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance manufactured in Northern Ireland, a manufacturer in Northern Ireland must comply with the principles and guidelines of good manufacturing practice for active substances.

(2) Where principles and guidelines of good distribution practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance distributed in Great Britain, a distributor in Great Britain must comply with the principles and guidelines of good distribution practice for active substances.

(2A) Where the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies to an active substance distributed in the Northern Ireland, a distributor in Northern Ireland must comply with the principles and guidelines of good distribution practice for active substances.

(3) Without prejudice to regulation 37(4) (manufacture and assembly in relation to active substances) and paragraph 9A of Schedule 8 (material to accompany an application for a UK marketing authorisation in relation to an active substance), where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance imported into Northern Ireland and where an active substance is imported into Northern Ireland from a country other than an EEA State—

(a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance;

(b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice; and

(c) the active substances must be accompanied by a written confirmation from the competent authority of the exporting country of the following—

(i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in Northern Ireland, and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting country to the Union without any delay.

(3A) Without prejudice to regulation 37(4) and paragraph 9A of Schedule 8, where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance imported into Great Britain other than from Northern Ireland and where an active substance is so imported—

(a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance,

(b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice, and

(c) the active substances must be accompanied by a written confirmation from the competent authority of the exporting country of the following—

(i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in Great Britain, and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting country to the licensing authority without any delay.

(4) Paragraph (3)(c) and (3A)(c) do not apply—

(a) where the country from where the active substance is exported is included in the list referred to in Article 111b of the 2001 Directive (in the case of an import into Northern Ireland) or paragraph (6) (in the case of an import into Great Britain); or

(b) for a period not exceeding the validity of the certificate of good manufacturing practice, where—

(i) in relation to a plant where active substances are manufactured where the competent authority of a member State or licensing authority (in the case of an import into Northern Ireland) or licensing authority or an appropriate authority responsible for the licensing of medicinal products in a country included in a list under paragraph (6) (in the case of an import into Great Britain) has found, upon inspection, that a plant complies with the principles and guidelines of good manufacturing practice, and

(ii) the licensing authority is of the opinion that it is necessary to waive the requirement to ensure availability of the active substance.

(5) The criteria in this regulation apply regardless of whether an active substance is intended for export.

(6) The licensing authority may publish a list of countries which it is satisfied have a regulatory framework applicable to active substances exported to Great Britain that is equivalent to the regulatory framework in Great Britain, in that the respective control and enforcement activities in those countries ensures an equivalent level of protection of public health.

(7) Before including a country in the list under paragraph (6), the licensing authority must assess the equivalence referred to in that paragraph by—

(a) reviewing relevant documentation; and

(b) unless the country is included in the approved country for batch testing list, carrying out—

(i) an on-site review of the country's regulatory system, and

(ii) if the licensing authority considers it necessary, an inspection of one or more of that country's manufacturing sites for active substances.

(8) In carrying out an assessment under paragraph (7) the licensing authority must in particular take account of the—

(a) country's rules for good manufacturing practice;

(b) regularity of inspections to verify compliance with good manufacturing practice;

(d) regularity and rapidity of information provided by that country relating to non-compliant producers of active substances.

(9) The licensing authority must—

(a) review the list under paragraph (6) to determine if a country included in it still satisfies the requirements for inclusion in the list, and if it is not so satisfied, remove that country; and

(b) undertake such a review at least every three years, beginning with the date on which a country is included in the list .

Provision of information

45P

(1) In this regulation—

“R” means a person who is, or has applied to the licensing authority to become, a registered importer, manufacturer or distributor of active substances;

“reporting year” means a period of twelve months ending on 31st March.

(2) On or before the date specified in paragraph (3), R must submit a report to the licensing authority which—

(a) includes a declaration that R has in place an appropriate system to ensure compliance with regulations 45N, 45O and this regulation; and

(b) details the system which R has in place to ensure such compliance.

(3) The date specified for the purposes of this paragraph is—

(a) in relation to any application made before 31st March 2014, the date of the application; and

(b) in relation to each subsequent reporting year, 30th April following the end of that year.

(4) R must without delay notify the licensing authority of any changes to the matters in respect of which evidence has been supplied in relation to paragraph (2) which might affect compliance with the requirements of this Chapter.

(5) Any report or notification to the licensing authority under paragraph (2) or (4) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(6) The licensing authority may give a notice to R, requiring R to provide information of a kind specified in the notice within the period specified in the notice.

(7) A notice under paragraph (6) may not be given to R unless it appears to the licensing authority that it is necessary for the licensing authority to consider whether the registration should be varied, suspended or removed from the active substance register.

(8) A notice under paragraph (6) may specify information which the licensing authority thinks necessary for considering whether the registration should be varied, suspended or removed from the active substance register.

Power to suspend or vary or remove an active substance registration

45Q

(1) The licensing authority may in accordance with regulation 45R—

(a) suspend an active substance registration for such period as the authority thinks fit;

(b) vary an active substance registration; or

(2) The suspension of registration may be—

(a) total;

(b) limited to active substances of one or more descriptions; or

(c) limited to active substances imported, manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to an active substance registration except on one or more of the following grounds—

(a) the information in the application as a result of which the active substance registration was granted was false or incomplete in a material respect;

(b) a material change of circumstances has occurred in relation to any of the matters stated in the application;

(d) the person with an active substance registration has without reasonable excuse failed to supply information to the licensing authority with respect to active substances of a description to which the registration relates when required to do so under regulation 45P(6).

Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register

45R

(1) This regulation applies where—

(a) the provisions of regulation 45S do not apply; and

(b) the licensing authority proposes to exercise the power in regulation 45Q(1).

(2) The licensing authority must notify the person with an active substance registration in writing of—

(a) its proposal;

(b) the reasons for it; and

(c) the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or removal from the active substance register should take effect.

(3) The person with an active substance registration may before the date specified in the notice—

(a) make written representations to the licensing authority with respect to the proposal; or

(b) notify the licensing authority that the person wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the person with an active substance registration makes written representations in accordance with sub-paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) If the person with an active substance registration notifies the licensing authority that the person wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—

(a) Schedule 5 has effect; and

(b) the person with an active substance registration must pay a fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend or vary a registration or remove a person from the active substance register in accordance with the provisions of regulation 45Q it must give a notice to that person.

(7) The notice must—

(a) give particulars of the suspension, variation or removal; and

(b) give reasons for the decision to suspend, vary or remove a person’s entry on the active substance register.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of an active substance registration in cases of urgency

45S

(1) The licensing authority may immediately suspend a person’s active substance registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a) a person’s active substance registration has been suspended under paragraph (1); and

(b) it appears to the licensing authority that it is necessary to consider whether a person’s active substance registration should be—

(i) further suspended or varied, or

(ii) removed from the active substance register.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45R (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45R and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 45R to suspend, vary or remove a person’s active substance registration is made on an application to the High Court under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).

Variation of an active substance registration on an application from the registered person

45T

(1) This regulation applies if a person with an active substance registration applies to the licensing authority for a variation of the registration.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e) include the appropriate fee in accordance with the Fees Regulations.

(3) The licensing authority must vary an active substance registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

(4) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a) beginning with the day on which notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 45Q and 45S.

Offences: breach of regulations and false information

45U

(1) A person is guilty of an offence if the person imports, manufactures or distributes an active substance in breach of regulation 45M(1).

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a) a registration form received by the licensing authority under regulation 45N(1);

(b) a notification to the licensing authority under regulation 45N(2) or 45P(4);

(d) response to a notice under regulation 45T(4).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45P(6) or 45T(4).

Penalties

45V

(1) A person guilty of an offence under regulation 45U(1) or (2) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 45U(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A

210A

(1) A holder is guilty of an offence if the holder—

(a) in relation to a UKMA(NI), UKMA(UK)(Category 2), THR(NI) THR(UK) or Article 126a authorisation, fails to comply with any requirement or obligation contained in a provision of the Implementing Regulation listed in paragraph (2); or

(aa) in relation to a UKMA(GB) , UKMA(UK)(Category 2) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or

(b) provides information which is false or misleading in a material particular to the licensing authority or the EMA pursuant to an obligation in the Implementing Regulation.

(2) The provisions mentioned in paragraph (1)(a) are—

(a) Chapter I (pharmacovigilance system master file);

(b) Sections 1 and 2 of Chapter II (minimum requirements for the quality systems for the performance of pharmacovigilance activities);

(d) Chapter V (transmission of reports of suspected adverse reactions);

(e) Article 32 of Chapter VI (updates of risk management plans);

(f) Chapter VII (periodic safety update reports); and

(g) Chapter VIII (post-authorisation safety studies).

(2A) The provisions of Schedule 12A mentioned in paragraph (1)(aa) are—

(a) Part 1 (pharmacovigilance system master file);

(b) Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities);

(d) paragraph 24 (update of risk management plans);

(e) Part 8 (periodic safety update reports); and

(f) Part 9 (post-authorisation safety studies).

(3) Subject to paragraph (4), a person guilty of an offence under this regulation is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine.

(4) A person guilty of an offence under this regulation which relates to a breach of Article 34(5) or 36(3) of the Implementing Regulation , or of paragraph 26(8) or 29(1) of Schedule 12A, is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

Persons liable

SCHEDULE 7A — Information to be provided for registration as an importer, manufacturer or distributor of active substances

1

The name and address of the applicant.

2

The name and address of the person (if any) making the application on the applicant’s behalf.

3

The address of each of the premises where any operations to which the registration relates are to be carried out.

4

The address of any premises not mentioned by virtue of the above requirement, where—

(a) the applicant proposes to keep any living animals, from which substance(s) used in the production of the active substance(s) to which the application relates are to be derived;

(b) materials of animal origin from which an active substance is to be derived, as mentioned in the above sub-paragraph, are to be kept.

5

The address of each of the premises where active substances are to be stored, or from which active substances are to be distributed.

6

The address of each of the premises where any testing associated with the manufacture or assembly of active substances to which the registration relates.

7

The name, address, qualifications and experience of the person whose duty it will be to supervise any manufacturing operations, and the name and job title of the person to whom they report.

8

The name, address, qualifications and experience of the person who will have responsibility for the quality control of active substances, and the name and job title of the person to whom they report.

9

The name, address, qualifications and experience of the person whose duty it will be to supervise any importation, storage or distribution operations, and the name and job title of the person to whom they report.

10

The name, address and qualifications of the person to be responsible for any animals kept as mentioned in paragraph 4(a).

11

The name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of an active substance.

12

For each active substance to be manufactured, imported, or distributed—

(a) the CAS registration number assigned to that active substance by the Chemical Abstracts Service, a division of the American Chemical Society;

(b) where applicable, the Anatomical Therapeutic Category code assigned to that active substance under the Anatomical Therapeutic Chemical Classification System used for the classification of drugs by the World Health Organisation’s Collaborating Centre for Drug Statistics Methodology;

(i) the International Union of Pure and Applied Chemistry nomenclature, or

(ii) the common name; and

(d) the intended quantities of each active substance to be manufactured, imported or distributed.

13

Details of the operations to which the registration relates, including a statement of whether they include—

(a) the manufacture of active substances;

(b) the importation of active substances ...;

(d) the distribution of active substances.

14

A statement of the facilities and equipment available at each of the premises where active substances are to be manufactured, stored or distributed.

15

A statement as to whether the particular active substances are intended for—

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

(b) use in a special medicinal product; or

16

A separate statement in respect of each of the premises mentioned in the application of—

(a) the manufacturing, storage or distribution operations carried out at those sites, and the specific active substances to which those activities relate; and

(b) the equipment available at those premises for carrying out those activities.

17

A statement of the authority conferred on the person responsible for quality control to reject unsatisfactory active substances.

18

A description of the arrangements for the identification and storage of materials before and during the manufacture of active substances.

19

A description of the arrangements for the identification and storage of active substances.

20

A description of the arrangements at each of the premises where the applicant proposes to store active substances for ensuring, as far as practicable, the turn-over of stocks of active substances.

21

A description of the arrangements for maintaining—

(a) production records, including records of manufacture and assembly;

(b) records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials use in manufacture, or of active substances, with the specification for such materials or active substances;

(d) records of storage and distribution.

22

A description of the arrangements for keeping reference samples of—

(a) materials used in the manufacture of active substances; and

(b) active substances.

23

Where the application relates to active substances intended for use in an advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow traceability containing sufficient detail to enable the linking of an active substance to the advanced therapy medicinal product it was used in the manufacture of and vice versa.

24

Details of—

(a) any manufacturing, importation, storage or distribution operations, other than those to which the application for registration relates, carried on by the applicant on or near each of the premises, and

(b) the substances or articles to which those operations relate.

9A

Except in the case of an active substance that contains human cells or tissues, or that is part of a medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture, a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing—

(a) information about the date of the audit; and

(b) a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.

11.

The medicinal product must—

have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied; and

be stored in a part of the aircraft which the operator is able to close so as to exclude the public.

Requirements for prescriptions to be dispensed in an EEA state ...

217A

(1) In this regulation—

“B” means a person who is an appropriate practitioner for the purposes of regulation 214(3) to (5B);

“P” means a person who is the patient of B.

(2) The information specified in paragraph (3) is to be included in any prescription where—

(a) P requests a prescription that is to be dispensed in an EEA state ...; and

(b) B determines that such a prescription is appropriate.

(3) The specified information is—

(a) the patient’s—

(i) surname,

(ii) first names written out in full, and

(iii) date of birth;

(b) the issue date of the prescription;

(i) surname,

(ii) first names written out in full,

(iii) professional qualification,

(iv) direct contact details including—

(aa) email address,

(bb) telephone or fax number with the appropriate international prefix,

(v) work address,

(vi) confirmation that B works as a health professional in the UK, and

(vii) electronic signature or a signature written in ink;

(d) details about the prescribed product, including where applicable the—

(i) common name of the product as defined by Article 1 of the 2001 Directive,

(ii) brand name if—

(aa) the prescribed product is a biological medicinal product, or

(bb) B deems it medically necessary for that product to be dispensed and B’s reasons justifying the use of the branded product,

(iii) pharmaceutical formulation (tablet, solution, etc.),

(iv) quantity,

(v) strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi) dosage regimen.

(4) A prescription under this regulation may only be issued by B in relation to those products that B is authorised to prescribe under regulation 214(3) to (5B).

Requirements for prescriptions: EEA health professionals

Electronic prescriptions

Obligation to update information supplied in connection with parallel import licence application

57A

(1) The applicant for a parallel import licence must update information supplied in accordance with Schedule 8A (material to accompany an application for a parallel import licence) in connection with the application.

(2) The applicant must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(3) Updated information within paragraphs (1) or (2) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.

Validity of parallel import licence

65A

(1) Unless paragraph (2) applies, a parallel import licence remains in force for a period of 5 years from the date it is granted or renewed.

(2) A parallel import licence will cease to be valid if—

(a) the information supplied in the application for a licence no longer matches the information currently approved for the reference product by the licensing authority;

(b) details about the product imported under the licence are not consistent with the details supplied in the application; or

(c) the patient information leaflet supplied with the product is not consistent with latest version of the leaflet that is required to be issued with the product by the licensing authority, and

an application to vary the licence to update any details in relation to sub-paragraph (a) to (c) has not been granted by the licensing authority because the condition in regulation 68(11) has not been met.

Application for renewal of authorisation

Application for renewal of a parallel import licence

66A

(1) The licensing authority may renew a parallel import licence in response to an application made in accordance with this regulation.

(2) The applicant must be established in the United Kingdom.

(3) The application must be—

(a) made in writing;

(b) signed by or on behalf of the applicant; and

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority within three months of the end of a period expiring 5 years after the date of grant or (as the case may be) latest renewal of the licence.

Failure to place on the market etc

Urgent safety restrictions: parallel import licences

80A

The holder of a parallel import licence is guilty of an offence if the holder—

(a) fails to inform the licensing authority that the holder has taken urgent safety restrictions on the holder’s own initiative;

(b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority; or

(c) fails to submit an application for variation of the parallel import licence to the licensing authority before the end of a period of fifteen days beginning on the day after—

(i) the taking of urgent safety restrictions under paragraph (a) or, as the case may be,

(ii) the imposition of urgent safety restrictions under paragraph (b).

Offences in connection with parallel import licence application

95A

A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel import licence for a relevant medicinal product, the person—

(a) fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; or

(b) provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular.

Provision of false or misleading information

Breach of pharmacovigilance condition

General offence of breach of provision of this Part

Penalties

Persons liable

Defences

Obligation on holder of a parallel import licence to submit periodic safety update reports

191A

(1) The holder of a parallel import licence must submit reports known as periodic safety update reports (“PSURs”) to the licensing authority if notified to do so by the licensing authority.

(2) Each PSUR must contain—

(a) summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the licence for the product;

(b) a scientific evaluation of the risk-benefit balance of the product; and

(c) all data relating to the volume of sales of the product and any data the holder of the licence has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

(3) For the purposes of paragraph (2)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product.

(4) Each PSUR must be submitted electronically.

(5) The PSUR must be submitted to the licensing authority within the period specified by that authority.

Obligation on holder to submit periodic safety update reports: derogation from general requirements

Harmonisation of PSUR frequency or date of submission

Responding to a single assessment of PSUR under Article 107e of the 2001 Directive

Obligation on licensing authority to assess PSURs ...

SCHEDULE8A — Material to accompany an application for a parallel import licence

1

The name or corporate name and permanent address of the applicant.

2

The name of the medicinal product. This may be—

(a) an invented name that is not liable to confusion with the product’s common name; or

(b) a common or scientific name accompanied by a trademark or by the name of the person who is to be the parallel import licence holder.

3

Details of the product to be imported if requested by the licensing authority.

4

Details of the UK reference product.

5

If requested by the licensing authority, an evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.

6

If requested by the licensing authority, a summary of the applicant’s pharmacovigilance system which shall include the following elements—

(a) proof that the applicant has at the applicant’s disposal an appropriately qualified person responsible for pharmacovigilance who resides and operates in the United Kingdom;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

(e) a reference to the location where the pharmacovigilance system master file for the medicinal product is kept or, if kept in electronic form, from which it can be accessed, which in either case, must be in the United Kingdom.

7

If requested by the licensing authority, the risk management plan, together with a summary, that—

(a) describes the risk management system which the applicant will introduce for the medicinal product concerned; and

(b) shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

8

If requested by the licensing authority, a summary of the product characteristics for the medicinal product in accordance with Part 2 of Schedule 8.

9

A mock-up, in accordance with Part 13 (packaging and leaflets) of—

(a) the outer packaging of the medicinal product;

(b) the immediate packaging of the medicinal product; and

The United Kingdom Health Security Agency .

Public Health Agency.

Electronic Prescriptions: EEA health professionals

219A

(1) This regulation applies to a prescription that is not a health prescription for a product subject to special medical prescription.

(2) A prescription only medicine is also sold or supplied in accordance with a prescription given by an approved country health professional if—

(a) conditions B and C in regulation 218 are not met; but

(b) the conditions in paragraph (3) of this regulation and conditions A and D to F in regulation 218 are met.

(3) The conditions mentioned in paragraph (2)(b) are that the prescription is—

(a) created in electronic form;

(b) signed with an electronic signature; and

(c) sent to the person by whom it is dispensed as an electronic communication (whether or not through one or more intermediaries).

Requirement for wholesale dealers to decommission the unique identifier

43A

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

Requirement for wholesale dealers to deal only with specified persons

Requirement as to responsible persons

Offences relating to the safety features appearing on the packaging of medicinal products

Offences relating to Commission Regulation 2016/161

94A

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

Sale etc by a pharmacist in accordance with a serious shortage protocol

226A

(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A, B and C are met.

(2) Condition A is that the prescription only medicine is sold or supplied for the purpose of being administered to a person in accordance with a serious shortage protocol (SSP).

(3) Condition B is that the requirements of the SSP are satisfied in respect of to whom, and subject to what conditions, the prescription only medicine may be sold or supplied for the purpose of being administered.

(4) Condition C is that the sale or supply of the prescription only medicine is by or under the supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that—

(a) in a case to which paragraph (5)(b)(i) applies, the sale or supply of a different strength, quantity or pharmaceutical form of the prescription only medicine to the strength, quantity or pharmaceutical form of the prescription only medicine ordered by the prescriber is reasonable and appropriate; or

(b) in a case to which paragraph (5)(b)(ii) applies, the sale or supply of—

(i) a prescription only medicine other than the prescription only medicine ordered by the prescriber is reasonable, and

(ii) the substituted prescription only medicine, in accordance with the directions for use that he or she specifies, is appropriate.

(5) For the purposes of this regulation, a SSP is a written protocol that—

(a) is issued by the Ministers (either of them acting alone or both of them acting jointly) in circumstances where the United Kingdom or any part of the United Kingdom is, in the opinion of the Ministers (either of them forming the opinion alone or both of them forming the opinion jointly), experiencing or may experience a serious shortage of a prescription only medicine or prescription only medicines of a specified description;

(b) provides for the sale or supply by or under the supervision of a pharmacist and subject to such conditions as may be specified in the SSP—

(i) of a different strength, quantity or pharmaceutical form of the prescription only medicine to the strength, quantity or pharmaceutical form ordered by the prescriber, or

(ii) of a prescription only medicine other than the prescription only medicine ordered by the prescriber;

(i) a generic version of the prescription only medicine being substituted, or that both products are generic versions of another prescription only medicine,

(ii) in the case of a biological medicinal product, a similar medicinal product to the prescription only medicine being substituted, or that both products are similar medicinal products to another biological medicinal product, or

(iii) a prescription only medicine that has a similar therapeutic effect to the prescription only medicine being substituted; and

(d) specifies the period for which, and the parts of the United Kingdom (which may be all of the United Kingdom) in which, the protocol is to have effect.

(6) As soon as is reasonably practical after the end of one year beginning on the day on which the first protocol issued under this regulation has effect, the Ministers must—

(a) review the operation of this regulation with a view to evaluating whether there have been any adverse consequences for the market in prescription only medicines or for patient safety as a consequence of the operation of this regulation;

(b) set out the conclusions of the review in a report; and

Exemption for sale or supply in hospitals

Exemptions relating to prescriptions given by certain health professionals

Exemption for supply by national health service bodies and local authorities

Exemption for supply etc under a PGD to assist doctors or dentists

Exemption for supply etc under a PGD by person conducting a retail pharmacy business

Exemption for supply etc of products under a PGD to assist the police etc

Exemption for sale, supply or administration by certain persons

Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public

255A

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

Exception to Article 25 of Commission Regulation 2016/161: health care institutions

255B

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

Offences relating to Commission Regulation 2016/161: management of the repository system

255C

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

Packaging Requirements: medicinal products required to bear safety features

257A

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

Transitional arrangements

257B

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

Packaging requirements: specific provisions

Package leaflets

Use of pictures and symbols etc

Labelling requirements for radionuclides

Leaflets relating to radionuclides

Homoeopathic medicines

Additional requirements for traditional herbal medicinal products

Language requirements etc

Submission of mock-ups of packaging and leaflets to licensing authority

18A

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

Conditions of temporary authorisations under regulation 174

174A

(1) Where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis under regulation 174, the licensing authority may attach conditions to that authorisation, those being conditions to which the following are subject—

(a) its recommendation or requirement as to the use of that product for the purposes of regulation 345; and

(b) its authorisation of the sale or supply of that product.

(2) The sale or supply of that medicinal product is not authorised by the licensing authority for the purposes of regulation 174 if—

(a) the sale or supply is for the purpose of any use other than the recommended or required use, as mentioned in paragraph (1)(a); or

(b) a condition attached in accordance with paragraph (1) to the authorisation of the sale or supply is breached.

(3) The use of that medicinal product is not in accordance with a recommendation or requirement of the licensing authority for the purposes of regulation 345 if—

(a) a condition attached in accordance with paragraph (1) to the authorisation of its sale or supply is breached; and

(b) any risk of death or personal injury that is wholly or partly attributable to that breach is such that a reasonable person with relevant expertise in the subject matter of the breach would regard the breach as sufficiently serious to justify the licensing authority setting aside the recommendation or requirement.

(4) Notwithstanding paragraph (3), the persons mentioned in regulation 345(3) are not subject to any civil liability resulting from a use of that medicinal product that was (but for the operation of that paragraph) in accordance with the recommendation or requirement of the licensing authority, if those persons were not wholly or partly responsible for the breach in question.

(5) As soon as is reasonably practical after the end of one year beginning on the day on which the first conditions are attached in accordance with paragraph (1), the Secretary of State must—

(a) review the operation of this regulation with a view to evaluating whether there have been any adverse consequences for the market in medicines or for patient safety as a consequence of the operation of this regulation;

(b) set out the conclusions of the review in a report; and

Protocols relating to coronavirus and influenza vaccinations and immunisations

247A

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

Exemption for certain collection and delivery arrangements

Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.

291A

(1) Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances), 287(4)(b) (material about effects of a medicinal product) and 291(2)(d) (form and content of advertisement) do not apply to an advertisement as part of a campaign that—

(a) relates to the use of a medicinal product in response to the suspected or confirmed spread of—

(i) pathogenic agents,

(ii) toxins,

(iii) chemical agents, or

(iv) nuclear radiation; and

(b) has been approved by the Ministers.

(2) Before approving a campaign that relates to—

(a) all or any area of Scotland, the Ministers must consult the Scottish Ministers;

(b) all or any areas of Wales, the Ministers must consult the Welsh Ministers.

Exception for approved vaccination campaigns

Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products

3A

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Regulation 17(1) does not apply in circumstances where a medicinal product used under relevant arrangements for vaccination against an infectious disease is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product.

(4) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)—

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

(b) is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part.

(5) For the purposes of this regulation—

“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special provisions for pharmacies etc

Classification of medicinal products

The licensing authority and the Ministers

Advertisements relating to medicinal products

General interpretation

Definition of advanced therapy medicinal product etc.

2A

(1) In these Regulations ... “advanced therapy medicinal product” means any of the following products—

(a) a gene therapy medicinal product;

(b) a somatic cell therapy medicinal product; or

(2) A “gene therapy medicinal product” is a biological medicinal product which has the following characteristics—

(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and

(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

(3) A vaccine against infectious diseases is not to be treated as a gene therapy medicinal product.

(4) A “somatic cell medicinal product” is a medicinal product which has the following characteristics—

(a) it contains or consists of cells or tissues that—

(i) have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or

(ii) are not intended to be used for the same essential function in the recipient as in the donor; and

(b) it is presented as having properties for, or is used in or administered to human beings with a view to, treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

(5) A “tissue engineered product” is a medicinal product which—

(a) contains or consists of engineered cells or tissues; and

(b) is presented as having properties for, or is used in or administered to human beings with a view to, regenerating, repairing or replacing a human tissue.

(6) A tissue engineered product may contain—

(a) cells or tissues of human or animal origin;

(b) viable or non-viable cells or tissues; and

(c) additional substances, including cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.

(7) A product is not a tissue engineered product if it—

(a) contains or consists exclusively of non-viable human or animal cells or tissues;

(b) does not contain any viable cells or tissues; and

(8) Cells or tissues are engineered if they—

(a) have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved; or

(b) are not intended to be used for the same essential function in the recipient as in the donor.

(9) The following manipulations are not substantial manipulations for the purposes of paragraphs (4)(a) and (8)(a)—

(a) cutting;

(b) grinding;

(d) centrifugation;

(e) soaking in antibiotic or antimicrobial solutions;

(f) sterilisation;

(g) irradiation;

(h) cell separation, concentration or purification;

(i) filtering;

(j) lyophilisation;

(k) freezing;

(l) cryopreservation; and

(m) vitrification.

(10) In these Regulations ... “combined advanced therapy medicinal product” means an advanced therapy medicinal product—

(a) which incorporates, as an integral part of the product, one or more medical devices or one or more active implantable medical devices; and

(b) the cellular part of which—

(i) contains viable cells or tissues; or

(ii) contains non-viable cells or tissues which are liable to act upon the human body with action that can be considered as primary to that of the medical devices.

(11) Where an advanced therapy medicinal product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues is to be treated as the principal mode of action of the product.

(12) An advanced therapy medicinal product containing both autologous and allogeneic cells or tissues is to be treated as being for allogeneic use.

(13) A product which falls within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product is to be treated as a tissue engineered product.

(14) A product which falls within the definition of—

(a) a somatic cell therapy medicinal product or a tissue engineered product; and

(b) a gene therapy medicinal product,

is to be treated as a gene therapy medicinal product.

Scope of these Regulations: special provisions

Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products

Special provisions for pharmacies etc

Classification of medicinal products

The licensing authority and the Ministers

Advertisements relating to medicinal products

General interpretation

Chapter 1A — Good manufacturing practice and good distribution practice

Regulations on good manufacturing practice

B17

(1) The Secretary of State may by regulations in respect of Great Britain set out principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products.

(2) Regulations under paragraph (1) may in particular make provisions as to—

(a) inspections;

(b) compliance with good manufacturing practice and, where relevant, the UK marketing authorisation ...;

(d) personnel;

(e) premises and equipment;

(f) documentation;

(g) production;

(h) quality control;

(i) the contracting out of work;

(j) complaints and product recall;

(k) self-inspection.

(3) Subject to any provision made in regulations under paragraph (1), the principles and guidelines set out in the Good Manufacturing Practice Directive have effect in Great Britain on and after IP completion day as they had effect immediately before IP completion day, but subject to the modifications specified in Schedule 2A.

(4) The Secretary of State may by regulations in respect of Great Britain amend or revoke Schedule 2A.

Guidelines on good manufacturing practice and good distribution practice

C17

(1) The licensing authority may publish in relation to the manufacture or assembly of a medicinal product in, or import to, the United Kingdom—

(a) detailed guidelines of good manufacturing practice in respect of medicinal products, and investigational medicinal products, referred to in Article 46(f) of the 2001 Directive, including guidelines as to the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients;

(b) principles and guidelines of good manufacturing practice for active substances, referred to in the first paragraph of point (f) of Article 46 and in Article 46b of that Directive;

(c) principles and guidelines of good distribution practice referred to in the first paragraph of point (f) of Article 46, and Article 84, of that Directive.

(2) Guidelines or principles under paragraph (1) may replace, amend or otherwise modify any guidelines or principles published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive.

(3) Unless replaced by principles or guidelines published under paragraph (1), principles and guidelines published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive, as they applied immediately before IP completion day, continue to apply on and after IP completion day (subject to any amendments or modifications published under paragraph (1)).

(4) Before exercising the power under paragraph (1), the licensing authority must consult such persons as it considers appropriate.

(5) The licensing authority may only exercise its power under paragraph (1) if it considers that it is necessary in order to take account of technical or scientific progress.

(6) If the licensing authority publishes principles and guidelines under paragraph (1), any reference in these Regulations to any principle or guideline adopted under the provisions of the 2001 Directive specified in those paragraphs is instead to be read as a reference to the principle or guideline published under paragraph (1), or that principle or guideline as amended or modified (as the case may be).

Approved country for import

18A

(1) The licensing authority must—

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