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

(b) vary or remove a condition in paragraph (2)(a), (c), (d) or (e) to which the parallel import licence is subject.

(2) Those conditions are—

(a) to take certain measures for ensuring the safe use of the medicinal product and include them in the risk management plan;

(b) to conduct post-authorisation safety studies;

(c) to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Part 11;

(d) any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

(e) the existence of an adequate pharmacovigilance system; and

(f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.

(3) In relation to a UKMA(NI) or UKMA(UK)(Category 2), an obligation to conduct such studies as are referred to in paragraph (2)(f) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive, while taking into account the scientific guidance referred to in Article 108a of the 2001 Directive.

(3A) In relation to a UKMA(GB) or a UKMA(UK)(Category 1), an obligation to conduct such studies as are referred to in paragraph (2)(f) must—

(a) be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and

(b) take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.

(3B) The Secretary of State may by regulations make provision ... specifying the situations in which post-authorisation efficacy studies may be required in relation to a UKMA(GB) or UKMA(UK)(Category 1) by virtue of the condition referred to in paragraph (2)(f).

(3C) Paragraph (3A)(a) ceases to apply on the coming into force of regulations made under paragraph (3B).

(4) The UK marketing authorisation or parallel import licence must lay down deadlines for the fulfilment of the conditions in paragraph (2) where relevant and necessary.

(4A) Where the application is one to which regulation 50A, 50E or 50F (applications to which paediatric-specific provisions apply) applies, the licensing authority must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a) a risk management system be set up comprising a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions; or

(b) specific post-marketing studies be performed and submitted for review.

(4B) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A (post-authorisation safety studies), a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4A).

(4C) If the licensing authority grants a conditional marketing authorisation—

(a) it must impose, as a condition of the conditional marketing authorisation, an obligation on the holder of the authorisation to complete ongoing studies, or to conduct new studies, with a view to confirming the that the positive therapeutic effects of the product outweigh the risks to the health of patients or the public associated with the product, and to provide the additional data referred to in regulation 50I(3)(a);

(b) it may impose, as a condition of the conditional marketing authorisation, an obligation on the holder of that authorisation in relation to collection of pharmacovigilance data.

(4D) If the licensing authority grants a UK marketing authorisation in relation to an advanced therapy medicinal product, it must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a) a risk management system be set up which is designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system; or

(b) that specific post-marketing studies be carried out and submitted for review by the licensing authority.

(4E) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A, a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4D).

(5) The licensing authority must notify the EMA of any UKMA(NI) or UKMA(UK)(Category 2) that it has granted subject to a condition included in accordance with this regulation.

(6) The holder of the authorisation must incorporate any condition included in a marketing authorisation or parallel import licence in accordance with this regulation into the risk management system for the product.

(7) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation is subject.

Conditions of UK marketing authorisation: exceptional circumstances

60

(1) The licensing authority may—

(a) grant a UK marketing authorisation or parallel import licence subject to conditions in accordance with the following paragraphs of this regulation; or

(b) vary or remove such a condition to which the UK marketing authorisation or parallel import licence is subject.

(2) The powers in paragraph (1) may be exercised only after consultation with the applicant for the authorisation or licence or (as the case may be) its holder.

(3) The power in paragraph (1)(a) to grant an authorisation or licence subject to conditions may be exercised only—

(a) in exceptional circumstances; and

(b) when the applicant can show that the applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use.

(4) The conditions must relate to a matter addressed by Annex I to the 2001 Directive.

(5) The conditions may, in particular, relate to the safety of the product to which the authorisation or licence relates.

(6) The conditions may, in particular, require that, where there is a serious adverse reaction relating to the use of the product—

(a) the reaction must be reported to the licensing authority; and

(b) such other action as may be specified in the conditions must be taken.

(7) The licensing authority must keep under review—

(a) the conditions under this regulation to which a UK marketing authorisation or parallel import licence is subject; and

(b) the holder's compliance with those conditions.

(8) The licensing authority must consider those matters no less frequently than—

(a) at the end of the period of one year beginning with the date on which the authorisation or licence was granted; and

(b) at the end of each subsequent period of one year.

(9) The licensing authority must notify the EMA of any UKMA(NI) or UKMA(UK)(Category 2) that it has granted subject to a condition included in accordance with this regulation.

(10) The holder of the authorisation or licence must incorporate any condition included in a marketing authorisation or licence in accordance with this regulation into the risk management system for the product.

(11) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation or parallel import licence is subject.

Conditions of UK marketing authorisation: new obligations post-authorisation

61

(1) After the granting of a UK marketing authorisation, the licensing authority may impose an obligation on the holder of the authorisation in accordance with either or both of —

(a) paragraph (4), in a case where paragraph (2) applies; or

(b) paragraph (5), in a case where paragraph (3) applies.

(2) This paragraph applies if there are concerns about the risks of a medicinal product that is the subject of a marketing authorisation.

(3) This paragraph applies if the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly.

(4) The obligation in this paragraph is—

(a) to conduct a post-authorisation safety study; or

(b) in relation to a UKMA(GB) or UKMA(UK)(Category 1), to comply with such other conditions or restrictions as the licensing authority considers essential for the safe and effective use of the medicinal product.

(5) The obligation in this paragraph is to conduct a post-authorisation efficacy study.

(6) If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(NI) or UKMA(UK)(Category 2), the licensing authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study.

(6A) If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB) or UKMA(UK)(Category 1), the licensing authority—

(a) must, where the obligation is to conduct a post-authorisation safety study, encourage the UK marketing authorisation holders concerned to conduct a joint study, and

(b) may, where the obligation is to comply with any other conditions or restrictions, encourage the UK marketing authorisation holders concerned to take co-ordinated action to comply with the conditions or restrictions.

(7) The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.

(7A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7B) The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the obligation under paragraph (5).

(7C) Paragraph (7A)(a) ceases to apply on the coming into force of regulations made under paragraph (7B).

(8) Where the licensing authority imposes an obligation under paragraph (4) or (5), it must without delay give written notice to the holder of —

(a) the imposition of the obligation;

(b) the justification for the imposition;

(d) the opportunity to present written observations in accordance with paragraph (9) and the time limit specified for doing so.

(9) Where the holder so requests within the period of thirty days beginning on the day after the receipt by the holder of the notice referred to in paragraph (8), the licensing authority must provide the holder of the authorisation with an opportunity to present written observations in response to the imposition of the obligation within the time limit specified by the licensing authority in the notice.

(10) Where the holder presents written observations under paragraph (9), the licensing authority must withdraw or confirm the imposition of the obligation under paragraph (4) or (5) on the basis of the written observations as soon as is reasonably practicable.

(11) Paragraph (12) applies where the licensing authority—

(a) imposes an obligation under paragraph (4) or (5) and the holder does not present written representations under paragraph (9); or

(b) confirms the imposition of an obligation under paragraph (10).

(12) Where this paragraph applies, the licensing authority must vary the marketing authorisation to include the obligation as a condition of the marketing authorisation as if it were a condition imposed under regulation 59 (conditions of UK marketing authorisations: general).

(13) The licensing authority must notify the EMA , in relation to a UKMA(NI) or UKMA(UK)(Category 2), that the marketing authorisation is subject to a condition included in accordance with paragraph (12).

(14) The holder of the authorisation must incorporate any condition included in a marketing authorisation in accordance with paragraph (12) into the risk management system for the product.

(15) Schedule 11, which makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation is subject, shall apply in relation to the variation or removal of a condition included in a marketing authorisation in accordance with paragraph (12).

Classification of UK marketing authorisation or parallel import licence

62

(1) A UK marketing authorisation or parallel import licence must include a term that the product to which the authorisation relates is to be available—

(a) only on prescription;

(b) only from a pharmacy; or

(2) In making a determination under paragraph (1), the licensing authority must have regard to the following in relation to the product—

(a) the maximum single dose;

(b) the maximum daily dose;

(d) its pharmaceutical form;

(e) its packaging; and

(f) such other circumstances relating to its use as the licensing authority considers relevant.

(3) A UK marketing authorisation or parallel import licence must be granted subject to a condition that the product to which the authorisation relates is to be available only on prescription if the licensing authority considers that the product—

(a) is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist;

(b) is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health;

(c) contains substances, or preparations of substances, of which the activity requires, or the side effects require, further investigation; or

(d) is normally prescribed by a doctor or dentist for parenteral administration.

(4) In deciding whether paragraph (3) applies to a product, the licensing authority must take into account whether the product—

(a) contains a substance listed in any of Schedules I, II or IV to the Narcotics Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention);

(b) contains a substance listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention);

(i) to present a substantial risk of medicinal abuse,

(ii) to lead to addiction, or

(iii) to be used for illegal purposes;

(d) contains a substance that, by reason of its novelty or properties, might fall within paragraph (c), but as to which there is insufficient information available to determine whether it does so fall;

(e) by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved for treatments that can only be followed in a hospital;

(f) is used in the treatment of conditions that must be diagnosed in a hospital or in an institution with special diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or

(g) is intended for outpatients but may produce very serious side effects which would require a prescription drawn up as required by a specialist and special supervision throughout the treatment.

(5) A UK marketing authorisation or parallel import licence may include a term that the product to which the authorisation relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12).

Frequency of periodic safety update reports

63

(1) The licensing authority must, if paragraph (2) applies, include in a UK marketing authorisation a term that specifies the frequency, calculated from the date on which the authorisation is granted, with which the holder of the authorisation must submit periodic safety update reports in accordance with regulation 191(8) (obligation on holder to submit periodic safety update reports: general requirements).

(2) This paragraph applies in the case of a medicinal product in relation to which regulation 191(8) applies by virtue of regulation 191(1).

Duties of licensing authority in connection with determination

64

(1) This regulation applies if the licensing authority grants a UK marketing authorisation.

(2) The licensing authority must inform the holder of the authorisation of the summary of the product characteristics as approved by the authority.

(3) The licensing authority must ensure that the summary of the product characteristics continues to match the version it has approved, subject to any changes it approves.

(4) As soon as is reasonably practicable after granting the marketing authorisation, the licensing authority must make available publicly—

(a) the marketing authorisation;

(b) the package leaflet;

(d) any conditions—

(i) in the case of a UKMA(NI) or UKMA(UK)(Category 2), established in accordance with Articles 21a, 22 and 22a of the 2001 Directive;

(ii) in the case of UKMA(GB) or UKMA(UK)(Category 1), imposed under regulations 59 to 61; and

(e) any deadlines for the fulfilment of those conditions.

(5) The licensing authority must draw up an assessment report and make comments on the file as regards—

(a) the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the product to which the authorisation relates; or

(b) in the case of a national homoeopathic medicinal product within the meaning of Schedule 10, the information submitted under paragraphs 3 to 5 of that Schedule.

(6) The licensing authority must—

(a) revise the assessment report whenever new information becomes available that is of importance for the evaluation of the quality, safety or efficacy of the medicinal product;

(b) make the assessment report publicly available (with the omission of information of a commercially confidential nature) as soon as is reasonably practicable after it has been prepared or revised; and

(c) include in the assessment report a summary, written in a manner that is understandable to the public, that contains, in particular, a section relating to the conditions of use of the medicinal product.

(7) The assessment must be provided separately for each indication that is authorised.

Validity of UK marketing authorisation

65

(1) Subject to the following paragraphs, a UK marketing authorisation remains in force—

(a) for an initial period of five years beginning with the date on which it is granted; and

(b) if the authorisation is renewed in accordance with regulation 66, for an unlimited period after its renewal.

(2) The licensing authority may, on the first application for renewal of an authorisation, determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3) In that event the authorisation remains in force—

(a) for a further period of five years beginning with the date on which it is first renewed; and

(b) if the authorisation is further renewed under regulation 66, for an unlimited period after its further renewal.

(4) If an application for the renewal or further renewal of an authorisation is made in accordance with regulation 66 the authorisation remains in force until the licensing authority notifies the applicant of its decision on the application.

(5) This regulation is subject to—

(za) regulation 65B;

(a) regulation 67 (failure to place on the market etc); and

(b) regulation 68 (revocation etc of marketing authorisations).

Application for renewal of authorisation

66

(1) The licensing authority may renew a UK marketing authorisation in response to an application made in accordance with this regulation.

(2) The applicant, where it is applying for renewal of—

(a) a UK marketing authorisation, must, subject to sub-paragraph (b), be established in the UK or an EEA State; and

(b) a UKMA(UK)(Category 2)—

(i) under the unfettered access route, must be established in Northern Ireland;

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (as the case may be) (3)(a) of regulation 65 (initial and further period of validity).

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy, including—

(a) the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and

(b) all amendments made since the authorisation was granted.

(7) The licensing authority may renew a UK marketing authorisation only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the authorisation relates outweigh the risks of the product to the health of patients or of the public.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a UK marketing authorisation.

Failure to place on the market etc

67

(1) A UK marketing authorisation ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom ... during the period of three years beginning immediately after the day on which it was granted.

(2) A UK marketing authorisation for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom ... for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a) in response to an application in writing by the holder of the UK marketing authorisation; or

(b) by the licensing authority of its own motion.

(5) An exemption may be granted only—

(a) in exceptional circumstances; and

(b) on public health grounds.

(6) An exemption—

(a) has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b) may be renewed or further renewed.

Revocation, variation and suspension of marketing authorisation

Revocation, variation and suspension of UK marketing authorisation or parallel import licence

68

(1) The licensing authority may revoke, vary or suspend a UK marketing authorisation or parallel import licence if any of the following conditions is met.

(2) Condition A is that the licensing authority thinks that—

(a) the product to which the authorisation relates is harmful;

(b) the positive therapeutic effects of the product do not outweigh the risks of the product to the health of patients or of the public;

(d) the product's qualitative or quantitative composition is not as described in the application for the authorisation or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the application or the material supplied with it is incorrect.

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a) a term of the authorisation or licence;

(b) in the case of a UK marketing authorisation, a requirement imposed by Part 13 (packaging and leaflets); or

(c) in the case of a parallel import licence, a requirement in relation to packaging and leaflets imposed by the licensing authority.

(5) Condition D is that the licensing authority thinks that a condition to which—

(a) the UK marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of UK marketing authorisations or parallel import licence: general); or

(b) the UK marketing authorisation is subject by virtue of regulations 60 (conditions of UK marketing authorisations: exceptional circumstances) , regulation 60A (conditions as to testing of samples by the appropriate authority) or 61 (conditions of UK marketing authorisations: new obligations post-authorisation),

has not been fulfilled.

(6) Condition E is that the licensing authority thinks that the holder of the authorisation has not complied with regulation 75(1) to (3) (requirements to provide information).

(7) Condition F is that the holder of the authorisation or licence has ceased to be established in—

(a) Northern Ireland, in the case of a UKMA(UK)(Category 2) granted under the unfettered access route, and

(b) the United Kingdom or an EEA State, in any other case,

in accordance with the requirements of these Regulations.

(8) Condition G is that—

(a) the product to which the authorisation relates is manufactured in the United Kingdom; and

(b) the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with regulations 37 (manufacturing and assembly), 38 (imports from countries other than approved countries for import), 39 (further requirements for manufacturer's licence), 40 (obligation to provide information relating to control methods) or 41 (requirements as to qualified persons).

(9) Condition H is that—

(a) the product to which the authorisation relates is manufactured in a member State ...; and

(b) the licensing authority thinks that the licensee under the manufacturer's licence for the product has failed to comply in relation to the product with provision giving effect to Article 41 of the 2001 Directive (requirements relating to manufacturing authorisations) in that member State.

(10) Condition I is that the licensing authority thinks that urgent action to protect public health is necessary, in which case it—

(a) may suspend the authorisation or licence.

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

(11) Condition J is that—

(a) the holder applies to vary the authorisation or licence; and

(b) the licensing authority thinks that the application should be granted.

(11A) Condition K is that the manufacture of the product to which the authorisation relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 8.

(11B) Condition L is that the licensing authority thinks that the term of the authorisation which specifies the way in which the product is to be made available, as described in regulation 62(1), is incorrect.

(11C) Condition M is that, in respect of a parallel import licence, the UK marketing authorisation in respect of the medicinal product that was specified in the application for that licence under paragraph 4 of Schedule 8A, has been varied, suspended or revoked by the licensing authority under this regulation.

(11D) Condition N is that, in respect of a parallel import licence, the licensing authority is no longer satisfied that the product is essentially similar to a product that has been granted a UK marketing authorisation.

(11E) The licensing authority may not exercise its powers under paragraph (1) by virtue of the condition in paragraph (11D)—

(a) before the end of the period of one year beginning with IP completion day; and

(b) in any event, in a way that prevents the import of any medicinal product in respect of which a qualified person undertook the certification referred to in Article 51(3) of the 2001 Directive before IP completion day.

(11F) Condition O is that the licensing authority thinks that a variation of a UK marketing authorisation is necessary as a result of the submission of the results of a study by the holder of that authorisation under regulation 78A(14).

(11G) Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.

(11H) Condition Q is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(UK)(Category 1).

(11I) Condition R is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(GB) and separate UKMA(NI).

(A12) Where Condition R is met, and the licence holder requests the cancellation of, or fails to renew, either the UKMA(GB) or UKMA(NI) that result from a variation being made under paragraph 11I, the licensing authority may revoke the corresponding UKMA(NI) or UKMA(GB) that results from that variation.

(12) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a UK marketing authorisation or parallel import licence, other than a proposal to vary an authorisation or licence on the application of its holder.

(13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Suspension of use etc of relevant medicinal product

69

(1) The licensing authority may, if any of the following conditions are met, suspend the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a UK marketing authorisation or parallel import licence relates.

(2) Condition A is that the licensing authority thinks that—

(a) the product to which the authorisation relates is harmful;

(b) the positive therapeutic effects of the product do not outweigh the risks of the product to the health of patients or of the public;

(d) the product's qualitative or quantitative composition is not as described in the application for the authorisation or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the holder of the authorisation has not complied with regulation 75(7) (requirements to provide proof of controls on manufacturing process).

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a) a term of the authorisation; or

(b) a requirement imposed by Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that paragraph (4) or (5) of regulation 26 (power to revoke, suspend or vary manufacturers' licences) applies in relation to the manufacturer's licence for the product to which the authorisation relates.

(6) A suspension under this regulation may relate to batches of the product.

(7) The licensing authority must give notice in writing of a suspension under this regulation to the holder of the UK marketing authorisation or parallel import licence.

(8) The licensing authority must provide in the notice that the suspension—

(a) is to take effect immediately or from a date specified in the notice; and

(b) is to apply for the period specified in the notice.

(9) Where a medicinal product is the subject of a suspension under this regulation, the licensing authority may—

(a) in exceptional circumstances; and

(b) for such a transitional period as the licensing authority may determine,

allow the supply of the medicinal product to patients who are already being treated with the medicinal product.

(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Authorisations granted under Chapter 4 of Title III of the 2001 Directive

70

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

Withdrawal of medicinal product from the market

71

(1) This regulation applies if—

(a) under regulation 68 the licensing authority revokes or suspends a UK marketing authorisation or parallel import licence; or

(b) under regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a UK marketing authorisation relates.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the authorisation or related parallel import licence requiring that person to comply with both of the following requirements.

(3) Requirement A is to take all reasonably practicable steps to inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of the product to which the authorisation relates of—

(a) the revocation or suspension;

(b) the reasons for the revocation or suspension; and

(4) Requirement B is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a) the product; or

(b) the batches of the product specified in the notice,

within the time and for the period specified in the notice.

Sale etc of suspended medicinal product

72

(1) This regulation applies if the use, sale, supply or offer for sale or supply of a medicinal product is suspended in accordance with regulation 69.

(2) A person must not—

(a) sell, supply or offer to sell or supply the product; or

(b) procure the sale, supply or offer for sale or supply of the product,

knowing, or having reasonable cause to believe, that such use, sale, supply or offer for sale or supply is suspended.

Obligations of holder of marketing authorisation

Obligation to notify placing on the market etc

73

(1) The holder of a UK marketing authorisation must notify the licensing authority of the date on which the product to which the authorisation relates is placed on the market in the United Kingdom, taking account of the various presentations authorised.

(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.

(3) The holder of a UK marketing authorisation must notify the licensing authority if the product to which the authorisation relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).

(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.

(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.

(5A) The holder of a UK marketing authorisation must notify the licensing authority forthwith if the holder takes action to—

(a) request the cancellation of the authorisation;

(b) not apply for the renewal of the authorisation; or

(c) withdraw the product to which the authorisation relates from the market in a country other than the United Kingdom (whether temporarily or permanently) and the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5B) A notification under paragraph (3) or (5A) must include the reasons for the action, in particular declaring if the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5C) The holder of a UKMA(NI) or UKMA(UK)(Category 2) must also notify the EMA forthwith where the action which is the subject of a notification by the holder under paragraph (3) or (5A) is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(6) The licensing authority may require the holder of a UK marketing authorisation to provide—

(a) information relating to the volume of sales in the United Kingdom of the product to which the authorisation relates; or

(b) information of which the holder is aware relating to the volume of prescriptions in the United Kingdom for the product.

(7) The holder of a UK marketing authorisation must provide the licensing authority with information that it requires under paragraph (6)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Obligation to take account of scientific and technical progress

74

(1) The holder of a UK marketing authorisation must keep under review the methods of manufacture and control of the product to which the authorisation relates, taking account of scientific and technical progress.

(2) As soon as is reasonably practicable after becoming aware of the need to do so, the holder must apply to vary the marketing authorisation to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

Obligation to provide information relating to methods of manufacture and control: MM medicinal products

75

(1) The holder of a UK marketing authorisation or parallel import licence must provide the licensing authority with any new information that might entail the variation of the authorisation.

(2) The holder of a UK marketing authorisation must, in particular, provide the licensing authority with the following information—

(a) information about any prohibition or restriction imposed in relation to the product to which the authorisation relates by the competent authority of any country in which the product is on the market;

(b) positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation;

(d) any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

(2A) The holder of a parallel import licence must, in particular, provide the licensing authority with—

(a) information about any prohibition or restriction imposed in relation to the product to which the licence relates by the competent authority of any country in which the product is on the market; and

(b) other information that the holder considers might influence the evaluation of the benefits and risks of the product.

(3) Information within paragraph (1) to (2A) must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a UK marketing authorisation to provide the authority with information that—

(a) is specified by the licensing authority; and

(b) demonstrates that the positive therapeutic effects of the product to which the authorisation relates continue to outweigh the risks of the product to the health of patients or of the public.

(4A) The licensing authority may require the holder of a parallel import licence to provide further information specified by the licensing authority.

(5) The information that may be required under paragraph (4) or (4A) includes information arising from use of the product—

(a) in a country other than the United Kingdom;

(b) outside the terms of the UK marketing authorisation,

including use in clinical trials.

(6) If the information supplied under paragraph (1), (2), (4) or (4A) entails the variation of the UK marketing authorisation or parallel import licence, the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a UK marketing authorisation to provide the authority with proof of the control methods employed by the manufacturer of the product to which the authorisation relates.

(8) The holder of a UK marketing authorisation or parallel import licence must provide the licensing authority with information it requests under paragraphs (4), (4A) or (7)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Obligation in relation to product information

76

(1) The holder of a UK marketing authorisation or parallel import licence for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a) in the case of a medicinal product authorised for sale or supply by a UKMA(NI) or a UKMA(UK)(Category 2)—

(i) the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii) the UK web-portal established in accordance with regulation 203(1);

(b) in the case of a medicinal product authorised for sale or supply by a UKMA(GB) or a UKMA(UK)(Category 1), the UK web-portal established in accordance with regulation 203(1).

Record-keeping obligations

77

The holder of a marketing authorisation or parallel import licence must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the authorisation relates.

Obligation to ensure appropriate and continued supplies

78

The holder of a marketing authorisation must take all reasonable steps to ensure appropriate and continued supplies of the product to which the authorisation relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.

Offences relating to specific requirements

Failure to provide information on marketing authorisations to EMA

79

(1) The holder of a UKMA(NI) or UKMA(UK)(Category 2) is guilty of an offence if the holder—

(a) has not submitted information to the EMA as required by Article 57(2)(b) of Regulation (EC) No 726/2004 (information on all existing medicinal products for human use authorised or registered in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted before 2nd July 2012; and

(b) fails to do so as soon as is reasonably practicable after the coming into force of these Regulations.

(2) The holder of UKMA(NI) or UKMA(UK)(Category 2) is guilty of an offence if the holder fails to submit information to the EMA as required by Article 57(2)(c) of Regulation (EC) No 726/2004 (information on any new or varied authorisations granted in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted on or after 2nd July 2012 as soon as is reasonably practicable after the grant of the authorisation.

Urgent safety restrictions

80

The holder of a UK marketing authorisation is guilty of an offence if the holder —

(a) fails—

(i) in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or

(ii) in respect of a UKMA(NI) or UKMA(UK)(Category 2), to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,

that the holder has taken urgent safety restrictions on the holder’s own initiative;

(b) fails—

(i) in respect of a UKMA(GB) or UKMA(UK)(Category 2), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or

(ii) in respect of a UKMA(NI) or UKMA(UK)(Category 2), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or

(c) fails in respect of a UKMA(NI) to submit an application for variation of the marketing authorisation to the licensing authority or the European Commission in accordance with Article 22(3) of that Regulation before the end of a period of fifteen days beginning on the day after—

(i) the taking under Article 22(1) or, as the case may be,

(ii) the imposition under Article 22(2),

of that Regulation of an urgent safety restriction.

(d) fails in respect of a UKMA(GB) or UKMA(UK)(Category 1) to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after—

(i) the taking under paragraph 14(1) of Schedule 10A or, as the case may be,

(ii) the imposition under paragraph 14(3) of that Schedule,

of an urgent safety restriction.

Offences relating to EU marketing authorisations

Obligation to update information supplied in connection with EU application

81

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

EU marketing authorisations: failure to notify placing on market etc

82

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

EU marketing authorisations: failure to take account of technical and scientific progress

83

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

EU marketing authorisations: failure to provide information as to safety etc

84

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

EU marketing authorisations: failure to update product information

85

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

EU marketing authorisations: breach of pharmacovigilance condition etc

86

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

Offences relating to advanced therapy medicinal products

Offences in connection with risk management systems and traceability systems

87

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

Offence concerning data for advanced therapy medicinal products

88

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

Offences relating to the Paediatric Regulation

Offences in connection with withdrawal of product from the market

89

(1) This regulation applies to a person (“H”) if—

(a) H is the holder of a UK marketing authorisation;

(b) H has benefited from one or more rewards or incentives under Article 37 or 38 of the Paediatric Regulation in relation to the product to which the authorisation relates, and

(2) H is guilty of an offence if H ceases to supply the product without previously in accordance with Article 35 of the Paediatric Regulation —

(a) transferring the UK marketing authorisation to another person who has declared an intention to continue to supply the product; or

(b) allowing such a person to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on that product as provided for in regulation 56.

(3) H is guilty of an offence if H—

(a) ceases to supply the product; and

(b) does not in accordance with Article 35 of the Paediatric Regulation inform the EMA of H's intention to do so before the beginning of the period of six months ending immediately before the day on which H does so.

Failure to place on the market taking account of paediatric indication

90

(1) A person (“P”) is guilty of an offence if—

(a) P is the holder of a UK marketing authorisation;

(b) P obtains a paediatric indication in respect of the product to which the authorisation relates following completion of an agreed paediatric investigation plan;

(d) P fails to place the product on the market taking account of the paediatric indication in accordance with Article 33 of the Paediatric Regulation before the end of the period of two years beginning immediately after the day on which the paediatric indication is authorised.

(2) In this regulation “paediatric indication” means a term of the marketing authorisation enabling the product to which it relates to be used by or administered to persons under the age of 18 years.

Failure to notify results of third country clinical trials

91

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

92

(1) This regulation applies to the sponsor (“S”) of a paediatric clinical trial in the United Kingdom in respect of a medicinal product if—

(a) the product has a UK marketing authorisation but S is not the holder of the authorisation; or

(b) the product does not have a marketing authorisation.

(2) S is guilty of an offence if S does not submit the results of the clinical trial to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of twelve months beginning with the day on which the trial ended.

Failure to notify results of paediatric study

93

(1) This regulation applies to a person (“H”) if—

(a) H is the holder of a UK marketing authorisation; and

(b) H sponsors a paediatric study in respect of the product to which the authorisation relates.

(2) H is guilty of an offence if H does not submit the results of the study to the licensing authority in accordance with Article 46(1) of the Paediatric Regulation within the period of six months beginning with the day on which the study ended.

(3) H is guilty of an offence if H does not submit the results of any clinical trial that forms part of that study to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of six months beginning with the day on which the trial ended.

Failure to submit report to EMA

94

The holder of a marketing authorisation is guilty of an offence if the holder fails to submit an annual report to the EMA as required by Article 34(4) of the Paediatric Regulation.

General provisions relating to offences

Offences in connection with application

95

A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a marketing authorisation 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;

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provision of false or misleading information

96

(1) The holder of a marketing authorisation or parallel import licence is guilty of an offence if the holder provides any information to which paragraph (2) applies that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product but that is false or misleading in a material particular to—

(a) the licensing authority;

(b) the EMA; or

(2) This paragraph applies to information about the product that is supplied pursuant to the obligations in—

(a) these Regulations; or

(b) Regulation (EC) No 726/2004.

(3) This regulation is without prejudice to the operation of regulation 95.

Breach of pharmacovigilance condition

97

(1) The holder of a marketing authorisation or a parallel import licence is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of a UK marketing authorisation or parallel import licence: general).

(2) The holder of a marketing authorisation is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation is subject by virtue of regulation 60 (conditions of a UK marketing authorisation: exceptional circumstances) , regulation 60A (condition as to the testing of samples by the appropriate authority) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).

General offence of breach of provision of this Part

98

(1) A person is guilty of an offence if that person commits a breach of a provision in this Part.

(2) A breach of a provision in this Part includes any—

(a) failure by the holder of a marketing authorisation or parallel import licence to comply with any requirement or obligation in this Part:

(b) contravention by any person of any prohibition in this Part; or

(3) Paragraph (1) is without prejudice to any offence established by any other provision in this Part.

Penalties

99

(1) A person guilty of an offence under this Part, other than a breach of regulation 79 (failure to provide information on marketing authorisations to EMA), 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 a breach of regulation 79 is liable—

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

(b) on conviction on indictment, to a fine.

Persons liable

100

If a breach of regulation 95 (offences in connection with application) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

Defences

101

(1) Paragraph (2) applies if the holder of a marketing authorisation or parallel import licence is charged with an offence under this Part in respect of anything that—

(a) has been manufactured or assembled to the holder's order by another person; and

(b) has been so manufactured or assembled as not to comply with the terms of the authorisation.

(2) It is a defence for the holder to prove that—

(a) the holder communicated the terms of the authorisation to the other person; and

(b) the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.

(3) It is a defence for a person charged with an offence consisting of a breach of regulations 73(3) or 78, or an offence under any of regulations 89 to 93, 95 and 96, to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

PART 6 — Certification of homoeopathic medicinal products

Application of Part

102

(1) This Part applies to a homoeopathic medicinal product (a “registrable homoeopathic medicinal product”) that meets the following conditions.

(2) Condition A is that the product is administered orally or externally.

(3) Condition B is that no specific therapeutic indication appears—

(a) on the labelling of the product; or

(b) in any information supplied with the product.

(4) Condition C is that—

(a) the product contains no more than one part per 10,000 of the mother tincture; and

(b) in a case where the product's active substance is a relevant allopathic substance, the product contains no more than 1/100th of the smallest concentration of that substance used in allopathy.

(5) In this regulation “relevant allopathic substance” means an active substance whose presence in an allopathic medicinal product means that the product is only available on prescription.

(6) For this purpose—

(a) “allopathic medicinal product” means a medicinal product other than a homoeopathic medicinal product; and

(b) “allopathy” means treatment using an allopathic medicinal product.

(7) The Secretary of State may make regulations in respect of Great Britain to amend paragraphs (4) to (6).

(8) The Secretary of State may only exercise the power in paragraph (7) if the Secretary of State considers that it is necessary to do so because of new scientific evidence.

Application for certificate of registration and consideration of application

Application for certificate of registration

103

(1) The licensing authority may, subject to regulation 104, grant an application for a certificate of registration for a registrable homoeopathic medicinal product in response to an application made in accordance with this Part.

(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a COR(GB) only where—

(a) there is already in place, or will be at the time the COR(GB) is granted, a certificate of registration in respect of the product authorising sale or supply in Northern Ireland,

(b) the applicant complies with the requirements in paragraph (5B), and

(1B) A certificate of registration must state whether it is in force in—

(a) the whole United Kingdom;

(b) Great Britain only; or

and in these Regulations the meaning of a reference to that certificate of registration being “in force” is limited to that territory.

(2) A certificate granted under paragraph (1) shall contain terms approved by the licensing authority.

(3) The application may relate to two or more homoeopathic medicinal products derived from the same homoeopathic stock or the same combination of homoeopathic stocks.

(4) The applicant where it is applying for—

(a) a COR(NI)—

(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii) on any other basis, must be established in the United Kingdom;

(b) a COR(GB)—

(i) under the unfettered access route, must be established in Northern Ireland;

(ii) other than under the unfettered access route, must be established in the United Kingdom;

(5) The application must be—

(a) made in writing;

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

(5A) The application must include a statement indicating whether the certificate sought is for sale or supply of the product in—

(a) the whole United Kingdom;

(b) Great Britain only; or

(5B) The applicant for the grant of a COR(GB) under the unfettered access route must provide—

(a) the application form submitted in connection with the granting of the COR(NI) which authorises the sale or supply of the product in Northern Ireland;

(b) a copy of all material submitted in support of the application for the COR(NI) which authorises the sale or supply of the product in Northern Ireland; and

together with any material specified in paragraph (8) which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.

(6) An application is treated as signed for the purposes of paragraph (5)(b) if it is signed with an electronic signature.

(7) The application and any accompanying material must be in English.

(8) The applicant must provide each of the following for each product to which the application relates—

(a) a statement of the scientific name, or other name given in a pharmacopoeia, of the homoeopathic stock or stocks from which the product is derived;

(b) a statement of the routes of administration, pharmaceutical forms and degree of dilution of the product;

(c) a dossier describing how the homoeopathic stock or stocks are obtained and controlled and justifying their homoeopathic use on the basis of an adequate bibliography;

(d) a manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation of the product;

(e) evidence that each manufacturer of the medicinal product is authorised to manufacture it (which, in the case of a product manufactured in the United Kingdom ..., means the manufacturer's licence or (as the case may be) its equivalent in a country other than the United Kingdom);

(f) where an authorisation to place the product on the market has been granted by a country other than the United Kingdom, a copy of the authorisation;

(g) a mock-up of the outer and immediate packaging of the product; and

(h) data concerning the stability of the product.

(9) This material, taken as a whole, must be such as to demonstrate the pharmaceutical quality and batch to batch homogeneity of each product to which the application relates.

(10) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.

Consideration of application

104

(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a certificate of registration before the end of the period of 210 days beginning immediately after the day on which an application for the certificate is submitted in accordance with regulation 103.

(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—

(a) beginning with the date on which the request is made; and

(b) ending with the date on which the information or material is provided.

(3) The licensing authority may grant a certificate only if, having considered the application and the accompanying material, the authority thinks that—

(a) the risks to the health of patients or of the public associated with the product do not outweigh any beneficial effects of the homoeopathic medicinal product in question;

(b) the application and the accompanying material complies with regulation 103; and

(c) the product's qualitative or quantitative composition is as described in the application and the accompanying material.

(4) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a certificate of registration.

(5) This regulation does not apply to an application that—

(a) has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive; or

(b) has been referred to the Committee for Medicinal Products for Human Use for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.

(6) An application to which paragraph (5) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.

(7) In the case of an application under the unfettered access route, the licensing authority may grant a COR(GB) (notwithstanding paragraph (3)) where the licensing authority—

(a) has considered the application under the unfettered access route and the accompanying material,

(b) is satisfied that the applicant has complied with the application requirements, and

(8) The licensing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.

Conditions of certificate of registration

105

(1) The licensing authority may—

(a) grant a certificate of registration subject to conditions; or

(b) vary or remove a condition to which the certificate of registration is subject.

(2) The powers in paragraph (1) may be exercised only after consultation with the applicant for the certificate or (as the case may be) its holder.

(3) The power in paragraph (1)(a) to grant an authorisation subject to conditions may be exercised only—

(a) in exceptional circumstances; and

(b) when the applicant can show that the applicant is unable to provide comprehensive data on the safety of the medicinal product under normal conditions of use.

(4) The conditions must relate to a matter addressed by Annex I to the 2001 Directive.

(5) The conditions may, in particular, relate to the safety of the product to which the certificate relates.

(6) The conditions may, in particular, require that, where there is an incident relating to the use of the product—

(a) the incident must be reported to the licensing authority; and

(b) such other action as may be specified in the conditions must be taken.

(7) The licensing authority must keep under review—

(a) the conditions to which a certificate of registration is subject; and

(b) the holder's compliance with those conditions.

(8) The licensing authority must consider those matters no less frequently than—

(a) at the end of the period of one year beginning with the date on which the certificate was granted; and

(b) at the end of each subsequent period of one year.

(9) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a certificate of registration is subject.

Classification of certificate of registration

106

(1) A certificate of registration must include a term that the product to which the certificate relates is to be available—

(a) only from a pharmacy; or

(b) on general sale.

(2) A certificate of registration may include a term that the product to which the certificate relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12).

Validity of certificate of registration

107

(1) Subject to the following paragraphs, a certificate of registration remains in force—

(a) for an initial period of five years beginning with the date on which it is granted; and

(b) if the authorisation is renewed under regulation 108 for an unlimited period after its renewal.

(2) The licensing authority may, on the first application for renewal of a certificate, determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3) In that event, the certificate remains in force—

(a) for a further period of five years beginning with the date on which it is first renewed; and

(b) if the authorisation is further renewed under regulation 108 for an unlimited period after its further renewal.

(4) If an application for the renewal or further renewal of a certificate is made in accordance with regulation 108 the certificate remains in force until the licensing authority notifies the applicant of its decision on the application.

(5) This regulation is subject to—

(a) regulation 109 (failure to place on the market etc); and

(b) regulation 110 (revocation etc of certificate of registration).

Application for renewal of certificate

108

(1) An application for the renewal of a certificate of registration must be made to the licensing authority.

(2) The applicant , where it is applying for renewal of—

(a) a COR(NI) and originally granted—

(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii) on any other basis, must be established in the United Kingdom;

(b) a COR(GB) and originally granted—

(i) under the unfettered access route, must be established in Northern Ireland;

(ii) other than under the unfettered access route, 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 before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (as the case may be) (3)(a) of regulation 107 (initial and further period of validity).

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy (including all amendments made since the authorisation was granted).

(7) The licensing authority may renew a certificate only if, having considered the application and the material accompanying it, the authority thinks that the risks to the health of patients or of the public associated with the homoeopathic medicinal product to which the certificate relates do not outweigh any beneficial effects of the product.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a certificate of registration.

Failure to place on the market etc

109

(1) A certificate of registration ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom (or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain) during the period of three years beginning immediately after the day on which it was granted.

(2) A certificate of registration for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom (or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain) for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a) in response to an application in writing by the holder of the certificate of registration; or

(b) by the licensing authority of its own motion.

(5) An exemption may be granted only—

(a) in exceptional circumstances; and

(b) on public health grounds.

(6) An exemption—

(a) has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b) may be renewed or further renewed.

Revocation, variation and suspension of certificate of registration

110

(1) The licensing authority may revoke, vary or suspend a certificate of registration if any of the following conditions are met.

(2) Condition A is that the licensing authority thinks that—

(a) the product to which the certificate relates is harmful;

(b) the risks of the product to the health of patients or of the public outweigh any beneficial effects of the product; or

(c) the product's qualitative or quantitative composition is not as described in the application for the certificate or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the application or the material accompanying it is incorrect.

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a) a term of the certificate; or

(b) a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that a condition to which the certificate is subject by virtue of regulation 105 (conditions of certificate or registration) has not been fulfilled.

(6) Condition E is that the licensing authority thinks that the holder of the certificate has not complied with regulation 115(1) to (3) (requirements to provide information).

(7) Condition F is that the holder of the certificate has ceased to be established in—

(a) the United Kingdom; or

(b) in relation to a COR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.

(8) Condition G is that—

(a) the holder applies to vary the certificate; and

(b) the licensing authority thinks that the application should be granted.

(8A) Condition H is that the manufacture and control of the product to which the certificate relates is not in compliance with the particulars provided under regulation 103(8)(c) and (d).

(8B) Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.

(9) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a certificate of registration, other than a proposal to vary a certificate on the application of its holder.

(10) This regulation is subject to regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive).

Certificates granted under Chapter 4 of Title III of the 2001 Directive

111

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

Withdrawal of homoeopathic medicinal product from the market

112

(1) This regulation applies if under regulation 110 ... the licensing authority revokes or suspends a certificate of registration.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the certificate requiring the holder to comply with the following requirement.

(3) That requirement is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a) the product to which the certificate relates; or

(b) the batches of the product specified in the notice,

within the time and for the period specified in the notice.

(4) The notice must specify the grounds for giving the notice.

Obligations of holder of certificate of registration

Obligation to notify placing on the market etc

113

(1) The holder of a certificate of registration must notify the licensing authority of the date on which the product to which the certificate relates is placed on the market in the United Kingdom taking account of the various presentations authorised.

(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.

(3) The holder of a certificate of registration must notify the licensing authority if the product to which the certificate relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).

(3A) A notification under paragraph (3) must include the reasons for the withdrawal ....

(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.

(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.

(6) The licensing authority may require the holder of a certificate of registration to provide information relating to the volume of sales in the United Kingdom of the product to which the certificate relates.

(7) The holder of a certificate of registration must provide the licensing authority with information that it requires under paragraph (6)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Obligation to take account of scientific and technical progress

114

(1) The holder of a certificate of registration must keep under review the methods of manufacture and control of the product to which the certificate relates, taking account of scientific and technical progress.

(2) As soon as is reasonably practicable after becoming aware of the need to do so, the holder must apply to vary the certificate of registration to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

Obligation to provide information relating to safety etc

115

(1) The holder of a certificate of registration must provide the licensing authority with any new information that might entail the variation of the certificate.

(2) The holder must, in particular, provide the licensing authority with the following information—

(a) information about any prohibition or restriction imposed in relation to the product to which the certificate relates by the competent authority of any country in which the product is on the market;

(b) positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the certificate of registration;

(d) any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

(3) Information within paragraph (1) or (2) must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a certificate of registration to provide the authority with information that—

(a) is specified by the licensing authority; and

(b) demonstrates that the risks of the product to the health of patients or of the public do not outweigh any beneficial effects of the product to which the certificate relates.

(5) The information that may be required under paragraph (4) includes information arising from use of the product—

(a) in a country other than the United Kingdom; or

(b) outside the terms of the certificate of registration.

(6) If the information supplied under paragraph (1), (2) or (4) entails the variation of the certificate of registration, the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a certificate of registration to provide the authority with proof of the control methods employed by the manufacturer of the product to which the certificate relates.

(8) The licensing authority may notify the holder of a certificate of registration that it requires the holder to provide to the licensing authority information of any description specified in the notice, within the period specified in the notice, subject to paragraph (9).

(9) A notice under paragraph (8) must not be served unless it appears to the licensing authority, or it is represented to the licensing authority by the Commission or by an expert committee appointed by the licensing authority—

(a) that circumstances exist by reason of which it is necessary to consider whether the certificate of registration should be varied, suspended or revoked; and

(b) that the information required by the notice is needed to consider that question.

(10) The holder of a certificate of registration must provide the licensing authority with information that it requires under paragraphs (4) or (7)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Obligation in relation to product information

116

(1) The holder of the certificate of registration for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a) in the case of a medicinal product authorised by a COR(NI) or COR(UK)—

(i) the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii) the UK web-portal established in accordance with regulation 203(1);

(b) in the case of a medicinal product authorised by a COR(GB), the UK web-portal established in accordance with regulation 203(1).

Record-keeping obligation

117

The holder of a certificate of registration must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of the product to which the certificate relates.

Obligation to ensure appropriate and continued supplies

118

The holder of a certificate of registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the certificate relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.

Provisions relating to offences

Offences in connection with applications

119

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The Human Medicines Regulations 2012

Conditions of UK marketing authorisation: exceptional circumstances

60

Conditions of UK marketing authorisation: new obligations post-authorisation

61

Classification of UK marketing authorisation or parallel import licence

62

Frequency of periodic safety update reports

63

Duties of licensing authority in connection with determination

64

Validity of UK marketing authorisation

Validity of UK marketing authorisation

65

Application for renewal of authorisation

66

Failure to place on the market etc

67

Revocation, variation and suspension of marketing authorisation

Revocation, variation and suspension of UK marketing authorisation or parallel import licence

68

Suspension of use etc of relevant medicinal product

69

Authorisations granted under Chapter 4 of Title III of the 2001 Directive

70

Withdrawal of medicinal product from the market

71

Sale etc of suspended medicinal product

72

Obligations of holder of marketing authorisation

Obligation to notify placing on the market etc

73

Obligation to take account of scientific and technical progress

74

Obligation to provide information relating to methods of manufacture and control: MM medicinal products

75

Obligation in relation to product information

76

Record-keeping obligations

77

Obligation to ensure appropriate and continued supplies

78

Offences relating to specific requirements

Failure to provide information on marketing authorisations to EMA

79

Urgent safety restrictions

80

Offences relating to EU marketing authorisations

Obligation to update information supplied in connection with EU application

81

EU marketing authorisations: failure to notify placing on market etc

82

EU marketing authorisations: failure to take account of technical and scientific progress

83

EU marketing authorisations: failure to provide information as to safety etc

84

EU marketing authorisations: failure to update product information

85

EU marketing authorisations: breach of pharmacovigilance condition etc

86

Offences relating to advanced therapy medicinal products

Offences in connection with risk management systems and traceability systems

87

Offence concerning data for advanced therapy medicinal products

88

Offences relating to the Paediatric Regulation

Offences in connection with withdrawal of product from the market

89

Failure to place on the market taking account of paediatric indication

90

Failure to notify results of third country clinical trials

91

Failure of sponsor of UK paediatric clinical trial to notify results of trial

92

Failure to notify results of paediatric study

93

Failure to submit report to EMA

94

General provisions relating to offences

Offences in connection with application