The Human Medicines Regulations 2012

• (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

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EU marketing authorisations: failure to notify placing on market etc

82

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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

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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

• (c) all of the periods of protection provided pursuant to those Articles have expired in relation to H.

• (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;

• (c) the product was placed on the market for other indications before P obtained that paediatric indication; and

• (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

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

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

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;

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (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

• (c) the competent authorities of other EEA States.

• (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

• (c) failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.

• (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

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

• (c) the registrable homoeopathic medicinal product satisfies the definition of qualifying Northern Ireland goods.

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

• (a) the whole United Kingdom;

• (b) Great Britain only; or

• (c) Northern Ireland only,

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;

• (c) a COR(UK), 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

• (c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

• (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

• (c) Northern Ireland only.

• (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

• (c) a copy of the COR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

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

• (c) is satisfied that the conditions in regulation 103(1A) will continue to be met.

• (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;

• (c) in the whole United Kingdom, 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

• (c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

• (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

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;

• (c) data on the use of the product where such use is outside the terms of the certificate of registration; and

• (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

A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a certificate of registration for a registrable homoeopathic medicinal product, the person—

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

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

Provision of false or misleading information

120

• (1) The holder of a certificate of registration for a medicinal product is guilty of an offence if the person provides the licensing authority with any information that is relevant to the quality of the product but that is false or misleading in a material particular.

• (2) Paragraph (1) is without prejudice to the operation of regulation 119.

General offence of breach of provision of this Part

121

• (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 certificate of registration to comply with any requirement or obligation in this Part;

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

• (c) failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.

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

Penalties

122

A person guilty of an offence under this Part 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

123

If an offence under regulation 119 (offences in connection with applications) 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

124

• (1) Paragraph (2) applies if the holder of a certificate of registration 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 certificate.

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

• (a) the holder communicated the terms of the certificate 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 regulation 113(3) or 118 or an offence under regulation 119 or 120 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 7 — Traditional herbal registrations

Interpretation and application of Part

Traditional herbal medicinal products

125

• (1) This Part applies to a herbal medicinal product (a “traditional herbal medicinal product”) if the following conditions are met.

• (2) Condition A is met if by virtue of its composition and indications the product is appropriate for use without the need for a medical practitioner to—

• (a) diagnose the condition to be treated by the product;

• (b) prescribe the product; or

• (c) monitor the product's use.

• (3) Condition B is met if the product is intended to be administered at a particular strength and in accordance with a particular posology.

• (4) Condition C is met if the product is intended to be administered externally, orally or by inhalation.

• (5) Condition D is met if—

• (a) the product has been in medicinal use for a continuous period of at least 30 years, and

• (b) in relation to—

• (i) a THR(NI) or THR(UK), the product has been in medicinal use in the European Union for a continuous period of at least 15 years;

• (ii) a THR(GB), the product has been in medicinal use in the United Kingdom or a country included in the list published under regulation 125A(1) for a continuous period of at least 15 years.

• (6) It is immaterial for the purposes of condition D whether or not during a period mentioned in that condition—

• (a) the sale or supply of the product has been based on a specific authorisation; or

• (b) the number or quantity of the ingredients (or any of them) has been reduced.

• (7) Condition E is met if there is sufficient information about the use of the product as mentioned in condition D (referred to in this Part as its “traditional use”), so that (in particular)—

• (a) it has been established that the traditional use of the product is not harmful; and

• (b) the pharmacological effects or efficacy of the product are plausible on the basis of long-standing use and experience.

Addition of vitamins or minerals

126

The addition to a traditional herbal medicinal product of a vitamin or mineral does not prevent a traditional herbal registration from being granted for the product if—

• (a) there is well-documented evidence of the safety of the vitamin or mineral; and

• (b) the action of the vitamin or mineral is ancillary to the action of the product's active herbal ingredients in connection with the use authorised by the traditional herbal registration.

Application for traditional herbal registration

Application for grant of traditional herbal registration

127

• (1) The licensing authority may, subject to regulation 130, grant an application for a traditional herbal registration for a traditional herbal 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 THR(GB) only where—

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

• (b) the applicant complies with the requirements in regulation 128(1A), and

• (c) the traditional herbal medicinal product satisfies the definition of qualifying Northern Ireland goods.

• (1B) A traditional herbal registration must state whether it is in force in—

• (a) the whole United Kingdom;

• (b) Great Britain only; or

• (c) Northern Ireland only,

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

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

• (3) The applicant , where it is applying for—

• (a) a THR(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 THR (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;

• (c) a THR(UK), must be established in the United Kingdom.

• (4) The application must be—

• (a) made in writing;

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

• (c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

• (4A) The application must include a statement indicating whether the traditional herbal registration sought is for sale or supply of the product in—

• (a) the whole United Kingdom;

• (b) Great Britain only; or

• (c) Northern Ireland only.

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

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

• (7) The application must include a statement indicating whether the product to which the application relates should be available—

• (a) only from a pharmacy; or

• (b) on general sale.

• (8) The application must include a statement indicating—

• (a) whether any terms of the registration are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and

• (b) if so, what terms are proposed.

Accompanying material

128

• (1) The applicant for the grant of a traditional herbal registration other than a THR(GB) under the unfettered access route must provide the material specified in Schedule 12 in relation to the product.

• (1A) The applicant for the grant of a THR(GB) under the unfettered access route must provide—

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

• (c) a copy of the THR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

together with any material specified in Schedule 12 which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.

• (2) 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.

• (3) If the application relates to a product that is contained in the list referred to in Article 16f(1) of the 2001 Directive where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)—

• (a) the applicant does not need to provide the material referred to in paragraphs 16 to 20 of Part 1 of Schedule 12; and

• (b) paragraph (2) of this regulation does not apply.

• (4) Material that is submitted under this regulation must be submitted in accordance with Annex I to the 2001 Directive, so far as applicable to traditional herbal medicinal products.

Obligation to update information supplied in connection with application

129

• (1) The applicant for a traditional herbal registration 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.

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

Consideration of application

Consideration of application

130

• (1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a traditional herbal registration before the end of the period of 210 days beginning immediately after the day on which an application for the registration is submitted in accordance with regulation 128.

• (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) If the licensing authority requests the applicant to give an oral or written explanation of the application, 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 explanation is provided.

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

• (a) the product complies with conditions A to E of regulation 125 (conditions for a product to be a traditional herbal medicinal product);

• (b) the product to which the application relates is not harmful under normal conditions of use;

• (c) the application and the accompanying material complies with the requirements of this Part;

• (d) the product's qualitative and quantitative composition is as described in the application and the accompanying material; and

• (e) the product's pharmaceutical quality has been satisfactorily demonstrated.

• (5) The licensing authority need not take into account any updated information supplied in connection with the application under regulation 129 (obligation to update information supplied in connection with application), unless it thinks that the information is unfavourable in respect of the safety, quality or efficacy of the product concerned

• (6) The licensing authority may refuse the application on the ground that it is more appropriate to consider whether to authorise the placing of the product on the market in response to an application for a UK marketing authorisation or certificate of registration for the product.

• (7) Paragraph (4)(a)

• (a) where the application is for a THR(NI) or THR(UK), is subject to Article 16c(4) of the 2001 Directive (procedure where product has been used in the European Union for less than 15 years);

• (b) where the application is for a THR(GB), is subject to regulation 130A.

• (8) If the application relates to a herbal medicinal product that is contained in the list referred to Article 16f(1) of the 2001 Directive where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)—

• (a) paragraph (4)(a) applies as if it referred to conditions A to D of regulation 125; and

• (b) paragraph (4)(b) does not apply.

• (9) Where , in relation to an application for a THR(NI) or THR(UK), Article 16d(1) of the 2001 Directive (products to which the mutual recognition procedure and decentralised procedure apply) does not apply to the product, the licensing authority must, in considering the application, take into account any registrations granted by other member States in accordance with Chapter 2a of Title III of the 2001 Directive.

• (10) The licensing authority must take into account—

• (a) any herbal monograph of the kind referred to —

• (i) in Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK);

• (ii) in regulation 143A, where the application is for a THR(GB),

that the authority thinks relevant to the application; or

• (b) if no relevant monograph within sub-paragraph (a) has been established, such other monographs, publications or data as the authority thinks relevant.

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

• (12) This regulation does not apply where , in relation to an application for a THR(NI) or THR(UK), Article 16d(1) applies to the product and the application—

• (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 Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.

• (13) An application to which paragraph (12) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.

• (14) In the case of an application under the unfettered access route, the licensing authority may grant a THR(GB) (notwithstanding paragraph (4)) 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

• (c) is satisfied that the conditions in regulation 127(1A) will continue to be met.

• (15) The licencing 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.

Classification of traditional herbal registration

131

• (1) A traditional herbal registration must include a term that the product to which the registration relates is to be available—

• (a) only from a pharmacy; or

• (b) on general sale.

• (2) A traditional herbal registration may include a term that the product to which the registration 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 traditional herbal registration

Validity of traditional herbal registration

132

• (1) Subject to the following paragraphs, a traditional herbal 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 registration is renewed under regulation 133 for an unlimited period after its renewal.

• (2) The licensing authority may on the first application for renewal of a registration 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 registration 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 registration is further renewed under regulation 133 for an unlimited period after its further renewal.

• (4) If an application for the renewal or further renewal of a registration is made in accordance with regulation 133 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 134 (failure to place on the market); and

• (b) regulation 135 (revocation etc of traditional herbal registration).

Application for renewal of registration

133

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

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

• (a) a THR(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 THR(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;

• (c) a THR(UK), 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

• (c) unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

• (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 (3)(a) of regulation 132 (initial and further period of validity), as the case may be.

• (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 variations introduced since the traditional herbal registration was granted.

• (7) The licensing authority may renew a traditional herbal registration 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 registration 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 traditional herbal registration.

Failure to place on the market etc

134

• (1) A traditional herbal 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 THR(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 traditional herbal 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 THR(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 traditional herbal registration; or

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

• (5) An exemption may only 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 traditional herbal registration

Revocation, variation and suspension of traditional herbal registration

135

• (1) The licensing authority may revoke, vary or suspend a traditional herbal 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 registration relates is harmful;

• (b) the pharmacological effects or efficacy of the product are no longer plausible; or

• (c) the product's qualitative or quantitative composition is not as described in the application for the registration or the material accompanying 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 registration; or

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

• (5) Condition D is that the licensing authority thinks that the holder of the registration has not complied with regulation 145(1) to (3) (requirement to provide information that may entail amendment of authorisation).

• (6) Condition E is that the holder of the registration has ceased to be established in—

• (a) the United Kingdom; or

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

in accordance with the requirements of these Regulations.

• (7) Condition F is that—

• (a) the product to which the registration 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 states other than EEA States / 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).

• (8) Condition G is that—

• (a) the product to which the registration relates is manufactured in an EEA State ...; 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 provision giving effect to Article 41 of the 2001 Directive (requirements relating to manufacturing authorisations) in that member State.

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

• (a) may suspend the registration; and

• (b) in the case of a THR(NI) or THR(UK), must notify the suspension to the EMA, the European Commission, and all other member States by the end of the next working day following the day on which the suspension comes into force.

• (10) Condition I is that—

• (a) the holder applies to vary the registration; and

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

• (10A) Condition J is that the manufacture of the product to which registration relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 12.

• (10B) Condition K 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.

• (11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation by licensing authority: further provisions

136

• (1) The licensing authority must revoke a traditional herbal registration if—

• (a) the application for the registration was submitted in accordance with regulation 128(3) on the basis that the herbal medicinal product to which it relates was contained in