Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles 4

Reform history JSON API

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

(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

(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

(1B) A traditional herbal 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 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;

(4) The application must be—

(a) made in writing;

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

(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

(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

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

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;

(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

(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

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;

(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 (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

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

(i) the list referred to in Article 16f(1) of the 2001 Directive, in the case of a THR(NI) or THR(UK);

(ii) the list established under regulation 126A where the application is for a THR(GB); and

(b) the product ceases to be contained in that list.

(2) Paragraph (1) does not apply if within the period of three months beginning immediately after the day on which product ceases to be contained on the list the holder—

(a) submits to the licensing authority the material specified in Schedule 12 (including that referred to in paragraphs 16 to 20 of Part 1 of that Schedule) in relation to the product; and

(b) provides the licensing authority with any material or information that the licensing authority reasonably considers necessary for considering the application and requests the holder to provide.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedures for revocation, variation or suspension

137

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

Suspension of use etc of traditional herbal medicinal product

138

(1) The licensing authority may suspend the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates if any of the following conditions are met.

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

(a) the product 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 holder has not complied with regulation 145(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 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 paragraph (4) or (5) of regulation 23 (power to revoke, suspend or vary manufacturers' licences) applies in relation to the manufacturer's licence for the product.

(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 registration.

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

139

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

Withdrawal of traditional herbal medicinal product from the market

140

(1) This regulation applies if—

(a) under—

(i) regulation 135 or 136, in the case of a THR(GB);

(ii) regulation 135 or 136 or Article 34(3) of the 2001 Directive, in the case of a THR(NI) or THR(UK),

the licensing authority revokes or suspends the registration; or

(b) under regulation 138 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the registration requiring the holder 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 registration 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 traditional herbal medicinal product

141

(1) This regulation applies if the use, sale, supply or offer for sale or supply of a traditional herbal medicinal product is suspended in accordance with regulation 138 ....

(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 traditional herbal registration

Obligation to notify placing on the market etc

142

(1) The holder of a traditional herbal registration must notify the licensing authority of the date on which the product to which the registration 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 traditional herbal registration must notify the licensing authority if the product to which the registration 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 traditional herbal registration must notify the licensing authority forthwith if the holder takes action to—

(a) request the cancellation of the registration;

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

(c) withdraw the product to which the registration relates from the market in a third country (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 THR(NI) or THR(UK) must 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 traditional herbal registration to provide information relating to the volume of sales in the United Kingdom of the product to which the registration relates.

(7) The holder of a traditional herbal 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

143

(1) The holder of a traditional herbal registration must keep under review the methods of manufacture and control of the product to which the registration 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 traditional herbal registration to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

Obligation following new herbal monograph

144

(1) Paragraph (2) applies where a new herbal monograph of the kind referred to—

(a) in the case of a THR (NI) or THR (UK), in Article 16h(3) of the 2001 Directive, or

(b) in the case of a THR (GB), in regulation 143A,

is established.

(2) Where this paragraph applies, the holder of the THR(GB), THR(NI) or THR(UK) to which the monograph relates must as soon as is reasonably practicable—

(a) consider whether to modify the registration dossier; and

(b) notify any modification to the licensing authority.

Obligation to provide information relating to safety etc

145

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

(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 registration 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 traditional herbal 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 traditional herbal registration 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 registration relates outweigh the risks of the product to the health of patients or of the public.

(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 traditional herbal registration,

including use in clinical trials.

(6) If the information supplied under paragraph (1), (2) or (4) entails the variation of the traditional herbal 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 traditional herbal registration to provide the authority with proof of the control methods employed by the manufacturer of the product to which the registration relates.

(8) The holder of a traditional herbal registration must provide the licensing authority with information that it requires under paragraph (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

146

(1) The holder of the traditional herbal 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 for sale or supply in Northern Ireland—

(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 for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).

Record-keeping obligations

147

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

Obligation to ensure appropriate and continued supplies

148

The holder of a traditional herbal registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the registration 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 traditional herbal registrations

Urgent safety restrictions

149

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

(a) fails to inform the licensing authority or 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 to implement an urgent safety restriction imposed on the holder by the licensing authority or the European Commission under Article 22(2) of that Regulation; or

(c) fails to submit an application for variation of the traditional herbal registration 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;

(2) The holder of a THR(GB) is guilty of an offence if the holder—

(a) fails to inform the licensing authority in accordance with regulation 148A(1) that the holder has taken urgent safety restrictions on the holder's own initiative;

(b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with regulation 148A(2); or

(c) fails to submit an application for variation of the traditional herbal registration to the licensing authority in accordance with regulation 148A(4) before the end of the period of 15 days beginning with the day after—

(i) the taking under regulation 148A(1), or

(ii) the imposition under regulation 148A(2),

of an urgent safety restriction.

Offences in connection with applications

150

A person is guilty of an offence if in the course of an application for the grant, renewal or variation of a traditional herbal registration for a traditional herbal 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 that is false or misleading in a material particular.

Provision of false or misleading information

151

(1) The holder of a traditional herbal registration is guilty of an offence if the holder provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of a traditional herbal medicinal product but that is false or misleading in a material particular.

(2) Paragraph (1) is without prejudice to regulation 150.

General offence of breach of provision of this Part

152

(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 traditional herbal registration 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

153

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

154

If an offence under regulation 150 (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

155

(1) Paragraph (2) applies if the holder of a traditional herbal 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 authorisation.

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

(a) the holder communicated the terms of the registration 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 142(3) or 148 or an offence under regulation 150 or 151 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 8 — Article 126a authorisations

Article 126a authorisations

156

(1) The licensing authority may grant an Article 126a authorisation for sale or supply of a medicinal product in Northern Ireland only, if the following conditions are met.

(2) Condition A is that no United Kingdom marketing authorisation, certificate of registration or traditional herbal registration is in force in Northern Ireland for the product.

(3) Condition B is that no application is pending in the United Kingdom for a marketing authorisation, certificate of registration or traditional herbal registration to be in force in Northern Ireland for the product.

(4) Condition C is that the licensing authority considers that the placing of the product on the market in Northern Ireland is justified for public health reasons.

(5) Condition D is that the product is imported from an EU member State that has, in accordance with the 2001 Directive, authorised the placing on the market of the product in that member State.

(6) Condition E is that the person to whom the authorisation is granted is established in the European Union.

(7) Before granting an Article 126a authorisation, the licensing authority must notify the authorisation holder in the member State mentioned in paragraph (5) of the proposal to grant the Article 126a authorisation.

(8) Before granting an Article 126a authorisation, the licensing authority may request the competent authority in the member State mentioned in paragraph (5) to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—

(a) the assessment report for that product as mentioned in Article 21(4) of the 2001 Directive; and

(b) the authorisation in force for that product.

(9) An Article 126a authorisation remains in force for the period specified in it unless revoked before the end of that period.

(10) That period may be specified by reference to the occurrence or non-occurrence of a particular event or events.

Requests from other member States

157

(1) Paragraph (2) applies where the licensing authority , in relation to a UKMA(NI), is requested by the competent authority of a member State to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—

(a) the assessment report for a medicinal product as mentioned in regulation 64(5) (duties of licensing authority in connection with determination); and

(b) the marketing authorisation in force for that product.

(2) The licensing authority must supply those documents to the competent authority before the end of the period of thirty days beginning on the day after the request is received.

Application of these Regulations

158

The following provisions of Part 5 (marketing authorisations) apply to an Article 126a authorisation as they apply to a marketing authorisation—

(a) regulation 62 (classification of marketing authorisation);

(b) regulation 63 (frequency of periodic safety update reports);

(c) regulation 68 (revocation etc of marketing authorisation) and Schedule 11 (advice and representations in connection with revocations etc) so far as relating to that regulation;

(d) regulation 69 (suspension of use etc of medicinal product);

(e) regulation 71 (withdrawal of medicinal products from the market);

(f) regulation 72 (sale etc of suspended medicinal product);

(g) regulation 80 (urgent safety restrictions); and

(h) regulations 98 (general offence of breach of provision of this Part), 99 (penalties) and 101(1) and (2) (defences), so far as relating to the regulations mentioned in sub-paragraphs (a) and (e) to (f).

PART 9 — Borderline products

Provisional determination

159

(1) This regulation applies if the licensing authority thinks that a product without a UK marketing authorisation, traditional herbal registration, certificate of registration or , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation ..., is a medicinal product.

(2) The licensing authority may give a notice in writing (a “provisional determination notice”) to any person (the “recipient”)—

(a) who has sold or supplied the product, or has offered to sell or supply it; or

(b) whom the licensing authority thinks may sell or supply the product.

(3) The provisional determination notice must—

(a) advise the recipient that the licensing authority has made a provisional determination that the product is a medicinal product;

(b) give reasons for the provisional determination;

(c) advise the recipient of the recipient's rights to challenge the provisional determination in accordance with regulation 160 and

(d) specify a period of at least six weeks beginning immediately after the date on which the provisional determination notice is given to the recipient (in this Part “the determination date”) within which any written representations in accordance with regulation 160(2)(a) must be made to the licensing authority.

Challenge to provisional determination

160

(1) A recipient of a provisional determination notice may, within the period of four weeks beginning immediately after the determination date, give notice in writing to the licensing authority requesting the authority to submit the provisional determination to review.

(2) If the recipient gives such notice the recipient must—

(a) within the period specified in the provisional determination notice, make written representations to the licensing authority explaining why the recipient thinks the product is not a medicinal product; or

(b) within the period of four weeks beginning immediately after the determination date, inform the licensing authority in writing that the recipient wants to make oral representations explaining why the recipient thinks the product is not a medicinal product.

(3) If—

(a) the recipient has informed the licensing authority that the recipient wants to make written representations in accordance with paragraph (2)(a); and

(b) the licensing authority thinks that, because of exceptional circumstances or the nature or complexity of the issues involved, additional time is needed for the preparation of written representations,

the licensing authority may alter the period for making written representations.

(4) The licensing authority must inform the recipient in writing of an alteration under paragraph (3) and of the reasons for it.

Written representations procedure

161

(1) If a recipient makes written representations in accordance with regulation 160(2)(a) the licensing authority must appoint a panel of at least two persons (“the reviewers”) to advise on the provisional determination.

(2) The licensing authority must provide the reviewers with—

(a) the recipient's written representations; and

(b) any written representations of the licensing authority.

(3) The reviewers must advise the licensing authority on the authority's provisional determination taking account of—

(a) the written representations; and

(b) any other evidence submitted to them.

(4) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(5) The licensing authority must—

(a) inform the recipient in writing of its final determination and of the reasons for it; and

(b) if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.

Oral representations procedure

162

(1) If a recipient informs the licensing authority in accordance with regulation 160(2)(b) that the recipient wants to make oral representations, the licensing authority must—

(a) appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b) after consultation with the recipient set a date for the hearing.

(2) The licensing authority may alter the date of the hearing at the request of the recipient or of its own motion if it thinks that because of exceptional circumstances or the nature or complexity of the issues involved additional time is needed for preparation for the hearing.

(3) The licensing authority must inform the recipient in writing of any alteration under paragraph (2) and of the reasons for it.

(4) The recipient and the licensing authority may make oral representations at the hearing.

(5) The reviewers must advise the licensing authority on the authority's provisional determination, taking account of—

(a) the oral representations made and any other evidence submitted by the recipient at the hearing;

(b) any oral representations made or other evidence submitted by the licensing authority at the hearing; and

(6) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(7) The licensing authority must—

(a) inform the recipient in writing of its final determination and of the reasons for it; and

(b) if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.

Final determination without representations

163

(1) This regulation applies if the recipient—

(a) does not give notification to the licensing authority that the recipient wishes to challenge its provisional determination within the period of four weeks beginning immediately after the determination date;

(b) gives such notification, but fails to make written representations to the licensing authority within the period for making those representations; or

(c) gives such notification, but fails to make oral representations at a hearing before the reviewers appointed for the purposes of advising on the provisional determination.

(2) The licensing authority must—

(a) make a final determination as to whether the product is a medicinal product; and

(b) inform the recipient in writing of its final determination and of the reasons for it.

Effect of final determination

164

(1) If the licensing authority makes a final determination that a product is a medicinal product, it may give a notice to any person—

(a) who has sold or supplied the product, or has offered to sell or supply it; or

(b) whom the licensing authority thinks may sell or supply the product.

(2) The notice must require the person—

(a) to cease to sell, supply or offer to sell or supply the product from the date specified in the notice until a UK marketing authorisation, traditional herbal registration, certificate of registration or , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation ..., is granted in respect of the product; or

(b) not to sell, supply or offer to sell or supply the product unless a UK marketing authorisation, traditional herbal registration, certificate of registration or , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation..., is granted in respect of the product.

Determination in other cases

165

Nothing in this Part prevents the licensing authority from determining that a product is a medicinal product in relation to these Regulations without following the procedures in this Part when it thinks it appropriate.

Offences relating to borderline products

166

(1) A person is guilty of an offence if that person sells or supplies, or offers to sell or supply a product in breach of a notice under regulation 164(1) imposing a requirement under—

(a) regulation 164(2)(a); or

(b) regulation 164(2)(b).

(2) A person guilty of an offence under this regulation is liable—

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

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

PART 10 — Exceptions to requirement for marketing authorisation etc

Exceptions

Supply to fulfil special patient needs

167

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product (a “special medicinal product”) if—

(a) the medicinal product is supplied in response to an unsolicited order;

(b) the medicinal product is manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

(c) the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and

(d) the following conditions are met.

(2) Condition A is that the medicinal product is supplied—

(a) to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or

(b) for use under the supervision of a pharmacist in a registered pharmacy, a hospital or a health centre.

(3) Condition B is that no advertisement relating to the medicinal product is published by any person.

(4) Condition C is that—

(a) the manufacture and assembly of the medicinal product are carried out under such supervision; and

(b) such precautions are taken,

as are adequate to ensure that the medicinal product meets the specification of the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber who requires it.

(5) Condition D is that written records of the manufacture or assembly of the medicinal product in accordance with condition C are maintained and are available to the licensing authority or to the enforcement authority on request.

(6) Except in the case of an MM medicinal product or a POC medicinal product, condition E is that if the medicinal product is manufactured or assembled in the United Kingdom , imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland—

(a) it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products; or

(b) it is manufactured, assembled or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the licensing authority for the purposes of regulation 36 of the Clinical Trials Regulations.

(6A) In the case of an MM medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (MM) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the MM master file relating to the product.

(6B) In the case of a POC medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (POC) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the POC master file relating to the product.

(7) Condition F is that if the product is imported into Northern Ireland from an EEA State or imported into Great Britain from ... an approved country for import—

(a) it is manufactured or assembled in that State or country (as appropriate) by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i) in the case of a product for sale or supply in Northern Ireland, the provisions of the 2001 Directive as implemented in that State, and

(ii) in the case of a product for sale or supply in Great Britain, in accordance with the provisions applicable in that country; or

(b) it is manufactured or assembled as an investigational medicinal product in that State or country (as appropriate) by the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i) in the case of a product for sale or supply in Northern Ireland, Article 13 of the Clinical Trials Directive as implemented in that State, and

(ii) in the case of a product for sale or supply in Great Britain, regulations 13 and 43 of the Clinical Trials Regulations,

and it is imported by the holder of a wholesale dealer’s licence in relation to the product in question.

(8) Condition G is that if the product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product in accordance with paragraph (6)(a) or (7)(a), P must be the holder of a wholesale dealer's licence in relation to the product in question.

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Use of non-prescription medicines in the course of a business

168

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to anything done in relation to a medicinal product if the following conditions are met.

(2) Condition A is that the medicinal product is not a prescription only medicine.

(3) Condition B is that the medicinal product is sold or supplied to a person who is a health care professional (“P”) exclusively for use by P—

(a) in the course of a business carried on by P, and

(b) for the purposes of administering it or causing it to be administered otherwise than by selling it.

(4) Condition C is that the medicinal product is—

(a) manufactured and assembled in accordance with the specification of P; and

(b) for use by a patient for whose treatment P is directly responsible in order to fulfil the special needs of that patient

(5) Condition D is that if sold or supplied through the holder of a wholesale dealer's licence the medicinal product is sold or supplied to such a person and for such use as mentioned in condition B.

(6) Condition E is that no advertisement relating to the medicinal product is published by any person.

(7) Condition F is that the sale or supply of the medicinal product is in response to an unsolicited order.

(8) Condition G is that if the medicinal product is—

(a) manufactured or assembled in the United Kingdom or imported into the United Kingdom from—

(i) in the case of a product for sale or supply in Northern Ireland, a country other than an EEA State, or

(ii) in the case of a product for sale or supply in Great Britain, a country other than an approved country for import,

it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products, or

(b) imported into—

(i) Northern Ireland from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii) Great Britain from an approved country for import—

(aa) it is manufactured or assembled in that country by a person who is the holder of an authorisation in that country in relation to its manufacture or assembly, and

(bb) it is imported by the holder of a wholesale dealer's licence under Part 3 that includes the import of a medicinal product from such a country.

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Mixing of general sale medicinal products

169

(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to a medicinal product (“the product”) in respect of which the following conditions are met.

(2) Condition A is that the product is manufactured by the mixing of authorised medicinal products with other authorised medicinal products, or with substances that are not medicinal products.

(3) Condition B is that any authorised medicinal product that is so mixed is subject to general sale.

(4) Condition C is that the product is manufactured by a person (“H”) who is the holder of a manufacturer's licence that—

(a) relates specifically to the manufacture of medicinal products in accordance with this regulation; and

(b) was granted or renewed not more than five years before the date on which the product is sold or supplied in accordance with paragraphs (5) and (6),

and that the product is manufactured in accordance with the terms of that licence.

(5) Condition D is that the product is sold or supplied by H to a person (“P”) for administration to P or to a member of P's household.

(6) Condition E is that P is present and asks H to use H's judgment as to the treatment required.

(7) Condition F is that no advertisement relating to the product is published by any person.

(8) Condition G is that written records of the manufacture of the product and of the sale or supply of the product are maintained and are made available to the licensing authority or to the enforcement authority on request.

(9) In this regulation, “authorised medicinal product” means a medicinal product that is the subject of—

(a) a UK marketing authorisation ...;

(b) a certificate of registration; or

Record-keeping requirements

170

(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.

(1) Where the sale or supply of a medicinal product relies on the exemptions under regulations 167, 168 or, subject to paragraph (4), 169, the person who sells or supplies the product must maintain for at least five years a record showing—

(a) the source from which and the date on which the person obtained the product;

(b) the person to whom and the date on which the sale or supply was made;

(d) the batch number of the batch of that product from which the sale or supply was made; and

(e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

(2) The person must make the records available for inspection by the licensing authority on request.

(3) The person must notify the licensing authority of any suspected adverse reaction to the medicinal product which is a serious adverse reaction.

(4) In the case of a medicinal product that is sold or supplied in reliance on the exemption in regulation 169—

(a) the reference in paragraph (1)(a) to “the product” means all the medicinal products that were mixed in the course of the manufacture of the product; and

(b) paragraph (1)(d) shall not apply.

Exempt advanced therapy medicinal products

171

(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an advanced therapy medicinal product (an “exempt advanced therapy medicinal product”) if the following conditions are met.

(2) Condition A is that the product is prepared—

(a) on a non-routine basis;

(b) in the United Kingdom; and

(c) according to specific quality standards equivalent to those provided for advanced therapy medicinal products authorised under regulation 49(1).

(3) Condition B is that the product is used—

(a) in a hospital in the United Kingdom;

(b) under the exclusive professional responsibility of a doctor; and

(4) Condition C is that no advertisement relating to the medicinal product is published by any person.

(5) Condition D is that the sale or supply of the medicinal product is in response to an unsolicited order.

(6) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation Part 14 advertising).

Parallel import licences

172

(1) The prohibitions in regulation 46 (requirement for authorisation) do not prevent—

(a) the holder of a parallel import licence from placing the medicinal product to which the licence relates on the market; or

(b) the sale or supply, or offer for sale or supply, of a medicinal product to which a parallel import licence relates, in accordance with the terms of that licence.

(2) In this regulation “parallel import licence” has the same meaning as in regulation 48(2).

Exemption for certain radiopharmaceuticals

173

Regulation 46 (requirement for authorisation) does not apply where a radiopharmaceutical is prepared—

(a) at the time when it is intended to be administered;

(b) in accordance with the manufacturer's instructions and by the person by whom it is to be administered;

(c) from radionuclide generators, radionuclide kits and radionuclide precursors in respect of which a UK marketing authorisation ... is in force; and

(d) for administration—

(i) in England and Wales and Scotland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(ii) in Northern Ireland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.

Supply in response to spread of pathogenic agents etc

174

The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—

(a) pathogenic agents;

(b) toxins;

(d) nuclear radiation,

which may cause harm to human beings.

Offences

Offences relating to exceptions

175

(1) A person to whom this paragraph applies is guilty of an offence if the person provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product that is false or misleading in a material particular.

(2) Paragraph (1) applies to any person who for the purposes of regulation 167 (special patient needs)—

(a) sells or supplies the product; or

(b) provides a specification for the product.

(3) A person is guilty of an offence if the person fails to—

(a) maintain any record required by regulation 167G(1)(g)(ii) (EAMS medicinal products: pharmacovigilance) , 170(1) (records in connection with special medicinal products etc), 170A(1) (MM medicinal products: pharmacovigilance requirements), or 170B(1) (POC medicinal products: pharmacovigilance requirements);

(b) make any record available as required by regulation 167G(1)(g)(iii) , 170(2), 170A(3) or 170B(3); or

(c) notify the licensing authority of any suspected serious adverse reaction as required by regulation 170(3) , 170A(4) or 170B(4) or of any relevant changes as required by regulation 167G(1)(f).

Penalties and supplementary provision about offences

176

(1) A person guilty of an offence under regulation 175 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) It is a defence for a person charged with an offence under regulation 175(1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(3) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (2), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

PART 11 — Pharmacovigilance

Application of this Part and interpretation

177

(1) This Part and Schedule 33 apply, except to the extent set out in paragraph (4)(b), in relation to medicinal products that are the subject of—

(a) a UK marketing authorisation;

(b) a traditional herbal registration; or

(1A) Schedule 12A applies in relation to medicinal products that are the subject of a UKMA(GB), UKMA(UK)(Category 1) or a THR(GB).

(1B) Regulations 178 and 179 apply in relation to EAMS medicinal products.

(2) Except in regulation 191A, references in this Part and Schedule 12A to a “holder” are to the holder of—

(a) a UK marketing authorisation;

(b) a traditional herbal registration; or

and, in relation to such references, “product” means the product to which the authorisation or registration relates.

(3) References to an “authorisation or registration” in this Part and in Schedules 12A and 33 are references to—

(a) a UK marketing authorisation;

(b) a traditional herbal registration; or

and “authorised or registered” is to be read accordingly.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) In this Part and in Schedules 33 and 33A—

“co-ordination group” means the group of that name established under Article 27 of the 2001 Directive;

“Eudravigilance database” means the database and data-processing network set up and maintained by the EMA under Article 24 of Regulation (EC) No 726/2004;

“Implementing Regulation” means Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council.

“infringement notice” has the meaning given to it in regulation 206 (infringement notices);

“relevant competent authorities” means the competent authority of each EEA state other than the United Kingdom which has granted in relation to a medicinal product—an authorisation in accordance with Chapter 1 of Title III to the 2001 Directive (marketing authorization);an authorisation in accordance with Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure);a registration in accordance with Chapter 2a of Title III to the 2001 Directive (traditional use registration for herbal medicinal products); oran authorisation in accordance with Article 126a of the 2001 Directive;

“relevant post-authorisation safety study” means a post-authorisation safety study which—is non-interventional;is initiated, managed or financed by the holder voluntarily or pursuant to conditions imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation); andinvolves the collection of safety data from patients or health care professionals; ...

“signal” means, in relation to a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and

“UK web-portal” has the meaning given in regulation 203 (obligations on licensing authority in relation to national medicines web-portal).

Obligations on licensing authority in relation to pharmacovigilance

General obligations of the licensing authority

178

The licensing authority must—

(a) take all appropriate measures to encourage the reporting to it of suspected adverse reactions;

(b) facilitate reporting through the provision of alternative reporting formats in addition to web-based formats;

(c) take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(d) ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner, through publication on the UK web-portal, and through other means of publicly available information as necessary; and

(e) ensure that all appropriate measures are taken to identify any biological medicinal product , MM medicinal product and POC medicinal product (including name and batch number or other product identifier if no batch number is available) prescribed, dispensed or sold in the United Kingdom which is the subject of a suspected adverse reaction report through—

(i) the methods for collecting data, and

(ii) where necessary, the follow up of suspected adverse reaction reports.

Obligation on licensing authority to operate pharmacovigilance system

179

(1) The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Great Britain.

(1A) The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland.

(2) Each pharmacovigilance system must in particular enable the collection of information on the risks that medicinal products present to patients' health or public health, including information on—

(a) adverse reactions in humans arising from use of a medicinal product (irrespective of whether the use was within the terms of an authorisation or registration); and

(b) adverse reactions associated with occupational exposure.

(3) The licensing authority must on an ongoing basis—

(a) evaluate scientifically the information collected under each pharmacovigilance system;

(b) consider options for minimising and preventing risks presented by medicinal products; and

Obligation on licensing authority to audit pharmacovigilance system

180

(1) The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply pursuant to a UKMA(GB) or a UKMA(UK)(Category 1) ....

(1A) The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Northern Ireland pursuant to a UKMA(NI) or a UKMA(UK)(Category 2) and report the results of that audit to the European Commission.

(2) The ... audit referred to in paragraph (1) must be performed—

(a) on the first occasion no later than 21st September 2013; and

(b) every two years after the first occasion.

(3) The results of the audit referred to in paragraph (1A) must be reported to the European Commission—

(a) on the first occasion no later than 21st September 2021;

(b) every two years after the first occasion.

Delegation of obligations under this Part

181

(1) The licensing authority may delegate any of its obligations under this Part in connection with its pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland pursuant to a UKMA(NI) or a UKMA(UK)(Category 2) to an EEA State where the conditions in paragraph (2) are met.

(2) The conditions in this paragraph are that the EEA State to whom the obligations are to be delegated—

(a) has given its written agreement to the delegation; and

(b) is not performing delegated obligations under this Part on behalf of another EEA State.

(3) Where the licensing authority has delegated any of its obligations under paragraph (1), it must—

(a) inform the European Commission, the EMA and all other EEA States in writing of the delegation as soon as is reasonably practicable; and

(b) make the delegation public as soon as is reasonably practicable.

(4) The licensing authority may agree to carry out any of the obligations of another EEA State under Title IX of the 2001 Directive on a delegated basis, but may carry out obligations under that Title only for one EEA State at any time.

Obligations on holders in relation to pharmacovigilance system

Obligation on holder to operate pharmacovigilance system

182

(1) The holder must operate a pharmacovigilance system.

(2) The holder must (as part of its pharmacovigilance system)—

(a) have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who resides and operates in the EU or United Kingdom and is responsible for the establishment and maintenance of the pharmacovigilance system;

(b) maintain and make available on the request of the licensing authority a pharmacovigilance system master file and ensure it is permanently and immediately available for inspection electronically in the United Kingdom at the single point from which the reports referred to in regulation 187(4) are accessible;

(c) operate a risk management system for the product in accordance with the risk management plan (if any) for the product (subject to regulation 183);

(d) monitor the outcome of the risk minimisation measures which are contained in the risk management plan (if any) for the product or which are laid down as conditions of the authorisation of the product under regulations 59 to 61 (conditions of UK marketing authorisation); and

(e) update the risk management system for the product and monitor pharmacovigilance data to determine whether in relation to the product—

(i) there are new risks,

(ii) risks have changed, or

(iii) there are changes to the risk-benefit balance.

(2A) Where the person the holder has permanently and continuously at its disposal under paragraph (2)(a) (“the qualified person”) does not reside and operate in the United Kingdom, the holder must nominate a contact person for pharmacovigilance at a national level who reports to the qualified person, resides and operates in the United Kingdom and has permanent access to the pharmacovigilance system master file.

(2B) Paragraph (2A) has effect from the day twelve months after IP completion day.

(3) Without prejudice to the requirements set out in regulation 65C and Schedule 10A (variations to a UK marketing authorisation) the holder must keep the licensing authority informed at all times of the name and contact details of—

(a) the appropriately qualified person mentioned in paragraph (2)(a); and

(b) the nominated person mentioned in paragraph (2A).

(3A) The holder must—

(a) ensure that the pharmacovigilance system master file is accessible electronically from the single point within the United Kingdom from which the reports referred to in regulation 187(4) are accessible; and

(b) immediately notify the licensing authority of any change to the single point where the pharmacovigilance system master file may be accessed electronically.

(4) The holder must use its pharmacovigilance system to—

(a) evaluate scientifically all information relevant to the product;

(b) consider options for minimising and preventing the risk presented by the use of the product; and

(i) investigate the potential risks of the product,

(ii) communicate the risks, and

(iii) implement actions for minimising and preventing the risks, including updating the risk management system for the product.

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

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