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

(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.

(5) Where the licensing authority requests that the pharmacovigilance system master file is made available under paragraph (2)(b), the holder must submit a copy of the pharmacovigilance system master file to the licensing authority before the end of the period of 7 days beginning on the day after the day when the request was made.

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

Exception to obligation to operate risk management system

183

(1) The holder is not required to operate a risk management system under regulation 182(2)(c) in relation to a medicinal product which has an authorisation or registration that was granted before 21st July 2012.

(2) The licensing authority may impose an obligation on the holder to operate a risk management system in relation to a medicinal product referred to in paragraph (1) if there are concerns about new or changed risks affecting the risk-benefit balance of that product.

(3) Paragraphs (4) to (6) apply where the licensing authority imposes an obligation to operate a risk management system on the holder under paragraph (2).

(4) The licensing authority must without delay notify the holder in writing of—

(a) the imposition of the obligation;

(b) the justification for the obligation;

(c) the timeframe for submission of the detailed description of the risk management system required under paragraph (8)(a); and

(d) the opportunity to present written observations in accordance with paragraph (5).

(5) Where the holder so requests before the end of the period of thirty days beginning on the day after the receipt by the holder of the notice referred to in paragraph (4), the licensing authority must provide the holder with an opportunity to present written observations in response to the imposition of the obligation within such a time limit as the licensing authority may specify.

(6) Where a holder presents written observations under paragraph (5), the licensing authority must withdraw or confirm the imposition of the obligation under paragraph (2), having regard to the written observations, as soon as is reasonably practicable.

(7) Paragraphs (8) and (9) apply where the licensing authority—

(a) imposes an obligation under paragraph (2) and the holder does not present written obligations under paragraph (5); or

(b) confirms the imposition of the obligation under paragraph (2) pursuant to paragraph (6).

(8) The holder must—

(a) submit to the licensing authority in writing a detailed description of the risk management system which it intends to introduce for the product in accordance with the timeframe set out in the notification under paragraph (4); and

(b) comply with the obligation to operate a risk management system.

(9) Where the imposition relates to a product with a UK marketing authorisation, the licensing authority must vary the authorisation to include the measures to be taken as part of the risk management system as conditions of the authorisation as if they were conditions imposed under regulation 59 (conditions of UK marketing authorisations: general).

Obligation on holder to audit pharmacovigilance system

184

(1) The holder must—

(a) perform a regular audit of its pharmacovigilance system;

(b) place a note concerning the main findings of each audit on the pharmacovigilance system master file on completion of each audit; and

(c) ensure that an appropriate corrective action plan is prepared and implemented as soon as is reasonably practicable after completion of each audit.

(2) The holder may remove the note placed on the pharmacovigilance system master file under paragraph (1)(b) when all the measures in the corrective action plan under paragraph (1)(c) have been fully implemented.

(3) The holder of a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB) must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.

Recording, reporting and assessment of pharmacovigilance data

Recording obligations on the licensing authority

185

The licensing authority must record all suspected adverse reactions to medicinal products that—

(a) occur in the United Kingdom; and

(b) are reported to it by a holder, a patient or a patient's carer, a health care professional, a coroner or a procurator fiscal.

Reporting obligations on the licensing authority

186

(1) The licensing authority must—

(a) when it receives a suspected adverse reaction report from a person mentioned in regulation 185(b), follow up the report with that person as appropriate;

(b) ensure that reports of suspected adverse reactions in the United Kingdom may be submitted to it, whether by the UK web-portal or by other means;

(c) collaborate with the EMA and the holders of authorisations or registrations in the detection of duplicates of suspected adverse reaction reports;

(d) submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i) a UKMA(NI),

(ii) a UKMA(UK)(Category 2),

(iii) a THR(NI),

(iv) a THR(UK), or

(v) an Article 126a authorisation,

to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and

(e) submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i) a UKMA(NI),

(ii) a UKMA(UK)(Category 2),

(iii) a THR(NI),

(iv) a THR(UK), or

(v) an Article 126a authorisation,

to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.

(2) Paragraph (3) applies where the licensing authority has received a report of a suspected adverse reaction arising from an error associated with the use of a medicinal product.

(3) The licensing authority must (in addition to meeting the requirements in paragraph (1) in respect of the report) ensure that the report is made available to any statutory body with functions in relation to patient safety within the United Kingdom.

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

Recording obligations on holders

187

(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product (including listed NIMAR products in Northern Ireland) occurring in the United Kingdom or another country which are brought to its attention irrespective of whether the reaction—

(a) is reported spontaneously by patients or health care professionals; or

(b) occurred in the context of a post-authorisation study.

(2) Paragraph (1) does not apply where the suspected adverse reaction occurred in the context of a clinical trial within the meaning of the Clinical Trials Regulations.

(3) The holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

(4) The holder must ensure that reports recorded under paragraph (1) are accessible (electronically or physically) at a single point within the United Kingdom.

Reporting obligations on holders

188

(1) Subject to paragraphs (1B) and (1C), the holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation must in relation to the product (including listed NIMAR products in Northern Ireland)—

(a) submit electronically to the licensing authority a report on all serious suspected adverse reactions that occur in the United Kingdom and countries other than the United Kingdom before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b) submit electronically to the licensing authority a report on all non-serious suspected adverse reactions that occur in the United Kingdom before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(c) establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(ca) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;

(d) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the licensing authority by way of an update to the original report within the specified time period; and

(e) collaborate with the licensing authority in the detection of duplicates of suspected adverse reaction reports.

(1A) Subject to paragraphs (1B) and (1C), the holder of a UKMA(UK)(Category 2), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product—

(a) submit electronically to the Eudravigilance database a report on all serious suspected adverse reactions that occur in the UK and other countries before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b) submit electronically to the Eudraviligance database a report on all non-serious suspected adverse reactions that occur in an EEA State or Northern Ireland before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(ba) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;

(c) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the Eudravigilance database by way of an update to the original report within the specified time period; and

(d) collaborate with the EMA and the competent authorities of the EEA States in the detection of duplicates of suspected adverse reaction reports.

(1B) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.

(1C) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.

(2) The holder of a UKMA(NI), a UKMA(UK)(Category 2), a THR(NI), a THR(UK) or an Article 126a authorisation is not required to submit a report of a suspected adverse reaction to the product under paragraph (1A)(a) or (b), or to provide follow-up information under paragraph (1A)(c), where—

(a) the suspected adverse reaction relates to a medicinal product which contains a monitored active substance; and

(b) the suspected adverse reaction is recorded in a monitored publication.

(3) Paragraph (4A) applies to medicinal products containing a monitored active substance.

(4) The holder must—

(a) monitor medical literature ... for reports of suspected adverse reactions to the product; and

(b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1).

(4A) The holder of a UKMA(NI), a UKMA(UK)(Category 2), a THR(NI), a THR(UK) or an Article 126a authorisation must—

(a) monitor medical literature other than the monitored publications for reports of suspected adverse reactions to the product; and

(b) report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1A).

(5) In this regulation—

“the specified time period” means—in the case of serious adverse reactions, the period of 15 days beginning on the day following the day on which the follow up information became known to the holder; andin the case of non-serious adverse reactions, the period of 90 days beginning on the day following the day on which the follow up information became known to the holder.

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

Signal detection

Signal detection: licensing authority obligations

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.