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The Human Medicines Regulations 2012

Changes over time for: Cross Heading: Consideration of application

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The Human Medicines Regulations 2012, Cross Heading: Consideration of application is up to date with all changes known to be in force on or before 23 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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Consideration of applicationU.K.

Consideration of applicationU.K.

58.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation before the end of 210 days beginning immediately after the day on which the application for the authorisation is submitted in accordance with regulations 49 to 55.

(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 applicant has established the therapeutic efficacy of the product to which the application relates;

(b)the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product;

(c)the application and the accompanying material complies with regulations 49 to 55; and

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

[F1(4A) When considering an application for a UK marketing authorisation, the licensing authority may, if it considers it appropriate, have regard to—

(a)an opinion of the Committee for Medicinal Products for Human Use; or

(b)the results of an assessment of an application for a marketing authorisation by the appropriate authority for the licensing of medicinal products of a country other than the United Kingdom,

in respect of the medicinal product to which the application relates.

(4B) The licensing authority may under paragraph (4A)—

(a)decide to have regard to the opinions and assessments described in that paragraph in relation to certain types of medicinal products only;

(b)determine and publish a list of the countries other than the United Kingdom whose assessments of applications for a marketing authorisation are relevant for the purposes of paragraph (4A)(b); and

(c)decide to have regard to the assessments described in paragraph (4A)(b) in relation to medicinal products that have been authorised by way of certain procedures only.

(4C) When considering an application for a UK marketing authorisation (other than an application under the unfettered access route), the licensing authority may, if it considers it appropriate and without undertaking further consideration, rely on a decision by the European Commission to authorise the medicinal product to which the application relates to establish that any or all of the conditions in paragraph (4)(a), (b) or (d) have been met.]

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

F2(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F4(8) In the case of an application under the unfettered access route, the licensing authority may grant a [F5UKMA(UK)(Category 2)] (notwithstanding paragraph (4)) where the licensing authority—

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

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

(c)is satisfied that the conditions in regulation 50 will continue to be met.

(9) 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.]

Textual Amendments

[F6Paediatric rewardsU.K.

58A.—( 1) Paragraph (2) applies if—

(a)an application—

(i)to which regulation 50A (requirement for certain applications to include the results of a paediatric investigation plan) applies, and in relation to which there is an agreed paediatric investigation plan; or

(ii)to which Article 7 or 8 of the Paediatric Regulation applies, and in relation to which there is an EU agreed paediatric investigation plan,

is granted by the licensing authority; and

(b)the licensing authority is satisfied that the material provided by the applicant pursuant to—

(i)regulation 50A(3), where paragraph (1)(a)(i) applies; or

(ii)Article 7 or 8 of the Paediatric Regulation, where paragraph (1)(a)(ii) applies,

demonstrates compliance with the agreed paediatric investigation plan.

(2) Where this paragraph applies, the licensing authority must—

(a)include in the UK marketing authorisation a statement to the effect that it is satisfied as set out in paragraph (1)(b); and

(b)ensure that the results of all studies referred to in the paediatric investigation plan are included in the summary of product characteristics and, if the licensing authority considers that the information would be useful to patients, in the package leaflet.

(3) Where—

(a)paragraph (2) applies[F7,]

F8(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the holder of a patent or supplementary protection certificate covering the medicinal product to which the application relates is entitled to a six month extension of the period referred to in Articles 13(1) and 13(3) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (subject to paragraphs (4) to (5)).

(4) Paragraph (3) does not apply if the grant of the application referred to in paragraph (1)(a)—

(a)relates to a new paediatric indication; and

(b)the holder of the UK marketing authorisation is entitled to a one year extension of the ten year period referred to in [F9regulation 51B(6), under regulation 51B(7)].

(4A) Paragraph (3) does not apply where—

(a)the territorial protection conferred by the supplementary protection certificate referred to in paragraph (3) does not cover the whole of the United Kingdom; and

(b)the UK marketing authorisation in which the statement of compliance is included is not in force in the same part of the United Kingdom as the supplementary protection certificate.

(4B) Where—

(a)the territorial protection conferred by the supplementary protection certificate referred to in paragraph (3) does cover the whole of the United Kingdom; and

(b)the UK marketing authorisation in which the statement of compliance is included is in force in in Great Britain only or in Northern Ireland only,

the extension provided for in paragraph (3) only applies in relation to Great Britain only or Northern Ireland only (as appropriate).

(5) If the UK marketing authorisation to which this regulation applies is an orphan marketing authorisation, paragraph (3) does not apply and regulation 58D(5) (orphan rewards) applies.

(6) Paragraphs (7) and (8) apply if the licensing authority grants a UK marketing authorisation in response to an application to which regulation 50E (paediatric use marketing authorisation) applies.

(7) Where this paragraph applies, the medicinal product to which the paediatric use marketing authorisation relates may retain the name of any medicinal product which contains the same active substance and in respect of which the holder of the paediatric use marketing authorisation has been granted a UK marketing authorisation for use in adults.

(8) Where this paragraph applies, the holder of the paediatric use marketing authorisation is entitled to benefit from the periods of data and marketing exclusivity referred to in [F10regulation 51B(1) and (6)] in relation to the material supplied pursuant to regulation 50E(2).

Textual Amendments

Publication of information relating to paediatric marketing authorisationsU.K.

58B.—(1) The licensing authority must publish a register of UK marketing authorisations—

(a)which include a paediatric indication following completion of an agreed paediatric investigation plan; and

(b)in relation to which the medicinal product was placed on the market for other indications before the holder obtained that paediatric indication.

(2) The register referred to in paragraph (1) must include the date by which the product must be placed on the market taking account of the paediatric indication in accordance with regulation 78A(4) (post-authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply).

(3) The licensing authority must publish a list of the marketing authorisation holders which have—

(a)benefitted from any of the rewards in regulation 58A; or

(b)failed to comply with any of the obligations in regulation 78A.

(4) The licensing authority must publish decisions made under—

(a)regulation 50B(5) or (7) (agreement and modification of paediatric investigation plan);

(b)regulation 50C(2) (deferral of the initiation or completion of measures in a paediatric investigation plan); and

(c)regulation 50D(2) (waiver of production of information in a paediatric investigation plan) in relation to a specific medicinal product.

(5) The decisions referred to in paragraph (4) must be published, with the omission of information of a commercially confidential nature, as soon as reasonably practicable after the decision has been made.

Textual Amendments

Consideration of applications relating to orphan medicinal productsU.K.

58C.—(1) If the licensing authority is satisfied in relation to an application for a UK marketing authorisation (including an application under the unfettered access route)—

(a)the orphan criteria are met in relation to all of the therapeutic indications to which the application relates; and

(b)it is otherwise appropriate to grant a UK marketing authorisation in respect of the application under regulation 49(1)(a),

it may grant a UK marketing authorisation which is known as an orphan marketing authorisation.

(2) The licensing authority must publish and keep up to date a list of orphan marketing authorisations.

(3) Schedule 11 makes provision about advice and representations in relation to proposals to grant a UK marketing authorisation in respect of which the applicant intended to demonstrate that the orphan criteria were met, in cases where the licensing authority considers that those criteria are not met.

Textual Amendments

Orphan rewardsU.K.

58D.—(1) Subject to the following provisions of this regulation, for the period of ten years beginning with the date on which the licensing authority grants an orphan marketing authorisation, the licensing authority must not—

(a)grant an application for a UK marketing authorisation; or

(b)grant an application to vary a UK marketing authorisation;

in relation to a medicinal product which is similar to the medicinal product to which the orphan marketing authorisation relates and in respect of the therapeutic indications which are covered by the orphan marketing authorisation.

(4) The period of ten years referred to in paragraph (1) may be reduced to six years if, at the end of the fifth year beginning on the date referred to in paragraph (1), the licensing authority is satisfied that the orphan criteria are no longer met in relation to the medicinal product.

(5) The period of ten years referred to in paragraph (1) is extended to twelve years if regulation 58A(2) (paediatric rewards) applies to the orphan marketing authorisation.

(6) Paragraph (1) does not apply if—

(a)the holder of the orphan marketing authorisation consents to the grant or variation of a UK marketing authorisation in relation to a similar medicinal product;

(b)the licensing authority is satisfied that the holder of the orphan marketing authorisation is unable to supply sufficient quantities of the medicinal product to which the orphan marketing authorisation relates; or

(c)a subsequent applicant can establish to the satisfaction of the licensing authority that the medicinal product to which the application relates, although similar to the medicinal product to which the orphan marketing authorisation relates, is safer or more effective than, or clinically superior to, that product.

Textual Amendments

Consideration of applications relating to combined advanced therapy medicinal productsU.K.

58E.—(1) When determining an application to which regulation 50H(3) (applications relating to combined advance therapy medicinal products) applies, the licensing authority must—

(a)assess the entire combined advanced therapy medicinal product in accordance with these Regulations; and

(b)recognise the results of the assessment of the notified body, if supplied.

(2) The licensing authority may request the notified body, if relevant, to provide it with information related to the results of the assessment.

(3) Paragraph (4) applies if an application to which regulation 50H(3) applies does not include the results of the assessment of a notified body, or if the notified body fails to supply information related to the results of the assessment when requested by the licensing authority.

(4) Where this paragraph applies, the licensing authority must seek an opinion on the conformity of the device part in accordance with the Medical Devices Regulations 2002 from a notified body identified in conjunction with the applicant, unless the licensing authority decides that the involvement of a notified body is not required.

Textual Amendments

Consideration of applications relating to conditional marketing authorisationsU.K.

58F.—(1) If the licensing authority is satisfied in relation to an application to which regulation 50I (applications relating to conditional marketing authorisations) applies that—

(a)the criteria in regulation 50I(3)(b) are met; and

(b)it is otherwise appropriate to grant a [F11UKMA(UK)(Category 1)] in respect of the application in accordance with regulation 49(1)(a),

it may grant a UK marketing authorisation which is known as a conditional marketing authorisation.

(2) Where regulation 50I(2)(b) (applications relating to conditional marketing authorisations) applies, the licensing authority may grant a conditional marketing authorisation if, in addition to comprehensive clinical data, comprehensive pre-clinical or pharmaceutical data have not been supplied.

(3) The licensing authority may, of its own motion, propose that a conditional marketing authorisation be granted if, having consulted the applicant for a UK marketing authorisation, it considers that the criteria in regulation 50I(3)(b) are met.

(4) If the licensing authority grants a conditional marketing authorisation in relation to a medicinal product, it may at any time decide that it is appropriate to grant a UK marketing authorisation in relation to that product which is not a conditional marketing authorisation.

(5) If the licensing authority grants a conditional marketing authorisation, the product's summary of product characteristics and package leaflet must include a statement to that effect, and the summary of product characteristics must include the date on which the conditional marketing authorisation is due for renewal.

Textual Amendments

Consideration of applications in relation to medicinal products containing or consisting of genetically modified organismsU.K.

58G.—(1) When determining an application for a UK marketing authorisation in relation to which regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms) applies, the licensing authority must be satisfied that the application respects the environmental safety requirements laid down by Directive 2001/18/EC.

(2) In reaching its view under paragraph (1), the licensing authority must consult the bodies responsible for the giving of consent pursuant to the legislation referred to in regulation 50J(2)(a).]

Textual Amendments

Conditions of UK marketing authorisation [F12or parallel import licence]: generalU.K.

59.—(1) [F13Unless paragraph (1A) applies the licensing authority] may—

(a)grant a UK marketing authorisation subject to one or more of the conditions in paragraph (2); or

(b)vary or remove a condition in paragraph (2) to which the UK marketing authorisation is subject.

[F14(1A) Where the application concerns a parallel import licence, the licensing authority may—

(a)grant a parallel import licence subject to one or more of the conditions in paragraph (2)(a), (c), (d) or (e); or

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

(2) Those conditions are—

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

(b)to conduct post-authorisation safety studies;

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

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

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

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

(3) [F15In relation to a UKMA(NI) or [F16UKMA(UK)(Category 2)], an obligation] to conduct such studies as are referred to in paragraph (2)(f) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive, while taking into account the scientific guidance referred to in Article 108a of the 2001 Directive.

[F17(3A) In relation to a UKMA(GB) [F18or a UKMA(UK)(Category 1)], an obligation to conduct such studies as are referred to in paragraph (2)(f) must—

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

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

(3B) The Secretary of State may by regulations make provision F19... specifying the situations in which post-authorisation efficacy studies may be required [F20in relation to a UKMA(GB) or UKMA(UK)(Category 1)] by virtue of the condition referred to in paragraph (2)(f).

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

(4) The [F21UK] marketing authorisation [F22or parallel import licence] must lay down deadlines for the fulfilment of the conditions in paragraph (2) [F23where relevant and necessary].

[F24(4A) Where the application is one to which regulation 50A, 50E or 50F (applications to which paediatric-specific provisions apply) applies, the licensing authority must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

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

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

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

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

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

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

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

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

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

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

(5) The licensing authority must notify the EMA of any [F25UKMA(NI) or] [F26UKMA(UK)(Category 2)] that it has granted subject to a condition included in accordance with this regulation.

(6) The holder of the authorisation must incorporate any condition included in a marketing authorisation [F27or parallel import licence] in accordance with this regulation into the risk management system for the product.

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

Textual Amendments

F12Words in reg. 59 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(d)

F13Words in reg. 59(1) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(2) and words in reg. 59(1) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(2)

F22Words in reg. 59(4) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59(4) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)

F23Words in reg. 59(4) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(4) and words in reg. 59(4) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(4)

F27Words in reg. 59(6) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59(6) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)

Conditions of UK marketing authorisation [F28or parallel import licence]: exceptional circumstancesU.K.

60.—(1) The licensing authority may—

(a)grant a UK marketing authorisation [F28or parallel import licence] subject to conditions in accordance with the following paragraphs of this regulation; or

(b)vary or remove such a condition to which the UK marketing authorisation [F28or parallel import licence] is subject.

(2) The powers in paragraph (1) may be exercised only after consultation with the applicant for the authorisation [F29or licence] or (as the case may be) its holder.

(3) The power in paragraph (1)(a) to grant an authorisation [F30or licence] subject to conditions may be exercised only—

(a)in exceptional circumstances; and

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

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

(5) The conditions may, in particular, relate to the safety of the product to which the authorisation [F29or licence] relates.

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

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

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

(7) The licensing authority must keep under review—

(a)the conditions under this regulation to which a UK marketing authorisation [F28or parallel import licence] is subject; and

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

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

(a)at the end of the period of one year beginning with the date on which the authorisation [F29or licence] was granted; and

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

[F31(9) The licensing authority must notify the EMA of any UKMA(NI) or [F32UKMA(UK)(Category 2)] that it has granted subject to a condition included in accordance with this regulation.]

(10) The holder of the authorisation [F29or licence] must incorporate any condition included in a marketing authorisation [F33or licence] in accordance with this regulation into the risk management system for the product.

(11) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation [F28or parallel import licence] is subject.

Textual Amendments

[F34Condition as to the submitting of samples and other information to the appropriate authority U.K.

60A.—(1) In this regulation—

“the appropriate authority” is to be construed in accordance with section 57(7) of the Health and Social Care Act 2012;

“appropriate documentation”, in relation to a sample of a batch submitted to the appropriate authority in accordance with the batch testing condition or pursuant to a notification under paragraph (12), means—

(a)

any certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted to the appropriate authority with that certificate; and

(b)

such other documentation as the appropriate authority notifies the holder of the UK marketing authorisation to which the sample relates that it requires;

“approved country list for batch testing and certification of biological medicinal products” means the list described in paragraph (5), and “approved country for batch testing and certification of biological medicinal products” means a country included in that list;

“the batch testing condition”, in respect of a UK marketing authorisation, is a condition to the effect that, unless the batch testing exemption applies, the holder of the UK marketing authorisation—

(a)

must submit a sample from each batch of the medicinal product that is the subject of that authorisation to the appropriate authority, together with appropriate documentation; and

(b)

must not sell or supply, or offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined—

(i)

the sample from that batch,

(ii)

the appropriate documentation, or

(iii)

both that sample and that documentation,

and confirmed that it is satisfied that the batch is in conformity with the approved specifications in the UK marketing authorisation; and

[F35“the batch testing exemption” means that—

(a)

in the case of a medicinal product for sale or supply in Northern Ireland only and authorised under a UKMA(NI) or a UKMA(UK)(Category 2), a certificate—

(i)

has been issued by a laboratory in an EEA State, and

(ii)

in the case of a product of a kind listed in Article 114(1) of the 2001 Directive, was issued in the same EEA State as that in which the batch was manufactured, and

the appropriate authority is satisfied that the certificate provides confirmation of conformity with the approved specifications in the UKMA(NI) or UKMA(UK)(Category 2), as applicable, or

(b)

in the absence of such a certificate, or in the case of a medicinal product authorised for sale or supply under a UKMA(GB) or a UKMA(UK)(Category 1)—

(i)

a certificate has been issued by a laboratory in a country other than the United Kingdom,

(ii)

an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), and

(iii)

that agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both.]

(2) The licensing authority may impose the batch testing condition in respect of a UK marketing authorisation for a medicinal product that is—

(a)a live vaccine;

(b)an immunological product used in the primary immunisation of infants or other groups at risk;

(c)an immunological product used in public health immunisation programmes;

(d)subject to paragraph (3), a new immunological product manufactured using new or altered kinds of technology or new for a particular manufacturer; or

(e)derived from human blood or human plasma.

(3) If the licensing authority imposes a condition in respect of a UK marketing authorisation for a medicinal product of a kind mentioned in paragraph (2)(d), it must, in imposing that condition, specify a period of time for the duration of the condition.

(4) The appropriate authority must complete its examination of the sample for testing, the appropriate documentation or both (as the case may be) within the period of 60 days, beginning with the date on which the appropriate authority is in receipt of both the sample for testing, and the appropriate documentation.

(5) The appropriate authority must publish a list, to be known as the approved country list for batch testing and certification of biological medicinal products, specifying the countries that are approved for the purposes of the appropriate authority's assessment under paragraph (6) F36....

(6) Where a holder of a UK marketing authorisation, in order to comply with the batch testing condition, submits appropriate documentation that includes a certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products in respect of the batch, the appropriate authority must, in addition to any other factors it considers relevant, take that into account in determining whether the appropriate authority needs to undertake any further testing of the medicinal product submitted to it.

(7) In order to determine whether a country should be included in the approved country list for batch testing and certification of biological medicinal products, the appropriate authority may, in particular, take into account whether the relevant certification process in that country is based on testing performed under a quality assurance system that undergoes regular external assessment to ensure it meets an appropriate standard of competence for testing biological medicines.

(8) The appropriate authority must—

(a)review the countries it has included in the approved country list for batch testing and certification of biological medicinal products to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and

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

(9) The appropriate authority must—

(a)publish a list of countries, or organisations, with whom the United Kingdom has an agreement for the purposes of the application of the batch testing exemption under this regulation F37...;

(b)include in that list any conditions or restrictions in that agreement that affect the applicability of the batch testing exemption under this regulation F38...; and

(c)update that list as soon as reasonably practicable if—

(i)the United Kingdom no longer has an agreement with a country or organisation included in the list,

(ii)any such agreement is amended, or

(iii)the United Kingdom enters in to a new agreement with a country or organisation.

(10) [F39Subject to paragraph (10A), where] a holder of a UK marketing authorisation relies on the batch testing exemption in relation to a batch of a medicinal product, that holder must submit the certificate in respect of that batch to the licensing authority and the appropriate authority, and such other documentation as those authorities may notify that holder they require, before it sells or supplies, or offers to sell or supply, a medicinal product that forms part of that batch in the United Kingdom.

[F40(10A) Where a holder of a UK marketing authorisation intends to rely on paragraph (a) of the batch testing exemption in relation to a batch of a medicinal product, that holder must not sell or supply, or offer to sell or supply, in Northern Ireland, a medicinal product that forms part of that batch until the appropriate authority has confirmed that it is satisfied as set out in that paragraph.]

(11) Paragraph (12) applies where the appropriate authority considers that there are public health concerns in respect of a batch of a medicinal product (“the relevant batch”) in relation to which the batch testing exemption would otherwise apply.

(12) Where this paragraph applies, the appropriate authority must, subject to paragraph (13), notify the holder of the UK marketing authorisation in respect of the relevant batch that it nevertheless requires that holder—

(a)to submit a sample from the relevant batch to the appropriate authority, together with appropriate documentation; and

(b)not to sell or supply, or to offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined—

(i)the sample from that batch,

(ii)the appropriate documentation, or

(iii)both that sample and that documentation,

and confirmed that it is satisfied that the relevant batch is in conformity with the approved specifications in the UK marketing authorisation.

(13) The appropriate authority may only exercise its powers under paragraph (12) if the agreement made between the country in which the certificate was issued, and the United Kingdom (whether the agreement is solely with that country, a group of countries or an organisation of which that country is a part) provides for the relevant batch to be re-examined by the appropriate authority in the circumstances described in paragraph (11).

(14) The appropriate authority may, in any particular case, apply this regulation to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this regulation to—

(a)a UK marketing authorisation should be read as a reference to a parallel import licence for a medicinal product,

(b)the holder of a UK marketing authorisation should be read as a reference to the holder of a parallel import licence, and

(c)the approved specifications in a UK marketing authorisation should be read as a reference to the approved specifications in the UK reference product specified for the purposes of the parallel import licence in accordance with paragraph 4 of Schedule 8A.

(15) Where, pursuant to paragraph (14), this regulation is applied to a medicinal product imported into the United Kingdom pursuant to a parallel import licence, sub-paragraph (a) of the definition of “the batch testing exemption” does not apply.

(16) In the application of this regulation to a medicinal product for sale or supply in Northern Ireland only to which Article 114 of the 2001 Directive applies, a reference in this regulation to a laboratory is to an Official Medicines Control Laboratory or a laboratory referred to in that Article.]

Textual Amendments

Submitting of samples and other information: EU marketing authorisationsU.K.

F4160B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Conditions of UK marketing authorisation: new obligations post-authorisationU.K.

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

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

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

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

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

[F42(4) The obligation in this paragraph is—

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

(b) in relation to a UKMA(GB) [F43or UKMA(UK)(Category 1)], to comply with such other conditions or restrictions as the licensing authority considers essential for the safe and effective use of the medicinal product.]

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

(6) If concerns as described in paragraph (2) apply to more than one medicinal product [F44authorised by a UKMA(NI) [F45or UKMA(UK)(Category 2)]], the licensing authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study.

[F46(6A) If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB) [F47or UKMA(UK)(Category 1)], the licensing authority—

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

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

[F48(7) The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.]

F49[F50(7A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

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

(a)the imposition of the obligation;

(b)the justification for the imposition;

(c)the objectives and timeframe for submission and conduct of the study; and

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

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

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

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

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

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

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

(13) The licensing authority must notify the EMA [F51, in relation to a UKMA(NI) [F52or UKMA(UK)(Category 2)],] that the marketing authorisation is subject to a condition included in accordance with paragraph (12).

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

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

Textual Amendments

Classification of UK marketing authorisation [F53or parallel import licence] U.K.

62.—(1) A UK marketing authorisation [F54or parallel import licence] must include a term that the product to which the authorisation relates is to be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

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

(a)the maximum single dose;

(b)the maximum daily dose;

(c)the strength of the product;

(d)its pharmaceutical form;

(e)its packaging; and

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

(3) A UK marketing authorisation [F55or parallel import licence] must be granted subject to a condition that the product to which the authorisation relates is to be available only on prescription if the licensing authority considers that the product—

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

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

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

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

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

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

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

(c)is likely, if incorrectly used—

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

(ii)to lead to addiction, or

(iii)to be used for illegal purposes;

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

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

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

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

(5) A UK marketing authorisation [F56or parallel import licence] may include a term that the product to which the authorisation relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist.

Textual Amendments

F53Words in reg. 62 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(f)

F54Words in reg. 62(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)

F55Words in reg. 62(3) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(3) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)

F56Words in reg. 62(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)

Frequency of periodic safety update reportsU.K.

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

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

Duties of licensing authority in connection with determinationU.K.

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

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

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

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

(a)the marketing authorisation;

(b)the package leaflet;

(c)the summary of the product characteristics;

[F57(d)any conditions—

(i)in the case of a UKMA(NI) [F58or UKMA(UK)(Category 2)], established in accordance with Articles 21a, 22 and 22a of the 2001 Directive;

(ii)in the case of UKMA(GB) [F59or UKMA(UK)(Category 1)], imposed under regulations 59 to 61; and]

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

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

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

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

(6) The licensing authority must—

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

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

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

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

Textual Amendments

[F60Obligation of licensing authority in case of change of classificationU.K.

64A.—(1) In this regulation, “classification”, in relation to a medicinal product, means the term of the product's UK marketing authorisation which determines the way in which the product is to be made available, as described in regulation 62(1).

(2) This regulation applies where—

(a)the licensing authority grants or varies—

(i)a UK marketing authorisation;

(ii)an Article 126a authorisation;

(iii)a traditional herbal registration; or

(iv)a certificate of registration of a homoeopathic medicinal product;

(b)the grant or variation of the UK marketing authorisation involves a change of the classification of the medicinal product to which the authorisation relates; and

(c)the application for the UK marketing authorisation or variation was supported by the results of significant pre-clinical tests or clinical trials relating to the proposed classification.

(3) Where this regulation applies, the licensing authority may not, for the period of one year beginning with the date on which the UK marketing authorisation was granted or varied, refer to the results of the tests or trials referred to in paragraph (2)(c) when examining an application by another applicant or UK marketing authorisation holder for a change of classification of the same kind as that to which the tests or trials relate.]

Textual Amendments

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