Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles 4

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(a) the premises on which medicinal products of the descriptions to which the application relates will be stored;

(b) the equipment which is or will be available for storing medicinal products on those premises;

(c) the equipment and facilities which are or will be available for distributing medicinal products from those premises; and

(d) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored on or distributed from those premises.

Grant or refusal of licence

23

(1) Subject to the following provisions of these Regulations, on an application to the licensing authority for a licence under this Part the licensing authority may—

(a) grant a licence containing such provisions as it considers appropriate; or

(b) refuse to grant a licence if having regard to the provisions of these Regulations ... it considers it necessary or appropriate to do so.

(2) The licensing authority must grant or refuse an application for a licence under this Part within the period of 90 days beginning immediately after the day on which it receives the application.

(3) Paragraph (2) applies to an application only if the requirements of Schedule 3 have been met.

(4) If a notice under regulation 30 requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (2).

(5) In paragraph (4), the “information period” means the period—

(a) beginning with the day on which the notice is given, and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(6) The licensing authority must give the applicant a notice stating the reasons for its decision in any case where—

(a) the licensing authority refuses to grant an application for a licence; or

(b) the licensing authority grants a licence otherwise than in accordance with the application and the applicant requests a statement of its reasons.

Standard provisions of licences

24

(1) The standard provisions set out in Schedule 4 may be incorporated by the licensing authority in a licence under this Part granted on or after the date on which these Regulations come into force.

(2) The standard provisions may be incorporated in a licence with or without modifications and either generally or in relation to medicinal products of a particular class.

(3) In Schedule 4, in relation to a licence holder in Great Britain, references to the principles and guidelines set out in the Good Manufacturing Practice Directive are to those principles and guidelines as they apply under or by virtue of regulation B17.

Duration of licence

25

A licence granted under this Part remains in force until—

(a) the licence is revoked by the licensing authority; or

(b) the licence is surrendered by the holder.

General power to suspend, revoke or vary licences

26

(1) The licensing authority may in accordance with the procedure specified in regulation 27—

(a) suspend a licence under this Part for such period as the authority thinks fit;

(b) revoke a licence under this Part; or

(2) The suspension or revocation of a licence may be—

(a) total;

(b) limited to medicinal products of one or more descriptions; ...

(c) limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises;

(d) in the case of a manufacturer’s licence (MM), limited to modular units specified in the MM master file associated with the licence; or

(e) in the case of a manufacturer’s licence (POC), limited to POC sites specified in the POC master file associated with the licence.

(3) The powers conferred by this regulation may not be exercised in relation to a manufacturer's licence or a wholesale dealer's licence except on one or more of the grounds specified in—

(a) paragraph (4) (in relation to either a manufacturer's licence or a wholesale dealer's licence);

(b) paragraph (5) (in relation to a manufacturer's licence); or

(4) Those grounds are that—

(a) the information in the application as a result of which the licence was granted was false or incomplete in a material respect;

(b) a material change of circumstances has occurred in relation to any of the matters stated in the application;

(d) the holder of the licence has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the licence relates when required to do so under regulation 30(2).

(5) In relation to a manufacturer's licence, the powers conferred by this regulation may also be exercised on either or both of the following grounds—

(a) that the holder of the manufacturer's licence has manufactured or assembled medicinal products to the order of a person who holds—

(i) in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), ...

(ii) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”), or

(iii) in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) (an “authorisation”),

and has habitually failed to comply with the provisions of that authorisation; or

(b) that the holder of the manufacturer's licence does not have appropriate facilities to carry out processes of manufacture or assembly authorised by the licence.

(6) In relation to a wholesale dealer's licence, the powers conferred by this regulation may also be exercised on the grounds that the equipment and facilities available to the holder of the licence for storing or distributing medicinal products are inadequate to maintain the quality of medicinal products of one or more descriptions to which the licence relates.

Procedure where licensing authority proposes to suspend, revoke or vary licence

27

(1) This regulation applies where—

(a) the provisions of regulation 28 do not apply; and

(b) the licensing authority proposes to suspend, vary or revoke a licence under regulation 26.

(2) The licensing authority must notify the licence holder in writing of—

(a) its proposal;

(b) the reasons for it; and

(c) the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, revocation or variation should take effect.

(3) The licence holder may before the date specified in the notice—

(a) make written representations to the licensing authority with respect to the proposal; or

(b) notify the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the licence holder makes written representations in accordance with paragraph 3(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) If the licence holder notifies the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—

(a) Schedule 5 has effect; and

(b) the licence holder must pay a fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend, revoke or vary a licence in accordance with the provisions of regulation 26 it must give a notice to the licence holder.

(7) The notice must—

(a) give particulars of the suspension, revocation or variation; and

(b) give reasons for the decision to suspend, revoke or vary the licence.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of licence in cases of urgency

28

(1) Notwithstanding anything in the preceding provisions of this Part, where it appears to the licensing authority that in the interests of safety it is necessary to suspend a licence under this Part with immediate effect, the licensing authority may do so for a period not exceeding three months.

(2) This paragraph applies where—

(a) a licence has been suspended under paragraph (1); and

(b) it appears to the licensing authority that it is necessary to consider whether the licence should be further suspended, revoked or varied.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 27 (but this is subject to paragraphs (4) and (5)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 27 and any proceedings under that regulation have not been finally disposed of before the end of the period for which the licence was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the licence for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 27 to suspend, vary or revoke the licence is made on an application to the High Court under regulation 322(4) paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a).

Variation of licence on the application of the holder

29

(1) This regulation applies if the holder of a licence under this Part applies to the licensing authority for a variation of the licence.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e) be accompanied by the required fee (if any).

(2A) In the case of an application of a type specified in paragraph (2C), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1A(2) of Schedule 3.

(2B) In the case of an application of a type specified in paragraph (2D), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1B(2) of Schedule 3.

(2C) The following types of application are specified for the purpose of paragraph (2A) and (2E)—

(a) an application to vary the licence so that it relates to the manufacture or assembly of MM medicinal products;

(b) an application to vary a manufacturer’s licence (MM) to add a new MM medicinal product.

(2D) The following types of application are specified for the purpose of paragraphs (2B) and (2F)—

(a) an application to vary the licence so that it relates to the manufacture or assembly of POC medicinal products;

(b) an application to vary a manufacturer’s licence (POC) to add a new POC medicinal product.

(2E) In dealing with an application of a type specified in paragraph (2C), the licensing authority must take into consideration the arrangements made or to be made for—

(a) supervising and controlling operations at a modular unit specified in the application; and

(b) ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently satisfies the requirements in the MM master file when manufactured at that modular unit.

(2F) In dealing with an application of a type specified in paragraph (2D), the licensing authority must take into consideration the arrangements made or to be made for—

(a) supervising and controlling operations at a POC site specified in the application; and

(b) ensuring that manufacturing or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site.

(3) The licensing authority must consider an application made in accordance with this regulation.

(4) If paragraph (5) applies, the licensing authority must vary the licence or refuse to vary it before the end of the period allowed for considering the application.

(5) This paragraph applies to a variation which would have the effect of altering—

(a) the types of medicinal product in respect of which the licence was granted;

(b) any operation carried out under the licence; ...

(d) the responsible person (import) under regulation 45AA.

(6) The period allowed for consideration of an application under this regulation is—

(a) in a case where the licensing authority considers that it is necessary to inspect premises to which the licence relates, 90 days beginning with the day after the date when the licensing authority receives the application; and

(b) in any other case 30 days beginning with that day.

(7) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application.

(8) If a notice under paragraph (7) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (6).

(9) In paragraph (8), the “information period” means the period—

(a) beginning with the day on which the notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(10) Nothing in this regulation affects the powers conferred by regulation 26.

Provision of information

30

(1) Where an application has been made to the licensing authority for a licence under this Part, the licensing authority may, before determining the application, require the applicant to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

(2) The licensing authority may give a notice to the holder of a licence under this Part, requiring the holder to provide information of a kind specified in the notice within the period specified in the notice.

(3) A notice under paragraph (2) may not be given to the holder of a licence unless it appears to the licensing authority, or representations are made to the licensing authority by the Commission, an expert advisory group of the Commission, or an expert committee appointed by the licensing authority, that it is necessary for the licensing authority to consider whether the licence should be varied, suspended or revoked.

(4) A notice under paragraph (2) may specify information which the licensing authority, or the Commission, an expert advisory group of the Commission, or an expert committee appointed by the licensing authority, thinks necessary for considering whether the notice should be varied, suspended or revoked.

Miscellaneous and offences

Certification of manufacturer's licence

31

(1) The licensing authority must issue a certificate in accordance with the following paragraphs of this regulation in relation to a manufacturer's licence relating to the manufacture or assembly of medicinal products if requested to do so by—

(a) subject to paragraph (5), the holder of the licence;

(b) a person who intends to export a medicinal product manufactured or assembled by the holder under the licence; or

(c) the competent authorities of a country other than the United Kingdom into which a medicinal product manufactured or assembled under the licence is, or is proposed to be, imported.

(2) The certificate must contain —

(a) information sufficient to identify the holder of the manufacturer's licence;

(b) details of the medicinal products that may be manufactured or assembled under the licence; and

(c) any other information concerning the holder, the product or the licence that the licensing authority thinks it appropriate to include, including information relating to clinical trials.

(3) If—

(a) a request is made—

(i) under paragraph (1)(a) in relation to the export or the proposed export of a product, or

(ii) under paragraph (1)(b) or (c); and

(b) there is a UK marketing authorisation ..., Article 126a authorisation or a traditional herbal registration in force for any product to which the licence relates,

the certificate must be accompanied by the summary of the product characteristics relating to that product.

(4) The licensing authority may restrict the information provided under sub-paragraphs (2)(a) and (b) and paragraph (3) to information relating to the specific medicinal products mentioned in the request made under paragraph (1).

(5) A licence holder who makes a request under paragraph (1) must—

(a) produce to the licensing authority a UK marketing authorisation ..., Article 126a authorisation, certificate of registration or traditional herbal registration in relation to any product to which the certificate is to relate; or

(b) make a declaration to the licensing authority explaining why no UK marketing authorisation ..., Article 126a authorisation, certificate of registration or traditional herbal registration is available.

(6) The licensing authority must have regard to the prevailing administrative arrangements of the World Health Organisation when issuing the certificate.

Sale and supply of starting materials

32

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

Offence concerning data for advanced therapy medicinal products

33

(1) A person who is, or immediately before its revocation or suspension was, the holder of a manufacturer's licence relating to an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a) keep the data referred to in paragraph 8 of Schedule 6 in accordance with the requirements of paragraph 9 of that Schedule; or

(b) transfer the data referred to in paragraph 8 to the licensing authority in the event of that person's bankruptcy or liquidation,

but this is subject to paragraphs (2) and (3).

(2) Sub-paragraph (1)(b) does not apply if—

(a) the person is bankrupt or in liquidation and has transferred the data to another person; or

(b) the period for which the person was required to keep the data in accordance with the requirements of paragraph 9 mentioned in sub-paragraph (1)(a) has expired.

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

Offences: breach of regulations and false information and defence concerning starting materials

34

(1) A person is guilty of an offence if the person contravenes the provisions of regulation 17(1) or 18(1).

(2) A person is guilty of an offence if the person knowingly gives false information in response to a notice under regulation 30(1).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 30(2).

(4) The defence in paragraph (5) applies to a person who is charged under paragraph (1) with an offence of contravening regulation 17(1) (prohibition on manufacturing a medicinal product except in accordance with a licence) by virtue of a breach of regulation 37(3) (requirement that active substances used as starting materials are manufactured or assembled in accordance with the Good Manufacturing Practice Directive).

(5) It is a defence for the person to show that the person could not, by taking all reasonable precautions and exercising all due diligence, have discovered that an active substance was not manufactured in accordance with regulation 37(3).

Penalties

35

(1) A person guilty of an offence under regulation 33(1) or regulation 34(1) or (2) is liable—

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

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

(2) A person guilty of an offence under regulation 34(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Conditions for holding a manufacturer's licence

Conditions for manufacturer's licence

36

(1) Regulations 37 to 41 apply to the holder of a manufacturer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products).

(2) Those provisions are regulations 37(3), 38, 39(6)(a) and (8) , 40 and 41.

(3) The requirements of Part 1 of Schedule 6 apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

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

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Manufacturing and assembly

37

(1) This regulation applies in relation to a manufacturer’s licence relating to the manufacture or assembly of medicinal products.

(2) The licence holder must comply with the principles and guidelines for good manufacturing practice set out in the Good Manufacturing Practice Directive which apply under or by virtue of regulation B17.

(3) Unless paragraph (10) applies, the licence holder shall use active substances as starting materials only if—

(a) those substances have been manufactured in accordance with good manufacturing practice for active substances; and

(b) those substances have been distributed in accordance with the guidelines on good distribution practice for active substances.

(4) The licence holder shall verify—

(a) that the manufacturer or distributor of an active substance used by the licence holder has complied with the requirements of good manufacturing practice and good distribution practice for active substances by means of audits performed—

(i) directly by the licence holder, or

(ii) by a person acting on behalf of the licence holder under a contract;

(b) that unless the active substance is imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State from a third country, any manufacturers, importers or distributors supplying active substances to the licence holder—

(i) in the case of a product imported into Great Britain, are registered with the appropriate authority for the registration of such persons in the approved country for import, and

(ii) in the case of a product imported into Northern Ireland, are registered with the competent authority of a member State in which they are established; and

(5) The licence holder shall ensure that—

(a) excipients are suitable for use in a medicinal product by—

(i) ascertaining what the appropriate good manufacturing practice is, and

(ii) ensuring that the ascertained good manufacturing practice is applied;

(b) the suitability of the excipient is ascertained on the basis of a formalised risk assessment as described ... in the guidelines which apply under or by virtue of regulation C17 (including in the case of a listed NIMAR product for sale or supply from Great Britain to Northern Ireland) ;

(i) the source,

(ii) requirements under other quality systems,

(iii) intended use of the excipients, and

(iv) previous instances of quality defects,

(d) the authenticity and quality of any excipient used is verified; and

(e) the measures taken under this paragraph are documented by the licence holder.

(6) The licence holder must maintain such staff, premises and equipment as are necessary for the stages of manufacture and assembly of medicinal products undertaken by the licence holder in accordance with—

(a) the manufacturer’s licence; ...

(aa) in the case of a product for supply as an EAMS medicinal product, the conditions attached to the EAMS scientific opinion in respect of the product; ...

(ab) in the case of an MM medicinal product, the MM master file;

(ac) in the case of a POC medicinal product, the POC master file; and

(b) in the case of a product for sale or supply—

(i) in Great Britain (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland), the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK), or

(ii) in Northern Ireland, the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisations or Article 126a authorisations,

applying to the medicinal products.

(7) The licence holder must not manufacture or assemble medicinal products, or classes of medicinal products, other than those specified in the licence.

(8) Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must not manufacture or assemble medicinal products on premises other than those specified in the licence as approved by the licensing authority for the purpose.

(9) The licence holder must ensure that blood, or blood components, imported into the United Kingdom and used as a starting material or raw material in the manufacture of a medicinal product meet—

(a) the standards of quality and safety specified in the Blood Quality and Safety Regulations 2005; or

(b) equivalent standards.

(10) The requirements in paragraphs (3) to (5) do not apply in relation to the manufacture or assembly of special medicinal product to which regulation 167 (supply to fulfil special needs) applies or an EAMS medicinal product to which regulation 167E(1) to (4) (EAMS medicinal product: manufacture, assembly, importation, distribution and supply) applies.

(11) The licence holder must immediately inform the licensing authority and, where applicable, the UK marketing authorisation holder, of medicinal products which come within the scope of manufacturing authorisation which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

to be falsified.

Imports from states other than EEA States / countries other than approved countries for import

38

(1) This regulation applies in relation to a manufacturer's licence relating to the import of medicinal products.

(2) The licence holder must comply with the conditions set out in this regulation in relation to the import of medicinal products from—

(a) in the case of an import into Great Britain, a country other than an approved country for import, or

(b) in the case of an import into Northern Ireland, a country other than an EEA State.

(3) The licence holder must—

(a) comply with the principles and guidelines on good manufacturing practice in the Good Manufacturing Practice Directive in so far as they are relevant to the import of medicinal products; and

(b) ensure that active substances have been used as starting materials in the manufacture of medicinal products, other than special medicinal products, imported from , in the case of an import into Great Britain, a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State only if those substances have been manufactured or assembled in accordance with good manufacturing practice for active substances.

Further requirements for manufacturer's licence

39

(1) This regulation applies in relation to any manufacturer's licence.

(2) The licence holder must maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of medicinal products under the licence as are appropriate in order to maintain the quality of the medicinal products.

(3) The licence holder must ensure that any arrangements made for the handling, control, storage and distribution of medicinal products are adequate to maintain the quality of the products.

(4) Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must not handle, control, store or distribute medicinal products on any premises other than those specified in the licence as approved by the licensing authority for the purpose.

(5) Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must inform the licensing authority before making a material alteration to the premises or facilities used under the licence, or to the purposes for which those premises or facilities are used.

(5A) The holder of a manufacturer’s licence (MM) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the MM control site and the modular units specified in the MM master file.

(5B) The holder of a manufacturer’s licence (MM) must inform the licensing authority before making a material alteration to the premises or facilities at the MM control site, or to any modular unit specified in the MM master file, or to the purposes for which those premises or facilities are used.

(5C) The holder of a manufacturer’s licence (POC) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the POC control site and those specified in the POC master file.

(5D) The holder of a manufacturer’s licence (POC) must inform the licensing authority before making a material alteration to the premises or facilities at the POC control site, or to the purposes for which those premises or facilities are used.

(5E) Paragraphs (5A) and (5C) do not apply to anything done in the course of the business of a hospital that consists of dealing with a medicine or making it ready for use for the purposes of its final supply or administration to a patient.

(6) The licence holder must inform the licensing authority of any proposed change to—

(a) the qualified person; and

(b) any person named in the licence as having responsibility for quality control.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority to do anything that the licensing authority could have done for the purposes of verifying a statement made in an application for a licence.

(8) In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—

(a) regulations 43(1), (2) and (5), 43ZA and 44(5) and (6).

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

Obligation to provide information relating to control methods

40

(1) This regulation applies in relation to any manufacturer's licence.

(2) The licensing authority may require the licence holder to provide the authority with proof of the control methods employed by the holder in relation to a medicinal product.

Requirements as to qualified persons

41

(1) This regulation applies in relation to any manufacturer's licence.

(2) The licence holder must ensure that there is at the disposal of the holder at all times at least one qualified person who is responsible for carrying out, in relation to medicinal products manufactured, assembled or imported under the licence, the duties specified in Part 3 of Schedule 7.

(3) If the licence holder satisfies the requirements of Part 1 or 2 of Schedule 7 the licence holder may act as a qualified person.

(4) A qualified person may be treated by the licence holder as satisfying the requirements of Part 1 or 2 of Schedule 7 if that person produces evidence that he or she—

(a) is a member of a body specified in paragraph (5); and

(b) is regarded by that body as satisfying those requirements.

(5) Those bodies are—

(a) the Society of Biology;

(b) the Royal Pharmaceutical Society;

(d) the Royal Society of Chemistry; and

(e) such other body as may be specified by the licensing authority for the purpose of this paragraph.

(6) Where the qualified person changes, the licence holder must give the licensing authority advance notification of—

(a) that change; and

(b) the name, address and qualifications of the new qualified person.

(7) The licence holder must not permit any person to act as a qualified person other than the person named in the licence or another person notified to the licensing authority under paragraph (6).

(8) Paragraph (9) applies if the licensing authority thinks, after giving the licence holder and a person acting as a qualified person the opportunity to make representations (orally or in writing), that the person—

(a) does not satisfy the requirements of Part 1 or 2 of Schedule 7 in relation to qualifications or experience;

(b) does not satisfy paragraph (b) of the definition of “qualified person” in regulation 8; or

(9) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a qualified person.

(10) The licence holder must at all times provide and maintain such staff, premises and equipment as are necessary to enable the qualified person to carry out the duties referred to in paragraph (2).

(11) The licence holder is not obliged to meet the requirements of this regulation in relation to any activity under the licence which relates to special medicinal products or , unless conditions attached in accordance with regulation 174A(1) provide otherwise, to products authorised on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc).

(12) The licence holder is not obliged to meet the requirements of this regulation in relation to any activities under the licence which relate to EAMS medicinal products, unless the conditions attached to the scientific opinion in respect of that product in accordance with regulation 167C(2)(c) provide otherwise.

Conditions for holding a wholesale dealer's licence

Conditions for wholesale dealer's licence

42

(1) Regulations 43 to 45 (not including regulation 43ZA) (in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA (including regulation 43ZA) (in the case of a wholesale dealer’s licence held in Great Britain) apply to the holder of a wholesale dealer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products).

(2) Those provisions are regulations 43(2) and (8) and 44.

(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

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

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Obligations of licence holder

43

(1) The licence holder must comply with the guidelines on good distribution practice—

(a) in the case of a licence holder in Great Britain, published under, or that apply by virtue of, regulation C17;

(b) in the case of a licence holder in Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive.

(2) The licence holder must ensure, within the limits of the holder's responsibility, the continued supply of medicinal products to pharmacies, and other persons who may lawfully sell medicinal products by retail or supply them in circumstances corresponding to retail sale, so that the needs of patients in the United Kingdom are met.

(3) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of medicinal products under the licence as are necessary—

(a) to maintain the quality of the products; and

(b) to ensure their proper distribution.

(4) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(5) Subject to paragraph (6), the licence holder must not sell or supply a medicinal product, or offer it for sale or supply, unless—

(a) in the case of a product for sale or supply—

(i) in Great Britain, there is a UKMA(GB), UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii) in Northern Ireland, there is a UKMA(NI), UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK) ... or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and

(b) the sale or supply, or offer for sale or supply, is in accordance with the authorisation.

(6) The restriction in paragraph (5) does not apply to—

(a) the sale or supply, or offer for sale or supply, of a special medicinal product in the United Kingdom;

(aa) the supply, or offer for supply, of an unauthorised EAMS medicinal product in the United Kingdom;

(b) the export from Northern Ireland to an EEA State, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that State without a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration by virtue of legislation adopted by that State under Article 5(1) of the 2001 Directive; ...

(ba) the export from Great Britain to an approved country for import, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that country without—

(i) a marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the 2001 Directive, by virtue of legislation adopted by that country under Article 5(1) of that Directive, where the approved country for import is an EEA State, or

(ii) such equivalent authorisation, certificate or registration in the approved country for import, under legislation in that country that makes provision that is equivalent to Article 5(1) of the 2001 Directive, where the approved country for import is not an EEA State.

(c) the sale or supply, or offer for sale or supply, of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of the product under regulation 174; or

(d) the wholesale distribution of medicinal products—

(i) from Northern Ireland to a person in a country other than Great Britain or a country other than an EEA State; or

(ii) from Great Britain to a person in a country other than Northern Ireland or a country other than an approved country for import.

(7) The licence holder must—

(a) keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with paragraph (b);

(b) maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

(i) ordered by the licensing authority or—

(aa) in the case of a licence holder in Great Britain, by an appropriate authority for the licensing of medicinal products in an approved country for import;

(bb) in the case of a licence holder in Northern Ireland, by the competent authority of any EEA State, or

(ii) carried out in co-operation with the manufacturer of, or the holder of—

(aa) in the case of a product for sale or supply in Great Britain, the UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration, or

(bb) in the case of a product for sale or supply in Northern Ireland, the UKMA(NI) or UKMA(UK) ..., Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and

(i) the date of receipt,

(ii) the date of despatch,

(iii) the date of brokering,

(iv) the name of the medicinal product,

(v) the quantity of the product received, dispatched or brokered,

(vi) the name and address of the person from whom the products were received or to whom they are dispatched,

(vii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) A licence holder in Northern Ireland (“L”) who imports from another EEA State a medicinal product in relation to which L is not the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration shall—

(a) notify the intention to import that product to the holder of the authorisation and—

(i) in the case of a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004, to the EMA; or

(ii) in any other case, the licensing authority; and

(b) pay a fee to the EMA in accordance with Article 76(4) of the 2001 Directive or the licensing authority as the case may be, in accordance with the Fees Regulations,

but this paragraph does not apply in relation to the wholesale distribution of medicinal products to a person in a country other than an EEA State.

(8A) Paragraph (8B) applies to a person (“P”) who—

(a) imports into Great Britain a medicinal product, other than for the sole purpose of wholesale distribution of that product to a person in a country other than the United Kingdom; but

(b) is not the holder of a UK marketing authorisation, certificate of registration or traditional herbal registration in respect of that product.

(8B) Where this paragraph applies, P must—

(a) notify—

(i) the holder of any authorisation, certificate or registration, granted by an authority in the country from which the product is exported, to sell or supply that product in that country, and

(ii) the licensing authority,

of the intention to import that product; and

(b) pay a fee to the licensing authority in accordance with the Fees Regulations.

(9) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

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

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

(12) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(13) The licence holder must immediately inform the licensing authority and, where applicable, the UK marketing authorisation holder ..., of medicinal products which the licence holder receives or is offered which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

to be falsified.

(14) Where the medicinal product is obtained through brokering—

(a) a licence holder in Great Britain must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b);

(b) a licence holder in Northern Ireland must verify that the broker involved is validly registered with the licensing authority or the competent authority of an EEA State.

(15) In this regulation as it applies in the case of a product for sale or supply in Northern Ireland, “marketing authorisation” means—

(a) a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; or

(b) an EU marketing authorisation.

Requirement for wholesale dealers to deal only with specified persons

44

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The licence holder must not obtain supplies of medicinal products from anyone except—

(a) the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

(b) the person who holds an authorisation granted by an approved country for import (in the case of a licence holder in Great Britain) or by an EEA State (in the case of a licence holder in Northern Ireland) authorising the manufacture of products of the description or their distribution by way of wholesale dealing; or

(i) in the case of a licence holder in Great Britain, from a country that is not an approved country for import (“A”), for export to a country that is not an approved country for import (“B”), and

(ii) in the case of a licence holder in Northern Ireland, from a country other than an EEA State (“A”) for export to another country other than an EEA State (“B”),

the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A.

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

(3) Where a medicinal product is obtained in accordance with paragraph ... (2)(a) or (b), the licence holder must verify that—

(a) the wholesale dealer who supplies the product complies with the principles and guidelines of good distribution practices; or

(b) the manufacturer or importer who supplies the product holds a manufacturing authorisation.

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

(5) The licence holder may distribute medicinal products by way of wholesale dealing only to—

(a) the holder of a wholesale dealer’s licence relating to those products;

(b) the holder of an authorisation granted by—

(i) in the case of a licence holder in Great Britain, the appropriate authority of an approved country for import;

(ii) in the case of a licence holder in Northern Ireland, the competent authority of an EEA State,

that is responsible for authorising the supply of those products by way of wholesale dealing;

(c) a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale;

(d) a person who may lawfully administer those products; or

(e) in relation to supply—

(i) in the case of a licence holder in Great Britain to persons in countries other than approved countries for import, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country to which the product is supplied;

(ii) in the case of a licence holder in Northern Ireland to persons in a country other than an EEA State, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country other than an EEA State concerned.

(6) Where a medicinal product is supplied to a person who is authorised or entitled to supply medicinal products to the public in accordance with paragraph ... (5)(c) or (e), the licence holder must enclose with the product a document stating the—

(a) date on which the supply took place;

(b) name and pharmaceutical form of the product supplied;

(d) name and address of the licence holder.

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) The licence holder must—

(a) keep a record of information supplied in accordance with paragraph (6) for at least five years beginning immediately after the date on which the information is supplied; and

(b) ensure that the record is available to the licensing authority for inspection.

(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(UK)(Category 2) was granted under the unfettered access route if the product satisfies the definition of qualifying Northern Ireland goods.

(9) Paragraph (2)(c) does not apply to—

(a) in the case of a licence holder in Great Britain, products received from Northern Ireland, and

(b) in the case of a licence holder in Northern Ireland, products received from Great Britain.

(10) Paragraph (5)(e) does not apply to—

(a) in the case of a licence holder in Great Britain, products supplied to Northern Ireland, and

(b) in the case of a licence holder in Northern Ireland, products supplied to Great Britain.

Requirement as to responsible persons

45

(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person”) who in the opinion of the licensing authority—

(a) has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and

(b) has adequate experience relating to those activities and procedures.

(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.

(2) Those functions are—

(a) ensuring that the conditions under which the licence was granted have been, and are being, complied with; and

(b) ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—

(i) in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and

(ii) in the case of a licence holder in Northern Ireland, the marketing authorisations, requirements of regulation 167A, Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.

(3) The licence holder must notify the licensing authority of—

(a) any change to the responsible person; and

(b) the name, address, qualifications and experience of the responsible person.

(4) The licence holder must not permit any person to act as a responsible person other than the person named in the licence or another person notified to the licensing authority under paragraph (3).

(5) Paragraph (6) applies if, after giving the licence holder and a person acting as a responsible person the opportunity to make representations (orally or in writing), the licensing authority thinks that the person—

(a) does not satisfy the requirements of paragraph (1) in relation to qualifications or experience; or

(b) is failing to carry out the functions referred to in paragraph (2) adequately or at all.

(6) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a responsible person.

PART 4 — Requirement for authorisation

Requirement for authorisation

46

(1) A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product.

(2) A person may not sell or supply, or offer to sell or supply, a medicinal product otherwise than in accordance with the terms of—

(a) a UK marketing authorisation;

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a certificate of registration;

(d) an Article 126a authorisation.

(3) A person may not possess an unauthorised medicinal product if the person knows or has reasonable cause to believe that the product is intended to be sold or supplied to another person within the United Kingdom or the European Economic Area.

(4) A person may not in the circumstances mentioned in paragraph (5)—

(a) manufacture or assemble a medicinal product; or

(b) procure the sale, supply, manufacture or assembly of a medicinal product.

(5) Those circumstances are that the person knows or has reasonable cause to believe that the medicinal product has been or is intended to be sold or supplied contrary to paragraph (1).

(6) For the purposes of this regulation a medicinal product is unauthorised if none of the following is in force for the product in the country in which the product is intended to be sold or supplied, or offered for sale or supply—

(a) a UK marketing authorisation;

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a certificate of registration;

(d) an Article 126a authorisation.

(7) This regulation is subject to—

(a) Part 10 (exceptions to requirement for marketing authorisation etc); and

(b) Article 83 of Regulation (EC) No 726/2004 (authorisation of placing on the market of medicinal product for compassionate reasons).

(8) A medicinal product is not unauthorised for the purposes of this regulation if—

(a) it is sold or supplied, or offered for sale or supply, for export to an EEA State; and

(b) the product may lawfully be sold or supplied in that state by virtue of legislation adopted by that state in compliance with the 2001 Directive.

(9) Paragraphs (1) and (2) do not apply to the sale, supply, or offer for sale or supply, of a medicinal product to a person outside the United Kingdom or the European Economic Area.

(10) Paragraphs (1) and (2) do not apply to the sale, supply, or offer for sale or supply, of an investigational medicinal product to a person specified in regulation 13(1) of the Clinical Trials Regulations for the purposes of administering that product in a clinical trial, provided that the conditions specified in regulation 13(2) of those Regulations are satisfied.

(11) Paragraph (3) does not apply to possession of an investigational medicinal product by a person who knows or has reasonable cause to believe—

(a) that the investigational medicinal product is intended to be sold or supplied within the United Kingdom or the European Economic Area; and

(b) that paragraph (10) will apply to the sale or supply.

Breach of requirement

47

(1) A person who breaches regulation 46 is guilty of an offence.

(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 not exceeding two years or to both.

(3) It is to be presumed for the purposes of regulation 46(3) that, if a person (“P”) knows or has reasonable cause to believe that a medicinal product is intended to be sold or supplied to another person, P knows or has reasonable cause to believe that the other person is within the United Kingdom or the European Economic Area.

(4) Paragraph (3) does not apply if P proves that P did not know or have reasonable cause to believe that the person was within the United Kingdom or the European Economic Area.

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

(6) Paragraph (7) applies if the holder of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation is charged with an offence under this regulation 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, certificate or registration.

(7) Where this paragraph applies, it is a defence for the holder to prove that—

(a) the holder communicated the terms of the authorisation, certificate or 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.

PART 5 — Marketing authorisations

Application of this Part

48

(1) This Part applies to relevant medicinal products.

(2) In this Part—

“excluded reference product” means— a medicinal product authorised on the basis that it was a generic medicinal product;a medicinal product authorised on the basis that one or more of the circumstances listed in Article 10(3) of the 2001 Directive or regulation 52(1)(b) applied; ora biological medicinal product authorised on the basis that it did not meet a condition for being a generic medicinal product for any of the reasons described in Article 10(4) of the 2001 Directive or regulation 53B(1);

“generic medicinal product”, in relation to a reference medicinal product for an application for— a UKMA(NI) or UKMA(UK)(Category 2), has the meaning given in Article 10(2)(b) of the 2001 Directive;a UKMA(UK)(Category 1), means a medicinal product—that has the same qualitative and quantitative composition in active substances as the reference medicinal product;that has the same pharmaceutical form as the reference medicinal product; andwhose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies;

“parallel import licence” means a licence that is granted by the licensing authority under this Part authorising the holder to place on the market a medicinal product imported in to the United Kingdom from an EEA State where that product—has been granted an EU marketing authorisation or a marketing authorisation in an EEA State under the 2001 Directive; andis essentially similar to a product that has been granted a UK marketing authorisation;

“relevant medicinal product” means a medicinal product that is not—a registrable homoeopathic medicinal product; ora traditional herbal medicinal product; and

“reference medicinal product” means— in relation to an application for a UKMA(NI), a medicinal product—authorised for sale or supply in Northern Ireland under regulation 49(1)(a), in accordance with the provisions of regulation 50; orin relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force,but which is not an excluded reference product;...in relation to an application for a UKMA(UK), a medicinal product—authorised under regulation 49(1)(a) for sale or supply in the whole of the United Kingdom, whether by virtue of one or more UK marketing authorisations, in accordance with the provisions of regulation 50, ...but which is not an excluded reference product;

(3) In this Part, references to a medicinal product to be imported that is “essentially similar to a product that has been granted a UK marketing authorisation” are to be read as references to a medicinal product to be imported that—

(a) has been manufactured to the same formulation as a product that has been granted a UK marketing authorisation (“the UK product”);

(b) contains the same active ingredients as the UK product;

and for the purposes of sub-paragraph (a), any differences in a product's formulation are to be ignored in so far as they are considered to be immaterial by the licensing authority.

(4) For the purposes of the definition of generic medicinal product—

(a) the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and

(b) the various immediate-release oral pharmaceutical forms are considered to be the same pharmaceutical form.

(5) When a medicinal product has been granted a UK marketing authorisation under regulation 49(1)(a) in accordance with the provisions of regulation 50 (“initial marketing authorisation”), any additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions in relation to which a UK marketing authorisation is granted under regulation 49(1)(a), or which are included in the initial UK marketing authorisation, belong to the same “global marketing authorisation”.

(6) Paragraph (7) applies if a medicinal product—

(a) belongs to a global marketing authorisation but is not the initial marketing authorisation; and

(b) is used as a reference medicinal product in accordance with regulations 51 to 53B.

(7) Where this paragraph applies, the medicinal product is treated for the purposes of the application of regulation 51B(1) and (6) as if it had been authorised on the date of authorisation of the medicinal product to which the initial marketing authorisation relates.

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for UK marketing authorisation

Application for grant of UK marketing authorisation or parallel import licence

49

(1) The licensing authority may grant—

(a) subject to regulation 58, 58C, 58E, 58F and 58G, a UK marketing authorisation; or

(b) a parallel import licence,

for a relevant medicinal product in response to an application made in accordance with this Part.

(1ZA) If the licensing authority determines to grant a UKMA(UK) under paragraph (1), it must determine if one or more of the following criteria are met in relation to the medicinal product—

(a) it belongs to a category of medicinal product referred to in Article 3(1) of Regulation (EC) No 726/2004;

(b) it belongs to a category of medicinal product referred to in Article 3(2) of Regulation (EC) No 726/2004 and—

(i) the medicinal product contains an active substance which, on 20th May 2004, was not authorised in the European Union, or

(ii) the licensing authority considers that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that granting the marketing authorisation is in the interest of patients’ health in the United Kingdom.

(1ZB) If the licensing authority determines that one or more of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 1).

(1ZC) If the licensing authority determines that none of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 2).

(1ZD) The licensing authority may grant a UKMA(NI) under Chapter 4 of Title III of the 2001 Directive where there is an application for a marketing authorisation for a medicinal product, unless there is a UKMA(UK), or an application yet to be determined for a UKMA(UK), for the same medicinal product.

(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a UKMA(UK)(Category 2) only where—

(a) there is in place, or will be at the time the UKMA(UK)(Category 2) is granted, a UKMA(NI) in respect of the product authorising sale or supply in Northern Ireland,

(b) the applicant complies with the requirements in regulation 50(1A), and

(1B) The licensing authority may only grant a parallel import licence if it is able to obtain the information necessary, whether from a competent authority of an EEA State or otherwise, to satisfy itself that the medicinal product to be imported—

(a) has been granted an EU marketing authorisation or a marketing authorisation under the 2001 Directive; and

(b) is essentially similar to a product that has already been granted a UK marketing authorisation.

(1C) A marketing authorisation or parallel import licence must state whether it is in force in—

(a) the whole United Kingdom;

(b) Great Britain only; or

and in these Regulations the meaning of a reference to that authorisation or licence being “in force” is limited to that territory.

(2) A marketing authorisation or parallel import licence granted under paragraph (1) shall contain terms approved by the licensing authority.

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

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

(b) a UKMA(UK)(Category 2) —

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

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

(3ZA) Where a UKMA(UK)(Category 2) is granted under the unfettered access route, any UKMA(NI) granted in relation to the same medicinal product ceases to have effect.

(3A) An application for a parallel import licence may not be made by—

(a) the holder of the marketing authorisation, within the meaning of the 2001 Directive, or the EU marketing authorisation, in respect of the relevant medicinal product to be imported; or

(b) a company which is in the same group as the holder of that marketing authorisation.

(4) The application must be—

(a) made in writing;

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

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

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

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

(a) only on prescription;

(b) only from a pharmacy; or

(8) The application must include a statement indicating—

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

(b) if so, what terms are proposed.

(9) The application must include a statement indicating whether the authorisation or licence sought is for sale or supply of the product in—

(a) the whole United Kingdom;

(b) ...; or

(10) In this regulation “group” has the same meaning as in Part 15 of the Companies Act 2006 (see section 474(1) of that Act).

Accompanying material

50

(1) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide the material specified in Schedule 8 in relation to the product.

(1A) An applicant for the grant of a parallel import licence for a relevant medicinal product must provide the material specified in Schedule 8A in relation to the product.

(1A) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide—

(a) in the case of an application under the unfettered access route—

(i) the material specified in Schedule 8C, and

(ii) any material specified in Schedule 8 which is not included in the material specified in Schedule 8C, and

(b) in all other cases, the material specified in Schedule 8,

in relation to the product.

(2) An applicant for the grant of a UK marketing authorisation or parallel import licence for a radionuclide generator must, in addition, provide—

(a) a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation; and

(b) qualitative and quantitative particulars of the eluate or the sublimate.

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

(3A) Paragraph (4) does not apply in respect of an application under the unfettered access route.

(4) If any of the medicinal products to which the application for a UK marketing authorisation relates—

(a) in the case of a UKMA(NI) or a UKMA(UK)(Category 2), is liable to be imported from a country other than an EEA State, or

(b) in the case of a UKMA(UK)(Category 1), is liable to be imported,

the material or information referred to in paragraph (3) may include an undertaking from the manufacturer of the product to comply with the matters set out in Schedule 9.

(5) Subject to paragraphs (5AA) and (5AB), material that is submitted under this regulation for the purposes of a UK marketing authorisation must be submitted in accordance with the applicable provisions of Annex I to the 2001 Directive.

(5AA) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the 2001 Directive, an applicant for the grant of a UK marketing authorisation for an MM medicinal product must also provide a copy of the MM master file for that product.

(5AB) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the Directive, an applicant for the grant of a UK marketing authorisation for a POC medicinal product must also provide a copy of the POC master file for that product.

(5A) The Secretary of State may by regulations... amend Schedule 8B (modifications of Annex I) in relation to a UKMA(UK)(Category 1) for the purpose of further modifying Annex I to the 2001 Directive in order to take account of scientific and technical progress.

(5B) The licensing authority may publish, for the purposes of applications made pursuant to this regulation—

(a) guidance on the presentation and content of the material specified in Schedule 8;

(b) scientific guidelines relating to the quality, safety and efficacy of medicinal products; and

(5C) Unless replaced by guidance or guidelines published under the power conferred by paragraph (5B), the following guidance and guidelines continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under that paragraph)—

(a) the guidance published by the European Commission in the rules governing medicinal products in the European Community, Volume 2B, Notice to Applicants, Medicinal Products for human use, Presentation and content of the dossier, Common Technical Document;

(b) the scientific guidelines relating to the quality, safety and efficacy of medicinal products as adopted by the Committee for Medicinal Products for Human Use and published by the EMA and the other pharmaceutical Community guidelines published by the European Commission in the different volumes of the rules governing medicinal products in the European Community; and

(6) Unless the application is for a parallel import licence this regulation is subject to—

(za) regulation 50A (requirement for certain applications to include results of paediatric investigation plan);

(zb) regulation 50E (application for paediatric use marketing authorisation);

(zc) regulation 50F (other applications including paediatric indications);

(zd) regulation 50G (applications relating to orphan medicinal products);

(ze) regulation 50H (applications relating to advanced therapy medicinal products);

(zf) regulation 50I (applications relating to conditional marketing authorisations);

(zg) regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms);

(a) regulation 51 (application for UKMA(NI) relating to generic medicinal products);

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ab) regulation 51B (application for UKMA(UK) relating to generic medicinal products);

(b) regulation 52 (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc);

(ba) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(bb) regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc);

(ca) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cb) regulation 53B (application for UKMA(UK) relating to similar biological medicinal products);

(d) regulation 54 (applications relating to products in well-established medicinal use);

(e) regulation 55 (applications relating to new combinations of active substances);

(f) regulation 56 (applications containing information supplied in relation to another medicinal product with consent); and

(g) Schedule 10 (applications relating to national homoeopathic products).

(7) The licensing authority may make appropriate arrangements with any EEA State or the EMA in order to obtain the information it considers necessary to satisfy itself that a product to be imported under a parallel import licence is essentially similar to a product that has been granted a UK marketing authorisation.

(8) If the licensing authority makes arrangements under paragraph (7), it must publish a list of the EEA States or the organisation with which it has made such arrangements.

Applications relating to generic medicinal products

51

(1) An applicant for a UKMA(NI) for a relevant medicinal product that is a generic medicinal product may provide information in relation to the application in accordance with Article 10(1), (5) and (6) of the 2001 Directive.

(2) If the licensing authority grants a UKMA(NI) for the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in Northern Ireland before the time at which it may be placed on the market in accordance with Article 10(1) of the 2001 Directive ....

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

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

Applications relating to certain medicinal products that do not qualify as generic etc

52

(1) This regulation applies where—

(a) an application is made for a UKMA(NI) by reference to another medicinal product as reference medicinal product; and

(b) one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.

(2) The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.

(3) Paragraph (2) of regulation 51 applies to the application as it applies in relation to an application made in accordance with paragraph (1) of that regulation.

Applications relating to similar biological medicinal products

53

(1) This regulation applies if an applicant for a UKMA(NI) for a biological medicinal product is not able to show that product meets a condition for its being a generic version of a similar medicinal product because of any of the reasons described in Article 10(4) of the 2001 Directive.

(2) The applicant must provide information in accordance with Article 10(4) and (6) of the 2001 Directive.

(3) Paragraph (2) of regulation 51 applies to the application as it applies in relation to an application made in accordance with paragraph (1) of that regulation.

Applications relating to products in well-established medicinal use

54

(1) This regulation applies if an applicant for a UK marketing authorisation for a relevant medicinal product is able to demonstrate that the active substances of the product have been in well-established medicinal use within the United Kingdom or the European Union for at least 10 years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I to the 2001 Directive.

(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, replace the results of pre-clinical tests or clinical trials with appropriate scientific literature.

Applications relating to new combinations of active substances

55

(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product that contains active substances, provided those active substances—

(a) have not been used in that combination for therapeutic purposes; and

(b) where the application is for—

(i) a UKMA(NI), have been used in medicinal products that have been the subject of a marketing authorisation under these Regulations, the 2001 Directive or Regulation (EC) No 726/2004;

(ii) ... or

(iii) a UKMA(UK), have been used in medicinal products that have been the subject of—

(aa) a UKMA(UK) under these Regulations; or

(bb) a UKMA(NI).

(2) The applicant must provide the results of new pre-clinical tests or new clinical trials relating to that combination in accordance with paragraph 10 of Schedule 8, but does not need to provide scientific references relating to each individual active substance.

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

56

(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product where—

(a) the product that is the subject of the application (“product A”) has the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as a product (“product B”);

(b) product B is the subject of a UK marketing authorisation; and

(c) the holder of the marketing authorisation for product B has allowed use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on product B with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.

(2) The documentation referred to in paragraph (1)(c) in relation to product B may be used in relation to the application in relation to product A ...

Obligation to update information supplied in connection with application

57

(1) The applicant for a UK marketing authorisation must update information supplied in accordance with paragraphs 18 to 21 of Schedule 8 (material to accompany an application for a UK marketing authorisation) in connection with the application.

(2) The applicant must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

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

Consideration of application

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;

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

(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.

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

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

(8) In the case of an application under the unfettered access route, the licensing authority may grant a UKMA(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

(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.

Conditions of UK marketing authorisation or parallel import licence: general

59

(1) Unless 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.

(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

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The Human Medicines Regulations 2012

Grant or refusal of licence

23

Standard provisions of licences

24

Duration of licence

25

General power to suspend, revoke or vary licences

26

Procedure where licensing authority proposes to suspend, revoke or vary licence

27

Suspension of licence in cases of urgency

28

Variation of licence on the application of the holder

29

Provision of information

30

Miscellaneous and offences

Certification of manufacturer's licence

31

Sale and supply of starting materials

32

Offence concerning data for advanced therapy medicinal products

33

Offences: breach of regulations and false information and defence concerning starting materials

34

Penalties

35

Conditions for holding a manufacturer's licence

Conditions for manufacturer's licence

36

Manufacturing and assembly

37

Imports from states other than EEA States / countries other than approved countries for import

38

Further requirements for manufacturer's licence

39

Obligation to provide information relating to control methods

40

Requirements as to qualified persons

41

Conditions for holding a wholesale dealer's licence

Conditions for wholesale dealer's licence

42

Obligations of licence holder

43

Requirement for wholesale dealers to deal only with specified persons

44

Requirement as to responsible persons

45

PART 4 — Requirement for authorisation

Requirement for authorisation

46

Breach of requirement

47

PART 5 — Marketing authorisations

Application of this Part

48

Application for UK marketing authorisation

Application for grant of UK marketing authorisation or parallel import licence

49

Accompanying material

50

Applications relating to generic medicinal products

51

Applications relating to certain medicinal products that do not qualify as generic etc

52

Applications relating to similar biological medicinal products

53

Applications relating to products in well-established medicinal use

54

Applications relating to new combinations of active substances

55

Applications containing information supplied in relation to another product with consent

56

Obligation to update information supplied in connection with application

57

Consideration of application

Consideration of application

58