The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

• Citation: S.I. 2019/775
• Sections: 295

Section 1 Citation and commencement

These Regulations may be cited as the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day.

Section 2 Amendment of the Human Medicines Regulations 2012

The Human Medicines Regulations 2012 are amended in accordance with Parts 2 to 19.

Section 3 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

Schedule 1 amends the Medicines (Products for Human Use) (Fees) Regulations 2016 and makes saving provision.

Section 4 Definitions in relation to advanced therapy medicinal products

After regulation 2, insert—

Definition of advanced therapy medicinal product etc.

(2A)

(1) In these Regulations, in their application to products for sale or supply in Great Britain only, “ advanced therapy medicinal product ” means any of the following products—

(a) a gene therapy medicinal product;

(b) a somatic cell therapy medicinal product; or

(c) a tissue engineered product.

(2) A “gene therapy medicinal product” is a biological medicinal product which has the following characteristics—

(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and

(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

(3) A vaccine against infectious diseases is not to be treated as a gene therapy medicinal product.

(4) A “somatic cell medicinal product” is a medicinal product which has the following characteristics—

(a) it contains or consists of cells or tissues that—

(i) have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or

(ii) are not intended to be used for the same essential function in the recipient as in the donor; and

(b) it is presented as having properties for, or is used in or administered to human beings with a view to, treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

(5) A “tissue engineered product” is a medicinal product which—

(a) contains or consists of engineered cells or tissues; and

(b) is presented as having properties for, or is used in or administered to human beings with a view to, regenerating, repairing or replacing a human tissue.

(6) A tissue engineered product may contain—

(a) cells or tissues of human or animal origin;

(b) viable or non-viable cells or tissues; and

(c) additional substances, including cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.

(7) A product is not a tissue engineered product if it—

(a) contains or consists exclusively of non-viable human or animal cells or tissues;

(b) does not contain any viable cells or tissues; and

(c) does not act principally by pharmacological, immunological or metabolic action.

(8) Cells or tissues are engineered if they—

(a) have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved; or

(b) are not intended to be used for the same essential function in the recipient as in the donor.

(9) The following manipulations are not substantial manipulations for the purposes of paragraphs (4)(a) and (8)(a)—

(a) cutting;

(b) grinding;

(c) shaping;

(d) centrifugation;

(e) soaking in antibiotic or antimicrobial solutions;

(f) sterilisation;

(g) irradiation;

(h) cell separation, concentration or purification;

(i) filtering;

(j) lyophilisation;

(k) freezing;

(l) cryopreservation; and

(m) vitrification.

(10) In these Regulations, in their application to products for sale or supply in Great Britain only, “ combined advanced therapy medicinal product ” means an advanced therapy medicinal product—

(a) which incorporates, as an integral part of the product, one or more medical devices or one or more active implantable medical devices; and

(b) the cellular part of which—

(i) contains viable cells or tissues; or

(ii) contains non-viable cells or tissues which are liable to act upon the human body with action that can be considered as primary to that of the medical devices.

(11) Where an advanced therapy medicinal product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues is to be treated as the principal mode of action of the product.

(12) An advanced therapy medicinal product containing both autologous and allogeneic cells or tissues is to be treated as being for allogeneic use.

(13) A product which falls within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product is to be treated as a tissue engineered product.

(14) A product which falls within the definition of—

(a) a somatic cell therapy medicinal product or a tissue engineered product; and

(b) a gene therapy medicinal product,

is to be treated as a gene therapy medicinal product.

Section 5 Amendment of regulation 3 (scope of Regulations: special provisions)

(1) Regulation 3 is amended as follows.

(2) In paragraph (12)(d)—

(a) in paragraph (i) insert “ UK ” before “marketing authorisation”;

(b) after paragraph (i) insert—

(ia) the EU marketing authorisation,

(3) In paragraph (15)—

(a) in sub-paragraph (a) insert “ UK ” before “marketing authorisation”; and

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

Section 6 Amendment of regulation 4 (special provision for pharmacies etc)

In regulation 4—

(a) in paragraph (4)(d)—

(i) in paragraph (i) insert “UK” before “marketing authorisation”;

(ii) after paragraph (i) insert—

(ia) the EU marketing authorisation,

(b) in paragraph (6) for “269 (offences relating to packaging and package leaflets: other persons)” substitute “269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.

Section 7 Amendment of regulation 5 (classification of medicinal products)

(1) Regulation 5 is amended as follows.

(2) In paragraph (1)(b), before “a product that” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”.

(3) In paragraph (2)—

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) in sub-paragraph (d), before “an Article 126a” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”.

(4) In paragraph (3)—

(a) in sub-paragraph (b), before “a medicinal product” insert “in the case of a medicinal product for sale or supply in Northern Ireland, ”;

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

(5) In paragraph (4), in sub-paragraph (b), before “an Article” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”.

(6) In paragraph (5)—

(a) in sub-paragraph (b), before “a product that” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”; and

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

Section 8 Amendment of Schedule 1 (further provisions for classification of medicinal products)

In Schedule 1—

(a) in paragraph 1—

(i) in sub-paragraph (b), insert “UK” before “marketing authorisation”;

(ii) in sub-paragraphs (e)(i), (f)(i) and (g)(i), for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence”; and

(b) in paragraph 4, for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation, Article 126a authorisation, parallel import licence”.

Section 9 Amendment of regulation 6 (the licensing authority and the Ministers)

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

Section 10 Amendment of regulation 8 (general interpretation)

(1) Regulation 8 is amended as follows.

(2) In paragraph (1), at the appropriate places, insert—

“active implantable medical device”—

(a) has the meaning given in regulation 2 of the Medical Devices Regulations 2002 ; or

(b) to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 137 of those Regulations ;

“ agreed paediatric investigation plan ” means a paediatric investigation plan which the licensing authority has agreed in accordance with regulation 50B;

“ Annex I to the 2001 Directive ” means , in relation to UKMA(GB), Annex I to the 2001 Directive, as modified in accordance with Schedule 8B;

“ approved country for batch testing list ” means the list published by the licensing authority under paragraph 14(3) of Schedule 7 (obligations of qualified persons) and “ approved country for batch testing ” means a country included in that list;

“ approved country for import list ” means the list published by the licensing authority under regulation 18A (approved country for import) and “ approved country for import ” means a country included in that list;

“ the Committee for Medicinal Products for Human Use ” means the committee established under Article 5(1) of Regulation (EC) No 726/2004 ;

“ conditional marketing authorisation ” means a UKMA(GB) granted under regulation 49(1)(a) in accordance with regulation 58F;

“ country ” means a country or territory;

“ Directive 2001/18/EC ” means Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration ;

“EU agreed paediatric investigation plan” means a paediatric investigation plan agreed in accordance with the Paediatric Regulation;

“ EU Exit Regulations ” means the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019;

“medical device”—

(a) has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or

(b) to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 69 of those Regulations ;

“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;

“ orphan criteria ” means the criteria listed in regulation 50G(2);

“ orphan marketing authorisation ” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58C;

“ Orphan Regulation ” means Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products as it has effect in EU law;

“ paediatric indication ” means a term of a UK marketing authorisation enabling the medicinal product to which the authorisation relates to be used by or administered to persons under the age of 18 years;

“ paediatric population ” means that part of the population consisting of persons under the age of 18 years;

“parallel import licence” has the meaning given in regulation 48(2);

“qualifying Northern Ireland goods” has the same meaning that it has in the European Union (Withdrawal) Act 2018, including any meaning defined for the purposes of that Act from time to time by regulations made under the power conferred by section 8C(6) of that Act;

“ supplementary protection certificate ” has the meaning given in section 128B(2) of the Patents Act 1977 ;

“under the unfettered access route” means an application for—

(a) a UKMA(GB) under reduced or alternative requirements specified in Part 5 (as referred to in regulation 49(1A));

(b) a COR(GB) under reduced or alternative requirements specified in Part 6 (as referred to in regulation 103(1A));

(c) a THR(GB) under reduced or alternative requirements specified in Part 7 (as referred to in regulation 127(1A));

“ variation to the terms of a UK marketing authorisation ” means any change to—

(a) the information provided in accordance with regulations 50 to 57 and Schedule 8; or

(b) the terms of the decision granting the UK marketing authorisation, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting that UK marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics,

and “vary” and “ variation ” in relation to a UK marketing authorisation are to be construed accordingly;.

“withdrawal agreement” has the meaning given in section 39 of the European Union (Withdrawal Agreement) Act 2020;

(3) In paragraph (1), amend or substitute (as the case may be) the following definitions—

(za) in the definition of “advanced therapy medicinal product”, after “means” insert “, in the case of a medicinal product for sale or supply by the holder of a UKMA(NI) or UKMA(UK),”;

(zb) in the definition of “certificate of registration”, after “these Regulations” insert—

and—

“COR(UK)” means such a certificate in force in the whole United Kingdom;

“COR(GB)” means such a certificate in force in Great Britain only;

“COR(NI)” means such a certificate in force in Northern Ireland only;

(a) for the definition of “the Good Manufacturing Practice Directive” substitute—

“the Good Manufacturing Practice Directive” means—

in the case of a medicinal product manufactured or assembled in, or imported into, Great Britain—

Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A, or

if Regulations have been made under the powers in regulation B17(1), and have come into force, those Regulations;

in the case of a medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;

(b) in the definition of “homoeopathic medicinal product”, in paragraph (b), for “in any pharmacopoeia used officially in an EEA State” substitute—

(i) in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in Great Britain only, the British Pharmacopoeia, or in an pharmacopoeia used officially in an country that is included in a list published by the licensing authority for this purpose;

(ii) in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in the whole United Kingdom or in Northern Ireland only, in the British Pharmacopoeia or in any pharmacopoeia used officially in an EEA State;

(c) in the definition of “import” , insert at the end “ and “ imported ” is to be construed accordingly ” ;

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

(e) in the definition of “pharmacovigilance system”, “pharmacovigilance system master file” and “post-authorisation safety study”, for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”

(f) in the definition of “post-authorisation efficacy study”, insert “ UK ” before “marketing authorisation”;

(g) at the end of the definition of “Regulation (EC) No 726/2004 ”, insert “ , as it has effect in EU law ” ;

(h) at the end of the definition of “Regulation (EC) No 1234/2008 ”, insert “ , as it has effect in EU law ” ;

(i) in the definition of “special medicinal product” for “an EEA State” substitute “ a country ” ;

(j) in the definition of “traditional herbal registration”, after “these Regulations” insert—

and—

“THR(UK)” means such a registration in force in the whole United Kingdom;

“THR(GB)” means such a registration in force in Great Britain only;

“THR(NI)” means such a registration in force in Northern Ireland only;

(k) for the definition of “UK marketing authorisation” substitute—

“UK marketing authorisation” means a marketing authorisation granted by the licensing authority under Part 5 of these Regulations or Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure) and—

“UKMA(UK)” means such an authorisation in force in the whole United Kingdom;

“UKMA(GB)” means such an authorisation in force in Great Britain only;

“UKMA(NI)” means such an authorisation in force in Northern Ireland only.

(4) In paragraph (1), omit the following definitions—

(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

(iii) “care home” ,

(iv) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v) “Directive 2002/98/EC ”,

(vi) “Directive 2004/23/EC ”,

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

(viii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ix) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(x) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xi) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xiii) “third country”.

(5) In paragraph (5)(a) insert “ UK ” before “marketing authorisation”.

(6) In paragraph (6)(a)—

(a) insert “ UK ” before “marketing authorisation”; and

(b) for “or 60(1)” substitute “ , 60(1) or 60A ” .

(7) In paragraph (8) , for “References” substitute “ Subject to regulation C17(6), references ” .

(8) After paragraph (8) insert—

(9) Unless otherwise provided, any provision of an EU Regulation made applicable to a UKMA(NI), COR(NI) or THR(NI) by virtue of Article 5(4) of, and Annex 2 to, the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement applies equally in respect of a UKMA(UK), COR(UK) or THR(UK).

Section 11 Insertion of Schedule 8B (modifications of Annex I to the 2001 Directive)

Schedule 2 inserts a new Schedule 8B after Schedule 8A.

Section 12 Insertion of Schedule 2A (modifications of Commission Directive 2003/94/EC )

Schedule 3 inserts a new Schedule 2A after Schedule 2.

Section 13 New regulation B17 and C17 (good manufacturing practice and good distribution practice)

After regulation A17 insert—

Good manufacturing practice and good distribution practice

Regulations on good manufacturing practice

(B17)

(1) The Secretary of State may by regulations in respect of Great Britain set out principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products.

(2) Regulations under paragraph (1) may in particular make provisions as to—

(a) inspections;

(b) compliance with good manufacturing practice and, where relevant, the UK marketing authorisation or EU marketing authorisation ;

(c) quality assurance systems;

(d) personnel;

(e) premises and equipment;

(f) documentation;

(g) production;

(h) quality control;

(i) the contracting out of work;

(j) complaints and product recall;

(k) self-inspection.

(3) Subject to any provision made in regulations under paragraph (1), the principles and guidelines set out in the Good Manufacturing Practice Directive have effect in Great Britain on and after IP completion day as they had effect immediately before IP completion day , but subject to the modifications specified in Schedule 2A.

(4) The Secretary of State may by regulations in respect of Great Britain amend or revoke Schedule 2A.

Guidelines on good manufacturing practice and good distribution practice

(C17)

(1) The licensing authority may publish in relation to the manufacture or assembly of a medicinal product in, or import to, Great Britain —

(a) detailed guidelines of good manufacturing practice in respect of medicinal products, and investigational medicinal products, referred to in Article 46(f) of the 2001 Directive, including guidelines as to the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients;

(b) principles and guidelines of good manufacturing practice for active substances, referred to in the first paragraph of point (f) of Article 46 and in Article 46b of that Directive;

(c) principles and guidelines of good distribution practice referred to in the first paragraph of point (f) of Article 46, and Article 84, of that Directive.

(2) Guidelines or principles under paragraph (1) may replace, amend or otherwise modify any guidelines or principles published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive.

(3) Unless replaced by principles or guidelines published under paragraph (1), principles and guidelines published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive, as they applied immediately before IP completion day , continue to apply on and after IP completion day (subject to any amendments or modifications published under paragraph (1)).

(4) Before exercising the power under paragraph (1), the licensing authority must consult such persons as it considers appropriate.

(5) The licensing authority may only exercise its power under paragraph (1) if it considers that it is necessary in order to take account of technical or scientific progress.

(6) If the licensing authority publishes principles and guidelines under paragraph (1), any reference in these Regulations to any principle or guideline adopted under the provisions of the 2001 Directive specified in those paragraphs is instead to be read as a reference to the principle or guideline published under paragraph (1), or that principle or guideline as amended or modified (as the case may be).

Section 14 Amendment of regulation 17 (manufacturing of medicinal products)

(1) Regulation 17 is amended as follows.

(2) For paragraph (1) substitute—

(1) A person may not except in accordance with a licence (a “manufacturer’s licence”)—

(a) manufacture a medicinal product,

(b) assemble a medicinal product,

(c) import a medicinal product into Great Britain from a country other than—

(i) Northern Ireland, or

(ii) an approved country for import,

(d) import a medicinal product into Northern Ireland from a country other than an EEA State, or

(e) possess a medicinal product for the purpose of any activity in sub-paragraphs (a) to (d).

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

(4) In paragraph (4), after sub-paragraph (a) insert—

(aa) a UK marketing authorisation; or

(5) In paragraph (5) omit “from a state other than an EEA State”.

(6) After paragraph (6) insert—

(7) Paragraph (1) does not apply to imports into Northern Ireland from Great Britain of—

(a) special medicinal products, and

(b) medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(8) For the purposes of paragraph (7) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.

Section 15 Amendment of regulation 18 (wholesale dealing in medicinal products)

(1) Regulation 18 is amended as follows.

(2) In paragraph (1)—

(a) in sub-paragraph (a), omit “or”;

(b) in sub-paragraph (b) for “distribution.” substitute “ distribution; or ” ;

(c) insert at the end—

(c) import a medicinal product into Great Britain from an approved country for import ....

(2A) After paragraph (2) insert—

(2A) Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(2B) For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.

(3) For paragraph (6) substitute—

(6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—

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

(b) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product,

but this is subject to the exceptions in regulation 43(6).

(4) In paragraph (7) for “paragraph (6)” substitute “paragraph (6)(b)”.

Section 16 Insertion of new regulation 18A (approved country for import)

After regulation 18, insert—

Approved country for import

(18A)

(1) The licensing authority must—

(a) publish a list of countries from which medicinal products may be imported under a wholesale dealing licence (“approved country for import list”); and

(b) only include in that list a country which is included in the approved country for batch testing list.

(2) In order to determine whether a country should be included in the approved country for import list, the licensing authority may, in particular, take into account—

(a) the country's system for ensuring that each batch of a medicinal product has been manufactured and checked in accordance with the requirements of its legislation and any authorisation in respect of that product;

(b) the country's rules for good distribution practice;

(c) the regularity of inspections to verify compliance with good distribution practice;

(d) the effectiveness of enforcement of good distribution practice;

(e) the regularity and rapidity of information provided by that country relating to non-compliant manufacturers and distributers of medicinal products;

(f) any on-site review of that country's regulatory system undertaken by the licensing authority;

(g) any on-site inspection of a manufacturing site in that country observed by the licensing authority; and

(h) any other relevant documentation available to the licensing authority.

(3) The licensing authority must—

(a) remove a country from the approved country for import list if that country is removed from the approved country for batch testing list;

(b) in any event review the countries it has included in the approved country for import list 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

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

Section 17 Amendment of regulation 19 (exemptions from requirement for wholesale dealer's licence)

(1) Regulation 19 is amended as follows.

(2) For paragraph (1)(a) substitute—

(a) the holder of—

(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”) which relates to the product, or

(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), a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”) which relates to the product,

including a holder of an authorisation who manufactured or assembled the product; or

(3) In paragraph (1)(b), after “or assembled the product” insert “ in the United Kingdom ” .

(4) At the end insert—

(6) Regulation 18 does not apply to a person (“P”) who imports a medicinal product into Great Britain from an approved country for import for administration to P or to any other person who is a member of P’s household.

Section 18 Amendment of Schedule 3 (applications for licences under Part 3)

(1) Schedule 3 is amended as follows.

(2) For paragraph 1(2)(g) substitute—

(g) the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of—

(i) in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or

(ii) in the case of a product for sale or supply in Northern Ireland, the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products,

a statement of that fact);

(3) For paragraph 2(1) substitute—

(2)

(1) This paragraph applies to an application for a manufacturer’s licence relating to the import from—

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

of medicinal products.

(4) In paragraph 3—

(a) in sub-paragraph (2)(d) at the end insert “ or the responsible person (import) ” .

(b) in sub-paragraph (3)(b)—

(i) for paragraph (i) substitute—

(i) in the case of a product for sale or supply in Great Britain, a UK marketing authorisation,

(ia) in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,

(ii) in paragraph (iv) before “an Article” insert “in the case of a product for sale or supply in Northern Ireland,”, and

(iii) after paragraph (iii) insert—

(v) an authorisation granted by an authority in a country other than the United Kingdom to sell or supply the medicinal product in that other country;

(c) in sub-paragraph (3)(d)—

(i) in paragraph (i) omit “or”,

(ii) in paragraph (ii) for “etc);” substitute “ etc), or ” ,

(iii) at the end insert—

(iii) to be distributed by means of export from Great Britain to an approved country for import;

(d) for sub-paragraph (4) substitute—

(4) In sub-paragraph (2)(d)—

“ the responsible person ” means the person who has the functions described in regulation 45(2);

“ the responsible person (import) ” means the person who has the functions described in regulation 45AA(4).

Section 19 Amendment of regulation 23 (grant or refusal of licence)

In regulation 23(1)(b), omit “and any European Union obligation”.

Section 19A Amendment of regulation 24 (standard provisions of licences)

In regulation 24, after paragraph (2) insert—

(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.

Section 20 Amendment of Schedule 4 (standard provisions of licences under Part 3)

(1) Schedule 4 is amended as follows.

(2) For paragraph 13(b) substitute—

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

(i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

contains provisions relating to them,

(2A) After paragraph 14 insert—

(14A) A licence holder—

(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.

(3) In the heading of Part 2, after “State Other Than an EEA State” insert “/ Country other than an Approved Country for Import”.

(4) In paragraph 15, for “from a state other than an EEA State” substitute—

from—

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

(4A) In paragraphs 22(1) and 23, for “a state other than an EEA State” substitute “, in the case of an import into Great Britain, a country other than Northern Ireland or 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”.

(4B) After paragraph 23, insert—

(23A) A licence holder—

(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.

(5) In paragraph 25(m), for the words “referred to in Article 8(2) of Directive 2004/23/EC ”, substitute—

assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 , as regards human gametes and embryos; and

(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 , as regards other human tissues and cells.

(6) In paragraph 33, for “another EEA State” substitute “, in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State”.

(7) After paragraph 41 insert—

(41A) A licence holder—

(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.

Section 21 Amendment of regulation 26 (general power to suspend, revoke or vary licences)

For regulation 26(5)(a) substitute—

(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”), or

(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”),

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

Section 22 Amendment of Schedule 5 (review upon oral representations)

(1) Schedule 5 is amended as follows.

(2) In paragraph 1(2)(e), 3(11)(b) and 5(2)(d) after—

(a) “UK marketing authorisation,” in each place it appears, insert “ parallel import licence, ” ; and

(b) “an authorisation,” or “the authorisation,” in each place it appears, insert “ licence, ” .

(3) In paragraph 3 omit sub-paragraph (11)(b)(iii).

(4) In paragraph 5 omit sub-paragraph (2)(c).

Section 23 Amendment of regulation 29 (variation of licence on the application of the holder)

In regulation 29(5)—

(a) in sub-paragraph (b) omit “or”;

(b) in sub-paragraph (c) for “granted.” substitute “ granted; or ” ; and

(c) at the end insert—

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

Section 24 Amendment of regulation 31 (certification of manufacturer's licence)

(1) Regulation 31 is amended as follows.

(2) In paragraph (1)(c), for “an EEA State” substitute “ the United Kingdom ” .

(3) In paragraphs (3)(b), (5)(a) and (5)(b) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation, Article 126a authorisation”.

Section 25 Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products)

(1) Regulation 33 is amended as follows.

(2) In paragraph (1)(a)—

(a) for “Article 15(1) of Regulation 1394/2007” substitute “ paragraph 8 of Schedule 6 ” ; and

(b) for “Article 15(4) of that Regulation” substitute “ paragraph 9 of that Schedule ” .

(3) In paragraph (1)(b), for “Article 15(1)” substitute “ paragraph 8 ” .

(4) In paragraph (2) for “Article 15(4)” substitute “ paragraph 9 ” .

Section 26 Amendment of Schedule 6 (manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products)

(1) Schedule 6 is amended as follows.

(2) In paragraph 3, for “Directive 2004/23/EC ”, substitute—

requirements imposed pursuant to—

(a) paragraphs 6 to 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b) paragraphs 9 to 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.

(3) In paragraph 4, for the words “laid down in” to the end, substitute—

imposed pursuant to—

(a) Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b) Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.

(4) In paragraph 5, for the words from “Commission” to the end substitute “ the Blood Quality and Safety Regulations 2005 ” .

(5) In paragraph 11, for the words from “laid down in” to the end, substitute—

imposed pursuant to—

(a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990 ;

(b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007;

Section 27 Amendment of regulation 36 (conditions for manufacturer's licence)

In regulation 36 —

(a) in paragraph (4)—.

(i) for “The requirements” substitute “Where a manufacturer’s licence relates to the manufacture or assembly of a medicinal product in, or import of a medicinal product into, Northern Ireland, the requirements”;

(ii) for “provisions of a manufacturer’s” substitute “provisions of that”;

(b) in paragraph (6), after “by way of wholesale dealing” insert “in Northern Ireland”.

Section 28 Amendment of regulation 37 (manufacturing and assembly)

(1) Regulation 37 is amended as follows.

(1A) In paragraph (2), after “Good Manufacturing Practice Directive” insert “which apply under or by virtue of regulation B17”.

(2) For paragraph (4)(b) substitute—

(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

(3) In paragraph (5)(b), after “as described” insert “in the case of a product for sale or supply in Great Britain, in the guidelines which apply under or by virtue of regulation C17 and, in the case of a product for sale or supply in Northern Ireland,

(4) For paragraph (6)(b) substitute—

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

(i) in Great Britain, 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.

(5) In paragraph (9)(a), from “Commission” to the end substitute “ the Blood Quality and Safety Regulations 2005 ; or ” .

(6) In paragraph (11)—

(a) for “competent authority of a member State” substitute “ licensing authority ” ; and

(b) insert “ UK ” before “marketing authorisation”.

Section 29 Amendment of regulation 38 (imports)

(1) Regulation 38 is amended as follows.

(2) In the heading, after “states other than EEA states” insert “/ countries other than approved countries for import”.

(3) In paragraph (2) for “from a state other than an EEA State” substitute—

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

(4) In paragraph (3)(b) for “a state other than an EEA State” substitute “, 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”.

Section 30 Amendment of regulation 39 (further requirements for manufacturer's licence)

(a) In regulation 39(8) , omit “, 43A” and

(b) after “and (6)” insert “ and, where the product is being distributed in Northern Ireland, regulation 43A, ” .

Section 31 Amendment of regulation 42 (conditions for wholesale dealer's licence)

(1) Regulation 42 is amended as follows.

(2) In paragraph (1), after “45” insert “(in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA (in the case of a wholesale dealer’s licence held in Great Britain)”.

(3) In paragraph (4)—

(a) for “The requirements” substitute “Where a wholesale dealer’s licence relates to wholesale dealings in Northern Ireland, the requirements”; and

(b) for “provisions of a wholesale dealer’s” substitute “provisions of that”.

Section 32 Amendment of Schedule 7 (qualified persons)

(1) Schedule 7 is amended as follows.

(2) In Part 1—

(a) in paragraph 3, for “the member State in which it is studied” substitute “ the licensing authority ” ;

(b) in paragraph 6, for “the member State in which the courses take place” substitute “ the licensing authority ” .

(3) In Part 3 (obligations of qualified person)—

(a) in paragraph 12—

(i) the existing text becomes sub-paragraph (1),

(ia) for “The qualified person” substitute “In Great Britain, the qualified person”;

(ii) in paragraph (a) of that sub-paragraph—

(zaa) for “the United Kingdom” substitute “Great Britain”;

(aa) for “marketing authorisation, Article 126a authorisation” substitute “ UK marketing authorisation ” ,

(bb) after “herbal registration” insert “ , or an equivalent authorisation, ” , and

(cc) insert “ and ” at the end,

(iii) in paragraph (b) of that sub-paragraph—

(aa) for “medicinal products imported from a country other than Northern Ireland or a non-EEA State, irrespective of whether the products have been manufactured in an EEA State” substitute “ medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import ” , and

(bb) in paragraph (iii), for “marketing authorisation, Article 126a authorisation” substitute “ UK marketing authorisation ” , and

(cc) after “herbal registration” insert “ , or an equivalent authorisation, ” ,

(iv) omit paragraph (c) of that sub-paragraph, and

(v) after that sub-paragraph insert—

(2) In this paragraph “ equivalent authorisation ” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.

(aa) after paragraph 12 insert—

(12A)

(1) In Northern Ireland, the qualified person is responsible for securing—

(a) that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(b) in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—

(i) a full qualitative analysis,

(ii) a quantitative analysis of all the active substances, and

(iii) all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(c) in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive and not intended to be exported to a country other than an EEA State, that the features specified in paragraph 18A of Schedule 24 have been affixed on the packaging.

(b) in paragraph 13—

(i) in sub-paragraph (1) after “This paragraph applies” insert “in Northern Ireland”;

(ii) in sub-paragraph (1)(a) for “paragraph 12 in another member State is imported to the United Kingdom” substitute “paragraph 12A in a member State is imported to Northern Ireland”;

(iii) in sub-paragraph (2) for “12” substitute “12A”;

(c) in paragraph 14—

(i) in sub-paragraph (1)(a) after “are imported” insert “into Great Britain from a country other than an approved country for import or into Northern Ireland;

(ii) for sub-paragraph (1)(b) substitute—

(b) appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that—

(i) the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down—

(aa) in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and

(bb) in the case of a product for sale or supply in Northern Ireland, by the European Union;

(ii) the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.

(iia) in paragraph (2) after “paragraph 12” insert “or 12A”.

(iii) at the end insert—

(3) The licensing authority must publish a list of the countries with whom it has made appropriate arrangements under sub-paragraph (1)(b) (“approved country for batch testing list”).

(4) A country may be included in the approved country for batch testing list subject to any condition or restriction that the licensing authority considers appropriate, including as to categories of medicinal product, and any such condition or restriction must be included in the list.

(5) In order to satisfy itself of the matters specified in sub-paragraph (1)(b)(i) and (ii), the licensing authority may, in particular, take into account—

(a) the country's rules for good manufacturing practice;

(b) the regularity of inspections to verify compliance with good manufacturing practice;

(c) the effectiveness of enforcement of good manufacturing practice;

(d) the regularity and rapidity of information provided by that country relating to non-compliant manufacturers;

(e) any on-site review of that country's regulatory system undertaken by the licensing authority;

(f) any on-site inspection of a manufacturing site in that country observed by the licensing authority;

(g) any other relevant documentation available to the licensing authority.

(6) The licensing authority must—

(a) review any appropriate arrangements it has made under sub-paragraph (1)(b) to determine if that country still satisfies the requirements of sub-paragraph (1)(b)(i) and (ii), and whether any condition or restriction in those arrangements remains appropriate;

(b) if it is not so satisfied, remove that country from the approved country for batch testing list or, as the case may be, amend or remove that condition or restriction; and

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

Section 33 Amendment of regulation 43 (obligations of licence holder)

(1) Regulation 43 is amended as follows.

(2) For paragraph (1), substitute—

(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.

(3) For paragraph (5)(a) substitute—

(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), and EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and

(4) In paragraph (6)—

(a) in sub-paragraph (a), insert at the end “ in the United Kingdom ” ; and

(aa) in sub-paragraph (b), after “the export” insert “from Northern Ireland”;

(b) after sub-paragraph (b), insert —

(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) for sub-paragraph (d) substitute—

(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.

(5) In paragraph (7)—

(a) in sub-paragraph (b)—

(i) for sub-paragraph (i) substitute—

(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) for sub-paragraph (ii) substitute—

(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), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and

(b) in sub-paragraph (c)(vii), before “the batch number” insert “where the receipt, dispatch or brokering of medicinal products takes places in Northern Ireland,”;

(5A) In paragraph (8)—

(a) after “A licence holder” insert “in Northern Ireland”;

(b) for “third country” substitute ““country other than an EEA State”.

(6) After paragraph (8) insert —

(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.

(7) In paragraph (10), after “The holder” insert “of a licence relating to wholesale dealings in Northern Ireland”.

(8) In paragraph (13), for “marketing authorisation holder” substitute “UK marketing authorisation holder or EU marketing authorisation holder”.

(9) For paragraph (14) substitute—

(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.

(10) In paragraph (15), after “In this regulation” insert “as it applies in the case of a product for sale or supply in Northern Ireland”.

Section 34 Amendment of regulation 43A (requirement for wholesale dealers to decommission the unique identifier)

In regulation 43A—

(a) in paragraph (2) for “in the United Kingdom” substitute “in Northern Ireland”; and

(b) in paragraph (3)—

(i) in sub-paragraph (g) omit “a police force in England, Wales or Scotland or”; and

(ii) in sub-paragraph (l) for “care” substitute “nursing”.

Section 35 Amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons)

(1) Regulation 44 is amended as follows.

(2) In paragraph (2)—

(a) in sub-paragraph (b), for “another EEA State” substitute “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)”; and

(b) for sub-paragraph (c) substitute—

(c) where the medicinal product is directly received—

(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.

(3) For paragraph (5)(b) substitute—

(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;

(4) For paragraph (5)(e) substitute—

(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.

(5) In paragraph (6)—

(a) insert “ and ” at the end of sub-paragraph (c); and

(b) in sub-paragraph (e) after “of the 2001 Directive” insert “, in the case of a licence holder in Northern Ireland.”.

(6) After paragraph (7) insert—

(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(GB) 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.

Section 36 Amendment of regulation 45 (requirement as to responsible persons)

(1) Regulation 45 is amended as follows.

(2) After paragraph (1) insert—

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

(3) For paragraph (2)(b) substitute—

(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, Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.

Section 37 Insertion of new regulations 45AA and 45AB (responsible persons: import)

After regulation 45, insert—

Requirement as to responsible persons where licence holder imports from an approved country for import

(45AA)

(1) Subject to paragraph (2), this regulation applies to a licence holder in Great Britain where the licence holder imports a medicinal product from an approved country for import under a wholesale dealer's licence.

(2) The requirements of this regulation do not apply where an unlicensed medicinal product falling under paragraph (1) is imported—

(a) from an approved country for import for the sole purpose of distribution by way of wholesale dealing as a special medicinal product; or

(b) for the sole purpose of wholesale distribution of that product to a person in a country other than an approved country for import.

(3) 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 (import) ”) whose name is included in the register established under regulation 45AB.

(4) A responsible person (import) must—

(a) carry out the functions under regulation 45(2), unless a responsible person under regulation 45 is performing those functions in respect of the licence; ...

(b) ensure that there is appropriate evidence to confirm that each production batch of a medicine imported from an approved country for import under the licence has been certified as provided for in Article 51 of the 2001 Directive, or such equivalent certification procedure as applies in the approved country for import ; and

(c) ensure that each production batch of a medicinal product that is subject to the batch testing condition and that is imported into Great Britain from an approved country for import has been certified as being in conformity with the approved specifications in the UK marketing authorisation by—

(i) the appropriate authority, or

(ii) where the batch testing exemption applies, a laboratory in a country that has an agreement with the United Kingdom to the effect that the appropriate authority will recognise that certificate in place of the appropriate authority’s own examination.

(5) The licensing authority must publish guidance on the documentation that it considers to be appropriate evidence for the purposes of paragraph (4)(b).

(6) Guidance published under paragraph (5) may be taken into account by the licensing authority in determining whether it considers there has been a failure to comply with this regulation.

(7) The licence holder must apply to vary the licence if a change is proposed to the responsible person (import).

(8) The licence holder must not permit any person to act as a responsible person (import) other than the person named in the licence.

(9) Paragraph (10) applies if—

(a) the person acting as responsible person (import) in respect of the licence is no longer included in the register under 45AB;

(b) the licensing authority thinks, after giving the licence holder and a person acting as a responsible person (import) the opportunity to make representations (orally or in writing), that the responsible person (import) is failing to carry out the functions referred to in paragraph (4) adequately or at all.

(10) Where this paragraph applies the licensing authority—

(a) must notify the licence holder in writing that the person is not permitted to act as a responsible person (import) in respect of that licence; and

(b) may, subject to regulation 45AB(3)(b), remove that person's name from the register under regulation 45AB.

(11) In this regulation, “ unlicensed medicinal product ” means a medicinal product in respect of which—

(a) there is no marketing authorisation, within the meaning of the 2001 Directive, in any EEA State in respect of that product, where the product is imported from an approved country for import that is an EEA State; or

(b) there is no licence or authorisation in respect of that product as regards its sale or supply in the approved country for import, where the product is imported from an approved country for import that is not an EEA State.

Register for responsible persons (import)

(45AB)

(1) The licensing authority must maintain a register of persons (“ the responsible person (import) register ”) who may carry out the role of responsible person (import) under regulation 45AA.

(2) The licensing authority may only include a person's name in the responsible person (import) register if that person—

(a) holds—

(i) a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, or

(ii) such other qualification as the licensing authority is satisfied is equivalent;

(b) is a member of—

(i) the Royal Society of Biology,

(ii) the Royal Pharmaceutical Society,

(iii) the Pharmaceutical Society of Northern Ireland,

(iv) the Royal Society of Chemistry, or

(v) such other body as may be specified by the licensing authority for the purpose of this paragraph; and

(c) has a minimum of 2 years' experience in performing the functions of a responsible person under regulation 45, or in performing such other functions that appear to the licensing authority to be equivalent.

(3) The licensing authority—

(a) may remove a person's name from the responsible person (import) register if it no longer considers that the person satisfies the requirements of paragraph (2); but

(b) it may not exercise that power unless it has given that person the opportunity to make representations to it (orally or in writing).

Section 38 Amendment of regulation 45A (brokering in medicinal products)

(1) Regulation 45A is amended as follows.

(2) For paragraph (1) substitute—

(1) A person may not broker a medicinal product in Great Britain unless—

(a) the product is covered by an authorisation granted—

(i) by the licensing authority, or

(ii) by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, and

(b) that person—

(i) is validly registered as a broker with the licensing authority,

(ii) has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice which apply under, or by virtue of, regulation C17 insofar as those guidelines apply to brokers.

(1A) A person may not broker a medicinal product in Northern Ireland unless—

(a) the product is covered by an authorisation granted—

(i) under Regulation (EC) No 726/2004 ,

(ii) by the licensing authority, or

(iii) by a competent authority of a member State, and

(b) that person—

(i) is validly registered as a broker with the licensing authority or a competent authority of a member State,

(ii) except where the person is validly registered with the competent authority of an EEA State, has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive insofar as those guidelines apply to brokers.

(3) In paragraph (2)—

(a) after “paragraph (1)(b)” insert “or (1A)(b)”;

(b) in sub-paragraphs (a) and (c), after “competent authority of a member State” insert “or the licensing authority (as appropriate)”.

(4) Omit paragraph (3).

Section 39 Amendment of regulation 45D (grant or refusal of a broker's registration)

In regulation 45D(1)(b) omit sub-paragraph (ii) (and “and” immediately preceding it).

Section 40 Amendment of regulation 45E (criteria of broker's registration)

In regulation 45E(3) —

(a) for sub-paragraph (b)(i) substitute—

(i) ordered by—

(aa) in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

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

(b) in sub-paragraph (d)(iii), before “the batch number” insert “where the sale or supply of the medicinal product is in Northern Ireland,”.

Section 41 Amendment of regulation 45F (provision of information)

In regulation 45F(1) for sub-paragraph (b) substitute—

(b) in the case of a broker in—

(i) Great Britain, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii) Northern Ireland, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the EU marketing authorisation holder,

Section 42 Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)

(1) Regulation 45M is amended as follows.

(2) For paragraph (2)(a) substitute—

(a) if—

(i) in the case of a product for sale or supply in Great Britain, the product has a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii) in the case of a product for sale or supply in Northern Ireland, the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, and

(3) In paragraph (3), omit “from a state other than an EEA State”.

Section 43 Amendment of Schedule 7A (information to be provided for registration as an importer, manufacturer or distributor of active substances)

(1) Schedule 7A is amended as follows.

(2) In paragraph 13(b), omit “from third countries”.

(3) In paragraph 15(c), omit “to a third country”.

Section 44 Amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance)

(1) Regulation 45O is amended as follows.

(2) For paragraph (1) substitute—

(1) Where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance manufactured in Great Britain, a manufacturer in Great Britain must comply with the principles and guidelines of good manufacturing practice for active substances.

(1A) Where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance manufactured in Northern Ireland, a manufacturer in Northern Ireland must comply with the principles and guidelines of good manufacturing practice for active substances.

(3) For paragraph (2) substitute—

(2) Where principles and guidelines of good distribution practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance distributed in Great Britain, a distributor in Great Britain must comply with the principles and guidelines of good distribution practice for active substances.

(2A) Where the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies to an active substance distributed in the Northern Ireland, a distributor in Northern Ireland must comply with the principles and guidelines of good distribution practice for active substances.

(4) In paragraph (3)—

(a) for “the UK” substitute “Northern Ireland”;

(b) for “from a third country” substitute “into Northern Ireland from a country other than an EEA State”;

(c) for “exporting third country” in both places it occurs substitute “exporting country”;

(d) in sub-paragraph (c)(ii), for “the Union” substitute “Northern Ireland”.

(4A) After paragraph (3) insert—

(3A) Without prejudice to regulation 37(4) and paragraph 9A of Schedule 8, where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance imported into Great Britain other than from Northern Ireland and where an active substance is so imported—

(a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance,

(b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice, and

(c) the active substances must be accompanied by a written confirmation from the competent authority of the exporting country of the following—

(i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in Great Britain, and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting country to the licensing authority without any delay.

(5) In paragraph (4)—

(a) for “(3)(c) does” substitute “(3)(c) and (3A)(c) do”;

(b) in sub-paragraph (a), after “Article 111b of the 2001 Directive” insert “(in the case of an import into Northern Ireland) or paragraph (6) (in the case of an import into Great Britain)”;

(c) in sub-paragraph (b)(i), after “competent authority of a member State” insert “or licensing authority (in the case of an import into Northern Ireland) or licensing authority or an appropriate authority responsible for the licensing of medicinal products in a country included in a list under paragraph (6) (in the case of an import into Great Britain)”.

(6) At the end insert—

(6) The licensing authority may publish a list of countries which it is satisfied have a regulatory framework applicable to active substances exported to Great Britain that is equivalent to the regulatory framework in Great Britain , in that the respective control and enforcement activities in those countries ensures an equivalent level of protection of public health.

(7) Before including a country in the list under paragraph (6), the licensing authority must assess the equivalence referred to in that paragraph by—

(a) reviewing relevant documentation; and

(b) unless the country is included in the approved country for batch testing list, carrying out—

(i) an on-site review of the country's regulatory system, and

(ii) if the licensing authority considers it necessary, an inspection of one or more of that country's manufacturing sites for active substances.

(8) In carrying out an assessment under paragraph (7) the licensing authority must in particular take account of the—

(a) country's rules for good manufacturing practice;

(b) regularity of inspections to verify compliance with good manufacturing practice;

(c) effectiveness of enforcement of good manufacturing practice; and

(d) regularity and rapidity of information provided by that country relating to non-compliant producers of active substances.

(9) The licensing authority must—

(a) review the list under paragraph (6) to determine if a country included in it still satisfies the requirements for inclusion in the list, and if it is not so satisfied, remove that country; and

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

Section 45 Amendment of regulation 46 (requirement for authorisation)

(1) Regulation 46 is amended as follows.

(2) In paragraph (2)—

(a) in sub-paragraph (a), before “marketing authorisation”, insert “ UK ” ;

(b) after sub-paragraph (a) insert—

(aa) an EU marketing authorisation;

(3) In paragraph (3), before “European Economic Area” insert “ United Kingdom or the ” .

(4) In paragraph (6)—

(a) after “in force for the product” insert “in the country in which the product is intended to be sold or supplied, or offered for sale or supply”;

(b) in sub-paragraph (a), before “marketing authorisation”, insert “UK”; and

(c) after sub-paragraph (a) insert—

(aa) an EU marketing authorisation;

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

(6) In paragraph (9), before “European Economic Area” insert “ United Kingdom or the ” .

(7) In paragraph (11)(a), before “European Economic Area” insert “ United Kingdom or the ” .

Section 46 Amendment of regulation 47 (breach of requirement)

(1) Regulation 47 is amended as follows.

(2) In paragraphs (3) and (4), before “European Economic Area”, insert “ United Kingdom or the ” .

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

Section 47 Amendment of regulation 48 (application of Part 5)

(1) Regulation 48 is amended as follows.

(2) In paragraph (2)—

(a) at the appropriate place insert—

“EU reference medicinal product” means a medicinal product which falls within paragraph (b)(ii) or (iii) of the definition of “reference medicinal product”;

“excluded reference product” means—

(a) a medicinal product authorised on the basis that it was a generic medicinal product;

(b) 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; or

(c) a 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 53A(1);

(b) for the definition of “generic medicinal product”, substitute—

“generic medicinal product”, in relation to a reference medicinal product for an application for—

(a) a UKMA(NI) or UKMA(UK), has the meaning given in Article 10(2)(b) of the 2001 Directive;

(b) a UKMA(GB), means a medicinal product—

(i) that has the same qualitative and quantitative composition in active substances as the reference medicinal product;

(ii) that has the same pharmaceutical form as the reference medicinal product; and

(iii) whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies;

(c) for the definition of “parallel import licence” substitute—

“ 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—

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

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

(d) for the definition of “reference medicinal product”, substitute—

“reference medicinal product” means—

(a) in relation to an application for a UKMA(NI), a medicinal product—

(i) authorised for sale or supply in Northern Ireland under regulation 49(1)(a), in accordance with the provisions of regulation 50; or

(ii) in 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;

(b) in relation to an application for a UKMA(GB), a medicinal product—

(i) authorised under regulation 49(1)(a), in accordance with the provisions of regulation 50;

(ii) in relation to which an EU marketing authorisation was in force on IP completion day, but in relation to which no UK marketing authorisation is in force because the holder of the EU marketing authorisation notified the licensing authority in accordance with paragraph 6(3) of Schedule 33A that it did not wish to be the holder of a converted EU marketing authorisation; or

(iii) in relation to which an EU marketing authorisation had ceased to be in force before IP completion day for reasons not related to safety, quality or efficacy,

but which is not an excluded reference product;

(c) in relation to an application for a UKMA(UK), a medicinal product—

(i) 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; or

(ii) in 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;

(3) After paragraph (2) insert—

(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;

(c) has the same therapeutic effect 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 51A(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) Paragraph (9) applies in relation to a medicinal product if—

(a) it is an EU reference medicinal product;

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

(c) it belongs to a global marketing authorisation, as described in the second paragraph of Article 6(1) of the 2001 Directive; but

(d) it is not the initial marketing authorisation for the purposes of that global marketing authorisation.

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

Section 48 Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)

(1) Regulation 49 is amended as follows.

(2) In paragraph (1), after “regulation 58,” insert “ 58C, 58E, 58F and 58G, ” .

(3) After paragraph (1) insert—

(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(GB) only where—

(a) there is already in place, or will be at the time the UKMA(GB) is granted, a marketing authorisation in respect of the product authorising sale or supply in Northern Ireland,

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

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

(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

(c) Northern Ireland only,

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

(4) For paragraph (3) substitute—

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

(a) a UKMA(NI)—

(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii) on any other basis, must be established in the United Kingdom;

(b) a UKMA(GB)—

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

(ii) other than under the unfettered access route, must be established in the United Kingdom;

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

(5) After paragraph (3) insert—

(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.

(6) At the end insert—

(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) Great Britain only; or

(c) Northern Ireland only.

(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).

Section 49 Amendment of regulation 50 (accompanying material)

(1) Regulation 50 is amended as follows.

(1A) After paragraph (1) insert—

(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.

(1B) After paragraph (3) insert—

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

(2) For paragraph (4) substitute—

(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), is liable to be imported from a country other than an EEA State, or

(b) in the case of a UKMA(GB), 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.

(3) After paragraph (5) insert—

(5A) The Secretary of State may by regulations in respect of Great Britain amend Schedule 8B (modifications of Annex I) in relation to a UKMA(GB) 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

(c) guidelines describing the active substance manufacturing process and process controls.

(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

(c) guidelines published by the EMA for the purposes of paragraph 3.2.1.2 of Part I of Annex I to the 2001 Directive .

(4) In paragraph (6), before sub-paragraph (a), insert—

(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);

(4A) In paragraph (6)—

(a) for sub-paragraph (a), substitute—

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

(aa) regulation 51A (application for UKMA(GB) relating to generic medicinal products);

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

(b) for sub-paragraph (b), substitute—

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

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

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

(c) for sub-paragraph (c), substitute—

(c) regulation 53 (application for UKMA(NI) relating to similar biological medicinal products)

(ca) regulation 53A (application for UKMA(GB) relating to similar biological medicinal products);

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

(5) After paragraph (6), insert—

(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.