“(b)

after paragraph (i) insert—

“(ia)

the EU marketing authorisation,”.

“(2)

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

“(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).”.

“(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).”.

“(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.”.

“(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) ”.”.

“(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”.

“(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.”.

“(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.”.

“(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.”.

“(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.”.

“(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.”.

“(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 ”.”.

“and

(b)

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

“(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 ”.”.

“(ia)

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

“(zaa)

for “the United Kingdom” substitute “ Great Britain ”;”;

“(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 ”;”;

“(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”.

“(aa)

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

“(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.”.

“(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”.”;

“(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 ”.”.

“(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.”.

“(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.”.

“(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.”.

“; 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.”.

“(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) ”.”.

“(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, ”.”.

“(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) ”.”;

“(b)

after sub-paragraph (a) insert—

“(aa)

an EU marketing authorisation;”.

“(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;”.

““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;”;

““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;”;

“(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.”.

“(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.”.

“(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);”.

“18.

Where—

(a)

in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—

(i)

a list of the member State or States concerned, and

(ii)

in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;

(b)

in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.”;

“(4)

In paragraph 19, for “a member State or by a third country” substitute “ , in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission ”.”;

“(5)

In paragraph 20, after “Where” insert “ , in the case of a medicinal product for sale or supply in Northern Ireland, ”.”;

“(6)

For paragraph 21 substitute—

“21.

Where an authorisation for the medicinal product to be placed on the market has been refused—

(a)

in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b)

in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.”.

“(7)

In paragraph 22 for “A copy of any” substitute “ In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any ”.”;

“(8)

For paragraph 23 substitute—

“23.

For medicinal products included on the list referred to—

(a)

in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b)

in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.”.

“(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.”;

“(4)

After paragraph (7) insert—

“(8)

In the case of an application under the unfettered access route, the licensing authority may grant a UKMA(GB) (notwithstanding paragraph (4)) where the licensing authority—

(a)

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

(b)

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

(c)

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

(9)

The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.”.

“(c)

for sub-paragraph (2) substitute—

“(2)

In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”;

“(4)

In paragraph 14(a) (application of Part 2), after “veterinary medicinal products” insert “ or paragraph 1 of Schedule 10A ”.”;

“(7)

For paragraph 17 substitute—

“17.

In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”.

“(ii)

for sub-paragraph (2) substitute—

“(2)

In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”; and

“(9)

In Part 4 (exceptions to Schedule) omit paragraphs 31, 34, 35, 37 and 38.”.

“(1A)

In paragraph (3) for “An obligation” substitute “ In relation to a UKMA(NI) or UKMA(UK), an obligation ”.”;

“(3)

After paragraph (3), insert—

“(3A)

In relation to a UKMA(GB), an obligation to conduct such studies as are referred to in paragraph (2)(f) must—

(a)

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

(b)

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

(3B)

The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the condition referred to in paragraph (2)(f).

(3C)

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

“(6)

In paragraph (5) for “marketing authorisation” substitute “UKMA(NI) or UKMA(UK).”.

“Submitting of samples and other information: EU marketing authorisations60B.

(1)

In this regulation—

“the appropriate authority” is to be construed in accordance with section 57(7) of the Health and Social Care Act 2012 M5;

“appropriate documentation”, in relation to a sample of a batch submitted to the appropriate authority in accordance with the batch testing requirement or pursuant to a notification under paragraph (8), means such documentation as the appropriate authority notifies the holder of the EU marketing authorisation to which the sample relates that it requires;

“approved country list for batch testing and certification of biological medicinal products” means the list described in regulation 60A(5), and “approved country for batch testing and certification of biological medicinal products” means a country included in that list;

“the batch testing exemption” means that—

(a)

1. (i)

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

2. (ii)

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

(b)

1. (i)

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

2. (ii)

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

3. (iii)

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

“the batch testing requirement”, in respect of an EU marketing authorisation, is a requirement that, unless the batch testing exemption applies, the holder of the EU marketing authorisation—

(a)

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

(b)

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

1. (i)

   the sample from that batch,

2. (ii)

   the appropriate documentation, or

3. (iii)

   both that sample and that documentation,

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

(2)

The licensing authority may impose the batch testing requirement on the holder of an EU marketing authorisation for a medicinal product—

(a)

that is—

(i)

a live vaccine;

(ii)

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

(iii)

an immunological product used in public health immunisation programmes;

(iv)

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

(v)

derived from human blood or human plasma, and

(b)

which is intended for sale or supply in Northern Ireland.

(3)

If the licensing authority imposes the batch testing requirement in respect of an EU marketing authorisation for a medicinal product of a kind mentioned in paragraph (2)(a)(iv), it must, in imposing that requirement, specify a period of time for the duration of the requirement.

(4)

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

(5)

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

(6)

Where a holder of an EU marketing authorisation relies on the batch testing exemption in relation to a batch of a medicinal product, that holder must submit the certificate in respect of that batch to the licensing authority and the appropriate authority, and such other documentation as those authorities may notify that holder they require, before it sells or supplies, or offers to sell or supply, a medicinal product that forms part of that batch in Northern Ireland.

(7)

Paragraph (8) applies where the appropriate authority considers that there are public health concerns in respect of a batch of a medicinal product (“the relevant batch”) in relation to which the batch testing exemption would otherwise apply.

(8)

Where this paragraph applies, the appropriate authority must, subject to paragraph (9), notify the holder of the EU marketing authorisation in respect of the relevant batch that it nevertheless requires that holder—

(a)

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

(b)

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

(i)

the sample from that batch,

(ii)

the appropriate documentation, or

(iii)

both that sample and that documentation,

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

(9)

The appropriate authority may only exercise its powers under paragraph (8) if the agreement made between the country in which the certificate was issued, and the United Kingdom (whether the agreement is solely with that country, a group of countries or an organisation of which that country is a part) provides for the relevant batch to be re-examined by the appropriate authority in the circumstances described in paragraph (7).

(10)

A reference in this regulation to a laboratory (other than in paragraph (b) of the definition of “the batch testing exemption” in paragraph (1)) is to an Official Medicines Control Laboratory or a laboratory referred to in Article 114 of the 2001 Directive.”.

“(2A)

In paragraph (6), after “one medicinal product” insert “ authorised by a UKMA(NI) or UKMA(UK) ”.”;

“(3)

After paragraph (6) insert—

“(6A)

If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB), the licensing authority—

(a)

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

(b)

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

“(3A)

In paragraph (7) for “The obligation under paragraph (5) shall” substitute “ In relation to a UKMA(NI) or UKMA(UK), the obligation under paragraph (5) must ”.”;

“(4)

After paragraph (7) insert—

“(7A)

In relation to a UKMA(GB), the obligation under paragraph (5) must—

(a)

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

(b)

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

(7B)

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

(7C)

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

“(5)

In paragraph (13), after “notify the EMA” insert “ , in relation to a UKMA(NI) or UKMA(UK), ”.”.

“(b)

for “established in the European Union” substitute—

“established in—

(a)

the United Kingdom; or

(b)

in relation to a UKMA(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.”.

“(5)

In paragraph (9)(a) omit “other than the United Kingdom”.”;

“(3)

For paragraph (a) substitute—

“(a)

fails—

(i)

in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or

(ii)

in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,

that the holder has taken urgent safety restrictions on the holder's own initiative;”.

“(4)

For paragraph (b) substitute—

“(b)

fails—

(i)

in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or

(ii)

in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or”.

“(4A)

In paragraph (c) after “fails” insert “ in respect of a UKMA(NI) ”.”;

“(1A)

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 COR(GB) only where—

(a)

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

(b)

the applicant complies with the requirements in paragraph (5B), and

(c)

the registrable homoeopathic medicinal product satisfies the definition of qualifying Northern Ireland goods.

(1B)

A certificate of registration 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 certificate of registration being “in force” is limited to that territory.”.

“for “must be established in the European Union” substitute—

“, where it is applying for—

(a)

a COR(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 COR(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 COR(UK), must be established in the United Kingdom.”.

“(2A)

After paragraph (5) insert—

“(5A)

The application must include a statement indicating whether the certificate sought is for sale or supply of the product in—

(a)

the whole United Kingdom;

(b)

Great Britain only; or

(c)

Northern Ireland only.

(5B)

The applicant for the grant of a COR(GB) under the unfettered access route must provide—

(a)

the application form submitted in connection with the granting of the COR(NI) which authorises the sale or supply of the product in Northern Ireland;

(b)

a copy of all material submitted in support of the application for the COR(NI) which authorises the sale or supply of the product in Northern Ireland; and

(c)

a copy of the COR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

together with any material specified in paragraph (8) which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.”.

“(2)

In paragraph (7) for “established in the European Union” substitute—

“established in—

(a)

the United Kingdom; or

(b)

in relation to a COR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.”.

“(2A)

After paragraph (8A) insert—

“(8B)

Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.”.

“for “is subject to” to the end substitute—

“(a)

where the application is for a THR(NI) or THR(UK), is subject to Article 16c(4) of the 2001 Directive (procedure where product has been used in the European Union for less than 15 years);

(b)

where the application is for a THR(GB), is subject to regulation 130A.”.

“after “of the 2001 Directive” insert “where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)”.”;

“(5)

In paragraph (9), after “Where” insert “ , in relation to an application for a THR(NI) or THR(UK), ”.”;

“for “in Article 16h(3)” to the end substitute—

“(i)

in Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK);

(ii)

in regulation 143A, where the application is for a THR(GB),

that the authority thinks relevant to the application; or”.

“(7)

In paragraph (12), after “This regulation does not apply where” insert “ , in relation to an application for a THR(NI) or THR(UK), ”.”;

“(8)

After paragraph (13) insert—

“(14)

In the case of an application under the unfettered access route, the licensing authority may grant a THR(GB) (notwithstanding paragraph (4)) where the licensing authority—

(a)

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

(b)

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

(c)

is satisfied that the conditions in regulation 127(1A) will continue to be met.

(15)

The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.”.

“(1A)

For paragraph (6) substitute—

“(6)

Condition E is that the holder of the registration has ceased to be established in—

(a)

the United Kingdom; or

(b)

in relation to a THR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.”.

“(3)

In paragraph (8)(a) omit “other than the United Kingdom”.”;

“(4A)

After paragraph (10A) insert—

“(10B)

Condition K is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.”.

“(2)

After paragraph (1) insert—

“(1A)

Schedule 12A applies in relation to medicinal products that are the subject of a UKMA(GB) ora THR(GB).”.

“(6)

In paragraph (5)—

(a)

for “Schedule 33” substitute “ Schedules 33 and 33A ”;

(b)

in paragraph (c) of the definition of “relevant post-authorisation safety study”, omit “and”; and

(c)

after that definition, insert—

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

“(2A)

After paragraph (1) insert—

“(1A)

The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Northern Ireland and report the results of that audit to the European Commission.”.

“(4)

After paragraph (2) insert—

“(3)

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

(a)

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

(b)

every two years after the first occasion.”.

“(2A)

In paragraph (2)(b), after “pharmacovigilance system master file” insert “ and ensure it is permanently and immediately available for inspection electronically in the United Kingdom at the single point from which the reports referred to in regulation 187(4) are accessible ”.

(2B)

After paragraph (2) insert—

“(2A)

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

(2B)

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

“(3)

For paragraph (3) substitute—

“(3)

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

(a)

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

(b)

the nominated person mentioned in paragraph (2A).

(3A)

The holder must—

(a)

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

(b)

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

“(za)

for “Subject to paragraph (2), the holder” substitute “ The holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation ”;”;

“(3A)

After paragraph (1) insert—

“(1A)

The holder of a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product—

(a)

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

(b)

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

(c)

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

(d)

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

“(4)

In paragraph (2)—

(a)

after “holder” insert “ of a UKMA(NI), a UKMA(UK), a THR(NI), a THR(UK) or an Article 126a authorisation ”;

(b)

for “paragraph (1)(a) or (b)” substitute “ paragraph (1A)(a) or (b) ”; and

(c)

for “paragraph (1)(d)” substitute “ paragraph (1A)(c) ”.

(4A)

In paragraph (3) for “paragraph (4)” substitute “ paragraph (4A) ”.”;