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

Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates) U.K.

7.—(1) Schedule 2 is amended as follows.

[F1 (2) For paragraph 4(a) substitute—

“(a) for an extension of a marketing authorisation—

(i) in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or

(ii) in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and”.]

(3) In paragraph 22—

(a) in sub-paragraph (1), for “Article 2(5) of Commission Regulation (EC) No 1234/2008” substitute

[F2 (a) in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations];

(b) in sub-paragraph (2)(f), for “Article 2(4) of Commission Regulation (EC) No 1234/2008” substitute

[F3 (i) in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008;

(ii) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations]

; and

(c) in sub-paragraph (3), for “Article 2(2) of Commission Regulation (EC) No 1234/2008” substitute

[F4 (a) in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations]

(4) In paragraph 23—

(a) in sub-paragraph (a), for “paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies” [F5 substitute in the case of a UKMA(NI) or UKMA(UK), paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies or, in the case of a UKMA(GB), sub-paragraph (a) (changes to active substances) or sub-paragraph (b) (changes to strength, pharmaceutical form and route of administration) of the definition of “extension of a UK marketing authorisation” in paragraph 1 of Schedule 10A to the Human Medicines Regulations applies];

(b) in sub-paragraph (b), for “Article 2(3) of Commission Regulation Commission Regulation (EC) No 1234/2008” substitute [F6 in the case of a UKMA(NI) or UKMA(UK), Article 2(3) of Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations]; and

(c) in sub-paragraph (c), for “Commission Regulation (EC) No 1234/2008” substitute [F7 in the case of a UKMA(NI) or UKMA(UK), Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations].

(5) For the table in paragraph 24, substitute—

[F8 “Fees for marketing authorisation applications

Column 1 Kind of application		Column 2 Fee payable
1. Major Application
(a)	in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies	£29,732
(b)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£62,421
(c)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£62,421
(d)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB)	£62,421
(e)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£18,437
(f)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£62,421
(g)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£18,437
(h)	in any other case	£92,753
2. Complex application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£17,330
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£10,443
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£17,330
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£10,443
(g)	in any other case	£25,643
3. Standard application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£6,350
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£5,783
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£6,350
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£5,783
(g)	in any other case	£9,402
4. Simple application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(b)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(c)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£2,564
(d)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive	£2,564
(e)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£2,564
(f)	in any other case	£2,564
5. Parallel import licence applications
(a)	in respect of a simple parallel import licence	£1,792
(b)	in respect of a standard parallel import licence	£6,663
(c)	in respect of a complex parallel import licence	£18,180
6. Change of ownership application		£442”].

(6) After paragraph 24, insert—

“Fees where an application for a European Union marketing authorisation had been made before [F9 IP completion day]

24A.— (1) This paragraph applies where, before [F10 IP completion day] —

(a) an application has been made to the EMA for a European Union marketing authorisation;

(b) day 120 has passed; and

(c) no final decision has been made by the European Commission in relation to the grant of an European Union marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2) Where this paragraph applies and the applicant for the European Union marketing authorisation applies for a UK marketing authorisation in accordance with paragraph 31(2) of Schedule 33A to the Human Medicines Regulations, the fee payable under regulation 12(1) shall be waived.

(3) In this paragraph, “day 120” means the day during the assessment of an application for a European Union marketing authorisation on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant.”.

(7) In paragraph 27—

(a) in sub-paragraph (2), for paragraphs (a) to (c) substitute—

“(a) in respect of the first or only marketing authorisation applied for by that secondary applicant—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £17,330; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for by that secondary applicant which relates to a medicinal product of the same dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24;

(c) in respect of the first additional marketing authorisation applied for by that secondary applicant relating to that medicinal product which is of a different dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £17,330; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(d) in respect of any other additional marketing authorisation applied for by that secondary applicant relating to that medicinal product which is of a different dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.”; and

(b) in sub-paragraph (3), for paragraph (a), substitute—

“(a) where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 12(1)(a) by the secondary applicant is—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24;”.

(8) In paragraph 28—

(a) in sub-paragraph (2), for paragraphs (a) to (c) substitute—

“(a) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form with a different route of administration—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £17,330; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorisation applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.”; and

(b) in sub-paragraph (3), for paragraphs (b) and (c), substitute—

“(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorisation applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.”.

[F11 (8A) After paragraph 28 (application for multiple authorisations) insert—

“Application by pre-assessment of modules

28A.— (1) Where an applicant for a United Kingdom marketing authorisation submits material in accordance with regulation 50(5) of the Human Medicines Regulations for pre-assessment by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—

(a) £23,188.25 in respect of Module 3 (chemical, pharmaceutical and biological information);

(b) £23,188.25 in respect of Module 4 (non-clinical reports);

(c) £23,188.25 in respect of Module 5 (clinical study reports).

(2) Where an applicant for a United Kingdom marketing authorisation for a similar biological medicinal product submits material in accordance with regulations 53, 53A or 53B of the Human Medicines Regulations for pre-assessment of a complex abridged application by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—

(a) £4,332.50 in respect of Module 3 (chemical, pharmaceutical and biological information);

(b) £4,332.50 in respect of Module 4 (non-clinical reports);

(c) £4,332.50 in respect of Module 5 (clinical study reports).

(3) The fee payable under sub-paragraphs (1) and (2) must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of the fee.

(4) Where a fee has been paid under this paragraph, any fee payable under regulation 12(1) in connection with an application for the grant of a United Kingdom marketing authorisation in respect of the same product is reduced by the amount paid under this paragraph provided that no further assessment of the Module concerned is required.”.]

[F12 (9) In paragraph 38—

(a) in sub-paragraph (4)(b), after “Commission Regulation (EC) 1234/2008” insert “and of marketing authorisations in force in Great Britain”;

(b) after sub-paragraph (6)—

(i) for Table 1 substitute—

“Table 1

Fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008

Column 1 Kind of variation		Column 2 Fee payable
1. Application for a single kind variation
(a)	Type IB Application	£277
(b)	Type II Application	£277
(c)	Type II Complex Variation Application	£2,493
(d)	Extended Type II Complex Variation Application	£7,693
2. Applications for a Group
(a)	Minor Variation (Type IB) Group Application	£277
(b)	Major Variation (Type II) Group Application	£496
(c)	Major Variation (Type II) Complex Group Application	£2,703
(d)	Major Variation (Type II) Extended Complex Group Application	£7,883”;

(ii) in Table 2—

(aa) in the heading to the table, after “Commission Regulation (EC) No 1234/2008” insert “and of marketing authorisations in force in Great Britain”;

(bb) after row 8 insert—

“9 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related UKMA(NI) for the same product	£nil
10 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related European Union marketing authorisation for the same product	Apply fees and fee categories in Table 1
11 Variation of a UKMA(UK) or a UKMA(GB) which was granted following an application other than an application made under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding variation has been approved to the related marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in Table 1
12 Variation of a UKMA(GB) which was granted following an application where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), provided a corresponding variation has been approved to the related European Union marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in table 1”;]

(10) In paragraph 39—

(a) in sub-paragraph (1), after “Subject to sub-paragraph (3)” insert “ and paragraph 39A ”;

(b) in sub-paragraph (2), for “in respect of an orphan medicinal product”, substitute “ an orphan marketing authorisation ”; and

(c) in sub-paragraph (3), for “an orphan medicinal product” substitute “ a medicinal product which meets the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations ”.

(11) After paragraph 39, insert—

“Variation of orphan marketing authorisations: small and medium companies

39A.— (1) Subject to sub-paragraph (2), if an application to vary an orphan marketing authorisation is made by, or on behalf of, a small or a medium company within 12 months of the date of grant of the marketing authorisation, the fee payable for that variation application shall be waived.

(2) Sub-paragraph (1) does not apply to an application to authorise use of the medicinal product in a new therapeutic area which does not meet the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.”.

(12) After paragraph 40, insert—

“Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before [F13 IP completion day]

40A.— (1) Paragraph (2) applies where, before [F14 IP completion day] —

(a) an application for a variation to which paragraph 11(7) of Schedule 33A to the Human Medicines Regulations applies, has been made to the EMA; and

(b) the Committee for Medicinal Products for Human Use has adopted a request for supplementary information to be sent to the applicant, or, in the case of an extension, day 120 has passed.

(2) Where this paragraph applies and the holder of a converted EU marketing authorisation submits the application to the licensing authority in order to have the variation made to the converted EU marketing authorisation, the fee payable under regulation 19(1) shall be waived.

(3) In this paragraph—

“day 120” means the day during the assessment of an extension on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant;

“converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the Human Medicines Regulations; and

“extension” has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations.”.

(13) For Part 6 substitute—

“PART 6 U.K. Capital Fee for the Renewal of a Marketing Authorisation

Renewal of a marketing authorisation

[F15 56.   Unless paragraph 57 applies, the fee payable under regulation 27A in connection with an application for the renewal of a United Kingdom marketing authorisation is—

(a) in respect of an application for renewal of a UKMA(GB) granted under the unfettered access route, £747;

(b) in respect of an application for renewal of a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), £747;

(c) in all other cases, £9,682.]

Renewal of multiple marketing authorisations

57.— (1) This sub-paragraph applies if more than one application falling within regulation 27A is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form and therapeutic indications, and the marketing authorisations for those products have the same date for renewal.

[F16 (2) The fee payable under regulation 27A for applications to which sub-paragraph (1) applies is—

(a) in respect of applications for renewal of more than one UKMA(GB) granted under the unfettered access route or UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding renewal application has been made to the related European Union marketing authorisation or UKMA(NI) for the same product—

(i) £747 for the first application considered by the licensing authority; and

(ii) £747 for each other application;

(b) in all other cases—

(i) £9,682 for the first application considered by the licensing authority; and

(ii) £747 for each other application.]

PART 6A U.K. Capital Fee for Conducting a Major Safety Review

57A.   The fee payable under regulation 19D(1) in connection with the carrying out of a major safety review is—

(a) £51,286, where one or two active ingredients, or combinations of active ingredients, are included in the assessment;

(b) £59,595, where three active ingredients, or combinations of active ingredients, are included in the assessment;

(c) £67,904, where four active ingredients, or combinations of active ingredients, are included in the assessment; or

(d) £76,213, where five or more active ingredients, or combinations of active ingredients, are included in the assessment.

PART 6B U.K. Capital Fee for Testing of Samples by the Appropriate Authority

57B.— (1) Unless sub-paragraph (2) applies, the fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of a medicinal product of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

(2) This sub-paragraph applies where—

(a) the holder of the marketing authorisation submits, with a sample of a batch of medicinal product, a certificate issued by a laboratory in a designated country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted; and

(b) on the basis of the documentation submitted with the sample, the appropriate authority considers that it is only necessary to carry out a paper based assessment of the sample.

(3) Where sub-paragraph (2) applies, the fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of medicinal product of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 3 of that table.

(4) Where a product falls within more than one of the Bands referred to in the following table, the product is to be treated as if it only falls within the Band which attracts the highest fee.

Fees for testing of samples

Column 1Product Type				Column 2Fee payable where the licensing authority carries out a full assessment	Column 3Fee payable where the licensing authority carries out a paper-based assessment
1. Plasma pools which require—
		(a)	three or fewer tests	£180	£90
		(b)	four or five tests	£215	£90
		(c)	six or more tests	£230	£90
2. Band A				£1,660	£305
3. Band B				£1,910	£305
4. Band C				£2,340	£305
5. Band D				£3,690	£677
6. Band E				£6,410	£677
7. Band F				£10,350	£677

(5) In this paragraph—

“Band A” means a single component product, other than Botulinum toxin, requiring five or fewer in vitro tests;

“Band B” means Factor VIII, Factor IX or intravenous Immunoglobulin;

“Band C” means a multi-component product, or Botulinum toxin, requiring five or fewer in vitro tests;

“Band D” means a product requiring six to nine in vitro tests;

“Band E” means a product requiring—

(a)

ten or more in vitro tests, or

(b)

one or more in vivo tests;

“Band F” means a product—

(a)

which requires one or more tests that must be carried out under containment measures applicable to hazard Group 3 or 4 biological agents under the Control of Substances Hazardous to Health Regulations 2002 M1 ; or

(b)

requires the use of human cells or tissues as part of its testing;

“Multi-component product” means a product containing two or more analytes that require testing; and

“Single component product” means a product containing a single analyte that requires testing.”

Textual Amendments

F1 Sch. 1 para. 7(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(i)

F2 Words in Sch. 1 para. 7(3)(a) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(aa)

F3 Words in Sch. 1 para. 7(3)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(bb)

F4 Words in Sch. 1 para. 7(3)(c) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(cc)

F5 Words in Sch. 1 para. 7(4)(a) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(aa)

F6 Words in Sch. 1 para. 7(4)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(bb)

F7 Words in Sch. 1 para. 7(4)(c) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(cc)

F8 Sch. 1 para. 7(5) Table substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iv)

F9 Words in Sch. 1 para. 7(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(v)(aa)

F10 Words in Sch. 1 para. 7(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(v)(bb)

F11 Sch. 1 para. 7(8A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vi)

F12 Sch. 1 para. 7(9) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii)

F13 Words in Sch. 1 para. 7(12) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(viii)(aa)

F14 Words in Sch. 1 para. 7(12) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(viii)(bb)

F15 Words in Sch. 1 para. 7(13) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(aa)

F16 Words in Sch. 1 para. 7(13) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(bb)

Commencement Information

I1 Sch. 1 para. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 S.I. 2002/2677