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The Medicines (Products for Human Use) (Fees) Regulations 2016

Type Statutory-Instrument

Publication 2016-02-11

Last updated 2025-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(d) £186 if the application is an administrative variation application.

Identical variations

51

(1) Unless paragraph 52 or 53 applies, where more than one application—

(a) of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorisation holder and all of the applications are for identical kinds of variations; or

(b) by the same applicant is made at the same time for a traditional herbal registration, a manufacturer's licence, or a wholesale dealer's licence and where the applications are for identical variations,

the fee payable under regulation 19(1) is that specified in sub-paragraph (3).

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type IB Application;

(b) Type II Application;

(d) Major Variation (Type II) Group Application.

(3) The fee referred to in sub-paragraph (1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and

(b) in connection with each of the other applications is 50% of that amount.

Complex Variation Applications

52

(1) Where more than one application of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorisation holder and all of the applications are for identical kinds of variations, the fee payable under regulation 19(1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of the Schedule; and

(b) in connection with each of the other applications in respect of which no further medical, scientific or pharmaceutical assessment is required, is the amount which would be payable if the application was a Type II Application.

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type II Complex Variation Application;

(b) Extended Type II Complex Variation Application;

(d) Major Variation (Type II) Extended Complex Group Application.

Multiple reclassification variation applications

53

Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 19(1)—

(a) if one or more of the applications is an application to which paragraph 40 does not apply—

(i) in connection with the first application to which paragraph 40 does not apply, is the appropriate amount specified in this Part of the Schedule;

(ii) in connection with each other application to which paragraph 40 does not apply, the fee payable is £1,308; and

(iii) in connection with each other application to which paragraph 40 does apply, the fee payable is £367; and

(b) in any other case—

(i) in connection with the first application, is the appropriate amount specified in this Part of the Schedule; and

(ii) in connection with each other application, the fee payable is £367.

PART 5 — Capital Fees for Assessment of Labels and Leaflets

A set of changes

54

(1) Unless paragraph 55 applies, the fee payable under regulation 25(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—

(a) £992, in respect of a product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence); and

(b) £440, in respect of a product which is the subject of a parallel import licence.

(2) If the proposed changes in respect of a product to which the fee in sub-paragraph (1)(a) applies are submitted in accordance with the National Guidance on labels and leaflets self-certification, the fee payable under regulation 25(1) is £224.

(3) For the purpose of this paragraph—

(a) changes are submitted in accordance with the National Guidance on labels and leaflets self-certification if they are of a type described in the National Guidance on labelling and patient information leaflets for self-certification and comply with the conditions set out in relation to those changes in that Guidance; and

(b) the “National Guidance on labelling and patient information leaflets for self-certification” means the documents entitled “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with Article 56(a) of the 2001 Directive – inclusion of Braille on the labelling” published by the licensing authority and available on its website .

More than one set of changes proposed

55

(1) In this paragraph, “clinical particulars” means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in of Article 11 of the 2001 Directive.

(2) This paragraph applies where more than one set of proposed changes falling within regulation 25(1) is submitted by the same marketing authorisation holder at the same time and where—

(a) the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or

(b) the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.

(3) Where this paragraph applies, the fee payable under regulation 25(1) is—

(a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 54; and

(b) in connection with each of the other sets of proposed changes, 50% of that amount.

PART 6 — Capital Fee for the Renewal of a Marketing Authorisation

Regulatory assistance

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, £1,239;

(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), £1,239;

Regulatory assistance – same manufacturer

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.

(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) £1,239 for the first application considered by the licensing authority; and

(ii) £1,239 for each other application;

(b) in all other cases—

(i) £16,042 for the first application considered by the licensing authority; and

(ii) £822 for each other application.

PART 7 — Relevant Substances

Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)

58

(1) The substances listed for the purposes of paragraphs 24(2)(b) and (4)(b) and 38(2)(b) (fees payable where the application concerns certain substances) are—

— Acetic Acid

— Aluminium Chloride

— Aluminium Hydroxide

— Aluminium Sulfate

— Ammonia

— Ammonium Bicarbonate

— Ammonium Chloride

— Ascorbic Acid

— Barium Sulfate

— Benzoic Acid

— Benzoyl Peroxide

— Benzyl Alcohol

— Benzyl Benzoate

— Bismuth Subgallate

— Calamine

— Calcium Acetate

— Calcium Carbonate

— Calcium Chloride

— Calcium Gluconate

— Calcium Glycerophosphate

— Calcium Hydroxide

— Calcium Lactate

— Calcium Phosphate

— Charcoal

— Chlorobutanol

— Chlorocresol

— Citric Acid

— Coal Tar

— Ethanol

— Ethanolamine

— Ferric Chloride

— Ferrous Fumarate

— Ferrous Gluconate

— Ferrous Sulfate

— Formaldehyde Solution

— Glucose

— Glycine

— Hydrogen Peroxide

— Iodine

— Isopropyl Alcohol

— Isopropyl Myristate

— Kaolin

— Lactic Acid

— Lactose

— Lactulose

— Lithium Carbonate

— Lithium Citrate

— Magnesium Acetate

— Magnesium Carbonate

— Magnesium Chloride

— Magnesium Hydroxide

— Magnesium Oxide

— Magnesium Sulfate

— Magnesium Trisilicate

— Malic Acid

— Manganese Sulfate

— Oleic Acid

— Paraffin

— Phenol

— Phosphoric Acid

— Potassium Acetate

— Potassium Bicarbonate

— Potassium Chloride

— Potassium Citrate

— Potassium Dihydrogen Phosphate

— Potassium Hydrogen Tartrate

— Potassium Hydroxide

— Potassium Iodate

— Potassium Iodide

— Potassium Nitrate

— Silver Nitrate

— Sodium Acetate

— Sodium Ascorbate

— Sodium Bicarbonate

— Sodium Carbonate

— Sodium Chloride

— Sodium Citrate

— Sodium Dihydrogen Phosphate

— Sodium Fluoride

— Sodium Hydroxide

— Sodium Iodide

— Sodium Lactate

— Sodium Sulfate

— Sorbic Acid

— Sucrose

— Sulpher

— Tar

— Tartaric Acid

— Undecenoic Acid

— Urea

— Wool Alcohols

— Wool Fat

— Zinc Acetate

— Zinc Chloride

— Zinc Oxide

— Zinc Sulfate

— Zinc Undecenoate

(2) The list of substances under this Part includes any dried, anhydrous, hydrate, hydrous, activated, strong, light, heavy and coloured forms of substances listed under paragraph (1) that are the subject of a pharmacopoeial monograph of the European Pharmacopoeia or the British Pharmacopoeia.

SCHEDULE 3 — Fees for inspections

General provisions relating to fees for inspections

1

(1) In this Schedule, a reference to 1 day means a period of 7 hours.

(2) For the purposes of paragraphs 3(2)(c), 4(2)(c), 6(2)(c) and 8, in calculating the number of days taken to make an inspection, any part day shall be calculated as a whole day.

(3) Where an inspection is made at a site which is outside the United Kingdom, the fee for the inspection shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs (such as interpreters' fees) reasonably incurred by the inspector in respect of that inspection as a result of its being at a site outside the United Kingdom.

(4) If an inspection is made by more than one inspector, the time taken by the licensing authority to make an inspection is the total amount of time spent by each inspector in making the inspection.

Fees: general

2

(1) The fee for an inspection made at a site is—

(a) £5,251, if the time taken to make the inspection is not more than 1 day; and

(b) thereafter, £2,625 for every additional period of 3 hours and 30 minutes or less taken to make the inspection.

(2) Sub-paragraph (1) does not apply if the inspection is one for which a fee is payable under paragraphs 3 to 7.

Traditional herbal medicinal products

3

(1) Sub–paragraph (2) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a manufacturer's licence or during the currency of such a licence, is—

(a) £994 if the time taken to make the inspection is not more than 3 hours;

(b) £1,615 if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,615.

Sites concerned with starting materials for traditional herbal medicinal products

4

(1) Sub-paragraph (2) applies if the site inspected is wholly concerned with the manufacture or assembly of starting material for use in the manufacture of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of an API manufacturer under Article 111(1g)(a) of the 2001 Directive, is—

(a) £994 if the time taken to make the inspection is not more than 3 hours;

(b) £1,615 if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days to make the inspection by £1,615.

Wholesale dealer's licence: general

5

Except in the case of an inspection falling within paragraphs 6 or 7, the fee for an inspection of a site made in connection with the grant or variation of a wholesale dealer's licence or during the currency of such a licence, is—

(a) if the time taken to make the inspection is not more than 1 day, £4,136; and

(b) if the time taken is 1 day or more, £4,136 for the first day and £2,068 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

Wholesale dealer's licence: traditional herbal medicinal products

6

(1) Sub–paragraph (2) applies if the site inspected is wholly concerned with the wholesale dealing of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a wholesale dealer's licence or during the currency of such a licence is—

(a) £1,114 if the time taken to make the inspection is not more than 3 hours;

(b) £2,047 if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £2,047.

Wholesale dealer's licences: inspection of short duration

7

(1) Sub-paragraph (3) applies if the time taken to make the inspection is not more than 3 hours and 30 minutes, and

(a) the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products classified as subject to general sale under regulation 5(1) of the Human Medicines Regulations;

(b) the site relates to a registered pharmacy as referred to in paragraph 31(3) of Part 2 of Schedule 2; or

(c) the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000.

(2) If paragraph (c) of sub-paragraph (1) applies because the applicant has not held a wholesale dealer's licence during the 12 month period preceding the date of the application, sub–paragraph (1) does not apply unless at the time of making the application—

(a) it is reasonable for the applicant to believe that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and

(b) the applicant so informs the licensing authority.

(3) If this sub-paragraph applies, the fee payable in respect of an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer's licence is £2,068.

Broker's registrations

8

(1) Except in the case of an inspection where sub–paragraph (2) applies, the inspection fee payable in connection with the grant, variation or review of a broker's registration is—

(a) £3,241 if the time taken to make the inspection is not more than 1 day; and

(b) if the time taken is 1 day or more, £3,241 for the first day and £1,621 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

(2) This paragraph applies where an application or variation of a broker's registration is considered under paragraph 10 but it is necessary to carry out a site inspection before the registration is granted or varied.

(3) If sub-paragraph (2) applies, a fee of £780 is payable in addition to any fee under paragraph 10.

Active substance registrations

9

(1) Except in the case of an inspection where sub–paragraph (2) applies, the fee payable in connection with the grant, variation or review of an active substance registration where the inspection relates to—

(a) a manufacturer of an active substance, is—

(i) £3,975 if the time taken to make the inspection is not more than 1 day; and

(ii) if the time taken is 1 day or more, £3,975 for the first day and £1,988 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection;

(b) an importer or distributor of an active substance, is—

(i) £2,898 if the time taken to make the inspection is not more than 1 day; and

(ii) if the time taken is 1 day or more, £2,898 for the first day and £1,449 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

(2) This paragraph applies where an application or variation of an active substance registration is considered under paragraph 10 but it is necessary to carry out a site inspection before the registration is granted or varied.

(3) If sub-paragraph (2) applies—

(a) a fee of £949 is payable in addition to any fee under paragraph 10 where the inspection relates to a manufacturer of an active substance;

(b) a fee of £697 is payable in addition to any fee under paragraph 10 where the inspection relates to an importer or distributor of an active substance.

Office-based inspections

10

The fee for an inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—

(a) good manufacturing practice, good clinical practice or good pharmacovigilance practice, is £4,924 per day;

(b) good distribution practice, is £3,810 per day.

SCHEDULE 4 — Periodic fees for licences

PART 1 — Interpretation

1

In this Schedule—

“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;

“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—a different dosage form of that drug or substance; orof the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; andin respect of which an application for a marketing authorisation was made before the determination of the application for the marketing authorisation for that drug or substance;

“general sale list medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as subject to general sale within the meaning of regulation 5(1) of the Human Medicines Regulations;

“limited use drug” means a medicinal product in respect of which an application for a marketing authorisation has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or in respect of which an orphan marketing authorisation has been granted;

“lower fee” means the periodic fee payable—where the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period; orin relation to a medicinal product that has been manufactured or imported into the United Kingdom during the period referred to in (a) above, where the value of the product sold or supplied during that period did not exceed £1,000; andin relation to a prescription only product, where the authorisation holder has notified the licensing authority that the medicinal product to which the marketing authorisation relates, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; orin relation to a pharmacy medicine or a general sale list medicine, the periodic fee payable during the relevant fee period;

“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;

“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as a pharmacy medicine within the meaning of regulation 5(5) of the Human Medicines Regulations;

“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic medicinal product, a new active substance or a derivative of a new active substance) classified as a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations;

“reduced rate fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period does not exceed £35,000;

“standard fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period exceeds £35,000; and

“total value of the product” means the amount calculated in accordance with Part 2 of this Schedule.

PART 2 — Value of the Product Sold or Supplied

Determining the total value of the product

2

For the purposes of this Schedule, the “total value of the product” means, the gross value at manufacturer's prices of all medicinal products to which the authorisation relates that are sold or supplied in the United Kingdom by the holder of that authorisation during a period of 12 months preceding the commencement of the relevant fee period.

Manufacturer's prices

3

For the purposes of paragraph 2 manufacturer's prices means—

(a) for products manufactured or obtained, sold or supplied by the authorisation holder to wholesalers or to distributors or assemblers named in the marketing authorisation, which that holder has manufactured or obtained from the manufacturer, the prices charged for the supply;

(b) for products sold or supplied by the authorisation holder to retailers, which that holder has manufactured or obtained from the manufacturer, the prices which, in the opinion of the licensing authority, the authorisation holder would have charged, in accordance with the practice prevailing during the relevant year, to a wholesaler of the product; or

(c) for products sold or supplied by the authorisation holder which that holder has neither manufactured nor obtained from the manufacturer, the price which the authorisation holder paid for the supply.

Information requirements

4

(1) The authorisation holder shall determine the total value of product sold or supplied in accordance with paragraphs 2 and 3 and provide such information to the licensing authority if required to do so.

(2) The licensing authority may additionally require an auditor's certificate verifying the authorisation holder's determination of the value of products sold or supplied.

(3) If an auditor's certificate has not been provided to the licensing authority within one month of it being required, or such longer period that the authority may allow, the periodic fee shall be calculated in accordance with sub-paragraph (4).

(4) The periodic fees for the relevant fee period in question shall be equal to the fee provided for in paragraphs 10 and 13 of Part 3 of this Schedule or, such lesser sum as the licensing authority may specify in a written notice served on the authorisation holder.

PART 3 — Periodic Fees for Marketing Authorisations and Licences

Marketing authorisations

5

Unless paragraphs 6 to 10 apply, the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.

Marketing authorisation: where Part 2 of the Act applies

6

In the case of an article or substance to which Part 2 of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971 , the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation or licence is £368.

Marketing authorisation: derivatives

7

Unless paragraph 8 applies, where a marketing authorisation is held in respect of a derivative of a new active substance, the fee payable under regulation 38(1) is—

(a) £11,627 where the medicinal product to which the authorisation relates has a different route of administration from that of the new active substance; or

(b) £7,847 in any other case.

Number of fee periods

8

(1) The fee specified in—

(a) paragraph 5 for a new active substance; and

(b) in paragraph 7 for a derivative of a new active substance,

is only payable for the five relevant fee periods following that in which the marketing authorisation is granted.

(2) The fee payable in accordance with entry 3(a) of the table set out in paragraph 5 is only payable for the three relevant fee periods following the year beginning 1st April during which the marketing authorisation is granted.

(3) Where a marketing authorisation is surrendered and at the same time another marketing authorisation held by the authorisation holder is varied so as to include in that other authorisation the provisions of the first authorisation, the fee payable—

(a) for the five relevant fee periods following the fee period during which the marketing authorisation is granted is the fee specified at entry 1 of the table set out in paragraph 5, where the first authorisation relates to a new active substance;

(b) in all other cases, for each fee period mentioned in sub-paragraph (2), is the fee specified at entry 3(a) of that table.

(4) In respect of fee periods following those referred to in sub-paragraphs (1) to (3) of this paragraph, the periodic fees are the appropriate fees for the kind of medicinal product in question specified in entries 3(b), (c) or (d) of the table set out in paragraph 5.

(5) In connection with the holding of a marketing authorisation in respect of a limited use drug or a derivative of a limited use drug—

(a) where the total value of the product sold or supplied exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorisation was granted, the periodic fee payable is the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;

(b) where the total value of the product sold or supplied does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorisation was granted, the periodic fee payable is the fee payable in respect of a prescription only medicine in accordance with entry 3(b)(i) of the table set out in paragraph 5.

Authorisation for two or more kinds of medicinal product

9

Where a marketing authorisation relates to any two or more medicinal products of a kind described in entries 3(b), (c) or (d) of column 1 of the table in paragraph 5, the fee payable under regulation 38(1) shall be the lower of the fee specified as corresponding to those entries in column 2 of that table.

Reduced fees

10

Where a reduced rate fee or a lower fee may be payable in respect of any relevant fee period and an authorisation holder does not submit information about the total value of the product sold or supplied in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable shall, where applicable, be the standard fee for each description of medicinal product in respect of which a marketing authorisation is held by the authorisation holder.

Manufacturer's licences or manufacturing authorisations

11

(1) Unless sub-paragraph (3) applies, the fee payable under regulation 38(1) in connection with the holding of a manufacturer's licence is £561.

(2) The fee payable under regulation 38(1) in connection with the holding of a manufacturing authorisation is £561.

(3) The fee payable under regulation 38(1) in connection with the holding of a manufacturer's licence which relates to the import of special medicinal products from a third country is the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 15.

Wholesale dealer's licences

12

(1) Subject to sub-paragraph (2) and to paragraphs 13 and 16, the fee payable under regulation 38(1) in connection with the holding of a wholesale dealer's licence is £346.

(2) The fee payable under regulation 38(1) is £206 where the wholesale dealer's licence—

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total value of the sale of authorised medicinal products carried on at that pharmacy;

(b) does not relate to anything done in a registered pharmacy, where the total value of the sale by way of wholesale dealing in authorised medicinal products does not exceed £35,000; or

(3) For the purposes of sub-paragraph (2), the total value shall be calculated in accordance with Part 2 of this Schedule and the references to “marketing authorisation” and “authorisation holder” in Part 2 shall be interpreted as if they were references to “wholesale dealer's licence” and “licence holder”, respectively.

Wholesale dealer's licences: evidence

13

Where in respect of any relevant fee period, the holder of a wholesale dealer's licence does not submit evidence of turnover in relation to the relevant fee period to the satisfaction of the licensing authority, the periodic fee payable shall be the fee prescribed in paragraph 12(1).

Wholesale dealer's licences: special medicinal products

14

The fee payable under regulation 38(1) in connection with the holding of a wholesale dealer's licence which relates to special medicinal products imported from another EEA member State is the fee payable in accordance with paragraphs 12 and 13 and an additional amount calculated in accordance with paragraph 15.

Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products

15

(1) The additional amount referred to in paragraphs 11(3) and 14 in relation to any fee period is—

(a) the fee specified in the entry in column 2 of Table 1 (additional periodic fee in connection with notices for imported special medicinal products) corresponding to the estimated number of special import notices for that fee period specified in column 1, and

(b) the fee specified in the entry in column 2 of Table 2 (additional periodic fee in connection with the number of different special medicinal products imported) corresponding to the estimated number of different special medicinal products imported for that fee period specified in column 1.

Column 1	Column 2
Number of special import notices	Additional amount
1 to 20	£86
21 to 100	£427
101 to 500	£2,131
501 to 1,000	£4,261
1,001 to 2,000	£8,521
2,001 to 5,000	£17,042
5,001 to 10,000	£34,083
10,001 to 15,000	£51,125
15,001 to 20,000	£68,166
20,001 to 25,000	£85,208
25,001 to 30,000	£102,249
30,001 to 35,000	£119,291
35,001 to 40,000	£136,333
40,001 to 45,000	£153,375
45,001 to 50,000	£170,417
Each additional 5,000 above 50,000	£170,417 plus £17,042 for each additional 5,000 special import notices
Column 1	Column 2
---	---
Number of different special medicinal products notified for import	Additional amount
1 to 5	£122
6 to 10	£244
11 to 20	£487
21 to 50	£1,218
51 to 100	£2,435
101 to 200	£,4,869
For each additional 100 special medicinal products notified for import above 200	£4,869 plus £2,435 for each additional 100 special medicinal products notified for import

(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.

(3) For the purposes of this paragraph, the estimated number of different special medicinal products notified for import for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.

Traditional herbal registrations

16

The fee payable under regulation 38(1) in connection with the holding of a traditional herbal registration is £92.

Online sellers of medicines

17

(1) Subject to sub-paragraph (2), the fee payable under regulation 39(1) by a person included on the list of online sellers of medicines is £97.

(2) For the fee period beginning with 1st April 2016 and ending with 31st March 2017, the fee payable under regulation 39(1) by a person included on the list of online sellers of medicines is the fee payable in accordance with sub-paragraph (1) and an additional amount of £100.

(3) The fee payable in accordance with sub-paragraph (2) is payable on invoice.

PART 4 — Types of Marketing Authorisation for which only One Periodic Fee is Payable

Parallel import licences

18

In a case where a parallel import licence has been granted by the licensing authority the periodic fee relating to that licence is payable once only.

SCHEDULE 5 — Fees for certificates of registration

Column 1	Column 1	Column 1	Column 2	Column 2	Column 3	Column 3
Type of application	Type of application	Type of application	Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fees for other applications	Fees for other applications
1	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	£194	£194	£479
2	An application in respect of a product which is either—	An application in respect of a product which is either—	An application in respect of a product which is either—	£582	£582	£857
	(a)	prepared solely from repeat stocks; or	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation.	is of a repeat formulation.
3	A mutual recognition procedure incoming application.	A mutual recognition procedure incoming application.	A mutual recognition procedure incoming application.	£610	£610	£777
4	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	£287	£287	£374
5	A decentralised procedure application where the UK is a concerned member State.	A decentralised procedure application where the UK is a concerned member State.	A decentralised procedure application where the UK is a concerned member State.	£524	£524	£686
6	A decentralised procedure application where the UK is the reference member State.	A decentralised procedure application where the UK is the reference member State.	A decentralised procedure application where the UK is the reference member State.	£813	£813	£1,063
7	Any other application.	Any other application.	Any other application.	£962	£962	£1,259

SCHEDULE 6 — Time for payment of capital fees: small companies

Interpretation

1

In this Schedule a reference to an application is to an application made by or on behalf of a small company.

Major application

2

In connection with a major application for a marketing authorisation for which the fee payable is that specified in entry 1(h) of the table in paragraph 24 of Part 2 of Schedule 2, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 25% at the time of the application and as to 75% within 30 days following written notice from the licensing authority that the application has been determined.

Complex application

3

In connection with a complex application for a marketing authorisation, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% at the time of the application; and

(b) as to 50% within 30 days following written notice from the licensing authority that the application has been determined.

Multiple application

4

In connection with an application to which paragraph 28 of Part 2 of Schedule 2 applies, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% of the total payable in accordance with that paragraph at the time of the application; and

(b) as to 50% of that total within 30 days following written notice from the licensing authority that the application has been determined.

Outgoing mutual recognition application

5

As regards the fee payable under regulation 17 in connection with an application—

(a) to which paragraph 36(2) of Part 3 of Schedule 2 applies—

(i) 25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated; and

(ii) 75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;

(b) to which paragraph 36(3), (4) or (5), of Part 3 of Schedule 2 applies—

(i) 50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated, and

(ii) 50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,

if the applicant so requests in writing.

Application for traditional herbal registration

6

In connection with an application for a traditional herbal registration, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Traditional herbal registration: complex variation

7

In connection with a complex variation application or a new excipient variation application to vary a traditional herbal registration, the fee payable under regulation 19(1) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence

8

In connection with an application for a manufacturer's licence, manufacturing authorisation, or a wholesale dealer's licence, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Inspection fees in connection with applications

9

In connection with an application for a marketing authorisation, traditional herbal registration, manufacturer's licence or manufacturing authorisation, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50% within the period of 14 days referred to in regulation 50(1)(b) and as to 50% within 12 months after that date.

SCHEDULE 7 — Waiver, reduction or refund of capital fees

Interruptions of manufacture, assembly, sale or supply

1

Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period and in consequence thereof the health of the community will be, or is likely to be, put at risk, any capital fees payable under these Regulations in connection with an application for the grant of a marketing authorisation or a manufacturer's licence relating to a medicinal product falling within that class or description and made during that period or, if the period will, or is likely to, exceed 3 months of that period, shall be waived.

Reclassification

2

(1) Where—

(a) an application for a marketing authorisation includes a reclassification element within the meaning of paragraph 25 of Part 2 of Schedule 2; and

(b) the licensing authority is satisfied that the reclassification element does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,

50% of the additional amount payable under paragraph 25(1)(a) or (b) or 28(4)(a) of Part 2 of that Schedule shall be refunded, or if it has not yet been paid, shall be waived.

(2) Where—

(a) an application for variation of a marketing authorisation is a reclassification variation application (not being an application falling within paragraph 40 of Part 4 of Schedule 2); and

(b) the licensing authority is satisfied that the application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,

50% of the fee payable under paragraph 38 of Schedule 2 and entry 1(c)(i) of Table 1 referred to in that paragraph or of the fee payable under paragraph 53 (a)(i) of Part 4 of Schedule 2 shall be refunded, or if it has not yet been paid, shall be waived.

(3) Where—

(a) an application for variation of a parallel import licence falls within paragraph 42 (1)(a) of Part 4 of Schedule 2; and

(b) the licensing authority is satisfied that the application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,

50% of the fee payable under that paragraph shall be refunded, or if it has not yet been paid, shall be waived.

(4) For the purposes of sub-paragraphs (1) to (3), a reclassification element or, as the case may be, a variation application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products where—

(a) the licensing authority is satisfied that the application does not require consideration by the Commission, committee or board; and

(b) the Commission, committee or board are consulted only by virtue of, or in accordance with any Community provision, referred to the Committee for Medicinal Products for Human Use or the Committee on Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the Directive.

(5) In sub-paragraph (4), “Committee for Medicinal Products for Human Use” and “Committee on Herbal Medicinal Products” mean the Committee for Medicinal Products for Human Use and Committee on Herbal Medicinal Products established under Regulation (EC) No 726/2004.

Variation of a traditional herbal registration

3

Where at the specific written request of the licensing authority, or in response to the imposition of an urgent safety restriction under regulation 149 (urgent safety restrictions) of the Human Medicines Regulations, an application is made for the variation of a traditional herbal registration so as to—

(a) restrict any one or more of the indications, dosage or target population; or

(b) add a new contraindication or a warning or both of these,

as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 19(1) shall be refunded or, if it has not yet been paid, shall be waived.

Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation

4

(1) Subject to sub-paragraph (2), where an application for the grant of, or for a variation to, a marketing authorisation or traditional herbal registration, or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 19(1) or 20(1) in connection with that application or notice shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application or notice has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;

(b) except in a case to which sub-paragraph (c) applies, if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;

(c) if a request for further information in connection with the application has been made by the licensing authority under regulation 30 (provision of information) of the Human Medicines Regulations or in pursuance of a European Union provision which applies to applications for marketing authorisations or traditional herbal registrations, 25%.

(2) If an application for the grant of, or for a variation to, a marketing authorisation or traditional herbal registration, or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products, no refund or waiver of the fee payable under regulation 12(1)(a), 19(1) or 20(1) in connection with that application or notice shall be made under this paragraph.

Withdrawal of application in relation to a certificate of registration

5

Where a person withdraws an application for the grant of a certificate of registration before it has been determined by the licensing authority the following percentage of the fee otherwise payable under regulation 46 of these Regulations shall be refunded, or if it has not yet been paid, shall be waived—

(a) if the application has been received but no medical, scientific or pharmaceutical assessment of the application has begun, 90%;

(b) if medical, scientific or pharmaceutical assessment of the application has begun but has not been completed, 50%;

(c) if medical, scientific or pharmaceutical assessment or consideration by the Advisory Board on the Registration of Homoeopathic Products of the application has been completed, no refund or waiver of the fee shall be made.

Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration

6

(1) Where an application for the grant of, or for a variation to, a manufacturing authorisation, a manufacturer's licence, a wholesale dealer's licence, a broker's registration or an active substance registration is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 12(1)(a) or 19(1) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application is withdrawn before any inspection in connection with that application has been made, 90%; or

(b) if such an inspection has been made, 50%.

Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation

7

Where an application for the grant of a marketing authorisation or traditional herbal registration, or an application for a clinical trial authorisation is refused by the licensing authority and—

(a) the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and

(b) if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3,

there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.

Parallel import licence

8

The fee payable for an application to vary a parallel import licence shall be waived if the application is made only—

(a) because of a change to the number of an authorisation granted under the provisions of the 2001 Directive by another member State for a product to which the licence relates; and

(b) so that the number of that authorisation shown on the licence can be changed.

Surrender of marketing authorisation at same time as a variation application

9

(1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorisation in the circumstances set out in paragraph 8(3) of Part 3 of Schedule 4, the fee payable under regulation 19(1) shall be refunded or waived.

(2) Subject to sub-paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.

(3) Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 51 and 52 of Part 4 of Schedule 2, sub-paragraph (1) shall apply to the application in respect of which of those paragraphs make provision for the higher or highest fee.

Clinical trial authorisation

10

(1) In relation to an application for a clinical trial authorisation in relation to a Phase I trial or a Phase II or Phase III trial, the fee payable in respect of such an application may be reduced in accordance with the following sub-paragraphs.

(2) Where the licensing authority is satisfied that the investigational medicinal product dossier submitted in accordance with paragraph 11 of Part 2 of Schedule 3 to the Clinical Trials Regulations does not require a full medical, scientific or pharmaceutical assessment, the fee may be reduced by an amount which the authority considers to be the cost of the assessment work which is not required.

(3) The fee payable may not be reduced below £100.

(4) Where the fee has been reduced by the licensing authority but the applicant has paid the full fee, the amount by which the fee has been reduced shall be refunded.

(5) In this paragraph, “Phase I trial” and “Phase II or Phase III trial” have the same meaning as in paragraph 1 of Schedule 2.

Scientific advice: paediatric indications

11

(1) Where the licensing authority holds a meeting referred to in regulation 3A in order to provide scientific advice with a view to a person making an application other than a major application or an application for a paediatric use marketing authorisation the fee shall be waived if—

(a) sub-paragraphs (2) or (3) apply to the application; and

(b) the meeting is held solely for the purpose of providing advice in relation to the application.

(2) This sub-paragraph applies to the application if—

(a) the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication; and

(b) no other product which has the same active ingredient and is intended to be used in accordance with the same indication and for the same part of the paediatric population as the product in question has previously been granted a marketing authorisation.

(3) This sub-paragraph applies to the application if—

(a) the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication;

(b) as a result of the application the medicinal product will be available in a formulation which the licensing authority considers to be of significant benefit to that population in comparison to other medicinal products on the market in the United Kingdom; and

(c) no other product which has the same active ingredient and is in the same formulation as proposed for the product in question has previously been granted a marketing authorisation.

(4) In this paragraph—

(a) a medicinal product is authorised for a paediatric indication if it is authorised for use in part or all of that part of the population aged between birth and 18 years and the details of the authorised indication are specified in the summary of characteristics drawn up in accordance with Article 11 of the 2001 Directive ;

(b) “paediatric use marketing authorisation” means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate or by a patent which qualifies for the granting of such a certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product; and

(c) “supplementary protection certificate” means a certificate granted under Council Regulation (EC) No 469/2009 concerning the creation of a supplementary protection certificate for medicinal products and a patent qualifies for the granting of such a certificate if the provisions of that Regulation so provide.

Refunds: treated as having been paid on account

12

Any sums payable to the applicant by way of refund of any fees under the provisions of this Schedule may be treated as having been paid on account of any other fee which the applicant is liable to pay (whether by instalments or otherwise) under the provisions of these Regulations.

SCHEDULE 8 — Adjustment , waiver reduction or refund of periodic fees

Refund on surrender or revocation of authorisation, registration or licence

1

Where, after payment of a periodic fee payable in accordance with the provisions of these Regulations, the marketing authorisation, traditional herbal registration or licence in respect of which such a fee has been paid is either—

(a) surrendered at the specific written invitation of the licensing authority; or

(b) revoked by the licensing authority on a date earlier than the date of expiry stated in the marketing authorisation, traditional herbal registration or licence,

the licensing authority shall refund the whole or any part of the difference between such periodic fee as has been paid and the amount of the periodic fee payable on the basis of the actual duration of the marketing authorisation, traditional herbal registration or licence up to the date of such surrender or revocation.

Adjustment and refund: licences relating to imported special medicinal products

2

(1) This paragraph applies to periodic fees payable in connection with a manufacturer's licence or a wholesale dealer's licence which relates to imported special medicinal products.

(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 4, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 4, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

Refunds: treated as having been paid on account

3

Signed

Signed by authority of the Secretary of State for Health.

George Freeman — Parliamentary Under-Secretary of State, — 2016-02-08

Simon Hamilton — Minister for Health, Social Services and Public Safety — 2016-02-10

John Penrose — George Hollingbery — Two of the Lords Commissioners of Her Majesty's Treasury — 2016-02-11

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1971 c.69; as amended by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). See therefore section 1 of the 1968 Act, as substituted by paragraph 2 of Schedule 34 to the Human Medicines Regulations 2012 (S.I. 2012/1916) (“the 2012 Regulations”) which provides the meaning of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. By virtue of regulation 348 of, and paragraph 36 of Schedule 34 to, the 2012 Regulations, references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence, or for the variation or renewal of such a licence under Part 2 of the 1968 Act, shall have effect as a reference to any application under Parts 3 to 8 of the 2012 Regulations.

[^f00002]: In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

[^f00003]: 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7).

[^f00004]: 1973 c.51. Section 56(1) was amended by article 6(1)(e) of the Treaty of Lisbon (Changes of Terminology) Order 2011 (S.I. 2011/1043).

[^f00005]: See article 2(1) of and Schedule 1 to the European Communities (Designation) Order 1972 (S.I. 1972/1811).

[^f00006]: Section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^f00007]: OJ No L 169, 12.7.1993, p1. This Directive has been amended by Directive 98/79/EC of the European Parliament and of the Council (OJ No L 331, 7.12.1998, p1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No L 313, 13.12.2000, p22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No L 6, 10.1.2002, p50), Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ No L 284, 31.10.2003, p1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No L 247, 21.9.2007, p21).

[^f00008]: Regulation 3 has been amended by S.I. 2006/1928.

[^f00009]: Regulation 44 has been amended by S.I. 2006/1928 and S.I. 2013/532.

[^f00010]: Regulation 24 has been amended by S.I. 2006/1928 and S.I. 2013/532.

[^f00011]: OJ No L 334, 12.12.2008, p.7. This Regulation has been amended by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00012]: OJ No L 22, 9.2.1965, P 369/65. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00013]: OJ No L 15, 17.1.1987, p38. This Directive has been repealed by Council Directive 93/41/EEC, OJ No L 214, 24.8.1993, p40.

[^f00014]: Regulation 45H was inserted by S.I. 2013/1855.

[^f00015]: Regulation 45R was inserted by S.I. 2013/1855.

[^f00016]: Regulation 256J was inserted by S.I.2013/1855.

[^f00017]: Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

[^f00018]: Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

[^f00019]: Article 28 has been substituted by Article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

[^f00020]: Article 29 has been substituted by article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

[^f00021]: 2006 c.46. A relevant amendment was made by S.I. 2015/980.

[^f00022]: S.I. 1995/449; relevant amendments are made by S.I. 2007/803, 2008/530 and 2010/557.

[^f00023]: S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532.

[^f00024]: Regulation 8 was amended by S.I. 2013/1855 and 2593.

[^f00025]: S.I. 2013/532.

[^f00026]: OJ No L 311, 28.11.2001, p67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No L 33, 8.2.2003, p30), Commission Directive 2003/63/EC (OJ No L 159, 27.6.2003, p46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34), Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No L 81, 20.3.2008, p51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No L 168, 30.6.2009, p33), Commission Directive 2009/120/EC (OJ No L 242, 15.9.2009, p3), Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74), Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74) and Directive 2012/26/EU of the European Parliament and of the Council (OJ No L 299, 27.10.2012, p1).

[^f00027]: 1968 c.67.

[^f00028]: S.I. 2004/1031; relevant amending instruments are S.I. 2004/3224, 2005/2754 and 2759, 2006/562, 1928 and 2984, 2007/289 and 3101, 2008/941, 2009/1164, 2010/1882 and 2012/1916.

[^f00029]: OJ No L 334, 12.12.2008, p7. This regulation has been amended by Commission Regulation (EC) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00030]: S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

[^f00031]: OJ No L 262, 14.10.2003, p22.

[^f00032]: OJ No L 147, 9.6.1975, p13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00033]: OJ No L 214, 24.8.1993, p1. This Regulation has been amended by Commission Regulation (EC) No 649/98 (OJ No L 88, 24.3.1998, p7), Council Regulation (EC) No 807/2003 (OJ No L 122, 16.5.2003, p36) and Council Regulation (EC) No 1647/2003 (OJ No L 245, 29.9.2003, p19).

[^f00034]: S.I. 2012/1916.

[^f00035]: Regulation 256A was inserted by S.I. 2013/1855.

[^f00036]: Section 104 has been amended by S.I. 2004/1031, 2006/2407, 2012/1916.

[^f00037]: Relevant amending instrument is S.I. 2012/1916.

[^f00038]: OJ No L 18, 22.1.2000, p1, as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ No L 188, 18.7.2009, p14).

[^f00039]: OJ No L 136, 30.4.2004, p1; relevant amending instruments are Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ No L 87, 31.3.2009, p109), Regulation (EC) No. 470/2009 of the European Parliament and of the Council (OJ No L 152, 16.6.2009, p11), Regulation (EU) No 1235/2010 of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p1) and Corrigendum (OJ L 201, 27.7.2012, p.138).

[^f00040]: Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

[^f00041]: Regulation 256C was inserted by S.I. 2013/1855.

[^f00042]: 2006 c.46.

[^f00043]: Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

[^f00044]: Paragraph 9 of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^f00045]: Copies of the documents can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk.

[^f00046]: S.I. 1971/1267: Part 2 of the Act is applied by article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407.

[^f00047]: Article 11 has been amended by Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34) and Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74).

[^f00048]: OJ No L 152, 16.6.2009, p1.

Editorial notes

[^c23108191]: 1971 c.69; as amended by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). See therefore section 1 of the 1968 Act, as substituted by paragraph 2 of Schedule 34 to the Human Medicines Regulations 2012 (S.I. 2012/1916) (“the 2012 Regulations”) which provides the meaning of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. By virtue of regulation 348 of, and paragraph 36 of Schedule 34 to, the 2012 Regulations, references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence, or for the variation or renewal of such a licence under Part 2 of the 1968 Act, shall have effect as a reference to any application under Parts 3 to 8 of the 2012 Regulations.

[^c23108201]: In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

[^c23108211]: 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7).

[^c23108221]: 1973 c.51. Section 56(1) was amended by article 6(1)(e) of the Treaty of Lisbon (Changes of Terminology) Order 2011 (S.I. 2011/1043).

[^c23108231]: See article 2(1) of and Schedule 1 to the European Communities (Designation) Order 1972 (S.I. 1972/1811).

[^c23108241]: Section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^c23108271]: Regulation 44 has been amended by S.I. 2006/1928 and S.I. 2013/532.

[^c23108281]: Regulation 24 has been amended by S.I. 2006/1928 and S.I. 2013/532.

[^c23108321]: Regulation 45H was inserted by S.I. 2013/1855.

[^c23108331]: Regulation 45R was inserted by S.I. 2013/1855.

[^c23108341]: Regulation 256J was inserted by S.I.2013/1855.

[^c23108351]: Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

[^c23108361]: Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

[^c23108371]: Article 28 has been substituted by Article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

[^c23108381]: Article 29 has been substituted by article 1(26) of Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34).

[^c23108391]: 2006 c.46. A relevant amendment was made by S.I. 2015/980.

[^c23108401]: S.I. 1995/449; relevant amendments are made by S.I. 2007/803, 2008/530 and 2010/557.

[^c23108411]: S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532.

[^c23108421]: Regulation 8 was amended by S.I. 2013/1855 and 2593.

[^c23108431]: S.I. 2013/532.

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