The Medicines (Products for Human Use) (Fees) Regulations 2012

• (3) Where this paragraph applies, the fee payable under regulation 22(1) is—

• (a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 49; and

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

PART 6 — Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations

Regulatory assistance

51

Unless paragraph 52 applies, the fee payable under regulation 26(1) in connection with regulatory assistance provided by the United Kingdom acting as reference Member State where an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization in relation to a medicinal product which has been subject to the procedures specified in regulation 26(2), is—

• (a) £10,465 if the application for renewal relates to a medicinal product which, at the time the United Kingdom marketing authorization was granted, contained a new active ingredient and that renewal is the first renewal in relation to which the United Kingdom is to provide regulatory assistance acting as reference Member State; or

• (b) £807 in any other case.

Regulatory assistance – same manufacturer

52

• (1) This paragraph applies if more than one application falling within regulation 26(1) 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, therapeutic indications and Periodic Safety Update Reports, and the United Kingdom marketing authorizations for those products have the same date for renewal.

• (2) The fee payable under regulation 26(1) for applications to which sub-paragraph (1) applies is—

• (a) if the applications fall within paragraph 51(a)—

• (i) £10,465 for the first application considered by the licensing authority; and

• (ii) £807 for each other application;

• (b) if the applications fall within paragraph 51(b)—

• (i) £807 for the first application considered by the licensing authority; and

• (ii) £405 for each other application.

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) £2,583, if the time taken to make the inspection is not more than 1 day; and

• (b) thereafter, £1,292 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) £967 if the time taken to make the inspection is not more than 3 hours;

• (b) £1,571 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 £1,571.

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 pursuant to Article 111(1)(a) of the 2001 Directive, is—

• (a) £967 if the time taken to make the inspection is not more than 3 hours;

• (b) £1,571 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 £1,571.

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, variation or renewal 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, £1,882; and

• (b) if the time taken is 1 day or more, £1,882 for the first day and £941 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) £724 if the time taken to make the inspection is not more than 3 hours;

• (b) £1,330 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 £1,330.

Wholesale dealer’s licences: inspection of short duration

7

• (1) Sub-paragraph (4) 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 falling within a description or class specified in an Order made under section 51(1) (general sale lists) of the Act;

• (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 £941.

Office-based inspections

8

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 £1,812 per day;

• (b) good distribution practice, is £1,317 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; or of 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; and in respect of which an application for a marketing authorization was made before the determination of the application for the marketing authorization 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) of a description or falling within a class specified in an Order made under section 51(1) (general sale lists) of the Act;

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

• “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; or in 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; and in relation to a prescription only product, where the authorization holder has notified the licensing authority that the medicinal product to which the marketing authorization relates, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; or in 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 authorization (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) which is neither a prescription only medicine nor a general sale list medicine;

• “prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic product, a new active substance or a derivative of a new active substance) of a description or falling within a class specified in an Order made under section 58(1) (medicinal products on prescription only) of the Act;

• “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 authorization relates that are sold or supplied in the United Kingdom by the holder of that authorization 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 authorization holder to wholesalers or to distributors or assemblers named in the marketing authorization, which that holder has manufactured or obtained from the manufacturer, the prices charged for the supply;

• (b) for products sold or supplied by the authorization holder to retailers, which that holder has manufactured or obtained from the manufacturer, the prices which, in the opinion of the licensing authority, the authorization 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 authorization holder which that holder has neither manufactured nor obtained from the manufacturer, the price which he 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 authorization holder.

PART 3 — Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations

5

Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(3) in connection with the holding of a marketing authorization 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.

Column 1 Type of Medicinal Product	Column 1 Type of Medicinal Product	Column 1 Type of Medicinal Product	Column 1 Type of Medicinal Product	Column 2 Fee payable
1. New Active Substance	1. New Active Substance	1. New Active Substance	1. New Active Substance	£23,025
2. Parallel Import	2. Parallel Import	2. Parallel Import	2. Parallel Import	£300
3. Others	3. Others	3. Others	3. Others
	(a)	Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989	Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989	£9,481
	(b)	Prescription Only Medicine	Prescription Only Medicine
		(i)	Standard Fee	£2,371
		(ii)	Reduced Rate Fee	£1,183
		(iii)	Lower Fee	£300
	(c)	Pharmacy	Pharmacy	£300
	(d)	General Sale List	General Sale List	£300
	(e)	Herbal remedy	Herbal remedy	£75
	(f)	Traditional herbal registrations	Traditional herbal registrations	£75
	(g)	National homoeopathic product	National homoeopathic product	£75
	(h)	Homoeopathic or anthroposophic product which is the subject of a licence of right	Homoeopathic or anthroposophic product which is the subject of a licence of right	£75

Marketing authorization: where Part 2 of the Act applies

6

In the case of an article or substance to which Part II of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971[^f00053], the fee payable under regulation 33(3) in connection with the holding of a marketing authorization or licence is £300.

Marketing authorization: derivatives

7

Unless paragraph 8 applies, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 33(3) is—

• (a) £9,481 where the medicinal product to which the authorization relates has a different route of administration from that of the new active substance; or

• (b) £6,400 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 authorization 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 authorization is granted.

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

• (a) for the five relevant fee periods following the fee period during which the marketing authorization is granted is the fee specified at entry 1 of the table set out in paragraph 5, where the first authorization 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 authorization 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 authorization 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 authorization 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 authorization 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 33(3) 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 authorization 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 authorization is held by the authorization holder.

Manufacturer’s licences or manufacturing authorisations

11

• (1) Unless sub-paragraph (3) applies, the fee payable under regulation 33(3) in connection with the holding of a manufacturer’s licence is £457.

• (2) The fee payable under regulation 33(3) in connection with the holding of a manufacturing authorisation is £457.

• (3) The fee payable under regulation 33(3) in connection with the holding of a manufacturer’s licence which relates to the import of exempt imported 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 33(3) in connection with the holding of a wholesale dealer’s licence is £281.

• (2) The fee payable under regulation 33(3) is £168 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

• (c) relates to general sale list medicines only.

• (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 authorization” and “authorization 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: exempt imported products

14

The fee payable under regulation 33(3) in connection with the holding of a wholesale dealer’s licence which relates to exempt imported products 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 exempt imported products

15

• (1) The additional amount referred to in paragraph 11(3) and 14 in relation to any fee period shall be the fee specified in the entry in column 2 of the following table corresponding to the estimated number of special import notices for that fee period specified in column 1.

Column 1 Number of special import notices	Column 2 Additional amount
1 to 20	£126
21 to 100	£505
101 to 1,000	£2,020
1,001 to 5,000	£10,100
5,001 to 20,000	£25,250
20,001 to 50,000	£50,500
50,001 to 100,000	£101,000
100,001 or more	£151,500

• (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.

Clinical trial authorisations

16

The fee payable under regulation 34(2) in connection with the holding of a clinical trial authorisation is £342.

Traditional herbal registrations

17

The fee payable under regulation 33(3) in connection with the holding of a traditional herbal registration is £75.

PART 4 — Types of Marketing Authorization 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 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 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.	£172	£425
2	An application in respect of a product which is either—	An application in respect of a product which is either—	£517	£761
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation.
3	A mutual recognition procedure incoming application.	A mutual recognition procedure incoming application.	£542	£690
4	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	£310	£405
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.	£465	£608
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.	£930	£1,217
7	Any other application.	Any other application.	£854	£1,118

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 authorization for which the fee payable is that specified in entry 1(f) 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 authorization, 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 16 in connection with an application—

• (a) to which paragraph 34(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 pursuant to 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 34(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 pursuant to 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 18(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 authorization, 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 45(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 authorization 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 authorization 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 a committee established under section 4 (establishment of committees) of the Act[^f00054] or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act[^f00055],

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 authorization is a reclassification variation application (not being an application falling within paragraph 37 of Part 4 of Schedule 2); and

• (b) the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act,

50% of the fee payable under paragraph 35 of Schedule 2 and entry 1(c)(i) of Table 1 referred to in that paragraph or of the fee payable under paragraph 48(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 39(1)(a) of Part 4 of Schedule 2; and

• (b) the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act,

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 a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act where—

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

• (b) the committee or the Commission are consulted only by virtue of, or in accordance with, paragraph 5 of Schedule 2 to the Marketing Authorisation Regulations (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations).

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 8 of the Herbal 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 18(1) shall be refunded or, if it has not yet been paid, shall be waived.

Withdrawal of application in relation to marketing authorization, 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 authorization 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), 18(1) or 19(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 section 44(1) (provision of information to licensing authority) of the Act[^f00056] or in pursuance of a European Union provision which applies to applications for marketing authorizations or traditional herbal registrations, 25%.

• (2) If an application for the grant of, or for a variation to, a marketing authorization 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 a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act, no refund or waiver of the fee payable under regulation 12(1)(a), 18(1) or 19(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 41 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 Board 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 or manufacturer’s licence

6

Where an application for the grant of, or for a variation to, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 12(1)(a) or 18(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 authorization, traditional herbal registration or clinical trial authorisation

7

Where an application for the grant of a marketing authorization 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 authorization granted pursuant to 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 authorization shown on the licence can be changed.

Surrender of marketing authorization at same time as a variation application

9

• (1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorization in the circumstances set out in paragraph 8(3) of Part 3 of Schedule 4, the fee payable under regulation 18(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 46 and 47 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 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 4 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 authorization.

• (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 authorization.

• (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[^f00057];

• (b) “paediatric use marketing authorization” means a marketing authorization 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[^f00058] 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, REDUCTION OR REFUND OF PERIODIC FEES

Refund on surrender or revocation of authorization, registration or licence

1

Where, after payment of a periodic fee payable in accordance with the provisions of these Regulations, the marketing authorization, 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 authorization, 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 authorization, traditional herbal registration or licence up to the date of such surrender or revocation.

Adjustment and refund: licences relating to exempt imported 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 exempt imported 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

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.

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — Department of Health — 20th February 2012

Edwin Poots — Minister for Health, Social Services and Public Safety — 23rd February 2012

Michael Fabricant — Brooks Newmark — Two of the Lords Commissioners of Her Majesty’s Treasury — 22nd February 2012

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations revoke and re-enact in consolidated form, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2010 (“the 2010 Regulations”). They make amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Regulations”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”).

These Regulations make provision for the fees payable under the Medicines Act 1971 and other fees payable in respect of EU obligations relating to marketing authorizations, licences and certificates in respect of medicinal products for human use.

The fees prescribed in the Regulations are revised on an annual basis and based on an assessment of the costs associated with a range of licensing requirements and functions. The fee amounts specified in these Regulations are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 21st December 2011. A summary of the consultation responses is published on the MHRA’s website (www.mhra.gov.uk).

In general these Regulations provide for fee reductions in some areas, simplification measures and amendments to facilitate better administrative practice.

Parts 2 to 9 and 11 and 12 and Schedules 2 and 3 provide for capital fees to be payable in connection with pre-application meetings; applications for, or variations to, marketing authorizations, manufacturer’s licences, wholesale dealer’s licences, clinical trial authorisations, traditional herbal registrations and certificates permitting the export of medicinal products; assistance in obtaining or renewing marketing authorizations in other EEA States; the assessment of labels and leaflets; renewals of certain manufacturer’s licences; and inspections. Most of the fees were previously provided for by the 2010 Regulations (as amended).

However, these Regulations also—

• (a) provide a 10% reduction in fees for applications under decentralised procedure where the UK is the Reference Member State;

• (b) simplify the fee structure for capital fees payable for authorizations, licenses, registrations and certificates so that there is no price differential between applications made electronically and others.

Part 10 and Schedule 4 provide for periodic fees in connection with authorizations, registrations and licenses. Schedule 4 includes amendments to—

• (a) clarify how the total value of products sold or supplied is to be determined;

• (b) introduce a “lower fee” in respect of periodic fees for prescription only medicines;

• (c) replace the 3 types of periodic fees previously payable in connection with pharmacy or general sale medicines with a single fee set at the same level as the lower fee for prescription only medicines;

• (d) replace the 3 types of periodic fees for parallel import licenses with a single fee; and

• (e) provide a single fee rate for herbal, homoeopathic and traditional herbal medicinal products licenses.

Part 13 and Schedule 5 provides for fees in relation to homoeopathic medicinal products. In particular, the fee provisions from the Homoeopathic Regulations have been consolidated into these Regulations.

Part 14 and Schedule 6, 7 and 8 deal with the time for payment and waiver or refund of both capital and periodic fees in specified circumstances. These Regulations make provision for payments to be made in advance of any application or the fee becoming due to the licensing authority.

Part 15 of these Regulations make consequential amendments to—

• (a) the Clinical Trials Regulations to update cross-references to these Regulations; and

• (b) the Homoeopathic Regulations to remove some obsolete definitions from those regulations.

Part 16 of these Regulations revokes and makes savings provisions in relation to—

• (a) earlier Regulations relating to fees for medicinal products for human use; and

• (b) parts of the Homoeopathic Regulations.

An impact assessment of the effect that this instrument will have on the costs of business is available from the MHRA at 151 Buckingham Palace Road, London SW1W 9SZ and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk

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(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 and by regulation 44 of, and Schedule 8 to, S.I. 2006/2407. Section 1(1) of the 1968 Act contains a definition of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) (“the 1994 Regulations”), by virtue of which the 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 include reference to an application for a marketing authorization under the 1994 Regulations or for the variation or renewal of such an authorization.

[^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.

[^f00004]: 1973 c.51.

[^f00005]: S.I. 1972/1811.

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

[^f00007]: Amendments have been made to section 51 by S.I. 2006/2407.

[^f00008]: OJ No. L 169, 12.7.1993, p.1. 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, p.1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L 313, 13.12.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L 6, 10.1.2002, p.50), Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L 284, 31.10.2003, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 247, 21.9.2007, p.21).

[^f00009]: Regulation 3 has been amended by S.I. 2006/1928.

[^f00010]: Section 50 has been amended by S.I. 2004/1031.

[^f00011]: Regulation 4 has been amended by S.I. 2001/795, 2002/236, 2005/2759, 2006/1952.

[^f00012]: Section 30 was substituted by S.I. 2005/2789.

[^f00013]: Regulation 44 has been amended by S.I. 2006/1928, 2010/551.

[^f00014]: Regulation 24 has been amended by S.I. 2006/1928, 2010/551.

[^f00015]: S.I. 1971/1450, to which amendments which are not relevant to these Regulations have been made.

[^f00016]: OJ No. L 22, 9.2.1965, p.369. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00017]: OJ No. L 15, 17.1.1987, p.38. This Directive has been repealed by Council Directive 93/41/EEC, OJ No. L 214, 24.8.1993, p.40.

[^f00018]: Regulation 19 has been amended by S.I. 2005/2754, 2010/1882.

[^f00019]: Sections 21 and 22 were substituted by regulation 8 of, and paragraphs 2 and 3 of Schedule 1 to, S.I. 2005/1094.

[^f00020]: Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.

[^f00021]: Paragraph 4 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.

[^f00022]: Schedule 2 was substituted by regulation 9 of, and paragraph 4 of Schedule 2 to, S.I. 2005/1094.

[^f00023]: Schedule 5 was inserted by regulation 20 of S.I. 2005/2753.

[^f00024]: 2006 c.46. A relevant amendment was made by S.I. 2008/393.

[^f00025]: S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928, 2010/551.

[^f00026]: The definition of “administrative variation” was inserted by S.I. 1998/574. The definitions of “concerned member state” and “set of applications” were inserted by S.I. 2005/2753. The definition of “standard variation” was inserted by S.I. 1998/574 and amended by S.I. 2001/795.

[^f00027]: S.I. 2010/551.

[^f00028]: Paragraph (4) was inserted by S.I. 1996/482.

[^f00029]: Regulation 13 was amended by S.I. 2005/2753. Regulation 14 was substituted by S.I. 1998/574 and amended by S.I. 1999/566, 2010/551. Regulation 15 was amended by S.I. 2010/551. Regulation 15A was inserted by S.I. 2009/389. Regulation 16 was amended by S.I. 2005/2573. Schedule 2 was substituted by S.I. 1996/482 and amended by S.I. 2005/2753, 2006/2125, 2010/551. Schedule 2A was inserted by S.I. 2005/2753 and amended by S.I. 2010/551.

[^f00030]: OJ No. L 311, 28.11.2001, p.67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No. L 33, 8.2.2003, p.30), Commission Directive 2003/63/EC (OJ No. L 159, 27.6.2003, p.46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.34), Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No. L 81, 20.3.2008, p.51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No. L 168, 30.6.2009, p.33) and Commission Directive 2009/120/EC (OJ No. L 242, 15.9.2009, p.3), Directive 2010/84/EU of the European Parliament and of the Council (OJ No. L 348, 31.12.2010, p.74), Directive 2011/62/EU of the European Parliament and of the Council (OJ No. L 174, 1.7.2011, p.74).

[^f00031]: 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 and 2009/1164.

[^f00032]: S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

[^f00033]: OJ No. L 214, 24.8.1993. This Regulation has been replaced by Regulation (EC) No. 726/2004.

[^f00034]: OJ No. L 262, 14.10.2003, p.22.

[^f00035]: OJ No. L 147, 9.6.1975, p.13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^f00036]: OJ No. L 334, 12.12.2008, p.7.

[^f00037]: S.I. 2005/2750, as amended by S.I. 2006/914.

[^f00038]: S.I. 1994/105; relevant amending instruments are S.I. 1994/899, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 254, 2003/625 and 2321, 2005/2753, 2006/2125 and 2407, 2007/803 and 2009/389.

[^f00039]: S.I. 1994/3144; relevant amending instruments are S.I. 1996/1499, 1998/3105, 2000/292, 2001/795, 2002/236 and 542, 2003/1618, 2317 and 2321, 2004/856 (as regards England), 1016 (as regards Wales), 1031, 2290 and 3224, 2005/50, 768, 1094, 1520, 1710, 2754 and 2759, 2006/562 (as regards England), 914, 1952 and 2407, 2007/289, 2008/3097 and 2009/1164, 2820, 3063 and 3222.

[^f00040]: Amendments have been made to these sections by S.I. 2004/1031 and 2006/2407.

[^f00041]: OJ No. L 18, 22.1.2000, p.1, as amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L 188, 18.7.2009, p.14).

[^f00042]: Repeals and amendments to section 7 have been made by S.I. 1977/1050, 1983/1724, 1992/604, 1994/276, 2004/1031, 2005/50 and 2753 and 2006/2407.

[^f00043]: OJ No. L 136, 30.4.2004, p.1; relevant amending instruments are Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Regulation (EC) No. 219/2009 of the European Parliament and of the Council (OJ No. L 87, 31.3.2009, p.109) and Regulation (EC) No. 470/2009 of the European Parliament and of the Council (OJ No. L 168, 16.6.2009, p.11).

[^f00044]: S.I. 2005/2789.

[^f00045]: Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

[^f00046]: 2006 c.46.

[^f00047]: S.I. 1971/1450 to which there are no relevant amendments.

[^f00048]: Section 51(1) has been amended by S.I. 2006/2407.

[^f00049]: OJ No. L 121, 1.5.2001, p.34. This Directive has been amended by Regulation (EC) No. 1901/2006 (OJ No. L 378, 27.12.2006, p.1), to which amendments which are not relevant to these Regulations have been made.

[^f00050]: See Article 1 of the Regulation.

[^f00051]: A copy of the guidance 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.

[^f00052]: 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.

[^f00053]: S.I. 1971/1267; Part II 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.

[^f00054]: Amendments and substitutions to section 4 have been made by S.I. 2004/1031, 2005/1094 and 2754 and 2006/2407.

[^f00055]: Section 2A was inserted by S.I. 2005/1094.

[^f00056]: Section 44 has been amended by S.I. 2005/1094, 2006/2407.

[^f00057]: Article 11 has been amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p.34).

[^f00058]: OJ L 152, 16.6.2009, p.1.