http://www.legislation.gov.uk/uksi/1991/1474/contents/made

The Medicines (Products for Human Use — Fees) Regulations 1991

Food related licences

Community health clinics

Community health services

King's Printer of Acts of Parliament

2017-05-23

MEDICINES

These Regulations make provision for the fees which are to be payable under the Medicines Act 1971 in respect of licences and certificates relating to medicinal products for human use granted under the Medicines Act 1968.

The Medicines (Products for Human Use — Fees) Regulations 1991

Pt IIIA

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.11(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.2(1) (defn of the Applications Regulations)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.3(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.2(01) (defn of radiopharmaceutical)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.3(b)

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.5

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.4

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.6(1)(a)-(c)(i)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.8

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.5

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.9A

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.11(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

regs 10

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.14(4)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.6

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt I para 1 (defn of active ingredient) rev in pt and

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(2)(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt I para 1 (defn of complex application)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(2)(b)(i)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt I para 1 (defn of complex application) paras (o)-(q)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(2)(b)(iii)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt I para 1 (defn of simple application) sub- para (b)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(2)(c)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II para 1 entry l(a)(b) 2-6

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II para 1 entry l(a)(i)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(3)(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II

para 2

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II para 4(1) (defn of primary applicant)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(3)(b)(i)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II

para 4(2)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(3)(b)(ii)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II

para 4(3)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(3)(b)(iii)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II

paras 6(1)(a)

paras 6(1)(b)

7(1)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II

para 7(2)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(3)(c)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt II

para 8

Pt III

para 1(a)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt III

para l(aa)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(4)(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt III

para 1(b)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt III

para 2

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(4)(b)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt III

para 2A

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.7(4)(c)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt III

paras 4

5(a)(b)

6-10

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 1(3)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.8(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 2(a)(i)-(iv)

para 2(a)(b)(i)-(iv)

para 2(a)(c)(i)-(iv)

(d)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 2A(1)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.8(3)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 4(a)-(c)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt I para 1 (defn of limited use drug)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.9(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III para 1 entries 1 -2(f)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III

paras 2(a)-(c)

3(a)(b)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III

para 4(4)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.9(3)(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III

paras 7

8(1)

(2)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.2

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III

para 8(2)(a)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.9(3)(b)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.4

para 2A

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.11(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.5

para 2(1)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.10(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.5

para 2(1A)

The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

reg.10(b)

The Medicines (Products for Human Use — Fees) Regulations 1991

Regulations

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Sch. 6

para. 5

reg. 1(1)

The Medicines (Products for Human Use — Fees) Regulations 1991

Pt 111A

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.4

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.2(01) (defns of blood product change of ownership application immunological product* and radiopharmaceutical)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.3(1)

(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.2(2)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.3(3)

The Medicines (Products for Human Use — Fees) Regulations 1991

regs.6(1)(a)

(b)

regs.6(1)(c)(i)

regs.6(1)(c)(ii)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.12

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.5

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.14(1)

(3)

(4)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.6

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.14(5)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.6

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.16(1)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.7(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

reg.16(1A)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.7(3)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.8(2)(c)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt I

para 1

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt I. para l(n) head (defn of complex application)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.8(2)(a)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt l(n). head (v)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.8(2)(b)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1. Pt II, para 1, Table

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.8(3)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1. Pt II, para 2,

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.8(4)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.1 Pt III

paras l(a)(b)

5(b)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 2

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.9(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

paras 2(a)(i)(ii)

(iii)

paras 2(a)(i)(iv)

paras 2(a)(b)(i)

(ii)

(iii)

(iv)

paras 2(a)(c)(i)

(ii)

paras 2(a)(c)(iii)

(iv)

paras 2(a)(d)

4(a)(b)

(c)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 2(b)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.9(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.2

para 2A

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.9(3)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt I para 1 (defn of

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.10(2)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III para 1.

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Sch

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3 Pt III

para 4(1)

(2)

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.10(3)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.3. Pt IV, para 2

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.10(4)

The Medicines (Products for Human Use — Fees) Regulations 1991

Sch.4

para 2A

The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

reg.11

The Medicines (Products for Human Use — Fees) Regulations 1991

Instrument

The Medicines (Products for Human Use — Fees) Regulations 1995

reg.22

The Medicines (Products for Human Use — Fees) Regulations 1991

PART IGENERAL

1Citation, commencement and scope

2Interpretation

3Fees payable in connection with applications and inspections

PART IICAPITAL FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS

4Applications for licences and certificates

5Inspections in connection with multiple applications for licences

6Applications for certificates by exporters of medicinal products

PART IIICAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS

7Variations of licences and certificates

8Inspections in connection with multiple applications for variations of licences

9Applications for multiple variations

PART IVCAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURERS' LICENCES AND FOR ASSOCIATED INSPECTIONS

10Renewals of clinical trial certificates

11Renewals of certain manufacturers' licences

12Renewals in terms which are not identical to the existing certificate or licence

PART VFEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A LICENCE

13Fees payable

PART VIPERIODIC FEES FOR LICENCES

14Fees payable

PART VIIADMINISTRATION

15Payment of fees to Ministers

16Time for payment of capital fees in connection with applications or inspections

17Time for payment of capital fees — applications made by small companies

18Time for payment of periodic fees

19Adjustment, waiver, reduction or refund of fees

20Suspension of licences or certificates

21Civil proceedings to recover unpaid fees

PART VIIIREVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS

22Revocation and Savings

23Transitional provisions

SCHEDULE 1CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, LICENCES AND CERTIFICATES

PART IINTERPRETATION

1In this Schedule— “active ingredient” means an ingredient of a...

PART IICAPITAL FEES FOR APPLICATIONS FOR LICENCES AND CERTIFICATES

1Product licences

2Notwithstanding the provisions of paragraph 1, in the case of...

3Where a major application is made by a person who...

4(1) In this paragraph— “joint development” means the development by...

5(1) Subject to sub-paragraphs (2) and (3), where an application...

6Manufacturers' licences

7Wholesale dealers' licences

8Clinical trial certificates

PART IIICAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES AND CERTIFICATES

1Product licences

2Where a product licence has been granted in accordance with...

3The fee payable under regulation 7(a) in connection with an...

4The fee payable under regulation 7(a) in connection with an...

5Manufacturers' licences

6The fee payable under regulation 7(a) in connection with an...

7Wholesale dealers' licences

8The fee payable under regulation 7(a) in connection with an...

9Clinical trial certificates

10Where an application is made for a variation to a...

11Identical variations

12Where more than one complex application is made at the...

SCHEDULE 2FEES FOR INSPECTIONS

1Interpretation

2Fees

3(1) Subject to sub-paragraph (2), unless the applicant or, as...

4In the case of an inspection in connection with the...

5The fee payable in respect of an inspection at a...

SCHEDULE 3PERIODIC FEES FOR LICENCES

PART IINTERPRETATION

1In this Schedule “anthroposophic product” means a medicinal product prepared...

PART IICALCULATION OF TURNOVER

1(1) Subject to sub-paragraph (2) below, “turnover” means, for the...

2For the purposes of paragraph 1, manufacturer’s prices are the...

3(1) For the purpose of satisfying the licensing authority for...

PART IIIPERIODIC FEES FOR LICENCES

1Product licences

2Notwithstanding the provisions of paragraph 1, in the case of...

3Subject to paragraph 4 below, where a licence is held...

4(1) The appropriate fee specified in the Table in paragraph...

5Where a product licence relates to any two or more...

6Where a reduced rate fee or a maintenance fee may...

7Manufacturers' licences

8Wholesale dealers' licences

9Where in respect of any relevant licence fee period, the...

PART IVTYPES OF PRODUCT LICENCE FOR WHICH ONLY ONE PERIODIC FEE IS PAYABLE

1Product licences (parallel import) held by the same person each...

2Licences held in respect of homoeopathic or anthroposophic products which...

SCHEDULE 4TIME FOR PAYMENT OF CAPITAL FEES — APPLICATIONS MADE BY SMALL COMPANIES

1In this Schedule a reference to an application is to...

2In connection with a major application for a product licence...

3In connection with an application to which paragraph 5 of...

4In connection with an application for a manufacturer’s licence or...

5In connection with an application for a product licence, manufacturer’s...

SCHEDULE 5WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

1Where the manufacture, assembly, sale or supply of medicinal products...

2(1) Subject to sub-paragraph (2), where an application for the...

3Where an application for the grant of, or a variation...

4Where the same site is inspected at the same time...

5In relation to a product licence (parallel import), the fee...

SCHEDULE 6ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

1(1) Subject to sub-paragraphs (2) and (3) below, where a...

2Where, after payment of any periodic fee payable in accordance...

3Any sums payable to the applicant by way of refund...

1991 No. 1474

MEDICINES

The Medicines (Products for Human Use — Fees) Regulations 1991

Made27th June 1991

Laid before Parliament27th June 1991

Coming into force18th July 1991

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 19711 or, as the case may be, those conferred by the said provisions and now vested in them2 and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations3, hereby make the following Regulations: