Search Legislation

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 and shall come into force on 1st April 1999.

(2) In these Regulations–

“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995(1);

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(2).

Amendment of the Homoeopathic Products Regulations

2.—(1) In regulation 14 of the Homoeopathic Products Regulations(3) (fees for variations of certificates)–

(a)in paragraph (1)(a), for “£75” there shall be substituted “£80”;

(b)in paragraph (1)(b)(i), for “£75” there shall be substituted “£80”;

(c)in paragraph (1)(b)(ii), for “£37.50” there shall be substituted “£40”;

(d)in paragraph (2)(a), for “£150” there shall be substituted “£155”;

(e)in paragraph (2)(b)(i), for “£150” there shall be substituted “£155”; and

(f)in paragraph (2)(b), for heads (ii) and (iii) there shall be substituted the following heads–

(ii)in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £155,

(iii)in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £77.50, and

(iv)in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £38.75..

(2) In the Table in Schedule 2 to the Homoeopathic Products Regulations (fees for applications for the grant of certificates of registration)–

(a)in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)–

(i)for “£90” there shall be substituted “£95”,

(ii)for “£270” there shall be substituted “£285”, and

(iii)for “£450” there shall be substituted “£470”; and

(b)in column (3) (fees for other applications)–

(i)for “£225” there shall be substituted “£235”,

(ii)for “£400” there shall be substituted “£420”, and

(iii)for “£585” there shall be substituted “£615”.

Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

3.  In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995(4) (fees)–

(a)in paragraph (1)(a), for “£1,910” there shall be substituted “£2,005”;

(b)in paragraph (1)(b), for “£5,355” there shall be substituted “£5,620”;

(c)in paragraph (2)(a), for “£475” there shall be substituted “£500”;

(d)in paragraph (2)(b), for “£1,335” there shall be substituted “£1,400”;

(e)in paragraph (3)(a), for “£1,910” there shall be substituted “£2,005”;

(f)in paragraph (3)(b), for “£5,355” there shall be substituted “£5,620”;

(g)in paragraph (4)(a), for “£475” there shall be substituted “£500”;

(h)in paragraph (4)(b), for “£1,335” there shall be substituted “£1,400”;

(i)in paragraph (5)(a), for “£24,500” there shall be substituted “£25,725”; and

(j)in paragraph (5)(b), for “£6,120” there shall be substituted “£6,425”.

Amendment of the General Fees Regulations

4.—(1) In paragraph 6(a) of Part III of Schedule 1 to the General Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates—fees payable in connection with an application for variation of a marketing authorization (parallel import)), after head (vi)(5) there shall be inserted the following head–

(vii)subject to paragraph 6(b) of Schedule 5, a change consequential upon any or any combination of the following–

(aa)a change of ownership of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(bb)a change to the number of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(cc)a change to the name of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(dd)a change to the address of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(ee)a change of ownership of the marketing authorization for the product in the country where the product originates,

(ff)a change to the number of the marketing authorization for the product in the country where the product originates,

(gg)a change to the name of the holder of the marketing authorization for the product in the country where the product originates,

(hh)a change to the address of the holder of the marketing authorization for the product in the country where the product originates,

where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise,.

(2) In each provision of the General Fees Regulations specified in the entries in column (1) (the content of which is described in column (2)) of the Schedule to these Regulations, for the amount specified opposite that provision in column (3) of that Schedule there shall be substituted the amount specified opposite that provision in column (4) of that Schedule.

Revocation

5.  Regulation 2(5) and 3 of the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998(6) are hereby revoked.

Signed by authority of the Secretary of State for Health

Hayman

Parliamentary Under Secretary of State,

Department of Health

25th February 1999

Signed by authority of the Secretary of State for Wales

Jon Owen Jones

Parliamentary Under Secretary of State, Welsh Office

5th March 1999

Sam Galbraith

Parliamentary Under Secretary of State, Scottish Office

25th February 1999

Jeff Rooker

Minister of State, Ministry of Agriculture, Fisheries and Food

25th February 1999

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

L.S.

D.C. Gowdy

Permanent Secretary

1st March 1999.

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on

L.S.

P. Small

Permanent Secretary

24th February 1999.

We consent,

Bob Ainsworth

Jim Dowd

Two of the Lords Commissioners of Her Majesty’s Treasury

3rd March 1999

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources