- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999. Any changes that have already been made by the team appear in the content and are referenced with annotations.
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
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 M1;
“the Homoeopathic Products Regulations" means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M2.
Marginal Citations
M1S.I. 1995/1116; amended by S.I. 1996/683 and 1998/574.
M2S.I. 1994/105; amended by S.I. 1995/541, 1996/482 and 1998/574.
2.—(1) In regulation 14 of the Homoeopathic Products Regulations M3 (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 ”.
Marginal Citations
M3 See regulation 2(3) of S.I. 1998/574.
3. In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 M4 (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 ”.
Marginal Citations
M4S.I. 1995/449; the relevant amending instrument is S.I. 1998/574.
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) M5 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.
Marginal Citations
M5Inserted by regulation 5(4) of S.I. 1996/683.
5. Regulation 2(5) and 3 of the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 M6 are hereby revoked.
Marginal Citations
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
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys