techiaith/legislation-gov-uk_en-cy huggingface dataset:
Part 4 deals with co-operation between a number of listed health care bodies and other organisations (regulation 22), and in particular, contains detailed arrangements with regards to the disclosure of information between the bodies that are required, by the Regulations, to co-operate with each other in connection with the identification of cases where action may need to be taken against individuals (regulations 24 to 27). There are record keeping requirements (regulation 28), and duties with regard to occurrence reports, which are quarterly statements that accountable officers must make about details of concerns that their designated body has (regulation 29). Accountable officers have duties to take action with regard to concerns that they have (regulation 30), and persons acting in good faith under the arrangements for sharing information under this Part are protected from damages claims (regulation 31).
Mae Rhan 4 yn ymwneud â chydweithredu rhwng nifer o gyrff gofal iechyd rhestredig a chyrff eraill (rheoliad 22), ac yn benodol, mae'n cynnwys trefniadau manwl o ran datgelu gwybodaeth rhwng y cyrff y mae'n ofynnol iddynt, drwy Reoliadau, gydweithredu â'i gilydd mewn cysylltiad â chanfod achosion lle y gall fod angen cymryd camau yn erbyn unigolion (rheoliadau 24 i 27). Mae gofynion ar gadw cofnodion (rheoliad 28), a dyletswyddau o ran adroddiadau ar ddigwyddiadau, sy'n ddatganiadau chwarterol y mae'n rhaid i swyddogion atebol eu gwneud am fanylion pryderon sydd gan eu corff dynodedig (rheoliad 29). Mae gan swyddogion atebol ddyletswyddau i gymryd camau o ran pryderon sydd ganddynt (rheoliad 30), ac amddiffynnir personau sy'n gweithredu'n ddidwyll o dan y trefniadau ar gyfer rhannu gwybodaeth o dan y Rhan hon rhag hawliadau am iawndal (rheoliad 31).
2006 c. 28. The powers of the National Assembly for Wales under sections 17, 18, 20 and 79 of the Health Act 2006 were transferred to the Welsh Ministers in accordance with paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c. 32).
2006 p.28. Trosglwyddwyd pwerau Cynulliad Cenedlaethol Cymru o dan adrannau 17, 18, 20 a 79 o Ddeddf Iechyd 2006 i Weinidogion Cymru yn unol â paragraff 30 o Atodlen 11 i Ddeddf Llywodraeth Cymru 2006 (p.32).
The Care and Social Services Inspectorate Wales ("CSSIW") is an operationally distinct division of the Department of Public Services and Performance within the Welsh Assembly Government.
1970 p.42; diwygiwyd gan Ddeddf Llywodraeth Leol 1972 (p.70), adran 195 (3), a Deddf Llywodraeth Leol (Cymru) 1994 (p.19), Atodlen 10, paragraff 7.
The Healthcare Inspectorate Wales ("HIW") is an operationally distinct division of the Department of Public Services and Performance within the Welsh Assembly Government.
1968 p.67. Mae diwygiadau i adran 132 nad ydynt yn berthnasol i'r diffiniad o "busnes manwerthu fferyllol".
Established by S.I. 1998/678.
Sefydlwyd gan O.S. 1998/678.
S.I. 2001/3998; the relevant amending instrument is 2003/1432.
O.S. 2001/3998; yr offeryn diwygio perthnasol yw 2003/1432.
The expression " relevant individual " is defined in section 17 (8) (b) of the Health Act 2006
Diffinnir yr ymadrodd " relevant individual " yn adran 17 (8) (b) o Ddeddf Iechyd 2006.
2008 No. 3266 (W.288)
2008 Rhif 3266 (Cy.288)
12 January 2009
12 Ionawr 2009
The Welsh Ministers have been designated (1) for the purposes of section 2 (2) of the European Communities Act 1972 (2) in relation to measures in the veterinary and phytosanitary fields for the protection of public health.
Mae Gweinidogion Cymru wedi'u dynodi (1) at ddibenion adran 2 (2) o Ddeddf y Cymunedau Ewropeaidd 1972 (2) o ran mesurau yn y meysydd milfeddygol a ffotoiechydol ar gyfer amddiffyn iechyd y cyhoedd.
The Welsh Ministers make the following Regulations under the powers conferred by section 2 (2) of the European Communities Act 1972.
Mae Gweinidogion Cymru yn gwneud y Rheoliadau canlynol o dan y pwerau a roddir gan adran 2 (2) o Ddeddf y Cymunedau Ewropeaidd 1972.
The Welsh Ministers have carried out the consultation required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (3).
Mae Gweinidogion Cymru wedi cynnal yr ymgynghoriad sy'n ofynnol gan Erthygl 9 o Reoliad (EC) Rhif 178/2002 o Senedd Ewrop â'r Cyngor yn gosod egwyddorion a gofynion cyffredinol cyfraith bwyd, yn sefydlu Awdurdod Diogelwch Bwyd Ewrop ac yn gosod gweithdrefnau mewn perthynas â diogelwch bwyd (3).
Amendment of regulation 2 (interpretation)
Diwygio rheoliad 2 (dehongli)
3. In regulation 2 (1) in the definition of "Community TSE Regulation," after sub-paragraph (b), insert -
3. Yn rheoliad 2 (1) yn y diffiniad o "Rheoliad TSE y Gymuned", ar ôl is-baragraff (b), mewnosoder -
" (c) Commission Decision 2008/908/EC authorising certain Member States to review their annual BSE monitoring programme (5); ."
" (c) Penderfyniad y Comisiwn 2008/908/EC yn awdurdodi Aelod-wladwriaethau penodol i adolygu eu rhaglen fonitro BSE flynyddol (5); ".
Amendment of regulation 20 (enforcement)
Diwygio rheoliad 20 (gorfodi)
4. In regulation 20 for paragraph (2) substitute -
4. Yn rheoliad 20 yn lle paragraff (2) rhodder -
" (2) The Food Standards Agency enforces in slaughterhouses and cutting plants: -
" (2) Yr Asiantaeth Safonau Bwyd sy'n gorfodi mewn lladd-dai a safleoedd torri: -
Schedule 7; and
Atodlen 7; a
of Schedule 8. ."
o Atodlen 8. ".
5. In schedule 2 -
5. Yn Atodlen 2 -
for paragraph 1 substitute -
yn lle paragraff 1 rhodder -
"Notification of the body of a goat for the purposes of monitoring under Article 6 of the Community TSE Regulation
"Hysbysiad o gorff gafr at ddibenion monitro o dan Erthygl 6 o Reoliad TSE y Gymuned
1. - (1) For the purpose of monitoring under Article 6 of the Community TSE Regulation, a person who has in their possession, or under their control, the body of a goat aged 18 months or over at death, must -
1. - (1) At ddibenion monitro o dan Erthygl 6 o Reoliad TSE y Gymuned, rhaid i berson sydd â chorff gafr 18 mis oed neu drosodd pan fu farw yn ei feddiant, neu dan ei reolaeth, -
within 24 hours from the time when the animal died or was killed or the body came into their possession or under their control notify the Welsh Ministers; and
o fewn 24 awr o'r amser pan fu'r anifail farw neu pan gafodd ei ladd neu pan ddaeth y corff i'w feddiant neu dan ei reolaeth hysbysu Gweinidogion Cymru; a
where the Welsh Ministers direct, detain it until it has been collected by or on behalf of the Welsh Ministers,
os yw Gweinidogion Cymru yn cyfarwyddo felly, ei gadw hyd nes ei fod yn cael ei gasglu gan Weinidogion Cymru, neu ar eu rhan,
This paragraph does not apply in relation to goats slaughtered for human consumption or killed in accordance with Schedule 4.
Nid yw'r paragraff hwn yn gymwys mewn perthynas â geifr a gigyddwyd i'w bwyta gan bobl neu a gafodd eu lladd yn unol ag Atodlen 4.
1A. - (1) For the purpose of monitoring under Article 6 of the Community TSE Regulation, a person who has in their possession or under their control the body of a bovine animal that must be tested in accordance with point 3 (1) of Part I of Chapter A of Annex III to that Regulation must, unless directed otherwise by the Welsh Ministers, within 24 hours either -
1A. - (1) At ddibenion monitro o dan Erthygl 6 o Reoliad TSE y Gymuned, rhaid i berson sydd â chorff anifail buchol yn ei feddiant, neu dan ei reolaeth, y mae'n rhaid ei brofi yn unol â phwynt 3 (1) o Ran 1 o Bennod A o Atodiad III i'r Rheoliad hwnnw, onis cyfarwyddir yn wahanol gan Weinidogion Cymru, o fewn 24 awr, naill ai -
make arrangements with another person for that person to collect it and to deliver it to an approved sampling site within 72 hours; or
gwneud trefniadau gyda pherson arall i'r person hwnnw ei gasglu a'i ddanfon i safle samplu a gymeradwywyd o fewn 72 o oriau; neu
identify an approved sampling site that will carry out the sampling and deliver the animal to that site so as to arrive at the site within 72 hours,
dynodi safle samplu a fydd yn gwneud y gwaith samplu a danfon yr anifail i'r safle hwnnw fel y bydd yn cyrraedd y safle o fewn 72 o oriau
The periods of 24 and 72 hours referred to in sub-paragraph (1) run from the time when the animal died or was killed or came into the possession or under the control of the person to whom the requirements of that sub-paragraph apply.
Mae'r cyfnodau o 24 awr a 72 awr y cyfeirir atynt yn is-baragraff (1) yn cychwyn o'r amser pan fu'r anifail farw neu pan gafodd ei ladd neu pan ddaeth i feddiant neu dan reolaeth y person y mae gofynion yr is-baragraff hwnnw yn gymwys iddo.
Persons collecting and delivering
Personau sy'n casglu ac yn danfon
1B. A person with whom arrangements are made under paragraph 1A for the delivery of a body to an approved sampling site must, unless directed otherwise by the Welsh Ministers, within 48 hours of the time when the body comes into their possession or under their control -
1B. Rhaid i berson y gwneir trefniadau gydag ef o dan baragraff 1A i ddanfon corff i safle samplu, onis cyfarwyddir yn wahanol gan Weinidogion Cymru, o fewn 48 o oriau i'r amser pan ddaw'r corff i feddiant neu dan reolaeth y person hwnnw -
identify an approved sampling site that will carry out the sampling; and
dynodi safle samplu a fydd yn gwneud y gwaith samplu; a
ensure it is delivered to that site,
sicrhau fod y corff yn cael ei ddanfon i'r safle hwnnw,
Destruction without sampling
Difa heb samplu
1C. Any person who destroys the body of a bovine animal to which paragraph 1A applies before it has undergone sampling at an approved sampling site, except in accordance with a direction of the Welsh Ministers, commits an offence.
1C. Mae unrhyw berson sy'n difa corff anifail buchol y mae paragraff 1A yn gymwys iddo cyn iddo gael ei samplu mewn safle samplu a gymeradwywyd, ac eithrio yn unol â chyfarwyddyd Gweinidogion Cymru, yn cyflawni tramgwydd.
1D. An approved sampling site to which the body of a bovine animal has been sent for sampling in accordance with this Part must retain it in accordance with point 6 (3) of Annex III to the Community TSE Regulation, and failure to do so is an offence; and
1CH. Mae'n rhaid i safle samplu a gymeradwywyd yr anfonwyd corff buchol iddo i'w samplu yn unol â'r Rhan hon gadw'r sampl yn unol â phwynt 6 (3) o Atodiad III i Reoliad TSE y Gymuned, ac mae peidio â gwneud hynny yn dramgwydd; a
" Approved sampling sites
" Safleoedd samplu a gymeradwywyd
4A. - (1) The Welsh Ministers must on application approve a sampling site to sample animals to which paragraph 1A applies if satisfied that the sampling site has adequate control procedures to carry out the sampling.
4A. - (1) Ar dderbyn cais mae'n rhaid i Weinidogion Cymru gymeradwyo safle samplu i samplu anifeiliaid y mae paragraff 1A yn gymwys iddynt os ydynt wedi'u bodloni fod gan y safle samplu weithdrefnau rheoli digonol i wneud y samplu.
Amendment of Schedule 3
Diwygio Atodlen 3
6. In Schedule 3 paragraph 5, sub-paragraph (3) for "sub-paragraph 2 (b) (ii) " substitute "sub-paragraph 1 (b) (ii) ."
6. Yn Atodlen 3 paragraff 5, is-baragraff (3) yn lle "is-baragraff 2 (b) (ii) " rhodder "is-baragraff 1 (b) (ii) ".
Substitution of Schedule 8
Disodli Atodlen 8
7. For Schedule 8 substitute the replacement schedule set out in the Schedule to these Regulations.
7. Yn lle Atodlen 8 rhodder yr atodlen newydd a osodir yn yr Atodlen i'r Rheoliadau hyn.
Amendment to regulation 12 (appointment of inspectors)
Diwygio rheoliad 12 (penodi arolygwyr)
8. In regulation 12 replace "Schedule 7" with "Schedules 7 and 8."
8. Yn rheoliad 12 yn lle "Atodlen 7" rhodder "Atodlenni 7 ac 8".
SCHEDULE Replacement Schedule 8
YR ATODLEN Yr Atodlen 8 Newydd
" SCHEDULE 8 Restrictions on placing on the market and export
" ATODLEN 8 Cyfyngiadau ar osod ar y farchnad ac allforio
Placing on the market or export to third countries of bovine products
Gosod cynhyrchion buchol ar y farchnad neu eu hallforio i drydydd gwledydd
1.A. - (1) It is an offence for any person to place on the market or to export (or offer to export) to third countries any products consisting of or incorporating any material (other than milk) derived from a bovine animal born or reared within the United Kingdom before 1 August 1996.
1.A. - (1) Mae'n dramgwydd i unrhyw berson osod ar y farchnad neu allforio (neu gynnig allforio) i drydydd gwledydd unrhyw gynhyrchion sy'n cynnwys neu sydd wedi'u cyfansoddi o unrhyw ddeunydd (ac eithrio llaeth) sy'n tarddu o anifail buchol a anwyd neu a fagwyd yn y Deyrnas Unedig cyn 1 Awst 1996.
For the purpose of enforcing the provisions of this paragraph the powers of an inspector may also be exercised by a person appointed as such in relation to a hide market or tannery by the Agriculture and Horticulture Development Board.
At y diben o orfodi darpariaethau'r paragraff hwn caiff person a benodwyd yn arolygydd mewn perthynas â marchnad grwyn neu danerdy gan y Bwrdd Datblygu Amaethyddiaeth a Garddwriaeth hefyd arfer pwerau arolygydd.
Placing on the market or export to third countries of bovine animals
Rhoi anifeiliaid buchol ar y farchnad neu eu hallforio i drydydd gwledydd
The prohibition in sub-paragraph (1) does not apply to the placing on the market of such animals for sale or supply to any person in the United Kingdom.
Nid yw'r gwaharddiad yn is-baragraff (1) yn gymwys i osod anifeiliaid o'r fath ar y farchnad i'w gwerthu neu i'w cyflenwi i unrhyw berson yn y Deyrnas Unedig. "
2. Subject to point 10 (2) of Annex V to the Community TSE Regulation, it is an offence for any person to export (or offer to export) a head or un-split carcase containing specified risk material to another
2. Yn ddarostyngedig i bwynt 10 (2) o Atodiad V i Reoliad TSE y Gymuned, mae'n dramgwydd i unrhyw berson allforio (neu gynnig allforio) unrhyw ben neu garcas heb ei hollti sy'n cynnwys deunydd risg
member State in the absence of an agreement of the kind specified in point 10 (1) of that Annex.
penodedig i Aelod-wladwriaeth arall, yn absenoldeb unrhyw gytundeb o'r math a bennir ym mhwynt 10 (1) o'r Atodiad hwnnw.
Appointment of Food Standards Agency inspectors
Penodi arolygwyr yr Asiantaeth Safonau Bwyd
4. For the purposes of paragraphs 1A, 2 and 3 of this Schedule, within a slaughterhouse or cutting plant an inspector is any person appointed for the purpose by the Food Standards Agency. "
4. Er dibynnion paragraffau 1A, 2 a 3 o'r Atodlen hon, o fewn lladd-dy neu safle torri, arolygydd yw person a aphwyntwyd i'r dibyn hynny gan yr Asiantaeth Safonau Bwyd.
(This note is not part of these Regulations)
(Nid yw'r nodyn hwn yn rhan o'r Rheoliadau)
Regulation 2 (interpretation) is amended to include a reference to Commission Decision 2008/908/EC authorising certain Member States to review their annual B.S.E monitoring programme (OJ No L 327, 5.12.2008, p.24) in the definition of "Community TSE Regulation" (regulation 3).
Diwygir Rheoliad 2 (dehongli) i gynnwys cyfeiriad at Benderfyniad y Comisiwn 2008/908/EC sy'n awdurdodi Aelod-wladwriaethau penodol i adolygu eu rhaglen fonitro B.S.E. flynyddol (OJ Rhif L 327, 5.12.2008, t.24) yn y diffiniad o "Rheoliad TSE y Gymuned" (rheoliad 3).
Regulation 20 (enforcement) is amended to make the Food Standards Agency the enforcement authority in respect of offences of placing products on the market (regulation 4).
Diwygir Rheoliad 20 (gorfodi) er mwyn peri mai'r Asiantaeth Safonau Bwyd yw'r asiantaeth orfodi ar gyfer tramgwyddau o osod cynhyrchion ar y farchnad (rheoliad 4).
Schedule 2 (TSE monitoring) is amended to place a duty on those in possession of fallen bovine stock to deliver or arrange for the delivery of carcases to an approved sampling site for brain stem sampling. Those collecting and delivering the carcases of the fallen stock are required to ensure that they are delivered to an approved sampling site. Failure to comply with these provisions is an offence.
Diwygir Atodlen 2 (monitro TSE) er mwyn gosod dyletswydd ar y rheini sydd â stoc buchol trig yn eu meddiant i ddanfon neu i drefnu i ddanfon carcasau i safle samplu a gymeradwywyd ar gyfer samplu coesyn yr ymennydd. Mae'n ofynnol i'r rheini sy'n casglu ac yn danfon carcasau'r stoc trig sicrhau fod y carcasau hynny yn cael eu danfon i safle samplu a gymeradwywyd. Mae methu â chydymffurfio â'r darpariaethau hyn yn dramgwydd.
Schedule 2 is also amended to create new offences of destroying a carcase to which these provisions apply before it has been sampled and of failing to retain carcases prior to obtaining a negative test result and to make provision for the approval of sampling sites by the Welsh Ministers (regulation 5).
Caiff Atodlen 2 ei diwygio hefyd i greu tramgwyddau newydd o ddifa carcas y mae'r darpariaethau hyn yn berthnasol iddo cyn ei fod wedi cael eu samplu ac o fethu â dal gafael ar garcasau cyn cael canlyniad negyddol i brawf ac i wneud darpariaeth ar gyfer cymeradwyo safleoedd samplu gan Weinidogion Cymru (rheoliad 5).
A substituted Schedule 8 (restrictions on placing on the market and export) makes it an offence to place on the market and export live bovine animals born or reared in the United Kingdom before 1 August 1996 and products derived from them (other than milk or hides) to other Member States and to third countries (regulation 7).
Gosodir Atodlen 8 newydd yn ei lle (cyfyngiadau ar osod ar y farchnad ac allforio) sy'n ei gwneud yn dramgwydd i osod ar y farchnad anifeiliaid buchol byw a anwyd neu a fagwyd yn y Deyrnas Unedig cyn 1 Awst 1996 a'u hallforio hwy a chynhyrchion sy'n tarddu ohonynt (ac eithrio llaeth neu grwyn) i Aelod-wladwriaethau eraill ac i drydydd gwledydd (rheoliad 8) (rheoliad 7).
Offences are punishable in accordance with regulation 18 of the 2008 Regulations by -
Mae tramgwyddau'n gosbadwy yn unol â rheoliad 18 o Reoliadau 2008 -
on summary conviction, a fine not exceeding the statutory maximum or imprisonment for a term of three months or both, or
ar gollfarn ddiannod, dirwy o ddim mwy na'r mwyafswm statudol neu garchariad am dymor o dri mis neu'r ddau, neu
on conviction on indictment, a fine or imprisonment for a term not exceeding two years or both.
ar gollfarn ar dditiad, dirwy neu garchariad am dymor heb fod yn hwy na dwy flynedd, neu'r ddau.
A regulatory impact assessment on the effect of this instrument on the costs of business has been prepared and is available from the Welsh Assembly Government, Cathays Park, Cardiff CF10 3NQ.
Paratowyd asesiad effaith rheoleiddiol ar effaith yr offeryn hwn ar gostau busnes ac mae ar gael oddi wrth Lywodraeth Cynulliad Cymru, Parc Cathays, Caerdydd CF10 3NQ.
2009 No. 3252 (W.282)
2009 Rhif 3252 (Cy.282)
The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 16 (1) (a) and (e), 17 (1) and (2), 26 (1) (a) and (3) and 48 (1) of the Food Safety Act 1990 (1).
Mae Gweinidogion Cymru yn gwneud y Rheoliadau a ganlyn drwy arfer y pwerau a roddwyd gan adrannau 16 (1) (a) ac (e), 17 (1) a (2), 26 (1) (a) a (3) a 48 (1) o Ddeddf Diogelwch Bwyd 1990 (1).
These Regulations make provision for a purpose mentioned in section 2 (2) of the European Communities Act 1972 (2) and it appears to the Welsh Ministers that it is expedient for any reference to an Annex to Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements (3) to be construed as a reference to that Annex as amended from time to time.
Mae'r Rheoliadau hyn yn gwneud darpariaeth at ddiben a grybwyllir yn adran 2 (2) o Ddeddf y Cymunedau Ewropeaidd 1972 (2) ac ymddengys i Weinidogion Cymru ei bod yn hwylus i unrhyw gyfeiriad at Atodiad i Gyfarwyddeb 2002/46/EC Senedd Ewrop a'r Cyngor ar gyd-ddynesiad cyfreithiau'r Aelod-wladwriaethau sy'n ymwneud ag atchwanegiadau bwyd (3) gael ei ddehongli fel cyfeiriad at yr Atodiad hwnnw fel y'i diwygir o bryd i'w gilydd.
As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (4) there has been open and transparent public consultation during the preparation of the following Regulations.
Fel sy'n ofynnol gan Erthygl 9 o Reoliad (EC) Rhif 178/2002 Senedd Ewrop a'r Cyngor, sy'n gosod egwyddorion cyffredinol a gofynion cyfraith bwyd, yn sefydlu Awdurdod Diogelwch Bwyd Ewrop ac yn gosod gweithdrefnau o ran materion diogelwch bwyd (4) cafwyd ymgynghoriad cyhoeddus agored a thryloyw tra bu'r Rheoliadau a ganlyn yn cael eu llunio.
1. The title of these Regulations is The Food Supplements (Wales) and Addition of Vitamins, Minerals and Other Substances (Wales) (Amendment) Regulations 2009 and they come into force on 1 January 2010.
1. Enw'r Rheoliadau hyn yw Rheoliadau Atchwanegiadau Bwyd (Cymru) ac Ychwanegu Fitaminau, Mwynau a Sylweddau Eraill (Cymru) (Diwygio) 2009 a deuant i rym ar 1 Ionawr 2010.
Amendment of the Food Supplements (Wales) Regulations 2003
Diwygio Rheoliadau Ychwanegion Bwyd (Cymru) 2003
2. - (1) The Food Supplements (Wales) Regulations 2003 (5) are amended in accordance with the following paragraphs.
2. - (1) Diwygir Rheoliadau Ychwanegion Bwyd (Cymru) 2003 (5) yn unol â'r paragraffau canlynol.
In paragraph (1) of regulation 2 (interpretation), for the definition "Directive 2002/46" there are substituted the following definitions -
Ym mharagraff (1) o reoliad 2 (dehongli), yn lle'r diffiniad "Cyfarwyddeb 2002/46" rhodder y diffiniadau canlynol -
"Directive 2001/83" (" Cyfarwyddeb 2001/83 ") means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (8) as last amended by Directive 2009/53/EC of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC , as regards variations to the terms of marketing authorisations for medicinal products (9);
ystyr "Cyfarwyddeb 2001/83" (" Directive 2001/83 ") yw Cyfarwyddeb 2001/83/EC Senedd Ewrop a'r Cyngor ar god y Gymuned sy'n ymwneud â chynhyrchion meddyginiaethol i'w defnyddio gan bobl (8) fel y'i diwygiwyd ddiwethaf gan Gyfarwyddeb 2009/53/EC Senedd Ewrop a'r Cyngor sy'n diwygio Cyfarwyddeb 2001/82/EC a Chyfarwyddeb 2001/83/EC, o ran amrywiadau i delerau awdurdodiadau marchnata ar gyfer cynhyrchion meddyginiaethol (9);
Immediately after paragraph (3) of regulation 2 (interpretation) there is inserted the following paragraph -
Yn union ar ôl paragraff (3) o reoliad 2 (dehongli) mewnosoder y paragraff a ganlyn-
" (4) In these Regulations any reference to an Annex to Directive 2002/46 is a reference to that Annex as amended from time to time. ."
" (4) Yn y Rheoliadau hyn mae unrhyw gyfeiriad at Atodiad i Gyfarwyddeb 2002/46 yn gyfeiriad at yr Atodiad hwnnw fel y'i diwygir o bryd i'w gilydd. ".
In regulation 3 (scope of Regulations), for paragraph (2) there is substituted the following paragraph -
Yn rheoliad 3 (cwmpas y Rheoliadau), yn lle paragraff (2), rhodder y paragraff canlynol-
" (2) These Regulations do not apply to medicinal products as defined by Directive 2001/83. ."
" (2) Nid yw'r Rheoliadau hyn yn gymwys i gynhyrchion meddyginiaethol fel y'u diffinnir gan Gyfarwyddeb 2001/83. ".
In regulation 5 (prohibitions on sale relating to composition of food supplements) -
Yn rheoliad 5 (gwaharddiadau gwerthu sy'n ymwneud â chyfansoddiad ychwanegion bwyd) -
at paragraph (1), omit the words "subject to paragraph (3) "
ym mharagraff (1) hepgorer y geiriau "Yn ddarostyngedig i baragraff (3) "
at sub-paragraph (a) of paragraph (1), for the words 'column 1 of Schedule 1' there is substituted the words "Annex I to Directive 2002/46";
yn is-baragraff (a) o baragraff (1), yn lle'r geiriau "yng ngholofn 1 o Atodlen 1" rhodder y geiriau "yn Atodiad I i Gyfarwyddeb 2002/46";
at sub-paragraph (b) (i) of paragraph (1), for the words "Schedule 2" there is substituted the words "Annex II to Directive 2002/46"; and
yn is-baragraff (b) (i) o baragraff (1), yn lle'r geiriau "Atodlen 2" rhodder y geiriau "Atodiad II i Gyfarwyddeb 2002/46"; ac
In regulation 6 (restrictions on sale relating to labelling etc of food supplements) -
Yn rheoliad 6 (cyfyngiadau ar werthu sy'n ymwneud â labelu etc ychwanegion bwyd) -