#853527
(a) le gach substaint íce luaidhtear sa Sceideal a ghabhann leis an Acht so;
( a ) every therapeutic substance specified in the Schedule to this Act;
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#853594
—(1) Ní bheidh sé dleathach do dhuine dar deonadh ceadúnas déantóra aon tsubstaint íce le n-a mbaineann an tAcht so do dhéanamh, chun a díolta, mara mbeidh an tsubstaint íce sin do réir na gcaighdeán nirt, cáile agus íodhaine a bheidh orduithe maidir leis an substaint íce sin leis na rialacháin i dtaobh caighdeán substaintí íce.
—(1) It shall not be lawful for a person to whom a manufacturer's licence has been granted to manufacture for sale any therapeutic substance to which this Act applies unless such therapeutic substance complies with the standards of strength, quality and purity prescribed in respect of such therapeutic substance by the regulations as to the standards of therapeutic substances.
#853533
(a) a dhearbhú aon tsubstaint íce, nách féidir dar leis an Aire a íodhaine no a neart do leor-thástáil tré shlí cheimiciúil, do bheith ina substaint íce le n-a mbaineann an tAcht so;
( a ) declare any therapeutic substance, the purity or potency of which cannot in the opinion of the Minister be adequately tested by chemical means, to be a therapeutic substance to which this Act applies;
#853580
(a) do dhuine ar bith aon tsubstaint íce le n-a mbaineann an tAcht so do dhéanamh, chun a díolta, mara mbeidh ag an duine sin ceadúnas déantóra bheidh i bhfeidhm de thurus na huaire chun na substainte íce sin do dhéanamh chun a díolta, ná
( a ) for any person to manufacture for sale any therapeutic substance to which this Act applies unless such person holds a manufacturer's licence for the time being in force to manufacture for sale such therapeutic substance, or
#853543
(a) caighdeán nirt, cáile agus íodhaine aon tsubstainte íce le n-a mbaineann an tAcht so;
( a ) the standard of strength, quality and purity of any therapeutic substance to which this Act applies;
#853582
(b) d'éinne dar deonadh ceadúnas déantóra aon tsubstaint íce den tsórt san do dhéanamh, chun a díolta, in áit ar bith eile seachas san áitreabh a luaidhtear sa cheadúnas san.
( b ) for any person to whom a manufacturer's licence has been granted to manufacture for sale any such therapeutic substance elsewhere than on the premises specified in such licence.
#853620
—(1) Féadfaidh an tAire ceadúnas (dá ngairmtear ceadúnas taighdthe san Acht so) chun aon tsubstainte íce le n-a mbaineann an tAcht so d'iomportáil do dheonadh d'éinne—
—(1) The Minister may grant a licence (in this Act referred to as a research licence) to import any therapeutic substance to which this Act applies to any person who—
#853644
—(1) Ní bheidh sé dleathach aon tsubstaint íce le n-a mbaineann an tAcht so d'iomportáil isteach i Saorstát Éireann maran rud é—
—(1) It shall not be lawful to import into Saorstát Eireann any therapeutic substance to which this Act applies unless—
#1010697
(b) aon tsubstaint urchoscach, nó eadargnaíoch nó freapach eile is féidir d'úsáid chun aon éalaing, éiglíocht, gortú nó éislinn a bhíos ar dhaoine a chosc nó a chóireáil;
( b ) any other prophylactic, diagnostic or therapeutic substance which may be used for the prevention or treatment of any human ailment, infirmity, injury or defect;
#853559
—(1) Féadfaidh an tAire ceadúnas (dá ngairmtear ceadúnas déantóra san Acht so) chun aon tsubstainte íce le n-a mbaineann an tAcht so do dhéanamh, chun a díolta, san áitreabh a luadhfar sa cheadúnas san do dheonadh d'éinne—
—(1) The Minister may grant a licence (in this Act referred to as a manufacturer's licence) to manufacture for sale any therapeutic substance to which this Act applies on the premises specified in such licence to any person who—
#853564
(b) a chuirfidh ina luighe ar an Aire, maidir leis na coinníollacha fé n-a bhfuil sé chun na substainte íce sin do dhéanamh agus maidir leis an áitreabh ina bhfuil an tsubstaint sin le déanamh, gur coinníollacha agus áitreabh iad a bheidh do réir aon rialachán a bheidh déanta fén Acht so ag ordú na gcoinníollacha gur fé n-a réir a bheidh an ceadúnas san le deonadh.
( b ) satisfies the Minister that the conditions under which such therapeutic substance is to be manufactured by him and the premises on which such substance is to be manufactured are such as to comply with any regulations made under this Act prescribing the conditions subject to which such licence is to be granted.
#853588
(a) le dochtúir leighis cláruithe d'ullamhú substainte íce le n-a mbaineann an tAcht so i gcóir éinne dá othair féin no do dhochtúir leighis cláruithe eile agus ar a iarratas san. má hullamhuítear go speisialta í i gcóir staide agus chun úsáide othair áirithe, ná
( a ) the preparation by a registered medical practitioner for any of his own patients or for and at the request of another such practitioner of a therapeutic substance to which this Act applies, if it is specially prepared with reference to the condition, and for the use, of an individual patient, or
#853590
(b) le máinliaigh beithíoch cláruithe d'ullamhú substainte íce le n-a mbaineann an tAcht so i gcóir aon ainmhithe atá fé n-a chúram no do mháinliaigh bheithíoch cláruithe eile agus ar a iarratas san, má hullamhuítear go speisialta í i gcóir staide agus chun úsáide ainmhí áirithe.
( b ) the preparation by a registered veterinary surgeon for any animals under his care or for and at the request of another such surgeon of a therapeutic substance to which this Act applies, if it is specially prepared with reference to the condition, and for the use, of an individual animal.
#853600
—(1) Féadfaidh an tAire ceadúnas (dá ngairmtear ceadúnas iomportála san Acht so) chun aon tsubstainte íce le n-a mbaineann an tAcht so agus do rinne déantóir a luadhfar sa cheadúnas san d'iomportáil do dheonadh d'éinne—
—(1) The Minister may grant a licence (in this Act referred to as an import licence) to import any therapeutic substance to which this Act applies manufactured by a manufacturer specified in such licence to any person who—
#853640
—Féadfaidh an tAire, aon tráth, más ceart é dar leis, cead (dá ngairmtear cead iomportála san Acht so) do dheonadh d'aon dochtúir leighis cláruithe chun méid áirithe de shubstaint íce le n-a mbaineann an tAcht so d'iomportáil laistigh d'aimsir áirithe agus fé réir pé coinníollacha eile (más ann dóibh) is oiriúnach leis an Aire d'fhorchur agus a luadhfa sé sa chead san.
—The Minister may, at any time, if he so thinks proper, grant a permit (in this Act referred to as an import permit) to any registered medical practitioner to import within a specified time and subject to such other conditions (if any) as the Minister may think fit to impose and may specify in such permit a specified quantity of a therapeutic substance to which this Act applies.
#853678
(2) Beidh cigire i dteideal dul isteach gach tráth réasúnta in aon áitreabh ina gcoimeádtar aon tsubstaint íce a hiomportáladh fé cheadúnas iomportála agus iniúchadh do dhéanamh ar an áitreabh agus ar conus a deintear (má deintear) tástáil ar an substaint sin, agus fós somplaí den tsubstaint sin do thógaint.
(2) An inspector shall be entitled at all reasonable times to enter any premises where any therapeutic substance imported under an import licence is stocked and to inspect the premises and the means (if any) employed for testing such substance and to take samples thereof.
#853694
(a) á cheangal, i gcás aon tsubstainte íce le n-a mbaineann an tAcht so d'fhógairt no do dhíol mar chógas dhílseánaigh no i gcás í do bheith i gcógas a bheidh á fhógairt no á dhíol amhlaidh, go mbeidh ar an duillín pé ainm aitheanta eolaíochta, no pé ainm thuariscithe fhíor-chinéil agus fhíor-bhunúis na substainte, a luadhfar sna rialacháin sin;
( a ) requiring that, if any therapeutic substance to which this Act applies is advertised or sold as a proprietary medicine or is contained in a medicine so advertised or sold, such accepted scientific name or name descriptive of the true nature and origin of the substance as may be specified in such regulations shall appear on the label;
#853696
(b) á cheangal go ndéanfar dáta déanta aon tsubstainte íce le n-a mbaineann an tAcht so do luadh sa tslí a hordófar leis na rialacháin sin ar gach árthach no pacáid cile ina mbeidh an tsubstaint sin á díol no á tairiscint chun a díolta, agus á thoirmeasc an tsubstaint sin do dhíol tar éis deire na tréimhse, o dháta an déanta, a luadhfar sna rialacháin sin;
( b ) requiring that the date of the manufacture of any therapeutic substance to which this Act applies shall be stated in the manner prescribed by such regulations on all vessels or other packages in which such substance is sold or offered for sale, and prohibiting the sale of such substance after the expiration of the period specified in such regulations from the date of manufacture;
#853698
(c) á thoirmeasc aon tsubstaint íce le n-a mbaineann an tAcht so do dhíol no do thairiscint chun a díolta in aon tslí ach amháin in árthach no i ngabhdán eile den tsaghas a luadhfar sna rialacháin sin, agus á cheangal go ndéanfar an duillín no an comhartha eile luadhfar sna rialacháin sin do ghreamú don árthach no don ghabhdán san.
( c ) prohibiting the sale or offering for sale of any therapeutic substance to which this Act applies otherwise than in a vessel or other container of such character as may be specified in such regulations and requiring that the label or other description specified in such regulations shall be affixed to such vessel or container.
#853704
—Má dhíolann duine ar bith aon tsubstaint íce le n-a mbaineann an tAcht so, no má bhíonn aon tsubstaint den tsórt san ar seilbh aige chun a díolta, agus a fhios aige gur contrárdha don Acht so no d'aon rialacháin a bheidh déanta fé a rinneadh no a hiomportáladh an tsubstaint sin, beidh an duine sin ciontach i gcionta fén Acht so.
—If any person sells or has in his possession for sale any therapeutic substance to which this Act applies knowing it to have been manufactured or imported in contravention of this Act or any regulations made thereunder, such person shall be guilty of an offence under this Act.
#1087711
(iii) mura bhfuil sa leigheas ach substaint íce a bhfuil ceadúnas nó cead a deonadh faoin Acht Substaintí Ice, 1932 (Uimh. 25 de 1932) , i bhfeidhm ina leith, ainm na substainte mar luaitear sa cheadúnas nó sa chead é agus uimhir an cheadúnais nó an cheada, agus
(iii) if the remedy consists solely of a therapeutic substance in respect of which a licence or permit granted under the Therapeutic Substances Act, 1932 (No. 25 of 1932), is in force, the name of the substance as stated in the licence or permit and the number of the licence or permit, and
#1087767
(b) más substaint íce lena mbaineann an tAcht Substaintí Ice, 1932 , an leigheas ainmhithe, go scoirfidh an tAcht sin, ina iomláine nó a mhéid a sonrófar, d'fheidhm a bheith aige maidir leis an leigheas.
( b ) if the animal remedy is a therapeutic substance to which the Therapeutic Substances Act, 1932 , applies, that that Act shall cease to apply, either wholly or to a specified extent, to the remedy.
#1087771
(3) Ní déanfar, gan toiliú an Aire Shláinte, rialacháin faoin alt seo d'fhorálfadh, dá ndéantaí iad, go mbeadh deireadh, ina hiomláine nó a mhéid a sonrófaí, le feidhm an Achta Shubstaintí Ice, 1932, maidir le substaint íce, agus ní déanfar, gan an tAire agus an tAire Sláinte do dhul i gcomhairle le chéile roimh ré, rialacháin faoin alt seo, a dhéanfadh difir, dá ndéantaí iad, in aon tslí eile do shubstaintí íce lena mbaineann an tAcht Substaintí Ice, 1932 .
(3) Regulations under this section which, if made, would provide for the cesser, either wholly or to a specified extent, of the application of the Therapeutic Substances Act, 1932 , to a therapeutic substance shall not be made without the consent of the Minister for Health and regulations under this section which, if made, would affect in any other manner therapeutic substances to which the Therapeutic Substances Act, 1932 , applies shall not be made without prior consultation between the Minister and the Minister for Health.