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Uimhir 25 de 1932.
ACHT SUBSTAINTÍ ÍCE, 1932.
[10adh Mí na Nodlag, 1932.]
Mínithe.
1.—San Acht so—
cialluíonn an abairt “an tAire” an tAire Rialtais Áitiúla agus Sláinte Puiblí;
cialluíonn an focal “orduithe” orduithe le rialacháin a dhéanfaidh an tAire fén Acht so;
foluíonn an abairt “substaint íce” substaint choiscthe ghalar agus substaint nochtaithe ghalar.
Coiste Comhairlitheach.
2.—(1) Chun comhairle agus congnamh do thabhairt don Aire, maidir le horduithe agus le rialacháin do dhéanamh fén Acht so, bunófar coiste ar a dtabharfar mar ainm agus mar theideal an Coiste Comhairlitheach Substaintí Ice (dá ngairmtear an Coiste Comhairlitheach san Acht so).
(2) Beidh ar an gCoiste Comhairlitheach deichniúr ball ceapfar o am go ham mar leanas, sé sin le rá:—
(a) ceapfaidh an tAire Rialtais Áitiúla agus Sláinte Puiblí ball amháin;
(b) ceapfaidh an tAire Talmhaíochta ball amháin; agus
(c) ceapfaidh gach cólucht acu so leanas ball amháin, sé sin le rá, Príomh-Scoil Bhaile Atha Cliath, Príomh-Scoil Náisiúnta na hÉireann, Comhairle Chlárathachta na nDochtúirí Leighis, Coláiste Ríoga Leagha na hÉireann, Comhlachas Dochtúirí Leighis na hÉireann, Comhairle na Máinliaigh Beithíoch, Cumann Coguiseoirí na hÉireann, agus Fundúireacht na gCeimiceoirí.
(3) Marab éag no eirghe as roimhe sin do beidh gach ball den Choiste Chomhairlitheach i seilbh oifige go ceann tréimhse trí mblian o dháta a cheaptha, ach beidh sé ion-athcheaptha.
(4) Fé réir forálacha an ailt seo, féadfaidh an tAire, tré rialacha do dhéanamh fén alt so, a shocrú cadiad na huaireannta ceapfar baill den Choiste Chomhairlitheach, cathain agus conus a líonfar foth-fholúntaisí sa Choiste Chomhairlitheach, cadé an tréimhse oifige bheidh ag daoine ceapfar chun na bhfolúntaisí sin do líonadh, cad is quorum ag cruinnithe den Choiste Chomhairlitheach, agus cadé an nós-imeachta leanfaidh an Coiste Comhairlitheach.
(5) Tiocfaidh an Coiste Comhairlitheach le chéile pé uair a ghairmfidh an tAire le chéile iad.
(6) Fé réir rialacha dhéanfaidh an tAire fén alt so déanfaidh an Coiste Comhairlitheach a nós-imeachta do rialáil i pé slí is oiriúnach leo.
Substaintí íce le n-a mbaineann an tAcht.
3.—(1) Baineann an tAcht so—
(a) le gach substaint íce luaidhtear sa Sceideal a ghabhann leis an Acht so;
(b) le pé substaintí íce eile dearbhófar, o am go ham le hordú ar n-a dhéanamh fén alt so agus a bheidh i bhfeidhm de thurus na huaire, do bheith ina substaintí íce le n-a mbaineann an tAcht so.
(2) Tar éis do dul i gcomhairle leis an gCoiste Comhairlitheach féadfaidh an tAire, tré ordú do dhéanamh fén alt so—
(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;
(b) aon ordú do rinne sé roimhe sin fén alt so do cheiliúradh.
(3) Gach ordú dhéanfaidh an tAire fén alt so leagfar é fé bhráid gach Tighe den Oireachtas chó luath agus is féidir é tar éis a dhéanta. agus má dheineann ceachtar Tigh acu san, laistigh den lá is fiche shuidhfidh an Tigh sin tar éis an orduithe sin do leagadh fé n-a bhráid, rún do rith ag cur an orduithe sin ar neambrí, beidh an t-ordú san curtha ar nea-mbrí dá réir sin ach beidh san gan dochar do dhleathacht éinní do rinneadh roimhe sin fén ordú san.
Rialacháin i dtaobh caighdeán substaintí íce.
4.—Tar éis do dul i gcomhairle leis an gCoiste Comhairlitheach féadfaidh an tAire, le hordú, rialacháin (dá ngairmtear san Acht so rialacháin i dtaobh caighdeán substaintí íce) do dhéanamh maidir leis na nithe seo leanas, sé sin le rá:—
(a) caighdeán nirt, cáile agus íodhaine aon tsubstainte íce le n-a mbaineann an tAcht so;
(b) na tástálanna a húsáidfear chun a fháil amach go cinnte an bhfuil aon tsubstaint íce áirithe do réir an chaighdeáin sin;
(c) aontáin chaighdeánúcháin.
Rialacháin ghenerálta.
5.—(1) Tar éis do dul i gcomhairle leis an gCoiste Comhairlitheach féadfaidh an tAire, le hordú, rialacháin do dhéanamh ag ordú éinní no aon ruda dá dtagartar san Acht so mar ní no mar rud atá orduithe no le hordú.
(2) Féadfaidh aon rialacháin a dhéanfaidh an tAire fén Acht so baint leis na nithe iomdha go ndeintear ina dtaobh an chomhacht déanta rialachán do bhronnadh le hailt deifriúla den Acht so.
(3) Gach rialachán a déanfar fén Acht so leagfar é fé bhráid gach Tighe den Oireachtas chó luath agus is féidir é tar éis a dhéanta, agus má dheineann ceachtar Tigh acu san, laistigh den lá is fiche shuidhfidh an Tigh sin tar éis an rialacháin sin do leagadh fé n-a bhráid, rún do rith ag cur an rialacháin sin ar nea-mbrí, beidh an rialachán san curtha ar nea-mbrí dá réir sin ach beidh san gan dochar do dhleathacht éinní do rinneadh roimhe sin fén rialachán san.
Ceadúnaisí déantóra.
6.—(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—
(a) a iarrfaidh an ceadúnas san ar an Aire sa bhfuirm agus sa tslí orduithe; agus
(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.
(2) Maidir le gach ceadúnas déantóra—
(a) beidh sé sa bhfuirm orduithe, agus
(b) déarfa sé agus déanfa sé a cheadúnú don duine dá ndeonfar é na substaintí íce uile le n-a mbaineann an tAcht so no pé ceann no cinn acu luadhfar sa cheadúnas san do dhéanamh, chun a ndíolta, san áitreabh a luadhfar sa cheadúnas san, agus
(c) deonfar é fé réir na gcoinníollacha bheidh orduithe maidir leis.
(3) Mara ndeintear roimhe sin é do cheiliúradh no é do chur ar fiunraoi fén Acht so, fanfaidh gach ceadúnas déantóra i bhfeidhm go ceann na tréimhse orduithe o dháta an cheadúnais sin agus raghaidh in éag ansan.
Toirmeasc ar shubstaintí íce do dhéanamh gan ceadúnas.
7.—(1) Fé réir forálacha an ailt seo ní bheidh sé dleathach—
(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
(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.
(2) Beidh gach duine dhéanfaidh éinní is sárú ar an alt-so ciontach i gcionta fén Acht so.
(3) Ní bhainfidh an t-alt so—
(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
(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.
Toirmeasc ar shubstaintí íce do dhéanamh ná beidh do réir chaighdeán nirt, íodhaine, etc.
8.—(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.
(2) Beidh gach duine dhéanfaidh éinní is sárú ar an alt so ciontach i gcionta fén Acht so.
Ceadúnaisí importála.
9.—(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—
(a) a iarrfaidh an ceadúnas san ar an Aire sa bhfuirm agus sa tslí orduithe. agus
(b) a chuirfidh i dteanta an iarratais sin gealltanas i scríbhinn (dá ngairmtear gealltanas déantóra san Acht so) agus é sighnithe ag an déantóir sin no thar a cheann á gheallúint go ndéanfaidh, má deontar an ceadúnas san, na coinníollacha orduithe do chólíonadh faid a bheidh an ceadúnas san i bhfeidhm.
(2) Maidir le gach ceadúnas iomportála—
(a) beidh sé sa bhfuirm orduithe, agus
(b) déarfa sé agus déanfa sé a cheadúnú don duine dá ndeonfar é na substaintí íce uile le n-a mbaineann an tAcht so no pé ceann no cinn acu luadhfar sa cheadúnas san d'iomportáil ón déantóir a hainmneofar sa cheadúnas san, agus
(c) deonfar é fé réir na gcoinníollacha bheidh orduithe maidir leis, agus
(d) deonfar é ar choinníoll go gcólíonfaidh an déantóir sin an gealltanas déantóra do shighnigh sé maidir leis an gceadúnas san.
(3) Mara ndeintear roimhe sin é do cheiliúradh no é do chur ar fiunraoi fén Acht so, fanfaidh gach ceadúnas iomportála i bhfeidhm go ceann na tréimhse orduithe o dháta an cheadúnais sin agus raghaidh in éag ansan.
Ceadúnaisí taighdthe.
10.—(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—
(a) a bheidh ag gabháil do thaighdeadh eolaíochta. agus
(b) a iarrfaidh an ceadúnas san ar an Aire sa bhfuirm agus sa tslí orduithe, agus
(c) a chuirfidh moladh i dteanta an iarratais sin mar thaca leis agus an moladh san sighnithe ag pé daoine bheidh orduithe.
(2) Maidir le gach ceadúnas taighdthe—
(a) beidh sé sa bhfuirm orduithe, agus
(b) déarfa sé agus déanfa sé a cheadúnú don duine dá ndeonfar é substaintí íce le n-a mbaineann an tAcht so no pé ceann no cinn acu luadhfar sa cheadúnas san d'iomportáil, agus
(c) deonfar é fé réir na gcoinníollacha bheidh orduithe maidir leis.
(3) Mara ndeintear roimhe sin é do cheiliúradh no é do chur ar fiunraoi fén Acht so, fanfaidh gach ceadúnas taighdthe i bhfeidhm go ceann na tréimhse orduithe o dháta an cheadúnais sin agus raghaidh in éag ansan.
Ceada íomportála.
11.—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.
Srian le substaintí íce d'iomportáil.
12.—(1) Ní bheidh sé dleathach aon tsubstaint íce le n-a mbaineann an tAcht so d'iomportáil isteach i Saorstát Éireann maran rud é—
(a) gurb é bheidh ag iomportáil na substainte sin ná duine is sealbhóir ar cheadúnas thaighdthe bheidh i bhfeidhm de thuras na huaire chun na substainte sin d'iomportáil, no
(b) gurb é bheidh ag iomportáil na substainte sin ná duine is sealbhóir ar cheadúnas iomportála bheidh i bhfeidhm de thurus na huaire chun na substainte sin d'iomportáil agus gur ón déantóir a bheidh luaidhte sa cheadúnas san a bheidh an tsubstaint sin á hiomportáil, no
(c) gurb é bheidh ag iomportáil na substainte sin ná duine is sealbhóir ar chead iomportála bheidh i bhfeidhm de thurus na huaire chun na substainte sin d'iomportáil agus gur do réir an cheada san a bheidh an tsubstaint sin á hiomportáil, no
(d) gurb é bheidh ag iomportáil na substainte sin ná dochtúir leighis cláruithe agus go dtabharfaidh an dochtúir sin d'oifigeach custum agus máil, le linn na substainte sin do bheith á hiomportáil, dearbhú i scríbhinn fé n-a láimh á rá go bhfuil an tsubstaint sin ag teastáil go práinneach i gcóir duine dá othair féin agus nárbh fhéidir do toisc cúrsaí áirithe (a luadhfar sa dearbhú san) cead iomportála chun na substainte sin d'iomportáil d'fháil luath go leor.
(2) Beidh gach duine dhéanfaidh éinní is sárú ar an alt so ciontach i gcionta fén Acht so.
Baint na nAchtanna Custum.
13.—Tuigfear carraí go dtoirmeasctar de bhuadh an Achta so iad d'iomportáil do bheith ar na hearraí a háirmhítear agus a tuairiscítear ar Chlár na dToirmease agus na Srian maidir le hEarraí do Theacht Isteach atá in Alt 42 den Customs Consolidation Act, 1876, agus na forálacha den Acht san, mar atá san leasuithe no leathnuithe le haon Acht ina dhiaidh sin. a bhaineann le hearraí toirmeasctar no sriantar d'iomportáil beidh baint acu dá réir sin.
Táillí ar cheadúnaisí do dheonadh.
14.—(1) Íocfar leis an Aire ar aon cheadúnas do dheonadh fén Acht so pé táille shocróidh an tAire, le toiliú an Aire Airgid, tré rialacháin do dhéanamh fén alt so agus féadfar táillí deifriúla do shocrú maidir le haicmí deifriúla ceadúnaisí.
(2) Déanfar na táillí uile gheobhaidh an tAire fén alt so d'íoc isteach sa Stát-Chiste no do chur chun tairbhe dho i pé slí ordóidh an tAire Airgid.
Ceadúnaisí do cheiliúradh agus do chur ar fiunraoi.
15.—(1) Má deintear duine is sealbhóir ar cheadúnas do deonadh fén Acht so do chiontú i gcionta fén Acht so, féadfaidh an tAire an ceadúnas no na ceadúnaisí uile bheidh ag an duine sin do cheiliúradh no an céanna do chur ar fiunraoi go ceann pé tréimhse is oiriúnach leis.
(2) Má bhíonn duine ina shealbhóir ar cheadúnas iomportála agus má deintear dar leis an Aire sárú ar an ngealltanas déantóra a thug an déantóir a luaidhtear sa cheadúnas san uaidh, féadfaidh an tAire an ceadúnas san do cheiliúradh no é do chur ar fiunraoi go ceann pé tréimhse is oiriúnach leis.
(3) Má deintear ceadúnas do chur ar fiunraoi fén alt so, scuirfidh an ceadúnas san de bheith i bhfeidhm faid a leanfaidh an fhiunraíocht san.
Comhachta cigirí.
16.—(1) Beidh cigire i dteideal dul isteach gach tráth réasúnta in aon áitreabh a bheidh luaidhte i gceadúnas déantóra agus iniúchadh do dhéanamh ar an áitreabh san agus ar an ngléasra agus ar an déantóireacht agus ar conus a deintear caighdeánú agus tástáil ar na substaintí íce deintear san áitreabh san, agus fós somplaí de sna substaintí íce sin do thógaint.
(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.
(3) Beidh cigire i dteideal dul isteach gach tráth réasúnta in aon áitreabh ina gcoimeádann duine is sealbhóir ar cheadúnas taighdthe aon tsubstaintí íce agus iniúchadh do dhéanamh ar an áitreabh san agus scrúdú do dhéanamh ar conus a húsáidtear na substaintí. agus fós somplaí dhíobh do thógaint.
(4) Má dheineann duine ar bith bac no cosc do chur le cigire agus é ag feidhmiú aon chomhachta dá mbronntar ar chigire fén alt so, beidh sé ciontach i gcionta fén Acht so.
(5) San alt so cialluíonn an focal “cigire” duine go n-údarás i scríbhinn ón Aire chun na gcomhacht a bronntar ar chigire leis an alt so d'fheidhmiú.
Coinníollacha ceadúnais do shárú.
17.—Má dheineann duine ar bith, is sealbhóir ar cheadúnas a deonadh fén Acht so, sárú ar na coinníollacha gur fé n-a réir a deonadh an ceadúnas san no má theipeann air na coinníollacha san do chólíonadh, beidh an duine sin ciontach i gcionta fén Acht so.
Cógas dílseánaigh is substaint íce no ina bhfuil substaint íce do dhíol.
18.—Tar éis do dul i gcomhairle leis an gCoiste Comhairlitheach féadfaidh an tAire, le hordú, rialacháin do dhéanamh i dtaobh gach ní no éinní acu so leanas, sé sin le rá:—
(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;
(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;
(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.
(2) Má dheineann duine ar bith sárú ar aon rialacháin a déanfar fén alt so no má theipeann air na rialacháin sin do chólíonadh, beidh sé ciontach i gcionta fén Acht so.
Substaintí íce do rinneadh no do hiomportáladh go neadhleathach do dhíol.
19.—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.
Pionós mar gheall ar chiontaí.
20.—Gach duine bheidh ciontach i gcionta fén Acht so dlighfear ar a chiontú ann ar an slí achmair fíneáil ná raghaidh thar céad púnt do chur air agus, má sé an dara cionta aige é no aon chionta ina dhiaidh sin, fíneáil den tsórt san do chur air no príosúntacht i dteanta no d'éamais daor-oibre ar feadh aon téarma nách sia ná ráithe, agus i gceachtar cás dlighfe sé aon carraí gur ina dtaobh do rinneadh an cionta do gheallbhruideadh.
Costaisí.
21.—Sa mhéid go gceadóidh an tAire Airgid é is amach as airgead a sholáthróidh an tOireachtas a híocfar aon chostaisí fé n-a raghfar chun an Achta so do chur i bhfeidhm.
Gearr-theideal agus tosach feidhme.
22.—(1) Féadfar an tAcht Substaintí Ice, 1932, do ghairm den Acht so.
(2) Tiocfaidh an tAcht so i ngníomh pé lá socrófar chuige sin le hordú ón Aire.
SCEIDEAL.
Substainti Ice le n-a mBaineann an tAcht so.
1.—Na substaintí ar a dtugtar de ghnáth vaesuíní, scra, tocsuíní, anti-tocsuíní agus antigení.
2.—An tsubstaint ar a dtugtar de ghnáth salvarsan (dioxydiamino-arseno-benzol-di-hydrochloride) agus substaintí dá shamhail a húsáidtear de bhithin a sain-fheidhme chun galair thógálaigh do leigheas.
3.—Ullmhóidí de shain-phrionsabal an phancreas i gcoinnibh an ghalair chraosaigh, ullmhóidí ar a dtugtar insulin.
4.—Ullmhóidí de chírín deiridh an bhaill réamach gur tré instealladh atáid le húsáid.
Number 25 of 1932.
THERAPEUTIC SUBSTANCES ACT, 1932.
ARRANGEMENT OF SECTIONS
THERAPEUTIC SUBSTANCES TO WHICH THIS ACT APPLIES.
Number 25 of 1932.
THERAPEUTIC SUBSTANCES ACT, 1932.
Definitions.
1.—In this Act—
the expression “the Minister” means the Minister for Local Government and Public Health;
the expression “prescribed” means prescribed by regulations made by the Minister under this Act;
the expression “therapeutic” includes prophylactic and diagnostic.
Advisory Committee.
2.—(1) For the purpose of advising and assisting the Minister in the making of orders and regulations under this Act there shall be established a committee to be called and known as the Therapeutic Substances Advisory Committee (in this Act referred to as the Advisory Committee).
(2) The Advisory Committee shall consist of ten members appointed from time to time as follows, that is to say:—
(a) one shall be appointed by the Minister for Local Government and Public Health;
(b) one shall be appointed by the Minister for Agriculture; and
(c) one shall be appointed by each of the following bodies, that is to say, the University of Dublin, the National University of Ireland, the Medical Registration Council, the Royal College of Physicians of Ireland, the Irish Medical Association, the Veterinary Council, the Pharmaceutical Society of Ireland, and the Institute of Chemists.
(3) Every member of the Advisory Committee shall, unless he previously dies or resigns hold office for a period of three years from the date of his appointment, but shall be eligible for re-appointment.
(4) Subject to the provisions of this section, the Minister may by rules made under this section regulate the times of appointment of members of the Advisory Committee, the time and mode of filling casual vacancies in the Advisory Committee, the period of office of persons appointed to fill such vacancies, the quorum at meetings of the Advisory Committee, and the procedure of the Advisory Committee.
(5) The Advisory Committee shall meet whenever summoned by the Minister.
(6) Subject to rules made by the Minister under this section the Advisory Committee shall regulate their proceedings in such manner as they think fit.
Therapeutic substances to which Act applies.
3.—(1) This Act applies to—
(a) every therapeutic substance specified in the Schedule to this Act;
(b) such other therapeutic substances as may from time to time be declared by order for the time being in force made under this section to be therapeutic substances to which this Act applies.
(2) The Minister may, after consultation with the Advisory Committee, by order made under this section—
(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;
(b) revoke any order previously made by him under this section.
(3) Every order made by the Minister under this section shall be laid before each House of the Oireachtas as soon as may be after it is made, and if either such House shall, within twenty-one days on which such House has sat after such order is laid before it, pass a resolution annulling such order, such order shall be annulled accordingly but without prejudice to the validity of anything previously done thereunder.
Regulations as to standards of therapeutic substances.
4.—The Minister may, after consultation with the Advisory Committee, by order make regulations (in this Act referred to as regulations as to the standards of therapeutic substances) in relation to the following matters, that is to say:—
(a) the standard of strength, quality and purity of any therapeutic substance to which this Act applies;
(b) the tests to be used for determining whether such standard has been attained;
(c) units of standardisation.
General regulations.
5.—(1) The Minister may, after consultation with the Advisory Committee, by order make regulations prescribing any matter or thing which is referred to in this Act as prescribed or to be prescribed.
(2) Any regulations made by the Minister under this Act may relate to the several matters in respect of which the power to make regulations is conferred by different sections of this Act.
(3) Every regulation made under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made, and if either such House shall, within twenty-one days on which such House has sat after such regulation is laid before it, pass a resolution annulling such regulation, such regulation shall be annulled accordingly but without prejudice to the validity of anything previously done thereunder.
Manufacturer's licences.
6.—(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—
(a) applies in the prescribed form and manner to the Minister for such licence; and
(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.
(2) Every manufacturer's licence shall—
(a) be in the prescribed form, and
(b) be expressed and operate to licence the person to whom it is granted to manufacture for sale all the therapeutic substances to which this Act applies or such one or more of them as may be specified in such licence on the premises specified in such licence, and
(c) be granted subject to the conditions prescribed in respect thereof.
(3) Every manufacturer's licence shall, unless sooner revoked or suspended under this Act, remain in force for the prescribed period from the date thereof and shall then expire.
Prohibition of manufacture of therapeutic substances without licence.
7.—(1) Subject to the provisions of this section, it shall not be lawful—
(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
(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.
(2) Every person who acts in contravention of this section shall be guilty of an offence under this Act.
(3) This section shall not apply to—
(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
(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.
Prohibition of manufacture of therapeutic substances not complying with standards of strength, purity, etc.
8.—(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.
(2) Every person who acts in contravention of this section shall be guilty of an offence under this Act.
Import licences.
9.—(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—
(a) applies in the prescribed form and manner to the Minister for such licence, and
(b) sends with such application a written undertaking (in this Act referred to as a manufacturer's undertaking) signed by or on behalf of such manufacturer that he will, in the event of such licence being granted, during the continuance of such licence comply with the prescribed conditions.
(2) Every import licence shall—
(a) be in the prescribed form, and
(b) be expressed and operate to licence the person to whom it is granted to import from the manufacturer named therein all the therapeutic substances to which this Act applies or such one or more of them as may be specified in such licence, and
(c) be granted subject to the conditions prescribed in respect thereof, and
(d) be granted subject to the observance by such manufacturer of the manufacturer's undertaking signed by him in respect of such licence.
(3) Every import licence shall, unless sooner revoked or suspended under this Act, remain in force for the prescribed period from the date thereof and shall then expire.
Research licences.
10.—(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—
(a) is engaged in scientific research, and
(b) applies in the prescribed form and manner to the Minister for such licence, and
(c) sends with such application a recommendation supporting such application signed by such persons as may be prescribed.
(2) Every research licence shall—
(a) be in the prescribed form, and
(b) be expressed and operate to licence the person to whom it is granted to import therapeutic substances to which this Act applies or such one or more of them as may be specified in such licence, and
(c) be granted subject to the conditions prescribed in respect thereof.
(3) Every research licence shall, unless sooner revoked or suspended under this Act, remain in force for the prescribed period from the date thereof and shall then expire.
Import permits.
11.—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.
Restriction on import of therapeutic substances.
12.—(1) It shall not be lawful to import into Saorstát Eireann any therapeutic substance to which this Act applies unless—
(a) such substance is imported by a person who is the holder of a research licence for the time being in force to import such substance, or
(b) such substance is imported by a person who is the holder of an import licence for the time being in force to import such substance and such substance is imported from the manufacturer specified in such licence, or
(c) such substance is imported by a person who is the holder of an import permit for the time being in force to import such substance and such substance is imported in accordance with such permit, or
(d) such substance is imported by a registered medical practitioner and such practitioner at the time of importing such substance delivers to an officer of customs and excise a declaration in writing signed by him to the effect that such substance is urgently required for one of his own patients and that circumstances (to be specified in such declaration) did not permit of his obtaining in sufficient time an import permit to import such substance.
(2) Every person who acts in contravention of this section shall be guilty of an offence under this Act.
Application of Customs Acts.
13.—Articles prohibited to be imported by virtue of this Act shall be deemed to be included among the goods enumerated and described in the Table of Prohibitions and Restrictions Inwards contained in Section 42 of the Customs Consolidation Act, 1876, and the provisions of that Act, as amended or extended by any subsequent Act, applying to the importation of prohibited or restricted goods, shall apply accordingly.
Fees on grant of licences.
14.—(1) There shall be paid to the Minister on the grant of any licence under this Act such fee as may be fixed by the Minister, with the consent of the Minister for Finance, by regulations made under this section and different fees may be fixed in respect of different classes of licences.
(2) All fees received by the Minister under this section shall be paid into or disposed of for the benefit of the Exchequer in such manner as the Minister for Finance may direct.
Revocation and suspension of licences.
15.—(1) Where a person who is the holder of a licence granted under this Act is convicted of an offence under this Act, the Minister may revoke or suspend for such period as he thinks fit, the licence or all the licences held by such person.
(2) Where a person is the holder of an import licence and there has in the opinion of the Minister been a breach of the manufacturer's undertaking given by the manufacturer specified in such licence, the Minister may revoke or suspend for such period as he thinks fit such licence.
(3) Where a licence is suspended under this section, such licence shall so long as such suspension continues cease to be in force.
Powers of inspectors.
16.—(1) An inspector shall be entitled at all reasonable times to enter any premises specified in a manufacturer's licence and to inspect such premises and the plant and the process of manufacture and the means employed for standardising and testing the therapeutic substances manufactured thereon and to take samples thereof.
(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.
(3) An inspector shall be entitled at all reasonable times to enter any premises where a person who is the holder of a research licence keeps any therapeutic substances and inspect such premises and investigate the manner in which the substances are used and to take samples thereof.
(4) If any person obstructs or impedes, an inspector in the exercise of any of the powers conferred on an inspector under this section, he shall be guilty of an offence under this Act.
(5) In this section the expression “inspector” means a person authorised in writing by the Minister to exercise the powers conferred on an inspector by this section.
Breach of licence conditions.
17.—If any person, being the holder of a licence granted under this Act, contravenes or fails to comply with the conditions subject to which such licence was granted, such person shall be guilty of an offence under this Act.
Sale of proprietary medicine consisting of or containing therapeutic substances.
18.—The Minister may, after consultation with the Advisory Committee, by order make regulations in relation to all or any of the following matters, that is to say:—
(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;
(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;
(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.
(2) If any person contravenes or fails to comply with any regulations made under this section he shall be guilty of an offence under this Act.
Sale of therapeutic substances unlawfully manufactured or imported.
19.—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.
Penalty for offences.
20.—Every person guilty of an offence under this Act shall be liable on summary conviction thereof to a fine not exceeding one hundred pounds and, in the case of a second or any subsequent offence, to such fine or to imprisonment with or without hard labour for any term not exceeding three months, and in either case to forfeit any goods in connection with which the offence was committed.
Expenses.
21.—Any expenses incurred in carrying this Act into execution shall, to such extent as may be sanctioned by the Minister for Finance, be paid out of moneys provided by the Oireachtas.
Short title and commencement.
22.—(1) This Act may be cited as the Therapeutic Substances Act, 1932.
(2) This Act shall come into operation on such day as shall be fixed for that purpose by order of the Minister.
SCHEDULE.
Therapeutic Substances To Which This Act Applies.
1.—The substances commonly known as vaccines, sera, toxins, antitoxins and antigens.
2.—The substance commonly known as salvarsan (dioxy-diamino-arseno-benzol-di-hydrochloride) and analogous substances used for the specific treatment of infective disease.
3.—Preparations of the specific antidiabetic principle of the pancreas, known as insulin.
4.—Preparations of the posterior lobe of the pituitary body intended for use by injection.