KONTROLL TAL-MEDI~INI [L.S.31.18 1 
LE{ISLAZZJONI SUSSIDJARJA 31.18 
REGOLAMENTI DWAR IL-KONTROLL 
TAL-MEDI~INI 
2 ta’ Awissu, 1985 
L-AVVI| LEGALI 22 ta’ l-1985, kif emendat bl-Avvi\i Legali: 65 ta’ l- 
1986, 26 ta’ l-1987, 70 ta’ l-1988, 34 u 103 ta’ l-1989, 173 ta’ l-1994, 78 
ta’ l-1998 u 183 ta’ l-1999. 
Titolu. 1. It-titolu ta’ dawn ir-Regolamenti hu Regolamenti dwar il- 
Kontroll tal-Medi`ini. 
Tifsir. 2. F’dawn ir-Regolamenti, kemm-il darba r-rabta tal-kliem 
ma te]tie[x xort’o]ra - 
Kap. 258. 
"karta ta’ l-identità" tfisser karta ta’ identità valida ma]ru[a 
skond id-disposizzjonijiet ta’ l-Att dwar il-Karti ta’ l-Identità u ta’ 
kull regolamenti mag]mula bis-sa]]a tieg]u; 
"medi`ina ristretta" tfisser kull wa]da minn dawk il-medi`ini 
jew sustanzi kimi`i mni\\lin fl-Ewwel Skeda li tinsab ma’ dawn ir- 
Regolamenti; 
"medi`ina spe`ifikata" tfisser kull wa]da minn dawk il-medi`ini 
jew sustanzi kimi`i spe`ifikati fit-Tieni Skeda li tinsab ma’ dawn 
ir-Regolamenti; 
"re[istru" tfisser ktieb illegat b’pa[ni numerati wara xulxin, i\da 
ma tinkludi ebda xorta ta’ re[istru bil-folji sfu\i jew indi`i talcards; 
"Suprintendent" tfisser is-Suprintendent tas-Sa]]a Pubblika. 
Importazzjoni, 
e``., ta’ medi`ini 
ristretti trid tkun 
awtorizzata b’mod 
spe`jali. 
3. (1) Ebda persuna ma tista’ timporta, timmanifattura, 
tesporta, tixtri, tbieg], tu\a jew ikollha fil-pussess tag]ha xi 
medi`ina ristretta ming]ajr awtorizzazzjoni spe`jali bil-miktub 
mis-Suprintendent. 
(2) Is-Suprintendent ma g]andux jag]ti l-awtorizzazzjoni 
spe`jali biex tintu\a xi medi`ina ristretta ]lief f’ka\ijiet spe`jali 
g]all-g]anijiet xjentifi`i jew g]all-g]anijiet medi`i limitati ]afna fi 
stabbilimenti medi`i jew xjentifi`i ta]t il-kontroll tal-gvern jew 
approvati b’mod spe`jali mis-Suprintendent, li jkollu s-setg]a li 
jimponi f’kull awtorizzazzjoni kull kondizzjoni jew ]tie[a li 
jidhirlu xierqa li jimponi bil-]sieb li jevita kull abbu\. 
(3) Is-Suprintendent jista’ f’kull \mien, ming]ajr ma jag]ti 
ebda ra[uni, jirtira kull awtorizzazzjoni mog]tija minnu skond issub-
regolament (1) ta’ dan ir-regolament. 
(4) Kull persuna li tkun [iet awtorizzata skond is-subregolament 
(l) ta’ dan ir-regolament g]andha \\omm dawk irre[
istri li jkunu me]tie[a skond it-Tielet Skeda li tinsab ma’ dawn 
ir-Regolamenti dwar il-manifattura, l-akkwist u/jew it-tne]]ija ta’ 
medi`ini ristretti, f’liema re[istri g]andhom jitni\\lu d-dettalji 
dwar dawk il-medi`ini. Kull re[istrazzjoni g]andha tkun iffirmata, 
mill-persuna awtorizzata ta]t is-sub-regolament (1), fi \mien

2 L.S.31.18] KONTROLL TAL-MEDI~INI 
erbg]a u g]oxrin sieg]a ta’ kull transazzjoni jew pro`ess, u kull 
re[istru g]andu jin\amm biex jista’ ji[i spezzjonat mis- 
Suprintendent jew mir-rappre\entant tieg]u g]al mill-anqas sentejn 
wara d-data li fiha tkun [iet imni\\la l-a]]ar re[istrazzjoni. 
(5) Kull re[istrazzjoni fir-re[istru g]andha ssir bl-inka jew 
b’xi materjal ie]or li ma jit]assarx u g]andha ssir fl-istess [urnata 
li fiha tkun saret kull transazzjoni, tkun xi tkun, jew, meta dan ma 
jkunx jista’ jsir, fil-[urnata ta’ wara. 
(6) Kull re[istru w\at jew li jkun qed jintu\a dwar xi post 
partikolari ma g]andux jintu\a wkoll dwar xi post ie]or jew g]al xi 
g]an ie]or barra minn dak ta’ dan ir-regolament. 
(7) Ebda re[istrazzjoni fir-re[istru msemmi fl-a]]ar subregolamenti 
qabel dan ta’ dan ir-regolament ma g]andha ti[i 
kan`ellata, m]assra jew mibdula jew ti[i mni\\la b’xi 
partikolaritajiet li ma jkunux veri: 
I\da jekk isir xi \ball f’xi re[istrazzjoni, dak l-i\ball 
g]andu ji[i korrett bil-mezz ta’ nota fil-mar[ini jew f’tarf il-pa[na, 
liema nota g]andu jkun fiha l-korrezzjoni me]tie[a u d-data tannota. 
(8) Ebda persuna ma tista’ tne]]i xi medi`ina ristretta ]lief 
g]al persuni li jkunu awtorizzati b’mod spe`jali li jkollhom jew 
ju\aw dawk il-medi`ini. 
Transazzjonijiet 
dwar medi`ini 
spe`ifikati li 
g]andhom ji[u 
re[istrati. 
4. (1) Kull persuna li jkollha li`enza jew tkun awtorizzata li 
timmanifattura, timporta, tbieg], tipprovdi, tqassam, jew tag]ti xi 
medi`ina spe`ifikata, sew jekk fil-linja tal-kummer` jew 
professjoni tag]ha jew b]ala medikament meta ti[i pre\entata 
ri`etta g]andha \\omm dawk ir-re[istri li jkunu me]tie[a biex ikun 
jidher li tkun saret dik it-transazzjoni dwar il-manifattura, 
importazzjoni, xiri, bejg], provvista, tqassim jew g]oti ta’ xi 
medi`ina spe`ifikata. 
(2) (i) Ebda persuna ma tista’ timporta, ta]\en jew tbieg] xi 
medi`ina spe`ifikata bl-ingrossa kemm-il darba ma 
jkollhiex li`enza spe`ifika g]al hekk ming]and is- 
Suprintendent. 
(ii) Ma g]andha tin]are[ ebda li`enza g]all-finijiet talparagrafu 
ta’ qabel dan kemm-il darba l-medi`ina jew 
il-medi`ini li dwarhom tkun in]ar[et ma jkunux ta]t 
ir-responsabbiltà diretta ta’ spi\jar. 
(3) Kull medi`ina spe`ifikata fabbrikata, importata, esportata, 
mixtrija, mibjug]a, provduta, imqassma jew mog]tija g]andha 
titni\\el fir-re[istru fil-forma murija b’dak it-tibdil skond ma 
je]tie[u `-`irkostanzi, u b’dawk il-partikolaritajiet kif murija fit- 
Tielet Skeda li tinsab ma’ dawn ir-Regolamenti u kif japplikaw 
g]all-ka\. 
(4) Kull re[istrazzjoni g]andha ssir bl-inka jew b’materjal 
ie]or li ma jit]assarx u g]andha ssir fl-istess [urnata meta ssir ittransazzjoni, 
l-g]oti jew il-pro`ess, jew, meta dan ma jkunx 
possibbli, fil-[urnata ta’ wara. 
(5) Kull re[istru w\at jew fl-u\u dwar xi post partikolari ma

KONTROLL TAL-MEDI~INI [L.S.31.18 3 
g]andux jintu\a wkoll dwar xi post ie]or jew g]al xi g]an ie]or 
barra minn dak ta’ dan ir-regolament. 
(6) Ebda re[istrazzjoni fir-re[istru msemmi fis-sub-regolament 
ta’ qabel ta’ dan ir-regolament ma g]andha ti[i kan`ellata, m]assra 
jew mibdula jew titni\\el b’xi partikolaritajiet li ma jkunux veri: 
I\da jekk isir xi \ball f’xi re[istrazzjoni, dak l-i\ball 
g]andu ji[i korrett permezz ta’ nota fil-mar[ini jew f’tarf il-pa[na, 
liema nota g]andu jkollha l-korrezzjoni me]tie[a u d-data tan-nota. 
(7) Ebda persuna ma tista’ tesporta xi medi`ina spe`ifikata 
ming]ajr l-awtorizzazzjoni minn qabel tas-Suprintendent. 
(8) Fil-ka\ ta’ importazzjoni jew esportazzjoni ta’ medi`ini 
spe`ifikati, is-Suprintendent ikollu s-setg]a li jordna l-pro`edura li 
g]andha tittie]ed u d-dettalji li g]andhom jing]ataw ma’ l-applikazzjoni 
relattiva, u jista’ wkoll, qabel ma jo]ro[ awtorizzazzjoni 
g]all-esportazzjoni, jitlob li tinkiseb l-awtorizzazzjoni tal-pajji\ li 
jkun ser jimporta. 
(9) Is-Suprintendent jista’ jipprojbixxi, jew xort’o]ra 
jirrestrin[i, l-importazjoni ta’ kull medi`ina spe`ifikata jekk ikun 
jidhirlu li hekk me]tie[ fl-interess pubbliku. 
Pussess ta’ 
medi`ini 
spe`ifikati. 
Kap. 31. 
5. (1) Ebda persuna, jekk ma tkunx awtorizzata kif imiss, ma 
jista’ jkollha fil-pussess tag]ha xi medi`ina spe`ifikata. 
(2) G]all-g]an ta’ dan ir-regolament, persuna titqies li hi 
awtorizzata kif imiss jekk isimha jkun imni\\el fir-Re[istru 
Mediku, fir-Re[istru tal-Kirurgi-Dentisti, jew fir-Re[istru tal- 
Veterinarji, jew jekk tkun spi\jar diri[ent, jew ikollha li`enza 
ma]ru[a mis-Suprintendent skond l-artikolu 89 ta’ l-Ordinanza 
dwar il-Professjoni Medika u l-Professjonijiet li g]andhom 
x’jaqsmu mag]ha, jew tkun kisbet dik il-medi`ina bis-sa]]a ta’ 
ri`etta medika, jew xort’o]ra skond id-disposizzjonijiet ta’ dawn ir- 
Regolamenti: 
I\da, dwar persuna awtorizzata bis-sa]]a ta’ ri`etta medika, 
dik ir-ri`etta ma g]andhix titqies li hi valida jekk, fil-]in li ti[i 
ri`evuta dik ir-ri`etta, dik il-persuna kienet ta]t il-kura ta’ tabib 
ie]or u kienet qed tir`ievi dawk il-medi`ini spe`ifikati bis-sa]]a ta’ 
ri`etta ming]and dak it-tabib l-ie]or u ma kenitx g]arrfet lil min 
g]amel ir-ri`etta b’dan l-fatt. 
Ti\mim fi\-\gur 
ta’ medi`ini 
ristretti u 
spr`ifikati. 
6. Kull persuna awtorizzata biex tippossjedi medi`ini 
spe`ifikati skond id-disposizzjonijiet tar-regolament 5 u kull 
persuna awtorizzata b’mod spe`jali dwar medi`ini ristretti, skond 
il-ka\, g]andha, meta ma tkunx qed tu\a dawk il-medi`ini, 
i\\ommhom maqfulin u hija fid-dmir li tie]u dawk il-passi kollha 
me]tie[a biex dan ikun fi\-\gur u biex tipprevjeni li jsir serq jew 
diversifikazzjoni o]ra ta’ l-istock: 
I\da dan ir-regolament ma japplikax g]al min ikollu filpussess 
tieg]u medi`ini spe`ifikati bis-sa]]a ta’ ri`etta medika. 
U\u u kontenut ta’ 
ri`etta. 7. (1) Kull ri`etta g]al medi`ina spe`ifikata g]andha tkun 
miktuba bl-inka jew b’materjal ie]or li ma jit]assarx fuq il-formula 
murija fis-Seba’ Skeda li tinsab ma’ dawn ir-Regolamenti.

4 L.S.31.18] KONTROLL TAL-MEDI~INI 
(2) It-tabib li jo]ro[ ri`etta g]al medi`ina spe`ifikata g]andu 
jimla’ b’kitba `ara u li tinqara t-Taqsima A tal-formula murija fis- 
Seba’ Skeda u g]andu jag]ti d-dettalji kollha u t-tag]rif kollu flispazju 
xieraq kif hemm hu me]tie[; g]andu ini\\el ukoll il-firma 
tieg]u s]i]a u d-data meta jkun ]are[ ir-ri`etta: 
Kap. 31. 
I\da fil-ka\ ta’ tabib awtorizzat ta]t l-artikolu 5 ta’ l- 
Ordinanza dwar il-Professjoni Medika u l-Professjonijiet li 
g]andhom x’jaqsmu mag]ha biex je\er`ita l-professjoni medika 
i\da li ma jkunx g]adu [ie re[istrat mal-Kunsill Mediku, dak ittabib 
g]andu jni\\el in-numru mog]ti lilu mis-Suprintendent 
minflok in-numru tar-re[istrazzjoni tal-Kunsill Mediku fuq limsemmija 
ri`etta. 
(3) Bla ]sara g]ad-disposizzjonijiet tas-sub-regolament (11) ta’ 
dan ir-regolament, ebda tabib ma jista’ jo]ro[ ri`etta g]al medi`ina 
spe`ifikata kemm-il darba r-ri`etta ma tkunx taqbel maddisposizzjonijiet 
ta’ dan ir-regolament u dik il-medi`ina ma tkunx 
me]tie[a g]all-fini ta’ kura medika: 
I\da, tabib jista’, bla ]sara g]ad-disposizzjonijet l-o]ra ta’ 
dawn ir-Regolamenti, jo]ro[ ri`etta g]al u\u professjonali g]al 
ammont ta’ mhux i\jed minn g]axar fjali g]al injezzjoni jew 
g]oxrin pillola jew kapsula. 
(4) Kull tabib li jikseb medi`ina spe`ifikata g]al u\u 
professjonali kif provdut fil-proviso g]as-sub-regolament (3) ta’ 
dan ir-regolament g]andu j\omm notament f’re[istru xieraq ta’ lisem 
u l-kunjom (jekk applikabbli), l-età u l-indirizz tal-pazjent li 
lilu ng]atat il-medi`ina u d-data meta ng]atat. 
(5) Ebda tabib ma jista’ jo]ro[ ri`etta g]al medi`ina 
spe`ifikata lil xi persuna kemm-il darba dik il-persuna ma jkunx 
jafha sewwa jew kemm-il darba t-tabib ma jkunx \gura l-identità ta’ dik il-persuna permezz tal-karta ta’ l-identità tag]ha. 
(6) Ebda tabib ma g]andu jo]ro[ ri`etta g]al medi`ina 
spe`ifikata lil xi persuna kemm-il darba dak it-tabib ma jkunx ]a lpassi 
xierqa bi\\ejjed biex ji\gura li dik il-persuna ma tkunx, fi\- 
\mien li jo]ro[ ir-ri`etta, qed tir`ievi kura minn tabib ie]or dwar 
dipendenza (addiction) minn xi medi`ina spe`ifikata jew xort’o]ra, 
u li dik il-persuna ma tkunx [iet provduta b’xi medi`ina b]al dik 
fuq ri`etta ma]ru[a minn dak it-tabib l-ie]or. 
Kap. 101. 
(7) Tabib g]andu ju\a formula separata dwar kull medi`ina 
preskritta minnu skond dan ir-regolament u ma tista’ ti[i preskritta 
ebda medi`ina jekk ma tkunx medi`ina spe`ifikata jew medi`ina li 
taqa’ ta]t id-disposizzjonijiet ta’ l-Ordinanza dwar Medi`ini 
Perikolu\i. 
(8) Tabib g]andu, meta jippreskrivi medi`ina spe`ifikata, ju\a 
biss formuli ta’ ri`etta mill-ktejjeb tal-formuli li jkollu numru tasserje, 
ma]ru[ lilu mis-Suprintendent fuq talba mag]mula fuq ilformula 
murija fit-Tmien Skeda li tinsab ma’ dawn ir-Regolamenti 
u kull tabib, sew g]all-fini tal-prattika privata tieg]u jew biex jaqdi 
d-dmirijiet tieg]u f’kariga uffi`jali min]abba l-impieg tieg]u malgvern, 
bil-g]an li jaqdi l-]ti[iet tal-pazjenti tieg]u, g]andu jag]mel 
kull talba g]al dak il-ktejjeb ta’ ri`etti fuq l-imsemmija formula. 
Dik il-formula g]andha timtela’ tajjeb f’kollox u g]andha tkun

KONTROLL TAL-MEDI~INI [L.S.31.18 5 
iffirmata mit-tabib, u g]andha jew ting]ata bl-idejn minn dak ittabib 
personalment lill-ispi\jar ewlieni fl-iStores Medi`i tal-Gvern 
fi Gwardamangia jew tintbag]at bil-posta lis-Suprintendent tas- 
Sa]]a Pubblika fid-Dipartiment tas-Sa]]a, il-Belt Valletta, u meta 
j i n t b a g ] a t b i l - p o s t a l - i n v i l o p p j i s t a ’ j k u n i m m a r k a t 
"Notifikazzjonijiet tas-Sa]]a Pubblika" g]all-fini ta’ e\enzjoni 
minn pusta[[. 
(9) It-tabib g]andu jirrapporta minnufih bil-miktub lis- 
Suprintendent kull ka\ ta’ serq jew telf ta’ ktejjeb u ma jkunx jista’ 
ju\a xi formula ta’ ri`etta minn xi ktejjeb ta’ formuli ma]ru[ lil xi 
tabib ie]or. 
(10) G]all-finijiet ta’ dan ir-regolament, kemm-il darba r-rabta 
tal-kliem ma te]tie[x xort’o]ra, l-espressjoni "tabib" tinkludi 
kirurgu-dentist, dentist u veterinarju. 
(11) Id-disposizzjonijiet tas-sub-regolamenti (l), (2), (7) u, 
safejn applikabbli, tas-sub-regolamenti (8) u (9) ta’ dan irregolament 
ma g]andhomx japplikaw meta jing]ataw medi`ini 
spe`ifikati g]all-u\u ta’ pazjenti fi swali fi sptarijiet tal-gvern, billi 
dan ikun ikkontrollat bir-regoli interni ta’ l-isptar. 
G]oti ta’ ri`etti. 8. (1) Ebda persuna ]lief spi\jar ma tista’ tag]ti medi`ina 
spe`ifikata b’ri`etta. 
(2) Spi\jar ma jistax jag]ti medi`ina spe`ifikata b’ri`etta 
kemm-il darba - 
(a) ma jkunx jag]raf il-firma tal-persuna li ming]andha 
tkun tidher li n]ar[et, ikollu ra[uni ja]seb li ma tkunx 
[enwina u ma jkunx ]a passi xierqa biex ji\gura lilu 
nnifsu li tkun [enwina; u 
(b) ir-ri`etta ma tkunx skond id-disposizzjonijiet tarregolament 
7 ta’ dawn ir-Regolamenti. 
(3) Ebda medi`ina spe`ifikata ma tista’ ti[i provduta iktar 
minn darba fuq l-istess ri`etta. 
(4) Spi\jar li jag]ti medi`ina spe`ifikata f’ri`etta g]andu 
jimla’ b’kitba `ara u li tinqara bl-inka jew b’materjal ie]or li ma 
jit]assarx, it-Taqsima ~ tal-formula murija fis-Seba’ Skeda li 
tinsab ma’ dawn ir-Regolamenti u jag]ti d-dettalji kollha u t-tag]rif 
kollu me]tie[ fiha; l-ispi\ar g]andu wkoll ini\\el il-firma tieg]u u 
d-data u g]andu, wara li jag]ti l-medi`ina, j\omm ir-ri`etta. 
(5) G]all-fini tas-sub-regolament (4) ta’ dan ir-regolament ikun 
id-dmir ta’ l-ispi\jar li jkun qed jag]ti medi`ina spe`ifikata 
f’ri`etta li jitlob il-karta ta’ l-identità tal-persuna li dwarha r-ri`etta 
tkun in]ar[et u jkun id-dmir tal-persuna li jkun fi ]siebha takkwista 
medi`ina spe`ifikata, sew jekk g]aliha jew g]all-persuna li lilha 
jkunu [ew preskritti l-medi`ini, li tippre\enta l-imsemmija karta ta’ 
l-identità kif ukoll il-karta ta’ l-identità tag]ha stess flimkien marri`
etta: 
I\da d-disposizzjonijiet ta’ dan is-sub-regolament u l-parti 
relattiva tad-disposizzjonijiet tas-sub-regolament (4) ta’ dan irregolament 
ma japplikawx dwar persuna li ma tkunx g]adha 
in]ar[itilha karta ta’ l-identità.

6 L.S.31.18] KONTROLL TAL-MEDI~INI 
(6) Kull spi\jar diri[ent ta’ spi\erija li`enzjata g]andu jibg]at 
lis-Suprintendent f’invilopp issi[illat fl-ewwel jum ta’ kull xahar 
ir-ri`etti kollha g]al medi`ini spe`ifikati li jkunu [ew mog]tja 
minn dik l-ispi\erija matul ix-xahar ta’ qabel; l-imsemmi invilopp 
g]andu jkun indirizzat "Suprintendent tas-Sa]]a Pubblika, 
Dipartiment tas-Sa]]a, il-Belt Valletta" u jista’ jkun immarkat 
"Notifikazzjonijiet tas-Sa]]a Pubblika" g]all-fini ta’ e\enzjoni 
minn pusta[[. 
Dokument ta’ 
kontroll. 
Mi\jud: 
A.L. 65 ta’ l-1986. 
Emendat: 
A.L. 34 ta’ l-1989. 
9.(1) (a) Ebda tabib ma jista’ jo]ro[ ri`etta g]al xi medi`ina 
spe`ifikata lil xi persuna ]lief lil min ikollu fil-pussess 
tieg]u dokument ta’ kontroll, b]al ma jidher fid-Disa’ 
Skeda li tinsab ma’ dawn ir-Regolamenti. Id-dokument 
jin]are[ g]al dan il-g]an mis-Suprintendent tas-Sa]]a 
Pubblika; 
(b) Meta tin]are[ ri`etta g]al medi`ina spe`ifikata lil xi 
persuna, min jo]ro[ ir-ri`etta g]andu jikteb b’mod `ar, 
li ma jit]assarx u li jinqara, dawk id-dettalji kollha 
ndikati fil-kolonni minn 1 sa 4 tad-dokument ta’ 
kontroll, u mbag]ad jag]ti lura dan id-dokument lil dik 
il-persuna flimkien mar-ri`etta: 
I\da tabib jista’, meta jkun qieg]ed japplika f’isem persuna 
fuq il-formula tat-talba kif indikata fl-G]axar Skeda li tinsab ma’ 
dawn ir-Regolamenti, jo]ro[ ukoll ri`etta g]al provvista ta’ 
medi`ina spe`ifikata lil dik il-persuna u jista’ jehme\ ir-ri`etta ma’ 
dik il-formula tat-talba: 
I\da wkoll dik ir-ri`etta ssir biss tiswa meta ddisposizzjonijiet 
tal-proviso g]as-sub-regolament (2) ta’ dan irregolament 
ikunu [ew osservati. 
(2) Is-Suprintendent g]andu jo]ro[ dan id-dokument ta’ 
kontroll lill-persuna interessata wara li ssir talba minn tabib g]al 
dan l-iskop, fuq il-formula indikata fl-G]axar Skeda li tinsab ma’ 
dawn ir-Regolamenti: 
I\da fil-ka\ ta’ ri`etta g]al provvista ta’ medi`ina 
spe`ifikata kif provdut fil-provisi g]as-sub-regolament (1) ta’ dan 
ir-regolament, is-Suprintendent g]andu jni\\el id-dettalji tar-ri`etta 
relattiva fil-kolonni 1 sa 4 tad-dokument ta’ kontroll. 
(3) Kull dokument ta’ kontroll huwa validu g]al sena mid-data 
li jin]are[. Dan jista’ ji[i m[edded mis-Suprintendent wara li ssir 
talba minn tabib fuq il-formula ndikata fl-G]axar Skeda li tinsab 
ma’ dawn ir-Regolamenti. 
(4) L-ebda spi\jar ma g]andu jservi xi medi`ina spe`ifikata lil 
xi ]add li ma jkollux fil-pussess tieg]u dokument ta’ kontroll kif 
indikat fis-sub-regolament (1) ta’ dan ir-regolament. 
(5) Meta spi\jar iservi medi`ina spe`ifikata, huwa g]andu, 
minbarra d-dmirijiet l-o]ra spe`ifikati b’dawn ir-Regolamenti jew 
b’xi li[i o]ra, ini\\el b’mod `ar, li ma jit]assarx u li jinqara sew, 
dawk id-dettalji kollha li hemm indikati fil-kolonni minn 5 sa 8 fuq 
id-dokument, u imbag]ad g]andu jibg]at lura d-dokument lil min 
ikun ippre\entalu r-ri`etta.

KONTROLL TAL-MEDI~INI [L.S.31.18 7 
(6) (a) Tabib jista’ jo]ro[ ri`etta g]al xi medi`ina spe`ifikata 
f’ka\ijiet ur[enti lill-pazjent li ma jkollux fil-pussess 
tieg]u dokument ta’ kontroll sakemm: 
(i) ir-ri`etta jkollha tikketta li tindika li hi 
"UR{ENTI"; 
(ii) l-ammont imni\\el fir-ri`etta jkun g]all-u\u ta’ 
mhux iktar minn sebat ijiem; 
(iii) tkun taqbel ma’ ]ti[iet o]ra ta’ dawn ir- 
Regolamenti; u 
(iv) min jo]ro[ ir-ri`etta g]andu jinforma lis- 
Suprintendent fi \mien tmienja u erbg]in sieg]a 
minn meta jo]ro[ ir-ri`etta billi jag]ti lpartikolaritajiet 
kollha tal-pazjent, l-isem, forma 
u do\a u l-kwantità ta’ medi`ina li g]aliha tkun 
]ar[et ir-ri`etta u r-ra[uni g]al din l-ur[enza. 
(b) Spi\jar ikun jista’ iservi din ir-ri`etta sakemm din tkun 
taqbel mal-]ti[iet tas-sub-paragrafi (i), (ii) u (iii) talparagrafu 
(a) ta’ dan is-sub-regolament. 
(7) Id-disposizzjonijiet ta’ dan ir-regolament ma g]andhomx 
japplikaw g]all-]ru[ ta’ ri`etta g]al medi`ini spe`ifikati minn 
tabib li jkun ja]dem fi sptar tal-gvern, biex din ting]ata lil pazjenti 
fis-swali ta’ l-isptar filwaqt li dawn ikunu ta]t il-kura tieg]u f’dan 
l-isptar, u din ir-ri`etta tkun regolata mir-regoli interni ta’ l-isptar. 
(8) Kull talba jew notifikazzjoni li jistg]u jsiru skond dan irregolament 
jistg]u jsiru mill-persuna nnifisha jew jistg]u 
jintbag]tu bil-posta f’invilopp si[illat li jkun indirizzat lis- 
Suprintendent tas-Sa]]a Pubblika, Dipartiment tas-Sa]]a, Valletta, 
u li jinkiteb fuqu "Notifikazzjoni dwar Sa]]a Pubblika - 
Konfidenzjali" sabiex dan ji[i e\entat mill-]las tal-posta. 
(9) G]all-iskop ta’ dan ir-regolament, il-kelma "tabib" tinkludi 
wkoll kirurgu dentist u dentist. 
(10) Is-Suprintendent jista’ jirtira d-dokument ta’ kontroll ta’ 
persuna li tkun suspettata li qieg]da tabbu\a minn medi`ina li 
g]aliha tkun in]ar[itilha ri`etta, jew li tkun qieg]da mod ie]or 
tabbu\a mis-sistema tad-dokument ta’ kontroll. 
(11) Is-Suprintendent jista’ jinkludi fuq id-dokument ta’ kontroll 
dawk id-direttivi li jqis li jkunu me]tie[a dwar il-]ru[ ta’ ri`etti 
g]al medi`ini spe`ifikati. 
E\emplari talfirma 
ta’ min jag]ti 
ri`etta. 
10. (1) L-ebda tabib, kirurgu-dentist, dentist jew veterinarju 
ma g]andu jippreskrivi xi medi`ina spe`ifikata jew ri`etta kemm-il 
darba s-Suprintendent ma jkollux l-e\emplari tal-firma tieg]u. 
(2) Is-Suprintendent jista’, g]all-fini tal-kontroll tal-medi`ini, 
ji``irkola lill-ispi\jara diri[enti kollha kopja ta’ kull e\emplari talfirma 
b]al dik li tkun fil-pussess tieg]u. 
Konsenja ta’ 
medi`ini 
spe`ifikati lil 
persuni li`enzjati 
jew awtorizzati. 
11. (1) L-ebda persuna ma g]andha tikkonsenja xi medi`ina 
spe`ifikata lil xi persuna o]ra jekk mhux wara li ting]ata r`evuta 
ffirmata kif imiss. 
(2) Ebda persuna ma g]andha tikkonsenja xi medi`ina

8 L.S.31.18] KONTROLL TAL-MEDI~INI 
spe`ifikata lil xi persuna o]ra li ma tkunx spi\jar diri[ent jew li 
xort’o]ra ma tkunx awtorizzata bil-mod xieraq biex ikollha filpussess 
tag]ha dik il-medi`ina, kemm-il darba dik il-persuna l-o]ra 
ma tipprodu`ix awtorizzazzjoni bil-miktub g]al hekk iffirmata kif 
imiss mill-ispi\jar diri[ent jew mill-persuna li tkun xort’o]ra 
awtorizzata b’mod xieraq li jkollha fil-pussess tag]ha dik ilmedi`
ina, u kemm-il darba l-persuna li tkun qed tikkonsenja dik ilmedi`
ina ma tkunx sodisfatta li l-awtorizzazzjoni hi [enwina. 
(3) Ebda ]a[a fis-sub-regolamenti ta’ qabel ta’ dan irregolament 
ma g]andha titqies li tirreferi g]all-provvista ta’ xi 
medi`ina spe`ifikata mal-pre\entazzjoni ta’ ri`etta medika skond 
id-disposizzjonijiet ta’ dawn ir-Regolamenti jew g]all-g]oti ta’ xi 
medi`ina b]al dik minn jew ta]t is-sorveljanza ta’ tabib, kirurgudentist, 
dentist jew veterinarju. 
(4) G]all-fini ta’ dan ir-regolament, "tikkonsenja" tinkludi kull 
eg]mil jew nuqqas fejn persuna tippermetti jew t]alli lil xi persuna 
o]ra, li ma tkunx persuna awtorizzata skond regolamenti, li jkollha 
fil-pussess tag]ha xi medi`ina spe`ifikata, li tie]u fil-pussess 
tag]ha dik il-medi`ina. 
Konservazzjoni ta’ 
ri`etti, re[istri, 
notamenti u 
dokumenti o]ra. 
12. Kull ri`etta li tkun [iet esegwita, u kull re[istru, notament, 
fattura jew dokument ie]or dwar il-manifattura, importazzjoni, xiri, 
bejg], provvista, tqassim, jew disponiment ie]or ta’ medi`ini 
spe`ifikati g]andhom jin\ammu fil-post li g]alih jirreferixxu u 
g]andhom ji[u konservati g]al \mien ta’ mhux inqas minn sentejn 
mid-data tar-ri`etta, notament, fattura jew dokument ie]or, jew 
mid-data ta’ l-a]]ar re[istrazzjoni fir-re[istru, skond il-ka\, u 
matul dak i\-\mien ikunu g]ad-disposizzjoni biex ji[u spezzjonati 
mis-Suprintendent jew mir-rappre\entant tieg]u. 
Avvi\ minn min 
jag]ti ri`etta u 
mill-ispi\jar 
diri[ent dwar `erti 
medi`ini. 
Emendat: 
A.L. 70 ta’ l-1988. 
13. (1) Ebda tabib ma jista’ jo]ro[ ri`etta g]al xi preparat li 
jkun mag]mul minn jew li jkun fih amfetamina, jew xi isomer ta’ 
amfetamina, cathine, fenetylline, flunitrazepam, mecloqualone, 
methaqualone, methylphenidate, jew phenmetrazine, jew xi salts jew esters ta’ dawn il-medi`ini, jew g]al xi preparat li jkun 
mag]mul minn secobarbital jew amobarbital jew minn ta]lita ta’ 
secobarbital u amobarbital, f’kull ka\ f’forma ta’ tablet jew 
kapsula, jew f’sachet jew cachet, jew minn xi salts jew esters tag]hom f’dik l-g]amla, jekk ma jkollux minn qabel lawtorizzazzjoni 
bil-miktub tas-Superintendent. 
(2) Is-Suprintendent jista’, qabel ma jag]ti xi awtorizzazzjoni 
kif imsemmi fis-sub-regolament (1) ta’ dan ir-regolament, jitlob 
ming]and it-tabib dak it-tag]rif li s-Suprintendent je]tie[, anki 
jekk fil-fehma tat-tabib il-pazjent ikun jkollu b\onn li jie]u dik ilmedi`
ina. 
(3) Meta ssir talba g]al dik l-awtorizzazzjoni, is-Suprintendent 
g]andu jissottometti dik it-talba lil panel ta’ spe`jalisti medi`i li 
g]andhom jag]tu parir lis-Suprintendent jekk dik it-talba g]andhix 
ti[i awtorizzata jew le. 
(4) Qabel ma jag]mlu r-rakkomandazzjoni, huma g]andhom 
jaraw jekk dik il-preskrizzjoni tkunx indikata u l-panel g]andhom 
ukoll, meta jkun il-ka\, jag]mlu dawk ir-rakkomandazzjonijiet li 
jkunu me]tie[a bil-]sieb li l-pazjent bil-mod il-mod jidra ming]ajr

KONTROLL TAL-MEDI~INI [L.S.31.18 9 
dik il-medi`ina. 
(5) Is-Suprintendent jista’, jekk jidhirlu li jkun fl-interess talpazjent, 
jawtorizza l-preskrizzjoni ta’ dik il-medi`ina sakemm 
jir`ievi r-rapport tal-panel. 
(6) Kull tabib li jag]ti ri`etta kif imsemmi fis-sub-regolament 
(1) ta’ dan ir-regolament g]andu jg]arraf lis-Suprintendent fi 
\mien erbg]a u g]oxrin sieg]a minn meta jkun ta ri`etta ta’ dak ilpreparat 
fejn jag]ti d-dettalji murija fir-Raba’ Skeda li tinsab ma’ 
dawn ir-Regolamenti. 
(7) Kull spi\jar li jipprepara medi`ina fuq ir-ri`etta kif 
imsemmi fis-sub-regolament (1) ta’ dan ir-regolament g]andu 
jg]arraf lis-Suprintendent fi \mien erbg]a u g]oxrin sieg]a minn 
meta jkun ipprepara dik il-medi`ina, fejn jag]ti d-dettalji murija 
fil-}ames Skeda li tinsab ma’ dawn ir-Regolamenti. 
(8) L-avvi\i kollha li jing]ataw skond is-sub-regolamenti (6) u 
(7) ta’ dan ir-regolament g]and]om ji[u mmarkati "Konfidenzjali". 
(9) Ebda veterinarju, kirurgu-dentist jew dentist ma jista’ 
jippreskrivi preparat kif imsemmi fis-sub-regolament (1) ta’ dan irregolament. 
(10) Jekk il-President tar-Repubblika jkollu g]aliex ja]seb li 
tabib, jew kirurgu-dentist jew dentist, ikun qed jag]ti jew 
jippreskrivi xi medi`ina spe`ifikata g]alih innifsu jew g]al xi 
persuna o]ra, li ma tkunx me]tie[a, jew aktar milli jkun me]tie[, 
g]all-kura medika jew dentali tieg]u nnifsu jew ta’ dik il-persuna lo]
ra, skond il-ka\, jew li veterinarju jkun qed jag]ti jew 
jippreskrivi xi medi`ina spe`ifikata dwar xi annimal ta]t il-kura 
tieg]u, li ma tkunx me]tie[a, jew aktar milli jkun me]tie[, g]allkura 
ta’ dak l-annimal, skond il-ka\, il-President jista’ jirreferi lkwistjoni 
lill-Kunsill Mediku, u, jekk l-imsemmi Kunsill hekk 
jirrakkomanda, l-President jista’ jipprojbixxi lill-imsemmi tabib, 
kirurgu-dentist jew dentist, jew veterinarju, milli jag]ti, 
jippreskrivi, jikseb jew li jkollu fil-pussess tieg]u dik il-medi`ina 
g]al dak i\-\mien li l-President jidhirlu xieraq, u f’dan il-ka\ ikun 
kontra l-li[i li dak it-tabib, kirurgu-dentist jew dentist, jew 
veterinarju jag]ti, jippreskrivi, jikseb jew li jkollu fil-pussess 
tieg]u xi medi`ina matul dak i\-\mien: 
I\da l-President jista’, f’kull \mien, jimmodifika jew jirtira 
kull projbizzjoni. 
(11) Avvi\ ta’ kull projbizzjoni, modifika jew irtirar ta’ kull 
projbizzjoni g]andu jing]ata bil-miktub lill-persuna hekk milquta. 
(12) Is-Suprintendent ikun jista’ jqassam lil kull tabib - 
(a) l-isem, u d-dettalji l-o]ra li jidhru fis-Sitt Skeda li 
tinsab ma’ dawn ir-Regolamenti, ta’ kull persuna li 
g]aliha jkun [ie preskritt xi preparat kif imsemmi fissub-
regolament (1) ta’ dan ir-regolament; u lil kull 
tabib, kirurgu-dentist u dentist 
(b) l-isem, u d-dettalji l-o]ra kif jidhru fis-Sitt Skeda li 
tinsab ma’ dawn ir-Regolamenti, ta’ kull persuna li 
g]aliha tkun [iet preskritta jew preparata xi medi`ina

10 L.S.31.18] KONTROLL TAL-MEDI~INI 
spe`ifikata. 
Avvi\i u twissijiet 
fuq it-tikketta, e``. 14. (1) Is-Suprintendent jista’ je]tie[ lill-manifatturi, 
importaturi u esportaturi kollha, u lill-persuni l-o]ra kollha li 
jikkummer`jaw jew xort’o]ra jinnegozjaw f’xi medi`ina ristretta 
jew f’xi medi`ina spe`ifikata, li jinkludi dawk it-twissijiet jew 
avvi\i o]ra fuq it-tikketta, meta jkun prattikabbli, jew mal-fuljett li 
jkollu mieg]u l-pakkett li fih jinbieg]u bl-imnut dawk il-medi`ini, 
li fil-fehma tieg]u jkunu me]tie[a g]as-sigurezza tal-persuni li 
ju\aw dawk il-medi`ini. 
(2) Ebda persuna ma tista’ b’xi mod tirreklama lill-pubbliku in 
[enerali xi medi`ina ristretta jew medi`ina spe`ifikata. 
Tag]rif minn 
fabbrikant jew 
importatur. 
Mi\jud: 
A.L. 173 ta’ l- 
1993. 
15. (1) Kull persuna li timmanifattura jew timporta xi 
medi`ina jew xi preparat farma`ewtiku g]andha, fi \mien tmint 
ijiem ta’ dik il-manifattura jew importazzjoni, tav\a lis- 
Suprintendent fejn tag]ti d-dettalji dwar il-kontenut u d-do\a ta’ 
dik il-medi`ina jew preparat farma`ewtiku: 
I\da meta persuna tkun ]arset darba d-disposizzjonijiet ta’ 
dan is-sub-regolament dwar medi`ina jew preparat farma`ewtiku 
partikolari, din ma tkunx marbuta li t]arishom dwar xi manifattura 
jew importazzjoni o]ra ta’ l-istess medi`ina jew preparat 
farma`ewtiku li jkollu l-istess isem kummer`jali u jkun mag]mul 
mill-istess kontenut u do\a. 
(2) Is-Suprintendent jista’, f’kull \mien, jitlob lill-manifattur 
jew lill-importatur ta’ kull medi`ina jew preparat farma`ewtiku, 
skond il-ka\, biex jag]ti dak it-tag]rif li s-Suprintendent jista’ 
je]tie[ dwar dik il-medi`ina jew preparat farma`ewtiku u limsemmi 
manifattur jew importatur, skond il-ka\, g]andu 
jissodisfa dik it-talba fi \mien ]mistax-il [urnata. 
(3) Is-Suprintendent jista’ - 
(a) jipprojbixxi l-importazzjoni ta’ xi medi`ina kemm-il 
darba dik il-medi`ina ma jkollhiex mag]ha - 
(i) `ertifikat a``ettabbli g]as-Suprintendent, millawtorità 
kompetenti tal-gvern tal-pajji\ ta’ lori[
ini, li jg]id li dik il-medi`ina tkun [iet 
manifatturata minn ditta awtorizzata kif imiss 
biex tipprodu`i dik il-medi`ina g]all-bejg] flistess 
pajji\, u li l-fa`ilitajiet g]all-kontroll talkwalità 
fid-ditta jkunu sodisfa`enti, u 
(ii) `ertifikat, a``ettabbli g]as-Suprintendent, li 
jg]id li l-medi`ina tkun taqbel mal-livell 
imsemmi fil-British Pharmacopea jew fil-British 
Pharmaceutical Codex jew ma’ livelli o]ra 
a``ettabbli g]as-Suprintendent, jew, meta ma 
jkun je\isti ebda livell b]al dak dwar dik ilmedi`
ina, `ertifikat, a``ettabbli bl-istess mod, 
ta’ l-anali\i ta’ dik il-medi`ina; 
(b) jissospendi jew jipprojbixxi li titqassam, jew li ti[i 
provduta, tinbieg], offerta g]all-bejg] jew tin]a\en 
kull medi`ina li tkun di[à mportata sakemm i`-

KONTROLL TAL-MEDI~INI [L.S.31.18 11 
`ertifikati msemmija fis-sub-paragrafi (i) u (ii) talparagrafu 
(a) ta’ dan is-sub-regolament ji[u prodotti: 
I\da ebda sospensjoni jew projbizzjoni b]al dik ma 
jkollha effett qabel ma jg]addi xahar mid-data tattalba 
ta’ dawk i`-`ertifikati mill-imsemmi 
Suprintendent. 
(4) Is-Suprintendent jista’ jirtira jew jara li ti[i rtirata mis-suq 
kull medi`ina jew preparat farma`ewtiku jekk, min]abba 
f’rejazzjoni kuntrarja jew f’tag]rif ie]or dwar effetti ]\iena, 
prattika ta’ manifattura jew tag]rif ie]or tekniku jew xjentifiku, 
ikun fil-fehma tieg]u a]jar li dik il-medi`ina jew dak il-preparat 
ji[u rtirati fl-interess tas-sa]]a tal-pazjenti. 
(5) G]all-g]anijiet ta’ dan ir-regolament, "medi`ina" tinkludi 
kull preparat medi`inali g]al u\u intern jew estern, sew jekk 
imni\\la jew spe`ifikata sew jekk ma tkunx fl-Ewwel jew fit-Tieni 
Skeda li tinsab ma’ dawn ir-Regolamenti. 
E\enzjonijiet. 16. (1) Dawn ir-Regolamenti ma g]andhomx japplikaw, dwar 
xi medi`ina spe`ifikata, g]al xi medi`ina li tkun tifforma parti, jew 
tkun inkorporata ma’ preparat lest g]all-u\u u li ma jkunx je]tie[ li 
jigi aktar ma]dum, kemm-il darba dik il-medi`ina ma tkunx lingredjent 
prin`ipali jew l-uniku ingredjent attiv tal-preparat. 
(2) Dawn ir-Regolamenti bl-istess mod ma g]andhomx 
japplikaw fil-ka\ ta’ preparat li jkun fih medi`ina spe`ifikata, li 
jkun ma]dum b’mod li ma jkun ta’ ebda riskju, jew ta’ riskju 
negli[ibbli, ta’ abbu\, u s-sustanza ma tkunx tista’ tinkiseb b’mezz 
li tista’ tapplikah malajr fi kwantità li tista’ twassal g]al abbu\, 
hekk illi l-preparat ma jistax jo]loq problema g]as-sa]]a pubblika 
jew so`jali. 
Riserva. 17. Kull ri`etta esegwita, re[istru, notament, fattura jew 
dokument ie]or li, fil-bidu fis-se]] ta’ dawn ir-Regolamenti, kienu 
konservati skond ir-Regolamenti ta’ l-1976 dwar il-Kontroll tal- 
Medi`ini*, g]andhom jibqg]u konservati u jin\ammu biex jistg]u 
ji[u spezzjonati u g]andhom g]al dawn l-g]anijiet jitqiesu li 
dejjem kienu konservati skond dawn ir-Regolamenti. 
*Im]assra b’dawn ir-Regolamenti.

12 L.S.31.18] KONTROLL TAL-MEDI~INI 
Sostitwita: L-EWWEL SKEDA 
A.L. 70 ta’ l-1988. 
Emendata: 
A.L. 183 ta’ l-1999. (Regolament 2) 
U kull derivattivi, salts, jew esters ta’ dawk imsemmija hawn fuq. 
Isem internazzjonali jew isem ie]or kif 
komunement mag]ruf Isem kimiku 
CATHINONE (-)-a-aminopropiophenone 
DET N.N-diethyltryptamine 
DMA d l - 2 , 5 - d i m e t h o x y - a - 
methylphenylethylamine 
DMHP 3-(1,2-dimethylheptyl)-l-hydroxy-7, 8, 9, 
10-tetrahydro-6, 6, 9-trimethyl- 
6Hdibenzo [b, d) pyran 
DMT N.N-dimethyltryptamine 
DOB, BROLAMFETAMINE 2,5-dimethoxy-4-bromoamphetamine 
(+) LYSERGIDE, LSD, LSD-25 (+)-N.N-diethyllysergamide (d-lysergic 
acid diethylamide) 
DOET dl-2, 5-dimethoxy-4-ethyl-a 
methylphenylethylamine 
ENTRYPTAMINE 3-(2-aminobutyl) indole 
MDA, METHYLENE 
DIOXYAMPHETAMINE 3,4, methylenedioxyamphetamine 
MDMA, TENAMFETAMINE d l - 3 , 4 - m e t h y l e n e d i o x y - N , a - 
dimethylphenylethylamine 
METHCATHINONE 2-(methylamino)-1-phenylpropan-1-one 
MESCALINE, MESCAL 
BUTTON, PEYOTE, PEYOTL 
3, 4, 5-trimethoxyphenethylamine 
MMDA dl-5-methoxy-3,4-methylenedioxy-a 
methylphenylethylamine 
PARAHEXYL 3-hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro- 
6, 6, 9-trimethyl-6H-dibenzo [b, d) 
pyran 
PCE, ETICYCLIDINE N-ethyl-l-phenylcyclohexylamine 
PHP, PCPY, ROLICYCLIDINE 1-(1-phenylcyclohexyl) pyrrolidine 
PMA 4-methoxy-a-methylphenylethylamine 
PSILOCINE, PSILOTSIN 3 - ( 2 - d i m e t h y l a m i n o e t h y l ) - 4 - 
hydroxyindole 
PSILOCYBINE 3-(2-dimethylaminoethyl)-indol-4-y1 
dihydrogen phosphate 
STP. DOM 2-amino-1-(2, 5-dimethoxy-4-methyl) 
phenylpropane 
TETRAHYDROCANNABINO-LS, ALL 
ISOMERS 
1 - h y d r o x y - 3 - p e n t y l - 6 a , 7 , 1 0 , 1 0 a - 
tetrahydro-6, 6, 9-trimethyl-6-Hdibenzo 
[b, d) pyran 
TCP, TENOCYCLIDNE 1-[1-(2-thienyl) cyclohexyl) piperidine 
TMA dl-3, 4, 5-trimethoxy-amethylphenylethylamine

KONTROLL TAL-MEDI~INI [L.S.31.18 13 
IT-TIENI SKEDA Emendata: 
(Regolament 2) A.L. 26 ta’ l-1987. 
Sostitwita: 
A.L. 70 ta’ l- 1988. 
Emendata: 
A.L. 103 ta’ l- 1989; 
A.L. 78 ta’ l- 1998; 
A.L. 183 ta’ l-1999. 
Isem internazzjonali jew isem ie]or kif 
komunement mag]ruf Isem kimiku 
ALLOBARBITAL 5, 5-diallylbarbituric acid 
AMFEPRAMONE, DIETHYLPROPION 2-(diethylamino) propiophenone 
AMINOREX 2-amino-5-phenyl-2-oxazoline 
AMOBARBITAL 5-ethyl-5-(3-methylbutyl) barbituric acid 
AMPHETAMINE (±)-2-amino-l-phenylpropane 
BARBITAL 5, 5-diethylbarbituric acid 
BENZPHETAMINE N-benzyl-N, -dimethylphenethylamine 
BROTIZOLAM 2-bromo-4(o-chlorophenyl)-9-methyl-6Hthieno 
[3,2-f]-s-triazolo [4,3-a] [1,4] 
diazepine 
BUPRENORHINE 21-cyclopropyl-7-alpha-[(S)-l-hydroxy- 
1 , 2 , 2 - t r i m e t h y l p r o p y l ] - 6 , 1 4 - 
e n d oe t h a n o - 6 , 7 , 8 , 1 4 - 
tetrahydrooripavine 
BUTALBITAL 5-allyl-5-isobutylbarbituric acid 
BUTOBARBITAL 5-butyl-5-ethylbarbituric acid 
CATHINE d - t h r e o - 2 - a m i n o - 1 - h y d r o x y - l - 
phenylpropane 
CHLORAL HYDRATE 2, 2, 2-trichloroethane-1, 1-diol 
CHLORDIAZEPOXIDE 7-chloro-2-(methylamino)-5-phenyl-3H-1, 
4benzodiazepine-4-oxide 
CHLORPHENTERMINE p-chloro- -dimethylphenethlylamine 
CYCLOBARBITAL 5-(l-cyclohexen-l-y1)-5-ethylbarbituric 
acid 
DEXAMPHETAMINE (+)-2-amino-1-phenylpropane 
DIAZEPAM u kull komposti o]ra tieg]u 
li fihom l-istruttura kimika ta’ 
DIHYDRO-1:4 BENZODIAZEPINE jew ta’ DIHYDRO-1:5 
BENZODIAZEPINE sostitwit sa kull 
grad 7-chloro-1, 3-dihydro-1-methyl-5-phenyl- 
2H-1, 4-benzodiazepine-2-one 
DRONABINOL delta-9-tetrahydrocannabinol 
and its stereochemical 
variants (This item refers to only 
one of the stereochemical variants 
of delta-9-tetrahydrocannabinol, 
n a m e l y ( - ) - t r a n s - d e l t a - 9 - 
tetrahydrocannabinol.) 
(6aR, 10aR)-6a7, 8, 10a-tetrahydro-6,6,9- 
trimethyl-3-penatyl-6H-dibenzo [b,d] 
pyran-1-o1 
ETHCHLORVYNOL ethyl-2-chlorovinylethynylcarbinol 
ETHINAMATE l-ethynylcyclohexanolcarbamate 
µ 
µ

14 L.S.31.18] KONTROLL TAL-MEDI~INI 
FENCAMFAMIN dl-N-ethyl-3-phenylbicyclo (2,2,1)- 
heptan-2amine 
FENETYLLINE dl-3,7-dihydro-1, 3 dimethyl-7-(2-[(lmethyl2-
phenylethyl) amino] ethyl)- 
1H-purine-2, 6-dione 
FENFLURAMINE N-ethyl- -methyl-m(trifluoromethyl) 
phenethylamine 
FENPROPOREX d l - 3 - [ ( a - m e t h y l p h e n e t h y l ) a m i n o ] 
propionitrile 
GLUTETHIMIDE 2-ethyl-2-phenylglutarimide 
KETAMINE ( ± ) - 2 - ( 2 - C h l o r o p h e n y l ) - 2 - 
methylaminocyclohezanone 
LEVAMPHETAMINE 1-a-methylphenethylamine 
LEVOMETHAMPHETAMINE l-N, a-dimethylphenethylamine 
MAZINDOL 5-(p-chlorophenyl)-2, 5-dihydro-3Himidazo 
[2, 1-a] isoindol-5-ol 
MECLOQUALONE 3-(o-chlorophenyl)-2-methyl-4 (3H)- 
quinazolinone 
MEFENOREX d l - N - ( 3 - c h l o r o p r o p y l ) - a - 
methylphenethylamine 
MEPHENTERMINE N- -trimethylphenethylamine 
MEPROBAMATE 2-methyl-2-propyl-1, 3-propanediol 
dicarbamate 
MESOCARB 3 - ( - m e t h y l p h e n e t h y l ) - N - 
phenylcarbamoyl) sydnone imine 
METHAMPHETAMINE (+)-2-methylamino-l-phenylpropane 
METHAMPHETAMINE RACEMATE 
METHAQUALONE 2-methyl-3-o-tolyl-4(3H)-quinazolinone 
METHYLPHENIDATE 2-phenyl-2 (2-piperidyl) acetic acid, 
methyl ester 
METHYLPHENOBARBITAL 5-ethyl-l-methyl-5-phenylbarbituric acid 
METHYPRYLON 3, 3-diethyl-5-methyl-2, 4-piperidinedione 
N-ETHYLAMPHETAMINE dl-N-ethyl-a-methylphenylethylamine 
PARALDEHYDE acetaldehyde trimer 
PEMOLINE 2-amino-5-phenyl-2-oxazolin-4-one or 2- 
imino-5-phenyl-4-oxazolidinone 
PENTAZOCINE 1, 2, 3, 4, 5, 6, hexahydro-6, 11-dimethyl-3 
-(3-methyl-2-butenyl)-2, 6-methano- 
3benzazocin-8-o1 
PENTOBARBITAL 5-ethyl-5-(1-methylbutyl) barbituric acid 
PHENCYCLIDINE 1-(l-phenylcyclohexyl) piperidine 
PHENDIMETRAZINE (+)-3, 4-dimethyl-2-phenylmorpholine 
PHENMETRAZINE 3-methyl-2-phenylmorpholine 
PHENOBARBITAL 5-ethyl-5-phenylbarbituric acid 
PHENTERMINE a,a-dimethylphenethylamine 
PIPRADROL 1,l-diphenyl-l-(2-piperidyl) methanol 
PROPYLHEXEDRINE dl-1-cyclohexyl-2-methylaminopropane 
µ 
µ
µ

KONTROLL TAL-MEDI~INI [L.S.31.18 15 
U kull salt jew ester ta’ dawn ta’ hawn fuq. 
PYROVALERONE dl-l-(4-methylphenyl)-2-(l-pyrrolidinyl)- 
lpentanone 
SECBUTABARBITAL 5-sec-butyl-5-ethylbarbituric acid 
SECOBARBITAL 5-allyl-5-(l-methylbutyl) barbituric acid 
SPA, LEFETAMINE (-)-l-dimethylarnine-1, 2, diphenylethane 
VINYLBITAL 5-(l-methyl-butyl)-5-vinylbarbituric acid 
ZIPEROL -( -µethoxybenzl)-4- 
( ( ß - m e t h o x p h e n e t h y l ) - 1 - 
piperazineethanol 
µ µ

16 L.S.31.18] KONTROLL TAL-MEDI~INI 
IT-TIELET SKEDA 
Regolamenti 3 u 4

KONTROLL TAL-MEDI~INI [L.S.31.18 17

18 L.S.31.18] KONTROLL TAL-MEDI~INI 
IR-RABA’ SKEDA 
(Regolament 13 (4) ) 
KONFIDENZALI 
(Avvi\ skond ir-Regolament 13 - Ri`etti g]al amfetamina u l-isomers tag]ha, 
flunitrazepam, mecloqualone, methaqualone, methylphenidate u phenmetrazine, u 
secobarbital jew g]aqda ta’ secobarbital u amobarbital f’forma ta’ tablet jew kapsula 
jew f’sachet jew cachet, u s-salts jew l-esters rispettivi tag]hom) 
IMPORTANTI - Ri`etti g]al dawn il-preparati jistg]u jing]ataw biss wara li tinkiseb 
l-approvazzjoni bil-miktub ming]and is-Suprintendent tas-Sa]]a Pubblika g]al kull 
ri`etta. 
ISEM U L-INDIRIZZ TAL-PAZJENT ............................................... 
............................................... 
NRU. TAL-KARTA TA’ L-IDENTITÀ ............................................... 
ETÀ ............................................... 
ISEM TAL-PREPARAT U L-QAWWA 
TIEG}U ............................................... 
KWANTITÀ PRESKRITTA ............................................... 
DO|A TA’ KULJUM ............................................... 
DATA TAR-RI~ETTA ............................................... 
DATA U NRU. TAR-RIFERENZA TA’ LAPPROVAZZJONI 
TAS-SUPRINTENDENT 
TAS-SA}}A PUBBLIKA ............................................... 
FIRMA TAT-TABIB ............................................... 
ISEM (Ittri Kapitali) ............................................... 
INDIRIZZ ............................................... 
............................................... 
...............................................

KONTROLL TAL-MEDI~INI [L.S.31.18 19 
IL-}AMES SKEDA 
(Regolament 13 (5) ) 
KONFIDENZALI 
(Avvi\ skond ir-Regolament 13 - Ri`etti g]al amfetamina u l-isomers tag]ha, 
flunitrazepam, mecloqualone, methaqualone, methylphenidate u phenmetrazine, u 
secobarbital jew g]aqda ta’ secobarbital u amobarbital f’forma ta’ tablet jew kapsula 
jew f’sachet jew cachet, u s-salts jew l-esters rispettivi tag]hom) 
ISEM U L-INDIRIZZ TAL-PAZJENT ............................................... 
NRU. TAL-KARTA TA’ L-IDENTITÀ ............................................... 
ISEM TAL-PREPARAT U L-QAWWA 
TIEG}U ............................................... 
KWANTITÀ PRESKRITTA ............................................... 
DATA TAR-RI~ETTA ............................................... 
ISEM MIN IPPRESKRIVA R-RI~ETTA ............................................... 
FIRMA TAT-TABIB ............................................... 
FIRMA TA’ L-ISPI|JAR ............................................... 
ISEM (Ittri Kapitali) ............................................... 
NRU. TAL-LI~ENZA DH 
INDIRIZZ (Ta’ l-Ispi\erija) ............................................... 
............................................... 
............................................... 
DATA META NG}ATAW ...............................................

20 L.S.31.18] KONTROLL TAL-MEDI~INI 
IS-SITT SKEDA 
(Regolament 13) 
Isem u l-indirizz tal-pazjent ...................................................................................... 
Numru tal-Karta ta’ l-Identità ................................................................................... 
Data tal-preskrizzjoni ............................................................................................... 
Isem tal-medi`ina ..................................................................................................... 
Ammont preskritt ..................................................................................................... 
Isem tat-tabib, kirurgu-dentist jew dentist li ppreskriva l-medi`ina ........................... 
.

KONTROLL TAL-MEDI~INI [L.S.31.18 21 
IS-SEBA’ SKEDA 
(Regolament 7) 
PRESCRIPTION FOR NARCOTIC AND PSYCHOTROPIC DRUGS 
(Only one item may be prescribed on this Form) 
Serial No. 
A. TO BE FILLED BY PRESCRIBER C. TO BE FILLED BY 
DISPENSING APOTHECARY 
PATIENT 
Name and Surname ................................................................. PATIENT 
Address ................................................................................... Surname Name 
ITEM Quantity 
(incl. Form& Dose) I.D 
Directions for use 
Additional information in respect of Prescriptions for METHADONE Male Female 
ITEM 
Expected Duration of Treatment .................... Quanity Supplied 
Medical Indication ........................................ Total Quantity 
in Units ............................................................... 
PRESCRIBER Med Council Reg. No. Total Quanity 
in Weight/Measure ............................................... 
Name and Surname .......................................................... PRESCRIPTION ORIGIN 
Address .......................................................................... Hospitals ............................................................. 
Signature ............................................... Date .................... Govt. Clinics ....................................................... 
.. 
Private ....................................................... 
.. 
B. FOR OFFICIAL USE ONLY DISPENSER 
To be filled by Government Dispenser Signature................................................................ 
. 
PRESCRIPTION TYPE Pharmacy Board Reg. No 
Pink Form Schedule III Others Dispensary Address 
Direct Postal ......................................................................... 
LOCATION DIDISPENSER Dispensary 
To be filled by Coder DH Licence No. 
Item No. Prescription Origin Date

22 L.S.31.18] KONTROLL TAL-MEDI~INI 
IT-TMIEN SKEDA 
(Regolament 7) 
REQUEST FOR PRESCRIPTION FORMS FOR NARCOTIC AND 
PSYCHOTROPIC DRUGS 
I request ........................ booklet/s by ..................... prescription forms. 
Name and surname of prescriber ........................................................................... 
(IN BLOCK LETTERS) 
Private address ..................................................................................................... 
(IN BLOCK LETTERS) 
Signature ....................................... Med. Council Reg. No. 
Supplied ..................... booklet/s by ..................... prescription forms. 
Serial No. ........................ to ........................ 
(a) If withdrawn personally by prescriber. 
........................................... ........................................ 
Signature of Prescriber Date 
(b) If forwarded by mail. 
Forwarded by .................................... on ........................... 
A.R. Card to be attached. 
FOR OFFICIAL USE

KONTROLL TAL-MEDI~INI [L.S.31.18 23 
Mi\juda: 
A.L. 65 ta’ l-1986. 
Emendata: 
A.L. 34 ta’ l-1989. 
ID-DISA’ SKEDA 
(Regolament 9) 
DEPARTMENT OF HEALTH 
CONTROL CARD FOR NARCOTIC/PSYCHOTROPIC DRUGS 
Name and Surname of Patient .................................... Address ................................................ 
Identity Card No. (where available, or Passport No., 
in case of non-Maltese citizens who do not hold an 
Identity Card): 
................................................ 
Date of Issue of Card .......... Valid till ........................ ............................................................. 
Superintendent of Public Health 
(Columns 1 - 4 to be filled by Prescriber) (Columns 5 - 8 to be filled by Dispensing Apothecary) 
Date of 
Prescription 
Name of 
Drug. 
Form and 
Dose 
Amount 
Prescribed 
Signature of 
Medical 
Practitioner 
and Medical 
Council Reg. 
No. 
Amount 
Dispensed 
Date of 
Dispensing 
Signature of 
Apothecary 
D.H. Licence 
No. of 
Dispensary

24 L.S.31.18] KONTROLL TAL-MEDI~INI 
L-G}AXAR SKEDA Mi\juda: 
A.L. 65 ta’ l-1986. 
(Regolament 9) 
REQUEST FOR THE ISSUE/RENEWAL OF A CONTROL CARD 
FOR NARCOTIC AND PSYCHOTROPIC DRUGS 
Superintendent of Public Health 
I hereby request that Mr/Ms............................................................. aged ............. 
I. D. No. *........................................................ residing at .................................... 
.............................................................................................................................. 
(i) be issued with a control card for narcotic/psychotropic drugs (§) 
(ii) have the control card for narcotic/psychotropic drugs renewed.(§) 
(§) Delete whatever is inapplicable. 
Signature of Medical Practitioner .......................................................................... 
Name and Address of 
Medical Practitioner ..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
Medical Council Reg. No. ..................................................................................... 
Date ....................................... 
* In case of non-Maltese citizens not holding an I.D. Card, the Passport No., is to be inserted; in the 
case of a minor the particulars inserted are to be in relation to the I. D. Card or passport of the father, 
mother or guardian.

