﻿KONTROLL TAL-MEDI_CINI _gL.S.31.18 1 
LE_GISLAZZJONI SUSSIDJARJA 31.18 
REGOLAMENTI DWAR IL-KONTROLL 
TAL-MEDI_CINI 
2 ta’ Awissu, 1985 
L-AVVI_Z LEGALI 22 ta’ l-1985, kif emendat bl-Avvi_zi 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_cini. 
Tifsir. 2. F’dawn ir-Regolamenti, kemm-il darba r-rabta tal-kliem 
ma te_htie_gx xort’o_hra - 
Kap. 258. 
"karta ta’ l-identit_a" tfisser karta ta’ identit_a valida ma_hru_ga 
skond id-disposizzjonijiet ta’ l-Att dwar il-Karti ta’ l-Identit_a u ta’ 
kull regolamenti mag_hmula bis-sa_h_ha tieg_hu; 
"medi_cina ristretta" tfisser kull wa_hda minn dawk il-medi_cini 
jew sustanzi kimi_ci mni_z_zlin fl-Ewwel Skeda li tinsab ma’ dawn ir- 
Regolamenti; 
"medi_cina spe_cifikata" tfisser kull wa_hda minn dawk il-medi_cini 
jew sustanzi kimi_ci spe_cifikati fit-Tieni Skeda li tinsab ma’ dawn 
ir-Regolamenti; 
"re_gistru" tfisser ktieb illegat b’pa_gni numerati wara xulxin, i_zda 
ma tinkludi ebda xorta ta’ re_gistru bil-folji sfu_zi jew indi_ci talcards; 
"Suprintendent" tfisser is-Suprintendent tas-Sa_h_ha Pubblika. 
Importazzjoni, 
e_c_c., ta’ medi_cini 
ristretti trid tkun 
awtorizzata b’mod 
spe_cjali. 
3. (1) Ebda persuna ma tista’ timporta, timmanifattura, 
tesporta, tixtri, tbieg_h, tu_za jew ikollha fil-pussess tag_hha xi 
medi_cina ristretta ming_hajr awtorizzazzjoni spe_cjali bil-miktub 
mis-Suprintendent. 
(2) Is-Suprintendent ma g_handux jag_hti l-awtorizzazzjoni 
spe_cjali biex tintu_za xi medi_cina ristretta _hlief f’ka_zijiet spe_cjali 
g_hall-g_hanijiet xjentifi_ci jew g_hall-g_hanijiet medi_ci limitati _hafna fi 
stabbilimenti medi_ci jew xjentifi_ci ta_ht il-kontroll tal-gvern jew 
approvati b’mod spe_cjali mis-Suprintendent, li jkollu s-setg_ha li 
jimponi f’kull awtorizzazzjoni kull kondizzjoni jew _htie_ga li 
jidhirlu xierqa li jimponi bil-_hsieb li jevita kull abbu_z. 
(3) Is-Suprintendent jista’ f’kull _zmien, ming_hajr ma jag_hti 
ebda ra_guni, jirtira kull awtorizzazzjoni mog_htija minnu skond issub-
regolament (1) ta’ dan ir-regolament. 
(4) Kull persuna li tkun _giet awtorizzata skond is-subregolament 
(l) ta’ dan ir-regolament g_handha _z_zomm dawk irre_g
istri li jkunu me_htie_ga skond it-Tielet Skeda li tinsab ma’ dawn 
ir-Regolamenti dwar il-manifattura, l-akkwist u/jew it-tne_h_hija ta’ 
medi_cini ristretti, f’liema re_gistri g_handhom jitni_z_zlu d-dettalji 
dwar dawk il-medi_cini. Kull re_gistrazzjoni g_handha tkun iffirmata, 
mill-persuna awtorizzata ta_ht is-sub-regolament (1), fi _zmien

2 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
erbg_ha u g_hoxrin sieg_ha ta’ kull transazzjoni jew pro_cess, u kull 
re_gistru g_handu jin_zamm biex jista’ ji_gi spezzjonat mis- 
Suprintendent jew mir-rappre_zentant tieg_hu g_hal mill-anqas sentejn 
wara d-data li fiha tkun _giet imni_z_zla l-a_h_har re_gistrazzjoni. 
(5) Kull re_gistrazzjoni fir-re_gistru g_handha ssir bl-inka jew 
b’xi materjal ie_hor li ma jit_hassarx u g_handha ssir fl-istess _gurnata 
li fiha tkun saret kull transazzjoni, tkun xi tkun, jew, meta dan ma 
jkunx jista’ jsir, fil-_gurnata ta’ wara. 
(6) Kull re_gistru w_zat jew li jkun qed jintu_za dwar xi post 
partikolari ma g_handux jintu_za wkoll dwar xi post ie_hor jew g_hal xi 
g_han ie_hor barra minn dak ta’ dan ir-regolament. 
(7) Ebda re_gistrazzjoni fir-re_gistru msemmi fl-a_h_har subregolamenti 
qabel dan ta’ dan ir-regolament ma g_handha ti_gi 
kan_cellata, m_hassra jew mibdula jew ti_gi mni_z_zla b’xi 
partikolaritajiet li ma jkunux veri: 
I_zda jekk isir xi _zball f’xi re_gistrazzjoni, dak l-i_zball 
g_handu ji_gi korrett bil-mezz ta’ nota fil-mar_gini jew f’tarf il-pa_gna, 
liema nota g_handu jkun fiha l-korrezzjoni me_htie_ga u d-data tannota. 
(8) Ebda persuna ma tista’ tne_h_hi xi medi_cina ristretta _hlief 
g_hal persuni li jkunu awtorizzati b’mod spe_cjali li jkollhom jew 
ju_zaw dawk il-medi_cini. 
Transazzjonijiet 
dwar medi_cini 
spe_cifikati li 
g_handhom ji_gu 
re_gistrati. 
4. (1) Kull persuna li jkollha li_cenza jew tkun awtorizzata li 
timmanifattura, timporta, tbieg_h, tipprovdi, tqassam, jew tag_hti xi 
medi_cina spe_cifikata, sew jekk fil-linja tal-kummer_c jew 
professjoni tag_hha jew b_hala medikament meta ti_gi pre_zentata 
ri_cetta g_handha _z_zomm dawk ir-re_gistri li jkunu me_htie_ga biex ikun 
jidher li tkun saret dik it-transazzjoni dwar il-manifattura, 
importazzjoni, xiri, bejg_h, provvista, tqassim jew g_hoti ta’ xi 
medi_cina spe_cifikata. 
(2) (i) Ebda persuna ma tista’ timporta, ta_h_zen jew tbieg_h xi 
medi_cina spe_cifikata bl-ingrossa kemm-il darba ma 
jkollhiex li_cenza spe_cifika g_hal hekk ming_hand is- 
Suprintendent. 
(ii) Ma g_handha tin_hare_g ebda li_cenza g_hall-finijiet talparagrafu 
ta’ qabel dan kemm-il darba l-medi_cina jew 
il-medi_cini li dwarhom tkun in_har_get ma jkunux ta_ht 
ir-responsabbilt_a diretta ta’ spi_zjar. 
(3) Kull medi_cina spe_cifikata fabbrikata, importata, esportata, 
mixtrija, mibjug_ha, provduta, imqassma jew mog_htija g_handha 
titni_z_zel fir-re_gistru fil-forma murija b’dak it-tibdil skond ma 
je_htie_gu _c-_cirkostanzi, u b’dawk il-partikolaritajiet kif murija fit- 
Tielet Skeda li tinsab ma’ dawn ir-Regolamenti u kif japplikaw 
g_hall-ka_z. 
(4) Kull re_gistrazzjoni g_handha ssir bl-inka jew b’materjal 
ie_hor li ma jit_hassarx u g_handha ssir fl-istess _gurnata meta ssir ittransazzjoni, 
l-g_hoti jew il-pro_cess, jew, meta dan ma jkunx 
possibbli, fil-_gurnata ta’ wara. 
(5) Kull re_gistru w_zat jew fl-u_zu dwar xi post partikolari ma

KONTROLL TAL-MEDI_CINI _gL.S.31.18 3 
g_handux jintu_za wkoll dwar xi post ie_hor jew g_hal xi g_han ie_hor 
barra minn dak ta’ dan ir-regolament. 
(6) Ebda re_gistrazzjoni fir-re_gistru msemmi fis-sub-regolament 
ta’ qabel ta’ dan ir-regolament ma g_handha ti_gi kan_cellata, m_hassra 
jew mibdula jew titni_z_zel b’xi partikolaritajiet li ma jkunux veri: 
I_zda jekk isir xi _zball f’xi re_gistrazzjoni, dak l-i_zball 
g_handu ji_gi korrett permezz ta’ nota fil-mar_gini jew f’tarf il-pa_gna, 
liema nota g_handu jkollha l-korrezzjoni me_htie_ga u d-data tan-nota. 
(7) Ebda persuna ma tista’ tesporta xi medi_cina spe_cifikata 
ming_hajr l-awtorizzazzjoni minn qabel tas-Suprintendent. 
(8) Fil-ka_z ta’ importazzjoni jew esportazzjoni ta’ medi_cini 
spe_cifikati, is-Suprintendent ikollu s-setg_ha li jordna l-pro_cedura li 
g_handha tittie_hed u d-dettalji li g_handhom jing_hataw ma’ l-applikazzjoni 
relattiva, u jista’ wkoll, qabel ma jo_hro_g awtorizzazzjoni 
g_hall-esportazzjoni, jitlob li tinkiseb l-awtorizzazzjoni tal-pajji_z li 
jkun ser jimporta. 
(9) Is-Suprintendent jista’ jipprojbixxi, jew xort’o_hra 
jirrestrin_gi, l-importazjoni ta’ kull medi_cina spe_cifikata jekk ikun 
jidhirlu li hekk me_htie_g fl-interess pubbliku. 
Pussess ta’ 
medi_cini 
spe_cifikati. 
Kap. 31. 
5. (1) Ebda persuna, jekk ma tkunx awtorizzata kif imiss, ma 
jista’ jkollha fil-pussess tag_hha xi medi_cina spe_cifikata. 
(2) G_hall-g_han ta’ dan ir-regolament, persuna titqies li hi 
awtorizzata kif imiss jekk isimha jkun imni_z_zel fir-Re_gistru 
Mediku, fir-Re_gistru tal-Kirurgi-Dentisti, jew fir-Re_gistru tal- 
Veterinarji, jew jekk tkun spi_zjar diri_gent, jew ikollha li_cenza 
ma_hru_ga mis-Suprintendent skond l-artikolu 89 ta’ l-Ordinanza 
dwar il-Professjoni Medika u l-Professjonijiet li g_handhom 
x’jaqsmu mag_hha, jew tkun kisbet dik il-medi_cina bis-sa_h_ha ta’ 
ri_cetta medika, jew xort’o_hra skond id-disposizzjonijiet ta’ dawn ir- 
Regolamenti: 
I_zda, dwar persuna awtorizzata bis-sa_h_ha ta’ ri_cetta medika, 
dik ir-ri_cetta ma g_handhix titqies li hi valida jekk, fil-_hin li ti_gi 
ri_cevuta dik ir-ri_cetta, dik il-persuna kienet ta_ht il-kura ta’ tabib 
ie_hor u kienet qed tir_cievi dawk il-medi_cini spe_cifikati bis-sa_h_ha ta’ 
ri_cetta ming_hand dak it-tabib l-ie_hor u ma kenitx g_harrfet lil min 
g_hamel ir-ri_cetta b’dan l-fatt. 
Ti_zmim fi_z-_zgur 
ta’ medi_cini 
ristretti u 
spr_cifikati. 
6. Kull persuna awtorizzata biex tippossjedi medi_cini 
spe_cifikati skond id-disposizzjonijiet tar-regolament 5 u kull 
persuna awtorizzata b’mod spe_cjali dwar medi_cini ristretti, skond 
il-ka_z, g_handha, meta ma tkunx qed tu_za dawk il-medi_cini, 
i_z_zommhom maqfulin u hija fid-dmir li tie_hu dawk il-passi kollha 
me_htie_ga biex dan ikun fi_z-_zgur u biex tipprevjeni li jsir serq jew 
diversifikazzjoni o_hra ta’ l-istock: 
I_zda dan ir-regolament ma japplikax g_hal min ikollu filpussess 
tieg_hu medi_cini spe_cifikati bis-sa_h_ha ta’ ri_cetta medika. 
U_zu u kontenut ta’ 
ri_cetta. 7. (1) Kull ri_cetta g_hal medi_cina spe_cifikata g_handha tkun 
miktuba bl-inka jew b’materjal ie_hor li ma jit_hassarx fuq il-formula 
murija fis-Seba’ Skeda li tinsab ma’ dawn ir-Regolamenti.

4 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
(2) It-tabib li jo_hro_g ri_cetta g_hal medi_cina spe_cifikata g_handu 
jimla’ b’kitba _cara u li tinqara t-Taqsima A tal-formula murija fis- 
Seba’ Skeda u g_handu jag_hti d-dettalji kollha u t-tag_hrif kollu flispazju 
xieraq kif hemm hu me_htie_g; g_handu ini_z_zel ukoll il-firma 
tieg_hu s_hi_ha u d-data meta jkun _hare_g ir-ri_cetta: 
Kap. 31. 
I_zda fil-ka_z ta’ tabib awtorizzat ta_ht l-artikolu 5 ta’ l- 
Ordinanza dwar il-Professjoni Medika u l-Professjonijiet li 
g_handhom x’jaqsmu mag_hha biex je_zer_cita l-professjoni medika 
i_zda li ma jkunx g_hadu _gie re_gistrat mal-Kunsill Mediku, dak ittabib 
g_handu jni_z_zel in-numru mog_hti lilu mis-Suprintendent 
minflok in-numru tar-re_gistrazzjoni tal-Kunsill Mediku fuq limsemmija 
ri_cetta. 
(3) Bla _hsara g_had-disposizzjonijiet tas-sub-regolament (11) ta’ 
dan ir-regolament, ebda tabib ma jista’ jo_hro_g ri_cetta g_hal medi_cina 
spe_cifikata kemm-il darba r-ri_cetta ma tkunx taqbel maddisposizzjonijiet 
ta’ dan ir-regolament u dik il-medi_cina ma tkunx 
me_htie_ga g_hall-fini ta’ kura medika: 
I_zda, tabib jista’, bla _hsara g_had-disposizzjonijet l-o_hra ta’ 
dawn ir-Regolamenti, jo_hro_g ri_cetta g_hal u_zu professjonali g_hal 
ammont ta’ mhux i_zjed minn g_haxar fjali g_hal injezzjoni jew 
g_hoxrin pillola jew kapsula. 
(4) Kull tabib li jikseb medi_cina spe_cifikata g_hal u_zu 
professjonali kif provdut fil-proviso g_has-sub-regolament (3) ta’ 
dan ir-regolament g_handu j_zomm notament f’re_gistru xieraq ta’ lisem 
u l-kunjom (jekk applikabbli), l-et_a u l-indirizz tal-pazjent li 
lilu ng_hatat il-medi_cina u d-data meta ng_hatat. 
(5) Ebda tabib ma jista’ jo_hro_g ri_cetta g_hal medi_cina 
spe_cifikata lil xi persuna kemm-il darba dik il-persuna ma jkunx 
jafha sewwa jew kemm-il darba t-tabib ma jkunx _zgura l-identit_a ta’ dik il-persuna permezz tal-karta ta’ l-identit_a tag_hha. 
(6) Ebda tabib ma g_handu jo_hro_g ri_cetta g_hal medi_cina 
spe_cifikata lil xi persuna kemm-il darba dak it-tabib ma jkunx _ha lpassi 
xierqa bi_z_zejjed biex ji_zgura li dik il-persuna ma tkunx, fi_z- 
_zmien li jo_hro_g ir-ri_cetta, qed tir_cievi kura minn tabib ie_hor dwar 
dipendenza (addiction) minn xi medi_cina spe_cifikata jew xort’o_hra, 
u li dik il-persuna ma tkunx _giet provduta b’xi medi_cina b_hal dik 
fuq ri_cetta ma_hru_ga minn dak it-tabib l-ie_hor. 
Kap. 101. 
(7) Tabib g_handu ju_za formula separata dwar kull medi_cina 
preskritta minnu skond dan ir-regolament u ma tista’ ti_gi preskritta 
ebda medi_cina jekk ma tkunx medi_cina spe_cifikata jew medi_cina li 
taqa’ ta_ht id-disposizzjonijiet ta’ l-Ordinanza dwar Medi_cini 
Perikolu_zi. 
(8) Tabib g_handu, meta jippreskrivi medi_cina spe_cifikata, ju_za 
biss formuli ta’ ri_cetta mill-ktejjeb tal-formuli li jkollu numru tasserje, 
ma_hru_g lilu mis-Suprintendent fuq talba mag_hmula fuq ilformula 
murija fit-Tmien Skeda li tinsab ma’ dawn ir-Regolamenti 
u kull tabib, sew g_hall-fini tal-prattika privata tieg_hu jew biex jaqdi 
d-dmirijiet tieg_hu f’kariga uffi_cjali min_habba l-impieg tieg_hu malgvern, 
bil-g_han li jaqdi l-_hti_giet tal-pazjenti tieg_hu, g_handu jag_hmel 
kull talba g_hal dak il-ktejjeb ta’ ri_cetti fuq l-imsemmija formula. 
Dik il-formula g_handha timtela’ tajjeb f’kollox u g_handha tkun

KONTROLL TAL-MEDI_CINI _gL.S.31.18 5 
iffirmata mit-tabib, u g_handha jew ting_hata bl-idejn minn dak ittabib 
personalment lill-ispi_zjar ewlieni fl-iStores Medi_ci tal-Gvern 
fi Gwardamangia jew tintbag_hat bil-posta lis-Suprintendent tas- 
Sa_h_ha Pubblika fid-Dipartiment tas-Sa_h_ha, il-Belt Valletta, u meta 
j i n t b a g _h 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_h_ha Pubblika" g_hall-fini ta’ e_zenzjoni 
minn pusta_g_g. 
(9) It-tabib g_handu jirrapporta minnufih bil-miktub lis- 
Suprintendent kull ka_z ta’ serq jew telf ta’ ktejjeb u ma jkunx jista’ 
ju_za xi formula ta’ ri_cetta minn xi ktejjeb ta’ formuli ma_hru_g lil xi 
tabib ie_hor. 
(10) G_hall-finijiet ta’ dan ir-regolament, kemm-il darba r-rabta 
tal-kliem ma te_htie_gx xort’o_hra, 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_handhomx japplikaw meta jing_hataw medi_cini 
spe_cifikati g_hall-u_zu ta’ pazjenti fi swali fi sptarijiet tal-gvern, billi 
dan ikun ikkontrollat bir-regoli interni ta’ l-isptar. 
G_hoti ta’ ri_cetti. 8. (1) Ebda persuna _hlief spi_zjar ma tista’ tag_hti medi_cina 
spe_cifikata b’ri_cetta. 
(2) Spi_zjar ma jistax jag_hti medi_cina spe_cifikata b’ri_cetta 
kemm-il darba - 
(a) ma jkunx jag_hraf il-firma tal-persuna li ming_handha 
tkun tidher li n_har_get, ikollu ra_guni ja_hseb li ma tkunx 
_genwina u ma jkunx _ha passi xierqa biex ji_zgura lilu 
nnifsu li tkun _genwina; u 
(b) ir-ri_cetta ma tkunx skond id-disposizzjonijiet tarregolament 
7 ta’ dawn ir-Regolamenti. 
(3) Ebda medi_cina spe_cifikata ma tista’ ti_gi provduta iktar 
minn darba fuq l-istess ri_cetta. 
(4) Spi_zjar li jag_hti medi_cina spe_cifikata f’ri_cetta g_handu 
jimla’ b’kitba _cara u li tinqara bl-inka jew b’materjal ie_hor li ma 
jit_hassarx, it-Taqsima _C tal-formula murija fis-Seba’ Skeda li 
tinsab ma’ dawn ir-Regolamenti u jag_hti d-dettalji kollha u t-tag_hrif 
kollu me_htie_g fiha; l-ispi_zar g_handu wkoll ini_z_zel il-firma tieg_hu u 
d-data u g_handu, wara li jag_hti l-medi_cina, j_zomm ir-ri_cetta. 
(5) G_hall-fini tas-sub-regolament (4) ta’ dan ir-regolament ikun 
id-dmir ta’ l-ispi_zjar li jkun qed jag_hti medi_cina spe_cifikata 
f’ri_cetta li jitlob il-karta ta’ l-identit_a tal-persuna li dwarha r-ri_cetta 
tkun in_har_get u jkun id-dmir tal-persuna li jkun fi _hsiebha takkwista 
medi_cina spe_cifikata, sew jekk g_haliha jew g_hall-persuna li lilha 
jkunu _gew preskritti l-medi_cini, li tippre_zenta l-imsemmija karta ta’ 
l-identit_a kif ukoll il-karta ta’ l-identit_a tag_hha stess flimkien marri_c
etta: 
I_zda 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_hadha 
in_har_gitilha karta ta’ l-identit_a.

6 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
(6) Kull spi_zjar diri_gent ta’ spi_zerija li_cenzjata g_handu jibg_hat 
lis-Suprintendent f’invilopp issi_gillat fl-ewwel jum ta’ kull xahar 
ir-ri_cetti kollha g_hal medi_cini spe_cifikati li jkunu _gew mog_htja 
minn dik l-ispi_zerija matul ix-xahar ta’ qabel; l-imsemmi invilopp 
g_handu jkun indirizzat "Suprintendent tas-Sa_h_ha Pubblika, 
Dipartiment tas-Sa_h_ha, il-Belt Valletta" u jista’ jkun immarkat 
"Notifikazzjonijiet tas-Sa_h_ha Pubblika" g_hall-fini ta’ e_zenzjoni 
minn pusta_g_g. 
Dokument ta’ 
kontroll. 
Mi_zjud: 
A.L. 65 ta’ l-1986. 
Emendat: 
A.L. 34 ta’ l-1989. 
9.(1) (a) Ebda tabib ma jista’ jo_hro_g ri_cetta g_hal xi medi_cina 
spe_cifikata lil xi persuna _hlief lil min ikollu fil-pussess 
tieg_hu dokument ta’ kontroll, b_hal ma jidher fid-Disa’ 
Skeda li tinsab ma’ dawn ir-Regolamenti. Id-dokument 
jin_hare_g g_hal dan il-g_han mis-Suprintendent tas-Sa_h_ha 
Pubblika; 
(b) Meta tin_hare_g ri_cetta g_hal medi_cina spe_cifikata lil xi 
persuna, min jo_hro_g ir-ri_cetta g_handu jikteb b’mod _car, 
li ma jit_hassarx u li jinqara, dawk id-dettalji kollha 
ndikati fil-kolonni minn 1 sa 4 tad-dokument ta’ 
kontroll, u mbag_had jag_hti lura dan id-dokument lil dik 
il-persuna flimkien mar-ri_cetta: 
I_zda tabib jista’, meta jkun qieg_hed japplika f’isem persuna 
fuq il-formula tat-talba kif indikata fl-G_haxar Skeda li tinsab ma’ 
dawn ir-Regolamenti, jo_hro_g ukoll ri_cetta g_hal provvista ta’ 
medi_cina spe_cifikata lil dik il-persuna u jista’ jehme_z ir-ri_cetta ma’ 
dik il-formula tat-talba: 
I_zda wkoll dik ir-ri_cetta ssir biss tiswa meta ddisposizzjonijiet 
tal-proviso g_has-sub-regolament (2) ta’ dan irregolament 
ikunu _gew osservati. 
(2) Is-Suprintendent g_handu jo_hro_g dan id-dokument ta’ 
kontroll lill-persuna interessata wara li ssir talba minn tabib g_hal 
dan l-iskop, fuq il-formula indikata fl-G_haxar Skeda li tinsab ma’ 
dawn ir-Regolamenti: 
I_zda fil-ka_z ta’ ri_cetta g_hal provvista ta’ medi_cina 
spe_cifikata kif provdut fil-provisi g_has-sub-regolament (1) ta’ dan 
ir-regolament, is-Suprintendent g_handu jni_z_zel id-dettalji tar-ri_cetta 
relattiva fil-kolonni 1 sa 4 tad-dokument ta’ kontroll. 
(3) Kull dokument ta’ kontroll huwa validu g_hal sena mid-data 
li jin_hare_g. Dan jista’ ji_gi m_gedded mis-Suprintendent wara li ssir 
talba minn tabib fuq il-formula ndikata fl-G_haxar Skeda li tinsab 
ma’ dawn ir-Regolamenti. 
(4) L-ebda spi_zjar ma g_handu jservi xi medi_cina spe_cifikata lil 
xi _hadd li ma jkollux fil-pussess tieg_hu dokument ta’ kontroll kif 
indikat fis-sub-regolament (1) ta’ dan ir-regolament. 
(5) Meta spi_zjar iservi medi_cina spe_cifikata, huwa g_handu, 
minbarra d-dmirijiet l-o_hra spe_cifikati b’dawn ir-Regolamenti jew 
b’xi li_gi o_hra, ini_z_zel b’mod _car, li ma jit_hassarx u li jinqara sew, 
dawk id-dettalji kollha li hemm indikati fil-kolonni minn 5 sa 8 fuq 
id-dokument, u imbag_had g_handu jibg_hat lura d-dokument lil min 
ikun ippre_zentalu r-ri_cetta.

KONTROLL TAL-MEDI_CINI _gL.S.31.18 7 
(6) (a) Tabib jista’ jo_hro_g ri_cetta g_hal xi medi_cina spe_cifikata 
f’ka_zijiet ur_genti lill-pazjent li ma jkollux fil-pussess 
tieg_hu dokument ta’ kontroll sakemm: 
(i) ir-ri_cetta jkollha tikketta li tindika li hi 
"UR_GENTI"; 
(ii) l-ammont imni_z_zel fir-ri_cetta jkun g_hall-u_zu ta’ 
mhux iktar minn sebat ijiem; 
(iii) tkun taqbel ma’ _hti_giet o_hra ta’ dawn ir- 
Regolamenti; u 
(iv) min jo_hro_g ir-ri_cetta g_handu jinforma lis- 
Suprintendent fi _zmien tmienja u erbg_hin sieg_ha 
minn meta jo_hro_g ir-ri_cetta billi jag_hti lpartikolaritajiet 
kollha tal-pazjent, l-isem, forma 
u do_za u l-kwantit_a ta’ medi_cina li g_haliha tkun 
_har_get ir-ri_cetta u r-ra_guni g_hal din l-ur_genza. 
(b) Spi_zjar ikun jista’ iservi din ir-ri_cetta sakemm din tkun 
taqbel mal-_hti_giet tas-sub-paragrafi (i), (ii) u (iii) talparagrafu 
(a) ta’ dan is-sub-regolament. 
(7) Id-disposizzjonijiet ta’ dan ir-regolament ma g_handhomx 
japplikaw g_hall-_hru_g ta’ ri_cetta g_hal medi_cini spe_cifikati minn 
tabib li jkun ja_hdem fi sptar tal-gvern, biex din ting_hata lil pazjenti 
fis-swali ta’ l-isptar filwaqt li dawn ikunu ta_ht il-kura tieg_hu f’dan 
l-isptar, u din ir-ri_cetta tkun regolata mir-regoli interni ta’ l-isptar. 
(8) Kull talba jew notifikazzjoni li jistg_hu jsiru skond dan irregolament 
jistg_hu jsiru mill-persuna nnifisha jew jistg_hu 
jintbag_htu bil-posta f’invilopp si_gillat li jkun indirizzat lis- 
Suprintendent tas-Sa_h_ha Pubblika, Dipartiment tas-Sa_h_ha, Valletta, 
u li jinkiteb fuqu "Notifikazzjoni dwar Sa_h_ha Pubblika - 
Konfidenzjali" sabiex dan ji_gi e_zentat mill-_hlas tal-posta. 
(9) G_hall-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_hda tabbu_za minn medi_cina li 
g_haliha tkun in_har_gitilha ri_cetta, jew li tkun qieg_hda mod ie_hor 
tabbu_za mis-sistema tad-dokument ta’ kontroll. 
(11) Is-Suprintendent jista’ jinkludi fuq id-dokument ta’ kontroll 
dawk id-direttivi li jqis li jkunu me_htie_ga dwar il-_hru_g ta’ ri_cetti 
g_hal medi_cini spe_cifikati. 
E_zemplari talfirma 
ta’ min jag_hti 
ri_cetta. 
10. (1) L-ebda tabib, kirurgu-dentist, dentist jew veterinarju 
ma g_handu jippreskrivi xi medi_cina spe_cifikata jew ri_cetta kemm-il 
darba s-Suprintendent ma jkollux l-e_zemplari tal-firma tieg_hu. 
(2) Is-Suprintendent jista’, g_hall-fini tal-kontroll tal-medi_cini, 
ji_c_cirkola lill-ispi_zjara diri_genti kollha kopja ta’ kull e_zemplari talfirma 
b_hal dik li tkun fil-pussess tieg_hu. 
Konsenja ta’ 
medi_cini 
spe_cifikati lil 
persuni li_cenzjati 
jew awtorizzati. 
11. (1) L-ebda persuna ma g_handha tikkonsenja xi medi_cina 
spe_cifikata lil xi persuna o_hra jekk mhux wara li ting_hata r_cevuta 
ffirmata kif imiss. 
(2) Ebda persuna ma g_handha tikkonsenja xi medi_cina

8 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
spe_cifikata lil xi persuna o_hra li ma tkunx spi_zjar diri_gent jew li 
xort’o_hra ma tkunx awtorizzata bil-mod xieraq biex ikollha filpussess 
tag_hha dik il-medi_cina, kemm-il darba dik il-persuna l-o_hra 
ma tipprodu_cix awtorizzazzjoni bil-miktub g_hal hekk iffirmata kif 
imiss mill-ispi_zjar diri_gent jew mill-persuna li tkun xort’o_hra 
awtorizzata b’mod xieraq li jkollha fil-pussess tag_hha dik ilmedi_c
ina, u kemm-il darba l-persuna li tkun qed tikkonsenja dik ilmedi_c
ina ma tkunx sodisfatta li l-awtorizzazzjoni hi _genwina. 
(3) Ebda _ha_ga fis-sub-regolamenti ta’ qabel ta’ dan irregolament 
ma g_handha titqies li tirreferi g_hall-provvista ta’ xi 
medi_cina spe_cifikata mal-pre_zentazzjoni ta’ ri_cetta medika skond 
id-disposizzjonijiet ta’ dawn ir-Regolamenti jew g_hall-g_hoti ta’ xi 
medi_cina b_hal dik minn jew ta_ht is-sorveljanza ta’ tabib, kirurgudentist, 
dentist jew veterinarju. 
(4) G_hall-fini ta’ dan ir-regolament, "tikkonsenja" tinkludi kull 
eg_hmil jew nuqqas fejn persuna tippermetti jew t_halli lil xi persuna 
o_hra, li ma tkunx persuna awtorizzata skond regolamenti, li jkollha 
fil-pussess tag_hha xi medi_cina spe_cifikata, li tie_hu fil-pussess 
tag_hha dik il-medi_cina. 
Konservazzjoni ta’ 
ri_cetti, re_gistri, 
notamenti u 
dokumenti o_hra. 
12. Kull ri_cetta li tkun _giet esegwita, u kull re_gistru, notament, 
fattura jew dokument ie_hor dwar il-manifattura, importazzjoni, xiri, 
bejg_h, provvista, tqassim, jew disponiment ie_hor ta’ medi_cini 
spe_cifikati g_handhom jin_zammu fil-post li g_halih jirreferixxu u 
g_handhom ji_gu konservati g_hal _zmien ta’ mhux inqas minn sentejn 
mid-data tar-ri_cetta, notament, fattura jew dokument ie_hor, jew 
mid-data ta’ l-a_h_har re_gistrazzjoni fir-re_gistru, skond il-ka_z, u 
matul dak i_z-_zmien ikunu g_had-disposizzjoni biex ji_gu spezzjonati 
mis-Suprintendent jew mir-rappre_zentant tieg_hu. 
Avvi_z minn min 
jag_hti ri_cetta u 
mill-ispi_zjar 
diri_gent dwar _certi 
medi_cini. 
Emendat: 
A.L. 70 ta’ l-1988. 
13. (1) Ebda tabib ma jista’ jo_hro_g ri_cetta g_hal xi preparat li 
jkun mag_hmul 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_cini, jew g_hal xi preparat li jkun 
mag_hmul minn secobarbital jew amobarbital jew minn ta_hlita ta’ 
secobarbital u amobarbital, f’kull ka_z f’forma ta’ tablet jew 
kapsula, jew f’sachet jew cachet, jew minn xi salts jew esters tag_hhom f’dik l-g_hamla, jekk ma jkollux minn qabel lawtorizzazzjoni 
bil-miktub tas-Superintendent. 
(2) Is-Suprintendent jista’, qabel ma jag_hti xi awtorizzazzjoni 
kif imsemmi fis-sub-regolament (1) ta’ dan ir-regolament, jitlob 
ming_hand it-tabib dak it-tag_hrif li s-Suprintendent je_htie_g, anki 
jekk fil-fehma tat-tabib il-pazjent ikun jkollu b_zonn li jie_hu dik ilmedi_c
ina. 
(3) Meta ssir talba g_hal dik l-awtorizzazzjoni, is-Suprintendent 
g_handu jissottometti dik it-talba lil panel ta’ spe_cjalisti medi_ci li 
g_handhom jag_htu parir lis-Suprintendent jekk dik it-talba g_handhix 
ti_gi awtorizzata jew le. 
(4) Qabel ma jag_hmlu r-rakkomandazzjoni, huma g_handhom 
jaraw jekk dik il-preskrizzjoni tkunx indikata u l-panel g_handhom 
ukoll, meta jkun il-ka_z, jag_hmlu dawk ir-rakkomandazzjonijiet li 
jkunu me_htie_ga bil-_hsieb li l-pazjent bil-mod il-mod jidra ming_hajr

KONTROLL TAL-MEDI_CINI _gL.S.31.18 9 
dik il-medi_cina. 
(5) Is-Suprintendent jista’, jekk jidhirlu li jkun fl-interess talpazjent, 
jawtorizza l-preskrizzjoni ta’ dik il-medi_cina sakemm 
jir_cievi r-rapport tal-panel. 
(6) Kull tabib li jag_hti ri_cetta kif imsemmi fis-sub-regolament 
(1) ta’ dan ir-regolament g_handu jg_harraf lis-Suprintendent fi 
_zmien erbg_ha u g_hoxrin sieg_ha minn meta jkun ta ri_cetta ta’ dak ilpreparat 
fejn jag_hti d-dettalji murija fir-Raba’ Skeda li tinsab ma’ 
dawn ir-Regolamenti. 
(7) Kull spi_zjar li jipprepara medi_cina fuq ir-ri_cetta kif 
imsemmi fis-sub-regolament (1) ta’ dan ir-regolament g_handu 
jg_harraf lis-Suprintendent fi _zmien erbg_ha u g_hoxrin sieg_ha minn 
meta jkun ipprepara dik il-medi_cina, fejn jag_hti d-dettalji murija 
fil-_Hames Skeda li tinsab ma’ dawn ir-Regolamenti. 
(8) L-avvi_zi kollha li jing_hataw skond is-sub-regolamenti (6) u 
(7) ta’ dan ir-regolament g_hand_hom ji_gu 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_haliex ja_hseb li 
tabib, jew kirurgu-dentist jew dentist, ikun qed jag_hti jew 
jippreskrivi xi medi_cina spe_cifikata g_halih innifsu jew g_hal xi 
persuna o_hra, li ma tkunx me_htie_ga, jew aktar milli jkun me_htie_g, 
g_hall-kura medika jew dentali tieg_hu nnifsu jew ta’ dik il-persuna lo_h
ra, skond il-ka_z, jew li veterinarju jkun qed jag_hti jew 
jippreskrivi xi medi_cina spe_cifikata dwar xi annimal ta_ht il-kura 
tieg_hu, li ma tkunx me_htie_ga, jew aktar milli jkun me_htie_g, g_hallkura 
ta’ dak l-annimal, skond il-ka_z, 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_hti, 
jippreskrivi, jikseb jew li jkollu fil-pussess tieg_hu dik il-medi_cina 
g_hal dak i_z-_zmien li l-President jidhirlu xieraq, u f’dan il-ka_z ikun 
kontra l-li_gi li dak it-tabib, kirurgu-dentist jew dentist, jew 
veterinarju jag_hti, jippreskrivi, jikseb jew li jkollu fil-pussess 
tieg_hu xi medi_cina matul dak i_z-_zmien: 
I_zda l-President jista’, f’kull _zmien, jimmodifika jew jirtira 
kull projbizzjoni. 
(11) Avvi_z ta’ kull projbizzjoni, modifika jew irtirar ta’ kull 
projbizzjoni g_handu jing_hata bil-miktub lill-persuna hekk milquta. 
(12) Is-Suprintendent ikun jista’ jqassam lil kull tabib - 
(a) l-isem, u d-dettalji l-o_hra li jidhru fis-Sitt Skeda li 
tinsab ma’ dawn ir-Regolamenti, ta’ kull persuna li 
g_haliha jkun _gie 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_hra kif jidhru fis-Sitt Skeda li 
tinsab ma’ dawn ir-Regolamenti, ta’ kull persuna li 
g_haliha tkun _giet preskritta jew preparata xi medi_cina

10 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
spe_cifikata. 
Avvi_zi u twissijiet 
fuq it-tikketta, e_c_c. 14. (1) Is-Suprintendent jista’ je_htie_g lill-manifatturi, 
importaturi u esportaturi kollha, u lill-persuni l-o_hra kollha li 
jikkummer_cjaw jew xort’o_hra jinnegozjaw f’xi medi_cina ristretta 
jew f’xi medi_cina spe_cifikata, li jinkludi dawk it-twissijiet jew 
avvi_zi o_hra fuq it-tikketta, meta jkun prattikabbli, jew mal-fuljett li 
jkollu mieg_hu l-pakkett li fih jinbieg_hu bl-imnut dawk il-medi_cini, 
li fil-fehma tieg_hu jkunu me_htie_ga g_has-sigurezza tal-persuni li 
ju_zaw dawk il-medi_cini. 
(2) Ebda persuna ma tista’ b’xi mod tirreklama lill-pubbliku in 
_generali xi medi_cina ristretta jew medi_cina spe_cifikata. 
Tag_hrif minn 
fabbrikant jew 
importatur. 
Mi_zjud: 
A.L. 173 ta’ l- 
1993. 
15. (1) Kull persuna li timmanifattura jew timporta xi 
medi_cina jew xi preparat farma_cewtiku g_handha, fi _zmien tmint 
ijiem ta’ dik il-manifattura jew importazzjoni, tav_za lis- 
Suprintendent fejn tag_hti d-dettalji dwar il-kontenut u d-do_za ta’ 
dik il-medi_cina jew preparat farma_cewtiku: 
I_zda meta persuna tkun _harset darba d-disposizzjonijiet ta’ 
dan is-sub-regolament dwar medi_cina jew preparat farma_cewtiku 
partikolari, din ma tkunx marbuta li t_harishom dwar xi manifattura 
jew importazzjoni o_hra ta’ l-istess medi_cina jew preparat 
farma_cewtiku li jkollu l-istess isem kummer_cjali u jkun mag_hmul 
mill-istess kontenut u do_za. 
(2) Is-Suprintendent jista’, f’kull _zmien, jitlob lill-manifattur 
jew lill-importatur ta’ kull medi_cina jew preparat farma_cewtiku, 
skond il-ka_z, biex jag_hti dak it-tag_hrif li s-Suprintendent jista’ 
je_htie_g dwar dik il-medi_cina jew preparat farma_cewtiku u limsemmi 
manifattur jew importatur, skond il-ka_z, g_handu 
jissodisfa dik it-talba fi _zmien _hmistax-il _gurnata. 
(3) Is-Suprintendent jista’ - 
(a) jipprojbixxi l-importazzjoni ta’ xi medi_cina kemm-il 
darba dik il-medi_cina ma jkollhiex mag_hha - 
(i) _certifikat a_c_cettabbli g_has-Suprintendent, millawtorit_a 
kompetenti tal-gvern tal-pajji_z ta’ lori_g
ini, li jg_hid li dik il-medi_cina tkun _giet 
manifatturata minn ditta awtorizzata kif imiss 
biex tipprodu_ci dik il-medi_cina g_hall-bejg_h flistess 
pajji_z, u li l-fa_cilitajiet g_hall-kontroll talkwalit_a 
fid-ditta jkunu sodisfa_centi, u 
(ii) _certifikat, a_c_cettabbli g_has-Suprintendent, li 
jg_hid li l-medi_cina tkun taqbel mal-livell 
imsemmi fil-British Pharmacopea jew fil-British 
Pharmaceutical Codex jew ma’ livelli o_hra 
a_c_cettabbli g_has-Suprintendent, jew, meta ma 
jkun je_zisti ebda livell b_hal dak dwar dik ilmedi_c
ina, _certifikat, a_c_cettabbli bl-istess mod, 
ta’ l-anali_zi ta’ dik il-medi_cina; 
(b) jissospendi jew jipprojbixxi li titqassam, jew li ti_gi 
provduta, tinbieg_h, offerta g_hall-bejg_h jew tin_ha_zen 
kull medi_cina li tkun di_g_a mportata sakemm i_c-

KONTROLL TAL-MEDI_CINI _gL.S.31.18 11 
_certifikati msemmija fis-sub-paragrafi (i) u (ii) talparagrafu 
(a) ta’ dan is-sub-regolament ji_gu prodotti: 
I_zda ebda sospensjoni jew projbizzjoni b_hal dik ma 
jkollha effett qabel ma jg_haddi xahar mid-data tattalba 
ta’ dawk i_c-_certifikati mill-imsemmi 
Suprintendent. 
(4) Is-Suprintendent jista’ jirtira jew jara li ti_gi rtirata mis-suq 
kull medi_cina jew preparat farma_cewtiku jekk, min_habba 
f’rejazzjoni kuntrarja jew f’tag_hrif ie_hor dwar effetti _h_ziena, 
prattika ta’ manifattura jew tag_hrif ie_hor tekniku jew xjentifiku, 
ikun fil-fehma tieg_hu a_hjar li dik il-medi_cina jew dak il-preparat 
ji_gu rtirati fl-interess tas-sa_h_ha tal-pazjenti. 
(5) G_hall-g_hanijiet ta’ dan ir-regolament, "medi_cina" tinkludi 
kull preparat medi_cinali g_hal u_zu intern jew estern, sew jekk 
imni_z_zla jew spe_cifikata sew jekk ma tkunx fl-Ewwel jew fit-Tieni 
Skeda li tinsab ma’ dawn ir-Regolamenti. 
E_zenzjonijiet. 16. (1) Dawn ir-Regolamenti ma g_handhomx japplikaw, dwar 
xi medi_cina spe_cifikata, g_hal xi medi_cina li tkun tifforma parti, jew 
tkun inkorporata ma’ preparat lest g_hall-u_zu u li ma jkunx je_htie_g li 
jigi aktar ma_hdum, kemm-il darba dik il-medi_cina ma tkunx lingredjent 
prin_cipali jew l-uniku ingredjent attiv tal-preparat. 
(2) Dawn ir-Regolamenti bl-istess mod ma g_handhomx 
japplikaw fil-ka_z ta’ preparat li jkun fih medi_cina spe_cifikata, li 
jkun ma_hdum b’mod li ma jkun ta’ ebda riskju, jew ta’ riskju 
negli_gibbli, ta’ abbu_z, u s-sustanza ma tkunx tista’ tinkiseb b’mezz 
li tista’ tapplikah malajr fi kwantit_a li tista’ twassal g_hal abbu_z, 
hekk illi l-preparat ma jistax jo_hloq problema g_has-sa_h_ha pubblika 
jew so_cjali. 
Riserva. 17. Kull ri_cetta esegwita, re_gistru, notament, fattura jew 
dokument ie_hor li, fil-bidu fis-se_h_h ta’ dawn ir-Regolamenti, kienu 
konservati skond ir-Regolamenti ta’ l-1976 dwar il-Kontroll tal- 
Medi_cini*, g_handhom jibqg_hu konservati u jin_zammu biex jistg_hu 
ji_gu spezzjonati u g_handhom g_hal dawn l-g_hanijiet jitqiesu li 
dejjem kienu konservati skond dawn ir-Regolamenti. 
*Im_hassra b’dawn ir-Regolamenti.

12 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
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_hor kif 
komunement mag_hruf 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 _gb, 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 _gb, 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 
_gb, d) pyran 
TCP, TENOCYCLIDNE 1-_g1-(2-thienyl) cyclohexyl) piperidine 
TMA dl-3, 4, 5-trimethoxy-amethylphenylethylamine

KONTROLL TAL-MEDI_CINI _gL.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_hor kif 
komunement mag_hruf 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 
_g3,2-f_h-s-triazolo _g4,3-a_h _g1,4_h 
diazepine 
BUPRENORHINE 21-cyclopropyl-7-alpha-_g(S)-l-hydroxy- 
1 , 2 , 2 - t r i m e t h y l p r o p y l _h - 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_hra tieg_hu 
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 _gb,d_h 
pyran-1-o1 
ETHCHLORVYNOL ethyl-2-chlorovinylethynylcarbinol 
ETHINAMATE l-ethynylcyclohexanolcarbamate 
µ 
µ

14 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
FENCAMFAMIN dl-N-ethyl-3-phenylbicyclo (2,2,1)- 
heptan-2amine 
FENETYLLINE dl-3,7-dihydro-1, 3 dimethyl-7-(2-_g(lmethyl2-
phenylethyl) amino_h ethyl)- 
1H-purine-2, 6-dione 
FENFLURAMINE N-ethyl- -methyl-m(trifluoromethyl) 
phenethylamine 
FENPROPOREX d l - 3 - _g ( a - m e t h y l p h e n e t h y l ) a m i n o _h 
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 
_g2, 1-a_h 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_CINI _gL.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_h KONTROLL TAL-MEDI_CINI 
IT-TIELET SKEDA 
Regolamenti 3 u 4

KONTROLL TAL-MEDI_CINI _gL.S.31.18 17

18 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
IR-RABA’ SKEDA 
(Regolament 13 (4) ) 
KONFIDENZALI 
(Avvi_z skond ir-Regolament 13 - Ri_cetti g_hal amfetamina u l-isomers tag_hha, 
flunitrazepam, mecloqualone, methaqualone, methylphenidate u phenmetrazine, u 
secobarbital jew g_haqda ta’ secobarbital u amobarbital f’forma ta’ tablet jew kapsula 
jew f’sachet jew cachet, u s-salts jew l-esters rispettivi tag_hhom) 
IMPORTANTI - Ri_cetti g_hal dawn il-preparati jistg_hu jing_hataw biss wara li tinkiseb 
l-approvazzjoni bil-miktub ming_hand is-Suprintendent tas-Sa_h_ha Pubblika g_hal kull 
ri_cetta. 
ISEM U L-INDIRIZZ TAL-PAZJENT ............................................... 
............................................... 
NRU. TAL-KARTA TA’ L-IDENTIT_A ............................................... 
ET_A ............................................... 
ISEM TAL-PREPARAT U L-QAWWA 
TIEG_HU ............................................... 
KWANTIT_A PRESKRITTA ............................................... 
DO_ZA TA’ KULJUM ............................................... 
DATA TAR-RI_CETTA ............................................... 
DATA U NRU. TAR-RIFERENZA TA’ LAPPROVAZZJONI 
TAS-SUPRINTENDENT 
TAS-SA_H_HA PUBBLIKA ............................................... 
FIRMA TAT-TABIB ............................................... 
ISEM (Ittri Kapitali) ............................................... 
INDIRIZZ ............................................... 
............................................... 
...............................................

KONTROLL TAL-MEDI_CINI _gL.S.31.18 19 
IL-_HAMES SKEDA 
(Regolament 13 (5) ) 
KONFIDENZALI 
(Avvi_z skond ir-Regolament 13 - Ri_cetti g_hal amfetamina u l-isomers tag_hha, 
flunitrazepam, mecloqualone, methaqualone, methylphenidate u phenmetrazine, u 
secobarbital jew g_haqda ta’ secobarbital u amobarbital f’forma ta’ tablet jew kapsula 
jew f’sachet jew cachet, u s-salts jew l-esters rispettivi tag_hhom) 
ISEM U L-INDIRIZZ TAL-PAZJENT ............................................... 
NRU. TAL-KARTA TA’ L-IDENTIT_A ............................................... 
ISEM TAL-PREPARAT U L-QAWWA 
TIEG_HU ............................................... 
KWANTIT_A PRESKRITTA ............................................... 
DATA TAR-RI_CETTA ............................................... 
ISEM MIN IPPRESKRIVA R-RI_CETTA ............................................... 
FIRMA TAT-TABIB ............................................... 
FIRMA TA’ L-ISPI_ZJAR ............................................... 
ISEM (Ittri Kapitali) ............................................... 
NRU. TAL-LI_CENZA DH 
INDIRIZZ (Ta’ l-Ispi_zerija) ............................................... 
............................................... 
............................................... 
DATA META NG_HATAW ...............................................

20 L.S.31.18_h KONTROLL TAL-MEDI_CINI 
IS-SITT SKEDA 
(Regolament 13) 
Isem u l-indirizz tal-pazjent ...................................................................................... 
Numru tal-Karta ta’ l-Identit_a ................................................................................... 
Data tal-preskrizzjoni ............................................................................................... 
Isem tal-medi_cina ..................................................................................................... 
Ammont preskritt ..................................................................................................... 
Isem tat-tabib, kirurgu-dentist jew dentist li ppreskriva l-medi_cina ........................... 
.

KONTROLL TAL-MEDI_CINI _gL.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_h KONTROLL TAL-MEDI_CINI 
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_CINI _gL.S.31.18 23 
Mi_zjuda: 
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_h KONTROLL TAL-MEDI_CINI 
L-G_HAXAR SKEDA Mi_zjuda: 
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.

