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ln_1984_39 MT

39 tal-1984

10 Articles / Provisions · Malta
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Statutory Text (10 Articles)

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

L N. J\I of 198-1

M EDICA L AND IUNDRED PROJo1::SSIONS ORDINANCE

(CAP. 51)

Dnp (Contrul) (A1M "'~.t) Rt lUlIoliolll, 1984

IN CJ<ercile of the powers conferred by _lion 35A of the Media l!

aod Kindred Professions Ordinance. the MiniJter of Health. 00 the

advice of the Council of Health. ha. made the followioa ~gu\ation,:-

I. Tbese reaulatioOill mly he d ied as the Drugs (Control) (Amend-

ment) Regulations. 1984. and 5""11 be read and conslnlcd as one with

the Drugs (Control) Regulations. 1976. hereinllfter referred to as "Ihe 1.1'1. II of 1916

prirw:ipal regulations".

Gazzetta tal-Gvern ta' Malta — Avviż Legali 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

Dawn ir·regolarnenli jistgl'lu jissejl'lu r-Regolamenli ta' 1-1984 li n.,lu.

jemendaw i.-Regolamenti dwar il-Kontroll tal-MediCini, u gIIandhom

jinqraw u jiftiehmu ha~a wallda ma._Regolamenti ta' 1·1976 dwar it- .... 1- II ta'

Koo!roU tal·Medi6ni, hawohel<l< itjed 'il qllddiem imsejlla "ir·regola_ !97~

menli prin~ipali".

F ir·regolament 2 tar-regolamentl prineipali. minnufill 'label it- 1,,,,._

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

10 regula tion 2 of the prino;ipu.1 regulatiom. immediately Ixfore

the definitioo of "regililcr" there ~hall be inscned lhe lollowing new

definition

"iden!i!, am'" means a vllid identity card issued in 1tC'OOI' •

H

dlnce with thc provisions of the Identity Clrd Act. 1975 and of Iny

regulalioM made theRullder;"

l . Regulltlon 4 of the principal regulltions shall be amended as

(I) for paragraph (I) A !hertof theR s hall be substituted the priocipot

following

" (lA) (i) No penon shall impOrt. slock or sell Iny

'pecifled drug by wholesale u nless he holds a specifIC lice~

for the purpoN: from the Superintendent

(ii) No liccnct for the purposes of the forrgoiDg

sut>-p.ragraph shall be issued unless the drug or drugs iD

respect 01 which 11 is issued all' under thc dirllCl responsibility

01' an apot~ry.": and

tb) paragraph (6) thereof shall be deleted.

Gazzetta tal-Gvern ta' Malta — Avviż Legali 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

mionok il·paragrnfu (l)A gl'landu jidllol dan li ~j

la)

"(lA) (i) Ebda persuna ma' I~ta' timporta. tallt.en Jew

tbiegl'l xi m<:diCina spcCifikata bl-ingr~ kemm-i\ darba rna

jkollhiex litenza sp«ifika ghal Ilekk mingltand is-Suprinten·

dMC

lii) Ma g!landha linharc~ ebda litenza ghall·fini·

jie! tas-sub-paragrafu ta' 'label dan kernrn-il darba l·meditina

Jew il.mediCioi li dwarhom (kun ;nl'lartel ma jkunux lallt ir·

responsabbiltA direlta ta' spit jar.": 11

(b)

il-paragrafu (6) tiegllu gIIandu jitltassar.

priD~ipali

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

For RKulati/)rl 701 the prioop!ll regulations there shall be SUbot:l .....

substi1ll\ed tbe followi ng

"7. 0) Every prescription for a speci fied drug !ihall be pri..cipo.t

written in ink or in other Indelible material /)rI the form $el rqw..x-.

out in the Sc~enth !icbeduLt: to these regutatioos.

(2) It shall be the duty of a mc<Iical praclitioner

issuing I prescription for a specified drug to fill in a clear

and legible hand Part A of the form $et ou t in the Seventh

Scheduk:. a nd 10 $Upply all the detail. and give ,Uthe informa-

lion in the appropriate space as therein required: the medical

prJclilioner shall further add hi. si gnature in fun and the

date when lbe JlIU('ription WII issued

Provided that ill the ca'iC of I medical pnlctili~r

authorised uoder _lion 4 of the Medical and Kindml Pro-

fessioD5 Ordinance to practise !be medical profession but who

i$ not yet Rgistered with the Medical Council. SIICh pnlcti·

tiotICT shall insert the DUmber gi\-cn to him by the Supcri.

tendent instea d of the Medical Council registration number

OD the said prescription _

IJ) Subjcct 10 the prD~i~ons of p:lragraph Ill) 01'

this n:gutation. DO medical pr1Icti~ shall issue a pn:scrip-

tioa for a specified drug unless the p«:SCription <.:Omplie!l with

the provisions of IlIis n:gulation and sucll drug is required

fOf the J!UI"IlCI'e of medial trea~nt

Provided that a medical practitiCNICr may. lubject

10 the OIher provisions of these Il:gIIla lions. issue a p rescrip-

tion for professional wc for ID amouDI nor. iD e~CC:5$ of k ll

phials for injection or of twenty lableu or ca psules.

(4) E~ry medical praclitioner who oblains a speci-

fied drull for profc&liooal wc u providod in thc proviso to

paragraph ()) of tllis Il:gulation sllaH k.eep~ in acoordaoce

with. a nd wi lholU pre"jud~ 10. !he provisions of regulation 4

of tllese regulations. a record in a n appropria\l:: n:aUkr of thc

!IafIIC and surname: (if a ppliabld . the a~ and add"", of lhe

palient 10 whom the d rua has been admi Diskn:d and lbe-aare

of administration.

(S) No medical praclitioner $hall is!uc a pn:scrip-

tion for a specified drull to Iny penoo unless sucb persoo is

well k.1I(lWn to him or unless the medical practitioner has

a.so:xrtained the identity of JUch person through his identity

card.

(6) No medical practi tiOMr shall issue a presct1p-

lion for I spe..;ified drug to any person unless the said medical

practitioner has IakCD n:a.sonably suffldcnt s~ps 10 a'lCC'rtain

tha t suc h person is DOl. I1 lhe time of issuilll the ~ption.

~iving lnalIneot from anolber medical practilloner in res-

pco;t ofldd iction 10 any Ipmficd doIg Of otherwise. a nd that

lucb person has nOI beeD supplied with any suc:h drug On a

pretcriplion issued by that other medical practiliCNICt.

(7) A medical praCtitiODCT ,halt wc a separate form

in respect 01' every drug pn:scribql by him under this tcgllla·

lion and 110 drug OIher than a speci fied drug or I d rug faUing

under lhe Dangerwus Drug& Ordina nc:c:. 1939. may be prc..

cribed on lhoso: ronns..

(8) A medical practitioner shaH in pn:scrihing a

specified druB . wc only prescription fOt'mi from the book.let

of forms in .serial nUIll~r. issued 10 him hy ihe

Superinkndent upon a reque&t made on the form set out in

the Eilhth Schedule 10 these n:gull tions and it shall be: the

dUly of every ~ical practitioner. whelher fOf the purpose

of hif privak practice or for carrying OUl his duties in an

offICial capacity u & n:sult of his c mployment with G overn-

ment. wi th a view to meetin&: lhe needs of his patients. 10 make

a ny requesl for such prescription bootlelS on- lhe &aid form

such reque!lt form shat! be corre.:lly filLed ;n all respects and

si&:no:d by the prac titio""r. and ,ha t! be either handed in by

s",h practitioner persona lly 10 tbe Chief Pllarmacist 11 the

Government Med ical Stores a t Gwardama n ~ia or SCnl by pOS l

10 the SuperinlcDdcnt o f Public Health a t lhe Departmenl of

Health in Vallcua : .... hen seD t by posl the envelope may be

marked " Public Health Notifocations" f(lf' the purpose or

~cmption from postage.

(9) It ~ha !l be the duly of I medictLl pract itioner

to n:porl in wri ting fOfthwith 10 the Superintendent any case

of theft or loss of such boo~lel and it shall not be lawful for a

medical practitioner to use any pre5criptiOD form from any

bookle t of forms issued to another medical practitioner.

OO! For the purpoee of this regulation. unless the

eontelll othcwi5C requires. the expression " medical pract;.

tiotw:r" hlc1 udc!1 I dental JUrgeoll. a dentist and a veterinary

surgeon.

m

Ill) The provisiOIll of paragraphs tlI. (21.

and.

in so far as applicable. parap:aphs (8) and (9) of Ibis regu·

lation shall IIQI: apply to the pn:$CI'iption of specif'tcd drugs

for a dm inistr:ation 10 ward patients in Goverorncnt hospitalt,

which puscri pcion shall be c;OOlrolled by !he hospital internal

rule$. ",

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

For regulation 8 of the priDCipal regulations tberc shall be rub-

,tilllted the following

'"DI ; " 01

Gazzetta tal-Gvern ta' Malta — Avviż Legali 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

" Fk_el kolonna ta' I·E_el Skeda li linsab mar-regolamenli

prio(:;pali millflok. J·iltri "DM PH" gbandhom jidl'llu I·ilui ··D M HP".

I . Minnufih wara [·panita "PARALDEHYDE- li bernrn fil·Tio: ni

Skeda li linsab rnar·regolamenli prin~paJi &!Iandu jidl'lnl dan li tej

" PENTAZOCINE

I.2J,4.5.6-Heuhydr0-6. Il-dimelhyl- 3-(3

melhylbllty 1-2-enyl)·2, 6-melhaoo-3«nza.

locio--80I".

FiI·Taqsima I l(b) tal·Tielel Skeda li lillSab mar-regolame nli

prin~ipali, rn innok

lI·klicm "Meta I·bcjgrt ,kiln bir,ri~nll, in-Dumru ta'

rH:ena " gllandhom jidlllu 1 . ldiem " Mcta l-bcjgb ikuu bit . ritella, I .. isem

ta' min p gllmel ir-r~lta u n·numru ta.He, je IIff~jali !itarnpal fuq il ..

formula tar .. ri te na",

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

(I) No pel"$On other than a n apothecary shaH dis-

pense a prcsaiptiOA for a IopO":irtcd drug.

(2) No apothecary shall dispense a prescription for

a specili«l drug unless -

be is acquainted with Ihe signatlln: of tbe per·

(a)

by whom it purports 10 have been i~ued. he has

toll

no IU.JOn 10 S U~ that it is not genuine and he ha:!

taken reasonable Sleps 10 satisfy himself that it is genuiJlC;

.od

(b) the prescription complies with the provisioll$

of ,."gula tion 7 of Ihese regulatioIlli.

(3) No specified drug shall be supplied moo: than

once OD the same prescription.

(4) An apothecary dispeDSing a prescription for a

llpecified drug shall fill in a clear and legible hand. in ink or

olher indelib le material . Part C of tlte form set OU I in the

Seventh Sched ule to these regulations. and 10 supply all the

delails aQd gi ve all Ihe information as therein required; the

apolhec4ry shall further add hi. signature in full a nd the dale .

and shall. afler dispensing the prescriplion. retain it.

(S) For the purp<'l$C of paragrapb (4) of this regula.

tion it shan be the duty of an apothecary dispe nsing a pn:s-

n lptlon for a specified drug to req uest the identity card of

the pel"$On in respecl 0( woom lite l'n:scriplion has b«n issued

and it .hall be tlte duty of the person woo intendS to al;'<juire

a specified drug, whelher for himself or on beehalf of Ihe person

10 woom the drugs have b«n pn:'lCTibcd. 10 prc:&ent Ihe said

idenlity card as wdl u his own icknti ty card together with

the prescription

Provided that the provisions of Ihi. paragr.l.ph and

the relative pan of Ihe provisions of paragraph (4) of this

regul atiOll. shall 001 apply in respect of a per$On ",,110 has DOl

yet b«n issued with an ideDtity card.

(6) It shall be the duty or every managilt& apothe.

ouy 0( a licensed disJxnsary 10 send to the Superinlendent

in a sealed ~D\-elope on the first day of every mon th an the

prescripllons for spccirocd drugs dispensed from lha t dispen·

Ary during lhe pn:ceding month; that cnvelope shall bee

addressed "SuperintendCDt of Public Health. Depart.mcDI of

H ~alth. Vallellll. and may be marked "PubLic HeaLth Noti f;·

~tions" for lbe purpose of uemption from postage.".

ReguLation 10 01 lhe principaL rtgulalions sllall be deleted.

6.

1. In the first column 01 the Finl Schedule 10 the principal r .. gu·

tions for the lellers " DMPH ~ lhert .hall be substil .. ted the: leners

uDMHP·· .

I. Immediately aller the item " PARA LDE HYDE" in the S.cond

Schedtlle 10 the principal rtgula tions there shall be inserted the

folLowing

" PENTAZOCINE

1.2.J.4.5.6· lkxuhydr0-6. II-dimethyl- H3

nlelhylbuly L ·2~nyH·2. 6-melnaoo-3·benza·

roein·801".

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

In Pari IHb) of lhe Third Schedule 10 the principal regulations

for the words " Where sale is on pr<:SCription. prescription number"

there sMII be substituted the words " When sale is 011 prcscrip{ion. tbe

name of the prescriber and the official serial Dumber printed on lhe

prescriplion form" .

Malta Government Gazette — Legal Notice 1984 39 — 39 tal-1984 – Regolamenti tal-1984 li jemendaw ir-Regolamenti dwar il-Kontroll tal-Mediċini

ImmcdialC'l y after the Sixth Schedule to the principal regula·

tions th:re shall be ad<kd lhe followi ng IlCW ScheduiC's

" SEVENTH SCHEDULE

(Regulation 7)

.. RESCRIPTI OS FOR NARCOTIC ASD PSYCHOTROPIC I)R UGS'

(Only DIM' It~m m~y'" pftiC:l'ilwod 00 th is Form )

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( RegUlation 7)

REQ UEST FOR PRES CRIPTION FORMS FOR

FREE MEDI CINALS

I reqtlesl .. .... . . . . bookle·,/. by .... . . .... prel§niplion form$

Name and Surname of Prescriber

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(IN BLOCK LETIERS )

Med.Council Reg. No. I

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Signature .......... .. ........ . .

lOOR OmClAL USE

Supplied ...... . . . . booklel!l by .. ... .... . prescripllon forms

Serial No .. ...•.• .... .•. 10 ..•.•.. . •..•.•

<a)

Ifwithdnown penonaUy by prescriber .

Signalure of Presdber

Dale

If forwarded by mail.

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