Drup (Control ) (Amtndrmnt) RqulaUoru; , 1993

LX In of 1993

MEDICAL AND KlNDRED PROJo·F.SS IONS ORDINANCE

(CA P. 31)

Drup (Control ) (Amtndrmnt) RqulaUoru; , 1993

IN exercise of the powers oonfc rred by section 40A o f the Medicsl

and Kindred Professiom Ordinanoe. the Minister for Home Affain and

Social De~lopme nt . o n the advi<:e of the Council of Healt h. has made

the following regulation5:~

I. These regulations may be cited 11$ the Drugs (Control)

(Amendmem) Regulations. 1993 and shall be read and oonstrued as one

with the Drugs Control Regulations. 1985. hereinafter refe rred to as

"the principal regulations.".

Immediately after regulation 13 of tne principal regulations

there shall be added the followi ng new regulalion :~

I3A. ( I) Any penon who manufactures or imports

''''by any drug or any pharmaceutical preparation shall. within

eight days of any manufact ure or importation, give notice

thelcof to the Su perintenden t gi~ing details 11$ to the contents

;,.,po.. ... and dosage form of such drug or pharmaceutical preparation

Provided that when a person hll$com pliedoncewith

the provisions o[ this paragraph in rcspc:ct of. panicular drug

or pharmace uticsl preparation, he shall not be bound to

compLy herewith in resp«! of any ot her manufacture or

importation of the same drug or pharmaceu tical preparation

havi ng the s.ame trade name and made up of the $amC

contents and dosagt: form .

(2) The Superintendent may at any time request

the manufaClure r or importer of any drug or pharm_ utical

preparation. as the case may be. to give such information as

the Superintendent may require in rcspe<;l of such drug Or

pharmaceutical preparat ion and the said manu[aClurer or

importer. as the case ma y be, shall comply with suc h request

within fifteen da ys.

(3) The Supenntenden l may '_

(a) proh ibit the importation of any drug unless

such drug is accompanied by:-

(i) a cenirtcate. acceptable to the

Superintendent, from the compe tent Government

authority in the cou ntry of origin. stating that the

drug has been manufactured by • firm duly

authorised to prodllCC such drug forsaLe in the same

coun try. and that the quality conlToI facilities I t the

firm are s.atisfactory, and

(in 8 ce rt ifica lC.

acccpl:lble 10 Ibe

Supe rinlen<ie nl. slali ng tbat Ihe drug complies w;lb

Ihe slandard refeTTed 10 in l he Brilish Pharmaropea.

or in Ibe Brilish Pharmac-eulical O:KIexorwilh olher

slandards KQCpla ble 10 Ihe Superinlendc m, or.

when: no such slandard exists in respttl of such

drug . a ce rtificate. si milarly accepl able. of anblysis

of such drug

(b) suspend or prohibi l lhe di'!rlbUlion. ~upply.

sale or keeping or offering for sa le. of any drug already

imported , unli l Ihe cert ifiea le. referred to in items (i)

and (ii ) of sub·paragrapb (a) of Ibis paragrapb are

produced

Provided Ihat no such suspension or prohibition

111311 take effecl before the expi ry of one monlh frolll the

dale of Ihe demand of such certifies le. by tbe $aid

Superinlen<ie nl.

(4) NOIwithslanding the provisions of paragraph

(3) of tllis regulation. the Superin lendc: nl may willldra w or

ca use to be withdrawn from the marhl any drug or

pllarmacculical preparation if. because of ad~ene reactions

or of Ol her information relaling to ill effects. manufac1 l1 ring

praCl ices or other teellnical or scie nt ific informalion. such

wil lldra .... al is in his opinion indicalcd in lhe inle resl of Ihe

health of patients.

(5) For th~ plUl'o ses of this re~:lIhtion, ·· ,h~l:i:··

indude . ~ny Ine diri~lu l'rel'ar~tion for int~l1lal or H-t~mal

us ~ , wlwrlwr or not li st~ ,1 or sl' e rifie,l in the First or Se r o",1

Srhe,hue to the se re :i:lu ation • . ··.

J . (I) Regul ation i3 of Ihe Drugs (Control) Rcgula lions. 1976

is hereby repealed "';Ihoul prejudice to anyliabi lily incu rred and!O any

proceedings taken 01" Ihal may he laken Ihereunder .

(2) An y dispen sed prescri plion. regisler. record. in'·oice or

OIlier documenl .. ·hich. immediatdy before Ihe coming ;010 force: of

IbQc regulalions. are p«:served unde r the said regulalion 13 hereby

reV()ited. shall conli nue 10 be preserved and 10 be open for in5peclion

~ nd shall for tbese purposes be deen'ed 10 have al ways been preserved

under Ihe principa l regulalio ns.

IfIalbllhht mtd-DIp1Ilimont .. · 1_Inf<ntW:ljont Kosnlj. Pubb~ by th< o.p.nm.l1l oflnfOlmll>On _ C",~il~

Mltbugll fl _l.llmp<rij. tal_G\"fiD - Printd at tM (;q,·.." .... t Prin~"g l'rc:;

Pro .. le - r rio"< 1,·

(1) Ir·regolamenl \3 lar·Regolamenli la' 1-1976 dwar il·

tal, M"ditina huwo b'dan imllassar itda bla IIsa.ra ghal kuU

responsabbihAli Ikun illichdet u ghalkuU protcdimcnl!i l1ielled jew Ii

gl\andu jiltielled bis-sahl'l.a ticghu.

(2) Kun ncetta es.egwila, rci islru. notamcnl . fattura jew

dokumcnt ichor H. fil·bidu fis-schh la' dawn ir·regolamenti . kienu

konscrvati skond ir·regolamenl 13 hawnhckk imhassar ghandllom

jibqgllu konscrvati u ji ntammu disponibbli glial spezzjon u gIIandhom

ghal dawn l-gI\anijict jilqicsu li dejjem kicnu kons.ervoli taht il-

rcgolamcnli prirKipali.