31 tal-1984

i'lIEDICAL AiXD KL\ 'DRED PROFESSIO NS ORDINANCE

(CA P. SI)

DispellSlU'il'S (Lkoe ll5ing) Regulations, 1984

Cita tion and commencement.

Interpre tation.

Lice nce.

Disqua lifica lion from holding a licence

Restrictions of the gra nt and Iransfer of licences.

5.

Dispensing area.

T oilets.

State o f pI'l: mises .

••

,.

ConlleCtion wi th habiUl\ion.

Stallal.lond.

Konl>C$Sjoni "",. abil.ajonl.

Restricted usc: of pI'l:mises.

Management of d ispensary.

! 2.

Order 10 close.

Conduct of employees.

13.

Ordni glllll gllcluq.

Kondolta ta · impjcgali.

Sale o f med icines.

Eq uipment. stoc::k Ilnd appearance.

15.

16. Labelling.

Safe keeping of drugs.

Deteriorated df\J gs. and drugs with an expiry date.

Keeping of I'l:gislers and I'l:por! of sates and stock of drugl.

Ope ning times.

U naccc!'tablc prescriptions.

22. StofCll.

l mtlaten .

LiJ:ijicl u Trgol. meoli ollfa.

Other laws or regulations.

L..N. 31 of 11184

i'lIEDICAL Ai\"D KL\' DRED PROFESSIONS ORDI NANCE

(CAP. 51)

Dispensaries (Lktnsi nK) Regulations , 1'84

IN e~ercise of the powers conferred by section JSA of the Mooical

Dnd Kindred Professions Ordinance. the Minister of Health. after eon·

sultation with the Council of I-I ealth. has made the following regula·

Illgulations may be ci ted as the Dispensaries

Th~

III

ILicellliing ) Regulations. 1984.

12. These regul ations shall come into force with immediate

effect. ellcept for regulation 10 whicb shall come into force on such

dllyas the Minister responsible for public health may appoi nt by notice

in the Gazette.

In thes.e regulations. unlcs~ lhe co nteJ<t otherwise requires -

2. "dispensary" means any premises from which any medicinal

substances are sold. dispensed or otherwise suppl ied direct ly to the

public by retail. irrespective of whether such sale. dispensing or

supply is carried out on the presentation of a prescription given

for the purpose by a medical pracrilioner. den tal surgoon. denti st

or veterinary su rgeon. or otherwise;

"drug" includes any medical substance.

" licence '" means a licence granted unde r section 18 of the

Ordinance

"Ordinance" means the Medical and Kindred Professions

Ord inance

"Superintendent" means the Supe rintendent of Publ ic Health

m

No licence: may be granted or renewed e.J[cept in con·

formity with ttle provisions of these regulations.

12) A licence shall Inpse on the 31st day of December of

any year in which it is gramed or renewed.

4. (1) No person shall qualify for a licence if he is a medica l

prachtJOncr. dental surgeon. dentist or veterinary surgeon. or if he is 'mm

ttle husband or wife of Ilny such m~ical pract itioner. dental surgeon. holdu.. •

dentist or veterinary surgeon.

(2) No licence shall be granted or renewed if a medical

practi tioner. dental surgeon. denti st or veterinary surgeon has any direct

or' indirect interest in the dispe nsary.

5. (I) III every town or village the number of dispensaries sha H M. • • tric,;on.

not exceed the ratio of one dispensary for every three thousa nd in. of the Vi'Dt

habitants

Provided that the number of dispensaries whiCh may be

licensed in any town or village shall not be less than two

Provided further that a licence for a dispensary may be gran!-

ed in the case of 11. newly developed area with morc than onc thousand

in habit an ts if there is no dispe nsary wi th in five hundred met res. cal-

cu lated as the shortest walking distance. of the nea rest part of such

area.

An y dispensary subsisting and operating on the coming

(2)

inlo force of these regulations. and which but for paragraph (I) and

paragraph (5) (in respect of the grant only) of this regulat ion would

be properly li censed under these regu latiollli. shall be so lice nsed.

()) Where in any [own or village the number of dispensaries

exceeds that laid down in pnragraph (1) of th is regulation, no transfer

of a licence of any dispensary other than a transfer 10 the husband or

wife or to a descen dant in the dircct line of 8 dece ased licensee. shal1

be effected.

(4) Saving the provisions of paragrapb (2) of this regulation.

no new licence sball be granted if the premises is witbin two hundred

metres. calcul ated as the shortest walk ing di stance. of another dispen-

s:\ry.

(S) No liecnce shall be gran ted or transferred unless the

licensee or transfe11:e of the di spensary is a person who is qualified to

practise as apothecary under the provisions of the Ordinance. or in the

case the transfere<l is the husband or wife or a deS(:endant in the dire<:t

line of a deceased lice nsee.

6. Eve ry dispensary shall have a dispensing area for the prepara-

tion nod com po:.lnding of medicinal sub.'ltances and there shall be pro-

vided and maintaine d in good working ordcr in that area, a supply of

wholesome drinking water. water at suitably con troUed temperature and

n properly drained sink.

7. (J) A toilet shall be provided and such toilet shall be con·

nl!(.: ted with a flushin g apparatus in good workin g order; and in the area

of such toilet there shall be provided a supply of water. roap. nail

brushes and hand dryi ng facilities.

(21 The provis ioru of paragra ph (\] of this regu lation shall

not nppl y in respec t of a dispensary existing before the coming into

force of these regulations and wh ich ca nnot be mad e 10 comply with

such provisions.

8. The premises shall be kepi in a good state of repair and at

all times ck:a n; and no strucwral alterations may be carried out with·

out the prior approval of the Superintendent.

9. m No dispensary shall form part of or communicate with

a premises used for habi tation. and no dispensary shall be used for

sleeping purposes.

(2) The provisions of paragraph (I) of this regulation $hall

not apply in respec t of a dispensary uisting before the comi ng into

fon:e of the$C regul ation, and which cannot be made 10 comply with

such provisions.

10. (1) It shall 001 be lawful for the licensee of a dispensary to

ca rry out Of cause, pennit Of suffer 10 be carried out on the premises

any activi ty which is not strictly Ihal of the storage. pre paration. dis·

pensing. sale or supply of drugs. or that of the storage and sale of other

anicl" as are mentioned in paragraph 0 ) of regulation 15.

(21 There shall be no communication. whether permanent or

temporury. between the pre mises of a dispensary and any other pre mis-

es which is used for any activity whatsoever. commercial. professional

or otherwise. el{cept in accordance wit h pal"llgl"llph (1) of this regulacion.

11 , (I) A d ispensary shall be managed by an apothecary who M ........... nl

is authorised to practise his profession under the Ordinancc, an d such or di. p<nu'1'.

apothecary shall be present in the dispensary during all times tlie dis-

pensary is kept open.

(2) The licensee and the managing apothecary and, in their

absence. any person acting on their behalf to open or close tbe d ispen-

sary for the dai ly runni ng thereof. shall inform forthwit h the Superin·

tendent of the absence tot her than momentary) of the managing apot he-

cary.

(3) The managing apothecary shall give to the Superinten-

dent previous notice in writing of the name a nd address of any new

pharmacy technician who will be assisting him in the dispensary.

(4) Where any pharmacy technician ceaSt! to be employed

in any d ispensary. the maDuging apothecary of such d ispensary shall

inform the Superintendent within forty-cight hours of suc h cess.ltion.

(il It shall be tbe duty of the managing apothecary.

(5)

any otber apothecary a Dd any pharmacy techDician in charge of

or em ployed at a dispe nsary. as the ease may be, to wear a clean

while overall al all times during whic h they are present at the dis-

pensary.

\iil It shall be the duty of the managi ng apothecary 10

wear 011 the overall a t all times du ring whic h he is present at the

dispen.'lary under his management. an ide nt ity card issued by the

Superintendent for the purpose. containing a recen t colour phOlo-

graph of the said apothecary. his name. surname. q ualifica tiotlS.

Ihe number of the identity card issued under the Identity Ca rd "'" U of

Ac t 1975. the designa tion 'managing apothecary' and the name of 1975

the dispensary.

(Ill) It shall be the duty of an apothecary to send to

the Superintendent two recent passPOTl sile colour pbotogl"llphs at

the lime he gives the notke of assumptioll of the management of a

dispensary.

(iv) The provisions of sub-paragraph (i ii) of this pal"ll.

graph shall apply also tD managing apothecarics already act ing in

that capacity at the time of comi ng inlo force of these regulations

Provided that such managing apot hecaries shall submit

the photographs within one week from the day of the comi ng into

force of these regulations

Provided further that the provisions of sub-paragnlph (iI)

of tbis paragraph shall. in their respect. apply on the lapse of two

months after the COmiDg in to force of these regulatioDS.

(6) T ile provisions of sub-paragraphs (iil, (ii i) a nd (iv) of

paragraph (5) of this regulation sha ll when so required by the Super·

intendent a pply muwris murumli.r to any other apothecary and to any

pharmacy technicia n employed at any dispensary.

12. If lhe managi ng apol hecary or another apothecary is not in

allendance, and the Superintendent is satisfied tht circumstances exist

which give rise 10 the suspicion Ihat a breach of the pro.isions of the

Ordinance or of any regulations made thereunder. or of any legislation

relating to drugs. may OC(:ur, the Superintendent may order that the dis-

pensary shall be clO5ed forthwith and be kepi clO6Cd unln suc h time as

he is satisfied that no such breach exists.

13. (l) Without prejudice to the provisions of tbe Ordinance

applicable 10 the practice of the profession of apothecary and of phar-

macy techn icia n, no person may be employed in a dispensary if he is

fOllnd guilty in any court in Mal ta (){ abroad of a n offence of theft

or abuse of drugs.

Prior to the grant or renewal of a licence. the owner or

(2)

other person running [he business of a dispensary, shall furn ish the

Superintendent with a list of persons employed by him at the dispen-

sary. T he Superinlendent may at any lime require any such em ployee

to produce 10 him a ceniflCllle of conduct from the Commissioner of

Police, and it shall be the duty of such employee to oomply with that

requut without delay .

14. No medicines may be sold in an y dispensary except by an

apothecary

Provided that a pharmacy technician may. subject to the pro-

visions of the Oniinance. tell those medical substa nces which do not

require a prescription.

15. (1) Every dispensary shal1 be provided with metric weights

and measures and such olher utensils a nd equipment as may be requir-

ed in accordance with good phllrmaCy praclice .

(2) There u.al1 also be provided in every dispensary such

medical substances as may from time to time be rcqui~ in accordance

with the provisions of se<:tion 31 of the Ordinance; and every dispen-

sary shall comply with every other condition that may from lime to

time be imposed by the Superi ntendent regarding the stocking and sakl

of drugs.

(3) The licensee shall ensure that Ihe appearance of the pre·

mises and the d ressing of the ' hop windows reflect the professional

cha racter of the dispensary and make it clear to the public that the

practice of pharmacy is the main purpose of the establishment, and

that the wording of Ihe signboa rd conforms to the dignity of the pro-

fession

Provided that besides medicinal preparations there may be

sold in a d ispensary medical appliances pertaining \0 the medical and

kindred professions. cosmetics. toilCl re<juisitc.s. perfumery, photo-

graphic and optical goods. baby food a nd other articles which in the

opinion of the Pharmacy Board do not lower the prestige of Ihe pro-

fession.

All D1edicinals sha ll be properly labelled.

Hi.

(I)

For the purpose of Ih is regulation proper labelling shall

(2)

incl ude the cxpiry date where in accord ance with good pharmacy prac-

tice such date is illdicated.

17. (I) The Jil:ensee of a dispensar)' shall ensure that facilities Safe k«pin.

are available in the premises for the safe k.ecpin g of drugs in such cf dIUC'.

manner as shall avoid the possibili ty of misuse of stock..

\2) All drugs listed under the Second Sclledulc \0 the Dru gs L.N. 31 of

(Control) Regu lations. 1976. or falling under the Da ngerous Dru gs 19'76

Ordinance. 1939. and all poisons shall be kepI under lock and key. ('ap. t61

which key shall be kepI by the managing apolhttary.

tJ) No person other than the managing apothecary shal! have

a duplicate of Ihe $aid key or have access to such key wi tho ut the per-

mission o f the Superintendent.

(4) The Superintendent may require tha l other medical sub-

stances or categories of medical substances besides those mentioned in

paragraph (21 of Ih is regulation shall be kept locked as aforesaid.

18. No delerioraled drug shall be: kepi at any dispensary.

(I)

(2) No dru g which bears an expiry date ~hall _

(a) be sold. dispensed or otherwise suppl ied after the expiry

date has expired, or

tb) be retained on the premises of any dispensary. even

though not fOT sale, dispensation or other supply. for a period in

ex~ of one monlh after tile expiry of such date.

(J) When any drug wilh an expiry date is soki. dispensed or

olherwise supplied in a container or wl'1lpper which is different from

Ihat in which it was original1y packed. it shall be the res ponsibility

of the managing apothecary to ensure that the expiry dllte is reproduced

legibly on any such new packing.

1.9. I U T here shall be provided in the dispensary a recent copy K ... piDl of

of Ihe British Pharmacopoea or the Internat ional Pharmacopoea.

(2) There shall also be: provided the following separate

registers and book -

(a\ a maill register ill which shall be entered the sale of

every medical substance whil.:h requires a prescription as provided

in $ub:seclion (I ) of section 28 of Ihe Ordinance,

Cb) a poisollS register in which shall be entered the sale of

every poisonous substll.llcc as provided in subsectioll (2) of section

34 of the Ordinance.

(cl a regis ter or registers in whil.:h shaH be entered every

purchase and $II le of drugs listed in the Second Schedule to the

Drugs (Control) Regulations. 1976.

Id ) registers in which shall be emered every purchase and

sale of drugs as required by rules or regulations made under the

Dallge rous Dru!lS Ordinance. 1939, and

lel a book in which shall be tl'1lnscribed the r«ord of lilt

proces verbal of the inspection of Ihe dispensary in accordance

with the provisions of se<:tions 36 and 37 of the Ordinance.

(3) All the pages of each register and book referred to in

paragraph (2) of this regulation shaH be numbered consecu tively and

sha ll be stamped by a medical officer of heallll. and shall be open for

inspection by a medical officer authorised by the Superintendent or by

an aUlhorised apothecary.

(4) Prior to each renewal of the licence, the managing apothe-

ca ry sha ll draw up a report in duplicate on a\1 transacti ons in respect of

drugs listed in the Second Schedule to the Drogs (Control) Regulations,

1976, as also und er the Dangerous Drugs Ordinance, 1939: such report

shall include. amongst other re levant da ta, in respect of each such drug.

the total amount purchased, its form and dosage, eacb date of purchase.

the total sales and on account of the slock taking carried out at the end

of the year. A copy of such report shall be sent 10 th e Supe rintendent

<lnd another copy shall be retained by the licensee.

(5) A report in dupl icate as is referred to in paragraph (4) of

th is rcgulation shall also be drawn up by the said apothecary before he

relinquishes the management of the dispell5llry under his care.

20. (l) Every dispell5llry shall be kept open on suc h days a nd III

such limes as the Superintendent may from time to lime order in accord-

ance wilh the provisions of section 42A of the Ord inance.

(2) The apothecary in charge of a dispell5llry which is not

required 10 be t ept open in terms of paragraph (i) of this regula tion shall

affi.t to the door o f the dispensary under his management a notice clearly

visible from the street showing the name and add re$S o f the d ispensary

or d ispc:nsaries requ ired 10 be kept open in tha t particular district.

(3) A nOlice showing the name and address of the managing

apothecary shall be kept affixed on the door o f the dispensary in such a

.... ay as 10 be visible from the streel a nd al all timC$ during .... hich the

diSpensary is closed.

21. /I) It shall not be lawful to dispense any medical prepa ration

on the prescription of a person who is authorised under section 4 (3) o r

secti on 5 tI) (d) (e) of the Ordinance to practise tbe mcdical profession

only as a house physician /surgeon in a Government hospita l or cli nic.

unless such prescription bears an indication of bei ng issued from a Go-

vernmen t hospital or clinic.

(2) It shall not be lawful 10 dispense any medical prepanllion

on the prescription of a person who though licensed to practice the

medica l or denta l profession, is disallowed by an agreement wi th Govern ·

ment from engaging in the privale practice of hi s profession until he has

served in a Government hospital or clinic ror such period as may be

specified in that agreement, unle$S such prescription bears an indication

of being issued trom a Government hospital o r cl in ic.

(3) The Superintendent shall from lime to lime furnish to the

managing apothecary of every licensed dispensary the na mes and

addresses of thoe medical and dental persons referred 10 in this regula tion.

22. The provisions of these regu lations shall, so far as applicable,

apply also to stores used in connection wilh any dispensary.

D . 1be provisions of these regula tions shaH be without prejud ice

10 the provisions of any other law or regula tions in so fa r as lhey are nOI

inconSIsten t therewith.

,..bUsloN., ," '0""_ 0 . _

, _ " _. T~. , ... T&&"ri'

1C ... ~/tI

K.ttllJo

N htq. M ... " , _ .. 0.0.-..... _

., ' M 0 ........... ' """" • • I'n ..

"',,~

rrl« le

prczz 4C -