Farmaci e Droghe Malta
Farmaci e Droghe Malta
18 1
(b) The pharmacist must ensure that the prescription was sent
by the official electronic system and fill in the details specified by
these regulations in the manner that is required by the electronic
system.
Control card. 9.(1) (a) No medical practitioner may prescribe any specified
Added by: drug to any person unless such person is in possession
L.N. 65 of 1986.
Amended by: of a control card, as per Ninth Schedule to these
L.N. 34 of 1989. Regulations, issued for the purpose by the
Superintendent of Public Health;
(b) in prescribing any specified drug to any person, the
prescriber shall enter in a clear, indelible and legible
manner all the details set out in columns 1 to 4 of the
control card, and shall then return the card to such
person together with the prescription:
Provided that a medical practitioner may, in making the
application on behalf of a person on the request form as set out in
the Tenth Schedule to these Regulations, also issue a prescription
for a supply of a specified drug to such person and may attach the
prescription to such request form:
Provided further that such prescription shall only become
valid when the provisions of the proviso to sub-regulation (2) of
this regulation have been complied with.
(2) The Superintendent shall issue such control card to the
DRUGS (CONTROL) [ S.L.31.18 7
Delivery of 11. (1) No person shall deliver any specified drug to any other
specified drugs to person except against the presentation of a duly signed receipt
licensed or
authorised persons. therefor.
(2) No person shall deliver any specified drug to any other
person who is not a managing apothecary or who is not otherwise
lawfully authorised to be in possession of such drug, unless such
other person produces a written authorisation in that behalf, duly
signed by the managing apothecary or by the person otherwise
lawfully authorised to be in possession of such drug, and unless the
person delivering the said drug is satisfied that the authorisation is
genuine.
(3) Nothing in the preceding sub-regulations of this regulation
shall be deemed to refer to the supply of any specified drug against
the presentation of a medical prescription in accordance with the
provisions of these Regulations or to the administration of any such
drug by or under the supervision of a medical practitioner, dental
surgeon, dentist or veterinary surgeon.
(4) For the purpose of this regulation, "deliver" includes any
act or omission whereby a person allows or suffers any other
person, not being a person authorised to be in possession of
specified drugs under these Regulations, to take possession of any
such drug.
the case may be, the President may refer the matter to the Medical
Council, and, if the Council so recommends, the President may
prohibit the said medical practitioner, dental surgeon or dentist, or
veterinary surgeon, from supplying, prescribing, procuring or
possessing such drug, for such period as the President may deem
fit, and it shall then be unlawful for that medical practitioner,
d e n ta l surg e on or den t ist , o r v e t e r in a r y su rg e o n to s up pl y,
prescribe, procure or possess any such drug during such period:
Provided that the said President may, at any time, modify or
withdraw any such prohibition.
(11) Notice of any prohibition, modification or withdrawal of
any prohibition as is referred to in sub-regulation (10) of this
regulation shall be given in writing to the person affected thereby.
(12) It shall be lawful for the Superintendent to circulate to -
(a) all medical practitioners the name, and other details as
are shown in the Sixth Schedule to these Regulations,
of any person in respect of whom any preparation as is
referred to in sub-regulation (1) of this regulation has
been prescribed; and
(b) all medical practitioners, dental surgeons and dentists
the name, and other details as are shown in the Sixth
Schedule to these Regulations, of any person in respect
of whom any specified drug has been prescribed or
dispensed.
Warning and 14. (1) The Superintendent may require all manufacturers,
cautions on label, importers, exporters, and all other persons who trade or otherwise
etc.
deal in any restricted drug or any specified drug, to include such
cautions or other warnings on the label, where practicable, or in the
accompanying leaflet of retail packages of such drugs, as are in his
opinion necessary for the safety of the persons using such drugs.
(2) It shall not be lawful for any person to advertise in any way
to the general public any restricted drug or any specified drug.
Information by 15. (1) Any person who manufactures or imports any drug or
manufacturer and any pharmaceutical preparation shall, within eight days of any
by importer.
Added by: manufacture or importation, give notice thereof to the
L.N. 173 of 1993. Superintendent giving details as to the contents and dosage form of
such drug or pharmaceutical preparation:
Provided that when a person has complied once with the
provisions of this sub-regulation in respect of a particular drug or
pharmaceutical preparation, he shall not be bound to comply
herewith in respect of any other manufacture or importation of the
same drug or pharmaceutical preparation having the same trade
name and made up of the same contents and dosage form.
(2) The Superintendent may at any time request the
manufacturer or importer of any drug or pharmaceutical
preparation, as the case may be, to give such information as the
Superintendent may require in respect of such drug or
pharmaceutical preparation and the said manufacturer or importer,
as the case may be, shall comply with such request within fifteen
DRUGS (CONTROL) [ S.L.31.18 11
days.
(3) The Superintendent may -
(a) prohibit the importation of any drug unless such drug
is accompanied by -
(i) a certificate, acceptable to the Superintendent,
from the competent government authority in the
country of origin, stating that the drug has been
manufactured by a firm duly authorised to
produce such drug for sale in the same country,
and that the quality control facilities at the firm
are satisfactory; and
(ii) a certificate, acceptable to the Superintendent,
stating that the drug complies with the standard
referred to in the British Pharmacopea or in the
British Pharmaceutical Codex or with other
standards acceptable to the Superintendent, or,
where no such standard exists in respect of such
drug, a certificate, similarly acceptable, of
analysis of such drug;
(b) suspend or prohibit the distribution, supply, sale or
keeping or offering for sale, of any drug already
imported, until the certificates referred to in sub-
paragraphs (i) and (ii) of paragraph (a) of this sub-
regulation are produced:
Provided that no such suspension or prohibition
shall take effect before the expiry of one month from
the date of the demand of such certificates by the said
Superintendent.
(4) The Superintendent may withdraw or cause to be withdrawn
from the market any drug or pharmaceutical preparation if, because
of adverse reactions or of other information relating to ill effects,
manufacturing practices or other technical or scientific
information, such withdrawal is in his opinion indicated in the
interest of the health of patients.
(5) For the purposes of this regulation, "drug" includes any
medicinal preparation for internal or external use, whether or not
listed or specified in the First or Second Schedule to these
Regulations.
16. (1) These Regulations shall not apply, in respect of any Exemptions.
specified drug, to any drug when it forms part of, or is incorporated
in, a preparation ready for use and which requires no further
compounding, unless such drug is a main or the only active
ingredient of the preparation.
(2) These Regulations shall likewise not apply in the case of a
preparation containing a specified drug, compounded in such a way
that it presents no risk, or only a negligible risk, of abuse, and the
substance cannot be recovered by readily applicable means in a
quantity liable to abuse, so that the preparation does not give rise to
a public health or social problem.
12 [ S.L.31.18 DRUGS (CONTROL)
Saving. 17. Any dispensed prescription, register, record, invoice or
other document which, immediately before the coming into force of
these Regulations, are preserved under the Drugs (Control)
Regulations, 1976, * shall continue to be preserved and to be open
for inspection and shall for these purposes be deemed to have
always been preserved under these regulations.
(Regulation 2)
AM-2201 1-[(5-Fluoropentyl)-1H-indol-3-yl]-
(naphthalene-1-yl)methanone
4-MEC (4-methylethcathinone) 2-(ethylamino)-1-(4-methylphenyl)propan-1-one
1-(2H-1,3-benzodioxol-5-yl)-2-
Ethylone
(ethylamino)propan-1-one
Pentedrone (α-methylaminovalerophenone) 2-(methylamino)-1-phenylpentan-1-one
Ethylphenidate (EPH) ethyl phenyl(piperidin-2-yl)acetate
Methiopropamine (MPA) N-methyl-1-(thiophen-2-yl)propan-2-amine
methyl N-{[1-(cyclohexylmethyl)-1H-indol-3-
MDMB-CHMICA
yl]carbonyl}-3-methyl-L-valinate
N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-
5F-APINACA (5F-AKB-48)
indazole-3-carboxamide
[1-(5-fluoropentyl)-1H-indol-3-yl](2,2,3,3-
XLR-11
tetramethylcyclopropyl)methanone".
AB-CHMINACA N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide
5F-ADB (5F-MDMB-PINACA) Methyl(2S)-2-{[1-(5-fluoropentyl)-1H-
indazole-3-carbonyl]amino}-3,3-
dimethylbutanoate
AB-PINACA N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-
1-pentyl)-1H-indazole-3-carboxamide
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone
5F-PB-22 Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-
carboxylate
4-Fluoroamphetamine (4-FA) 1-(4-Fluorophenyl)propan-2-amine
ADB-CHMINACA N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide
CUMYL-4CN-BINACA 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-
indazole-3-carboxamide
ADB-FUBINACA N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl]-1-
(4-fluorobenzyl)-1H-indazole-3-carboxamide
FUB-AMB (MMB- or AMB-FUBINACA) Methyl (2S)-2-{[1-[(4-
fluorophenyl)methyl]indazole-3-
carbonyl]amino}-3-methylbutanoate
N-ethylnorpentylone 1-(2H-1,3-benzodioxol-5-yl)-2-
(ethylamino)pentan-1-one)
And any derivatives, salts, or esters of the above.
16 [ S.L.31.18 DRUGS (CONTROL)
(Regulation 2)
International or other nonproprietary name Chemical name
or other trivial name
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-6H-
thieno [3,2-f]-s-triazolo [4,3-a] [1,4]
diazepine
BUPRENORHINE 21-cyclopropyl-7-alpha-[(S)-l-hydroxy-1,2,2-
trimethylpropyl]-6,14-endoethano-
6,7,8,14- tetrahydrooripavine
BUTALBITAL 5-allyl-5-isobutylbarbituric acid
BUTOBARBITAL 5-butyl-5-ethylbarbituric acid
CATHINE d-threo-2-amino-1-hydroxy-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
D I A Z E PA M a n d o t h e r c o m p o u n d s
containing the chemical structure of
DIHYDRO-1:4 BENZODIAZEPINE or
of DIHYDRO-1:5 BENZODIAZEPINE 7-chloro-1, 3-dihydro-1-methyl-5-phenyl-2H-
substituted to any degree 1, 4-benzodiazepine-2-one
DRONABINOL delta-9-tetrahydro-
cannabinol and its stereochemical
variants (This item refers to only one of
the stereochemical variants of delta-9- (6aR, 10aR)-6a7, 8, 10a-tetrahydro-6,6,9-
tetrahydrocannabinol, namely(-)-trans- trimethyl-3-penatyl-6H-dibenzo [b,d]
delta-9-tetrahydrocannabinol.) pyran-1-o1
ETHCHLORVYNOL ethyl-2-chlorovinylethynylcarbinol
ETHINAMATE l-ethynylcyclohexanolcarbamate
FENCAMFAMIN dl-N-ethyl-3-phenylbicyclo (2,2,1)-heptan-
2amine
FENETYLLINE dl-3,7-dihydro-1, 3 dimethyl-7-(2-[(l-methyl2-
phenylethyl) amino] ethyl)-1H-purine-2,
6-dione
DRUGS (CONTROL) [ S.L.31.18 17
THIRD SCHEDULE
(Regulations 3 and 4)
20 [ S.L.31.18 DRUGS (CONTROL)
DRUGS (CONTROL) [ S.L.31.18 21
22 [ S.L.31.18 DRUGS (CONTROL)
CONFIDENTIAL
(Return in terms of regulation 13 - Prescriptions for amphetamine and its isomers,
flunitrazepam, mecloqualone, methaqualone, and phenmetrazine and secobarbital or
a combination of secobarbital and amobarbital in tablet or capsule form or in sachet
or cachet and their respective salts or esters)
IMPORTANT - Prescription for these preparations can only be issued after written
approval is obtained from the Superintendent of Public Health for each prescription.
NAME AND ADDRESS OF PATIENT ...............................................
...............................................
L E G A L LY VA L I D IDE NTI FICATI ON ...............................................
DOCUMENT NUMBER
AGE ...............................................
NAME OF PREPARATION AND
STRENGTH ...............................................
...............................................
QUANTITY PRESCRIBED ...............................................
DAILY DOSE ...............................................
DATE OF PRESCRIPTION ...............................................
DATE AND REF. NO. OF APPROVAL
BY SUPERINTENDENT OF
PUBLIC HEALTH ...............................................
SIGNATURE OF MEDICAL
PRACTITIONER ...............................................
NAME (Block Letters) ...............................................
ADDRESS ...............................................
...............................................
...............................................
DRUGS (CONTROL) [ S.L.31.18 23
CONFIDENTIAL
(Return in terms of regulation 13 - Prescriptions for amphetamine and its isomers,
mecloqualone, methaqualone, and phenmetrazine and secobarbital or a combination
of secobarbital and amobarbital in tablet or capsule form or in sachet or cachet and
their respective salts or esters)
NAME AND ADDRESS
OF PATIENT .............................................
.............................................
L E G A L LY VA L I D I D E N T I F I C AT I O N .............................................
DOCUMENT NUMBER
NAME OF PREPARATION
AND STRENGTH .............................................
.............................................
QUANTITY PRESCRIBED .............................................
DATE OF PRESCRIPTION .............................................
NAME OF PRESCRIBER .............................................
SIGNATURE OF APOTHECARY .............................................
NAME (Block Letters) .............................................
DH LICENCE NUMBER .............................................
ADDRESS (of Pharmacy) .............................................
.............................................
.............................................
DATE OF DISPENSING .............................................
24 [ S.L.31.18 DRUGS (CONTROL)
SEVENTH SCHEDULE
(Regulation 7)
PRESCRIPTION FOR NARCOTIC AND PSYCHOTROPIC DRUGS
(Only one item may be prescribed on this Form)
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 Quantity
in Weight/Measure ...............................................
Name and Surname .......................................................... PRESCRIPTION ORIGIN
Address .......................................................................... Hospitals .............................................................
Serial No.
26 [ S.L.31.18 DRUGS (CONTROL)
EIGHTH SCHEDULE
(Regulation 7)
........................................... ........................................
Signature of Prescriber Date
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.