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Farmaci e Droghe Malta

The document summarizes regulations related to controlling drugs in Malta. It defines key terms like restricted drugs, specified drugs, and identity documents. It establishes that restricted drugs require special authorization to import, manufacture, or possess and can only be used for scientific or medical purposes with approval. It also requires those authorized to keep registers of restricted drug transactions. It mandates that transactions of specified drugs be registered and that those drugs require licenses to import or sell wholesale. Possession of specified drugs also requires authorization.
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0% found this document useful (0 votes)
73 views28 pages

Farmaci e Droghe Malta

The document summarizes regulations related to controlling drugs in Malta. It defines key terms like restricted drugs, specified drugs, and identity documents. It establishes that restricted drugs require special authorization to import, manufacture, or possess and can only be used for scientific or medical purposes with approval. It also requires those authorized to keep registers of restricted drug transactions. It mandates that transactions of specified drugs be registered and that those drugs require licenses to import or sell wholesale. Possession of specified drugs also requires authorization.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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DRUGS (CONTROL) [ S.L.31.

18 1

SUBSIDIARY LEGISLATION 31.18


DRUGS (CONTROL) REGULATIONS
2nd August, 1985
LEGAL NOTICE 22 of 1985, as amended by Legal Notices 65 of 1986,
26 of 1987, 70 of 1988, 34, 103 of 1989, 173 of 1994, 78 of 1998, 183 of
1999, 173, 424 of 2010, 148, 413, 426 of 2012, 363, 365, 405 of 2013, 47 of
2016, 356, 361 of 2017, 380 of 2017, 229 of 2018, 233 of 2018 and 267 of
2018 and 191 of 2019.

1. The title of these regulations is the Drugs (Control) Title.


Regulations.
2. In these Regulations, unless the context otherwise Interpretation.
requires - Amended by:
L.N. 426 of 2012;
L.N. 233 of 2018.
" i d e n t i t y identification document" means a legally valid
identification document issued in accordance with the provisions of the
Identity Card and other Identity Documents Act, and of any regulations Cap. 526.
made thereunder;
"prescription" means any medicinal prescription issued by a
professional person qualified to prescribe medicinal products by or
under the Medicines Act, including manual prescriptions, computer
generated prescriptions and eprescriptions;
"restricted drug" means any one of such drugs or chemical
substances as are listed in the First Schedule to these Regulations;
"specified drug" means any one of such drugs or chemical
substances as are specified in the Second Schedule to these
Regulations;
"register" means a bound book with consecutively numbered
pages, but does not include any form of loose leaf register or card
index;
"Superintendent" means the Superintendent of Public Health.
3. (1) No person may import, manufacture, export, purchase, Importation, etc.,
sell, use or be in possession of any restricted drug without a special of restricted drugs
to be specially
authorisation in writing by the Superintendent. authorised.
(2) The Superintendent shall not grant a special authorisation
to use any restricted drug except in special cases for scientific or
very l im i te d m ed ica l pu r po ses in sid e m edi ca l or scie nt ifi c
establishments under government control or specifically approved
by the Superintendent, who shall have the power to impose in any
authorisation any conditions and requirements he may deem fit to
impose with a view to safeguard against abuse.
(3) The Superintendent may at any time, without giving any
reason whatsoever, withdraw any authorisation granted by him
under sub-regulation (1) of this regulation.
(4) Any person who has been authorised in accordance with
sub-regulation (1) of this regulation shall keep such registers as
shall be necessary in accordance with the Third Schedule to these
Regulations in relation to the manufacture, acquisition and/or
2 [ S.L.31.18 DRUGS (CONTROL)

disposal of restricted drugs, in which registers there shall be


entered the details relative to such drugs. Each entry shall be
signed, by the person authorised under sub-regulation (1), within
twenty-four hours of any transaction or process, and any such
register shall be preserved and kept available for inspection by the
Superintendent or his representative for at least two years after the
date of the last entry recorded therein.
(5) Any entry in the register shall be made in ink or other
indelible material and shall be entered on the same day in which the
transaction, administration or process is effected, or, when this is
not possible, on the next following day.
(6) Any register used or in use with regard to one particular
premises shall not be used also with regard to any other premises or
for any purpose other than of this regulation.
(7) No entry in the register referred to in the last preceding sub-
regulations of this regulation shall be cancelled, obliterated or
altered or shall be entered with some untrue particulars:
Provided that if any mistake is committed in any entry, such
mistake shall be corrected by means of a note in the margin or at
the foot of the page, which note shall contain the correction
required and the date of the note.
(8) No person may dispose of any restricted drug except to
persons specially authorised to possess or use such drugs.

Transactions 4. (1) Any person who is licensed or authorised to


regarding specified manufacture, import, sell, supply, distribute, or administer any
drugs to be
registered. specified drug, whether in the line of his trade or profession or as a
medicament on the presentation of a prescription, shall keep such
registers as shall be necessary to show any transaction regarding
the manufacture, importation, purchase, sale, supply, distribution or
administration of any such drug.
(2) (i) No person shall import, stock or sell any specified drug
by wholesale unless he holds a specific licence for the
purpose from the Superintendent.
(ii) No licence for the purposes of the foregoing paragraph
shall be issued unless the drug or drugs in respect of
which it is issued are under the direct responsibility of
an apothecary.
(3) Any specified drug manufactured, imported, exported
purchased, sold, supplied, distributed or administered shall be
entered in the register in the form shown with such variations as
circumstances may require, and containing such particulars as are
shown in the Third Schedule to these Regulations and as are
applicable to the case.
(4) Any entry in the register shall be made in ink or other
indelible material and shall be entered on the same day in which the
transaction, administration or process is effected, or, when this is
not possible, on the next following day.
(5) Any register used or in use with regard to one particular
premises shall not be used also with regard to any other premises or
DRUGS (CONTROL) [ S.L.31.18 3

for any purpose other than of this regulation.


(6) No entry in the register referred to in the preceding sub-
regulations of this regulation shall be cancelled, obliterated or
altered or shall be entered with some untrue particulars:
Provided that if any mistake is committed in any entry, such
mistake shall be corrected by means of a note in the margin or at
the foot of the page, which note shall contain the correction
required and the date of the note.
(7) No person may export any specified drug without the prior
authorisation from the Superintendent.
(8) In the case of importation or exportation of specified drugs,
the Superintendent shall have the power to direct the procedure to
be f ol l ow e d a nd t h e det a i ls t o b e s ub m it t e d i n th e r e l a t iv e
application, and may also, before issuing an export authorisation,
require that the authorisation of the importing country be obtained.
(9) The Superintendent may prohibit, or otherwise restrict, the
importation of any specified drug if he so considers it necessary in
the public interest.

5. (1) No person, unless duly authorised, may have in his Possession of


possession any specified drug. specified drugs.

(2) For the purpose of this regulation, a person shall be deemed


to be duly authorised if his name is entered in the Medical Register,
in the Register of Dental Surgeons, or in the Veterinary Surgeons’
Register, or if he is a managing apothecary, or is in possession of a
licence issued by the Superintendent under article 89 of the
Medical and Kindred Professions Ordinance, or has obtained such Cap. 31.
drug in virtue of a medical prescription, or otherwise in accordance
with the provisions of these Regulations:
Provided that, in respect of a person authorised in virtue of
a medical prescription, such prescription shall not be deemed to be
valid if, at the time of the receipt of the prescription, such person
was under the treatment of another medical practitioner and had
been receiving such specified drugs in virtue of a prescription from
this other medical practitioner and had not informed the prescriber
of this fact.

6. Any person authorised to be in possession of specified Safe keeping of


drugs in accordance with the provisions of regulation 5 of these restricted and
specified drugs.
regulations and any person specially authorised in respect of
restricted drugs, as the case may be, shall, when such drugs are not
in use, keep same under lock and key and it shall be the duty of any
such person to take all steps necessary to ensure security and to
prevent theft or other diversification of stock:
Provided that nothing in this regulation shall apply to any
person who is in possession of specified drugs in virtue of a
medical prescription.
4 [ S.L.31.18 DRUGS (CONTROL)
Use and contents 7. (1) Every manual prescription for a specified drug shall be
of prescription. written in ink or in other indelible material on the form set out in the
Amended by:
L.N. 426 of 2012; Seventh Schedule to these Regulations. In the case of computer
L.N. 233 of 2018. generated prescriptions and eprescriptions, the medical practitioner
shall use the official prescription as approved by the Superintendent of
Public Health.
(2) It shall be the duty of a medical practitioner issuing a
prescription for a specified drug to fill in a clear and legible hand
Part A of the form set out in the Seventh Schedule, and to supply all
the details and give all the information in the appropriate space as
therein required; the medical practitioner shall further add his
signature in full and the date when the prescription was issued:
Provided that in the case of a medical practitioner
Cap. 31. authorised under article 5 of the Medical and Kindred Professions
Ordinance to practise the medical profession but who is not yet
registered with the Medical Council, such practitioner shall insert
the number given to him by the Superintendent instead of the
Medical Council registration number on the said prescription.
(3) Subject to the provisions of sub-regulation (11) of this
regulation, no medical practitioner shall issue a prescription for a
specified drug unless the prescription complies with the provisions
of this regulation and such drug is required for the purpose of
medical treatment:
Provided that a medical practitioner may, subject to the
other provisions of these Regulations, issue a prescription for
professional use for an amount not in excess of ten phials for
injection or of twenty tablets or capsules.
(4) Every medical practitioner who obtains a specified drug for
professional use as provided in the proviso to sub-regulation (3) of
this regulation shall keep in accordance with, and without prejudice
to, the provisions of regulation 4 of these Regulations, a record in
an appropriate register of the name and surname (if applicable), the
age and address of the patient to whom the drug has been
administered and the date of administration.
(5) No medical practitioner shall issue a prescription for a
specified drug to any person unless such person is well known to
him or unless the medical practitioner has ascertained the identity of
such person through his legally valid identification document.
(6) No medical practitioner shall issue a prescription for a
specified drug to any person unless the said medical practitioner
has taken reasonably sufficient steps to ascertain that such person is
not, at the time of issuing the prescription, receiving treatment from
another medical practitioner in respect of addiction to any specified
drug or otherwise, and that such person has not been supplied with
any such drug on a prescription issued by that other medical
practitioner.
(7) When issuing a manual prescription a medical practitioner
shall use a separate form in respect of every drug prescribed by him
Cap. 101. under this regulation and no drug other than a specified drug or a
drug falling under the Dangerous Drugs Ordinance, may be
prescribed on those forms.
DRUGS (CONTROL) [ S.L.31.18 5

(8) When issuing a manual prescription a medical practitioner


shall, in prescribing a specified drug, use only prescription forms
from the booklet of forms in serial number, issued to him by the
Superintendent upon a request made on the form set out in the
Eighth Schedule to these Regulations and it shall be the duty of
every medical practitioner, whether for the purpose of his private
practice or for carrying out his duties in an official capacity as a
result of his employment with Government, with a view to meeting
the needs of his patients, to make any request for such prescription
booklets on the said form; such request form shall be correctly
filled in all respects and signed by the practitioner, and shall be
either handed in by such practitioner personally to the chief
pharmacist at the Government Medical Stores at Gwardamangia or
sent by post to the Superintendent of Public Health at the
Department of Health in Valletta; and when sent by post the
envelope may be marked "Public Health Notifications" for the
purpose of exemption from postage.
(9) It shall be the duty of a medical practitioner to report in
writing forthwith to the Superintendent any case of theft or loss of
such booklet or unauthorised access to his electronic profile, and it
shall not be lawful for a medical practitioner to use any prescription
f o r m f r o m a n y bo o k l e t o f f o r m s i s s u e d t o a n o t h e r m e d ic a l
p r a c t i t i o n e r, o r i s s u e c o m p u t e r g e n e r a t e d p r e s c r i p t i o n s o r
eprescriptions from the electronic profile of another medical
practitioner.
(10) For the purpose of this regulation, unless the context
otherwise requires, the expression "medical practitioner" includes a
dental surgeon, a dentist and a veterinary surgeon.
(11) The provisions of sub-regulations (1), (2), (7) and, in so far
as applicable, sub-regulations (8) and (9) of this regulation shall
not apply to the prescription of specified drugs for administration
to ward patients in government hospitals, which prescription shall
be controlled by the hospital internal rules.

8. (1) No person other than an apothecary shall dispense a Dispensing of


prescription for a specified drug. prescriptions.
Amended by:
(2) No apothecary shall dispense a prescription for a specified L.N. 426 of 2012;
L.N. 233 of 2018.
drug unless -
(a) he is acquainted with the signature of the person by
whom it purports to have been issued, he has no reason
to suppose that it is not genuine and he has taken
reasonable steps to satisfy himself that it is genuine;
and
(b) the prescription complies with the provisions of
regulation 7 of these regulations.
(3) No specified drug shall be supplied more than once on the
same prescription.
(4) An apothecary dispensing a prescription for a specified
drug shall fill in a clear and legible hand, in ink or other indelible
material, Part C of the form set out in the Seventh Schedule to these
Regulations, and supply all the details and give all the information
6 [ S.L.31.18 DRUGS (CONTROL)

as therein required; the apothecary shall further add his signature in


full and the date, and shall, after dispensing the prescription, retain
it.
(5) For the purpose of sub-regulation (4) of this regulation, it
shall be the duty of an apothecary dispensing a prescription for a
specified drug to request a legally valid identification document of the
person in respect of whom the prescription has been issued and it shall
be the duty of the person who intends to acquire a specified drug,
whether for himself or on behalf of the person to whom the drugs have
been prescribed, to present the said identification document as well as
his own identification document together with the prescription:
Provided that the provisions of this sub-regulation and the
relative part of the provisions of sub-regulation (4) shall not apply
in respect of a person who has not yet been issued with a legally valid
identification document.
(6) It shall be the duty of every managing apothecary of a
licensed dispensary to send to the Superintendent in a sealed
envelope on the first day of every month all the prescriptions for
specified drugs dispensed from that dispensary during the
preceding month; that envelope shall be addressed "Superintendent
of Public Health, Department of Health, Valletta" and may be
marked "Public Health Notifications" for the purpose of exemption
from postage.

(7) (a) In the case of eprescriptions, the pharmacist shall access


the electronic system by the applicable official verification.

(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

person concerned on receipt of a request, from a medical


practitioner to this effect, made on the form as set out in the Tenth
Schedule to these Regulations:
Provided that in the case of a prescription for a supply of a
specified drug as provided for in the provisos to sub-regulation (1)
of this regulation, the Superintendent shall enter the details of the
relative prescription in columns 1 to 4 of the control card.
(3) No control card shall be valid in excess of a period of one
year from the date on which it is issued, unless it is renewed by the
Superintendent following a request by a medical practitioner to this
e ff e c t , o n t h e f o r m s e t o u t i n t h e Te n t h S c h e d u l e t o t h e s e
Regulations.
(4) No apothecary shall dispense any specified drug to any
person who is not in possession of a control card as set out in sub-
regulation (1) of this regulation.
(5) On dispensing a specified drug the apothecary shall, in
addition to other duties laid down by these regulations or by any
law, enter in a clear, indelible and legible manner all the details set
out in columns 5 to 8 on the card, and shall then return the card to
the person presenting the prescription.
(6) (a) With the exception of methylphenidate, it shall be lawful
for a medical practitioner to prescribe in urgent cases a
drug to a patient who is not in possession of a control
card, provided that:
(i) the prescription is labelled "URGENT";
(ii) the amount prescribed does not exceed seven
days’ supply;
(iii) it complies with other requirements of these
regulations; and
(iv) the prescriber notifies the Superintendent within
forty-eight hours of issuing such prescription,
giving full particulars of the patient, the name,
form, dose and amount of drug prescribed, and
the reason for the urgency.
(b) It shall be lawful for an apothecary to dispense such a
prescription complying with sub-paragraphs (i), (ii)
and (iii) of paragraph (a) of this sub-regulation.
(7) The provisions of this regulation shall not apply to the
prescription of specified drugs by a medical practitioner employed
in a government hospital, for administration to ward patients at that
time under his care in such hospital, which prescription shall be
controlled by hospital internal rules.
(8) Any request or notification in terms of this regulation may
be made in person or sent by post in a sealed envelope addressed to
the Superintendent of Public Health, Department of Health,
Valletta, and marked "Public Health Notification - Confidential"
for the purpose of exemption from postage.
(9) For the purpose of this regulation, the expression "medical
practitioner" includes a dental surgeon and a dentist.
8 [ S.L.31.18 DRUGS (CONTROL)

(10) The Superintendent may withdraw the control card of a


person who is suspected to be abusing a drug prescribed to him, or
who is in any other way abusing the control card system.
(11) The Superintendent may include on the control card such
guidelines as he may deem necessary regarding the prescription of
specified drugs.

Specimen 10. (1) No medical practitioner, dental surgeon, dentist or


signature of veterinary surgeon shall prescribe any specified or restricted drug
prescription.
unl ess t he Superintendent is in possession of his specimen
signature.
(2) The Superintendent may, for the purpose of the control of
drugs, circulate to all managing apothecaries a copy of any such
specimen signature in his possession.

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.

Preservation of 12. Saving the provisions of sub-regulation (6) of regulation 8


prescriptions, of these Regulations, any dispensed prescription, register, invoice
registers, records,
and other or other document relating to the manufacture, importation,
documents. purchase, sale, supply, distribution, or other disposal of specified
drugs shall be kept at the premises to which they refer and shall be
preserved for a period of not less than two years from the date of
the prescription, record, invoice or other document, or from the
date of the last entry in the register, as the case may be, and during
such time they shall be open to inspection by the Superintendent or
his representative.
DRUGS (CONTROL) [ S.L.31.18 9

13. (1) No medical practitioner may issue a prescription for Notification by


any preparation consisting of or containing amphetamine, or any prescriber and
managing
isomer of amphetamine, cathine, fenetylline, flunitrazepam, apothecary in the
mecloqualone, methaqualone, or phenmetrazine, or any salts or case of certain
drugs.
esters of any such drugs, or for any preparation consisting of Amended by:
secobarbital or amobarbital or of a combination of secobarbital and L.N. 70 of 1988;
amobarbital, in either case in tablet or capsule form, or in sachet or L.N. 380 of 2017.
cachet, or of any salts or esters thereof in such presentation, unless
he has the prior authorisation in writing by the Superintendent.
(2) The Superintendent may, before granting any authorisation
as is referred to in sub-regulation (1) of this regulation, request
from the medical practitioner such information as the
Superintendent may require, including whether according to the
opinion of the medical practitioner the patient is suffering from
drug dependency.
(3) When a request for such authorisation is made, the
Superintendent shall submit such request to a panel of medical
specialists who shall advise the Superintendent as to whether such
request is to be authorised or not.
(4) Before making their recommendations it shall be the duty
of the panel to see whether such prescribing is indicated and the
panel shall also, where indicated, make such recommendations as
may be necessary with a view to weaning of patient from such
drug.
(5) The Superintendent may, if he considers it is in the interest
of the patient, authorise the prescription of such drug until the
report of the panel is received.
(6) It shall be the duty of any medical practitioner who delivers
a prescription as is referred to in sub-regulation (1) of this
regulation to inform accordingly the Superintendent within twenty-
four hours of his prescribing such a preparation, giving the details
as set out in the Fourth Schedule to these Regulations.
(7) It shall be the duty of any apothecary dispensing a
prescription as is referred to in sub-regulation (1) of this regulation
to inform the Superintendent accordingly within twenty-four hours
of his dispensing such a preparation, giving the details as set out in
the Fifth Schedule to these Regulations.
(8) All notifications made in compliance with sub-regulations
(6) and (7) of this regulation shall be marked "Confidential".
(9) No veterinary surgeon, dental surgeon or dentist may
prescribe any preparation as is referred to in sub-regulation (1) of
this regulation.
(10) If the President of the Republic has reason to suspect that a
medical practitioner, or a dental surgeon or dentist, is supplying or
prescribing any specified drug to or for either himself or any other
person other than, or more than, is properly required for medical or
dental treatment of himself or that other person, as the case may be,
or that a veterinary surgeon is supplying or prescribing any
specified drug in respect of an animal under his care other than, or
more than, is properly required for the treatment of such animal, as
10 [ S.L.31.18 DRUGS (CONTROL)

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.

*Revoked by these Regulations.


DRUGS (CONTROL) [ S.L.31.18 13

Substituted by: FIRST SCHEDULE


L.N. 70 of 1988.
Amended by:
L.N. 183 of 1999;
L.N. 173 of 2010;
L.N. 424 of 2010;
L.N. 148 of 2012;
L.N. 363 of 2013;
L.N. 365 of 2013;
L.N. 405 of 2013;
L.N. 47 of 2016;
L.N. 355 of 2017;
L.N.361 of 2017;
L.N. 229 of 2018;
L.N. 267 of 2018;
L.N. 191 of 2019.

(Regulation 2)

International or other nonproprietary name Chemical name


or other trivial name
α-PVP 1-phenyl-2-(1-pyrrolidin-1-yl)pentan-1-one
CATHINONE (-)-a-aminopropiophenone
DET N.N-diethyltryptamine
DMA d1-2,5-dimethoxy-a-methylphenylethylamine
DMHP 3-(1,2-dimethylheptyl)-l-hydroxy-7, 8, 9, 10-
tetrahydro-6, 6, 9-trimethyl-6Hdibenzo
[b, 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 dl-3, 4-methylenedioxy-N, a-
dimethylphenylethylamine
4,4’-DMAR 4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-
oxazol-2-amine
4-MA 4-methylamphetamine
mephedrone (4-methylmethcathinone) 2-methylamino-1-(4-methylphenyl)propan-1-
one
METHCATHINONE 2-(methylamino)-1-phenylpropan-1-one
Methoxetamine 2-(ethylamino)-2-(3-
methoxyphenyl)cyclohexanone
MESCALINE, MESCAL 3, 4, 5-trimethoxyphenethylamine
BUTTON, PEYOTE, PEYOTL
MMDA 2-methoxy-alpha-methyl-4-5-
(methylenedioxy)phenethylamine
PARAHEXYL 3-hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro-6, 6,
9-trimethyl-6H-dibenzo [b, d) pyran
PCE, ETICYCLIDINE N-ethyl-l-phenylcyclohexylamine
14 [ S.L.31.18 DRUGS (CONTROL)

PHP, PCPY, ROLICYCLIDINE 1-(1-phenylcyclohexyl) pyrrolidine


PMA 4-methoxy-a-methylphenylethylamine
PSILOCINE, PSILOTSIN 3-(2-dimethylaminoethyl)-4-hydroxyindole
PSILOCYBINE 3-(2-dimethylaminoethyl)-indol-4-y1
dihydrogen phosphate
STP. DOM 2-amino-1-(2, 5-dimethoxy-4-methyl)
phenylpropane
TETRAHYDROCANNABINOL, 7, 8, 9, 10 - tetrahydro-6,6,9-trimethyl-thepentyl-
following isomers and their stereo 6H-dibenzo[b,d]pyran-1-ol
chemical variants ( 9 R , 1 0 a R ) - 8 , 9 , 1 0 , 1 0 a - t e t r a h y dr o- 6 , 6 , 9 -
trimethyl-3-pentyl-6H-ibenzo[b,d]pyran-1-
ol
(6aR,9R,10aR)- 6a,9,10,10a-tetrahydro-6, 6,9-
trimethyl-3pentyl-6H-ibenzo[b,d]pyran-1-
ol
(6aR,10aR)- 6a,7,10,10a-tetrahydro-6,6,9-
trimethyl-3pentyl-6H-dibenzo[b,d]pyran-1-
ol
6a,7,8,9-tetrahydro-6, 6,9-trimethyl-3pentyl-6H-
dibenzo[b,d]pyran-1-ol
(6aR,10aR)- 6a,7,8,9,10,10a-hexahydro-6,
6-dimethyl-9-methylene-3-pentyl-6H-
dibenzo[b,d]pyran-1-ol
TCP, TENOCYCLIDNE 1-[1-(2-thienyl) cyclohexyl) piperidine
TMA dl-3, 4, 5-trimethoxy-a-
methylphenylethylamine
mCPP 1-(3-chlorophenyl)piperazine
oCPP 1-(2-chlorophenyl)piperazine
pCPP 1-(4-chlorophenyl)piperazine
1-BENZYLPIPERAZINE 1-benzyl-1, 4-diazacyclohexane
2C-1 (2,5-dimethoxy-4-iodophenethylamine)
2C-T-2 (2,5-dimethoxy-4-ethylthiophenethylamine)
2C-T-7 (2,5-dimethoxy-4-(n)-
propylthiophenethylamine)
TMA-2 (2,4,5,-trimethoxyamphetamine)
PMMA paramethoxymethylamphetamine or N-
methyl-1-(4-methoxy-phenyl)-2-
aminopropane
4-MTA ( -methyl-4-methylthiophenethylamine)
5-IT 5-(2-aminopropyl)indole
25I-NBOMe (2C-I-NBOMe) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-
methoxyphenyl)methyl]ethanamine
25B-NBOMe (2C-B-NBOMe) 2-(4-bromo-2,5-dimethoxyphenyl)-N-[(2-
methoxyphenyl)methyl]ethanamine
25C-NBOMe (2C-C-NBOMe) 2-(4-chloro-2,5-dimethoxyphenyl)-N-[(2-
methoxyphenyl)methyl]ethanamine
3,4-methylenedioxypyrovalerone (MDPV) (RS)-1-(Benzo[d][1,3]dioxol-5-yl)-2-
(pyrrolidin-1-yl)pentan-1-one
Methylone (beta-keto-MDMA) (±)-2-Methylamino-1-(3,4-
methylenedioxyphenyl)propan-1-one
JWH-018 Naphthalen-1-yl-(1-pentylindol-3-
yl)methanone
DRUGS (CONTROL) [ S.L.31.18 15

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)

Amended by: SECOND SCHEDULE


L.N. 26 of 1987.
Substituted by:
L.N. 70 of 1988.
Amended by:
L.N. 103 of 1989;
L.N. 78 of 1998;
L.N. 183 of 1999.
L.N. 173 of 2010;
L.N. 413 of 2012.

(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

FENFLURAMINE N- ethyl-- methyl-m(trifluoromethyl)


phenethylamine
FENPROPOREX dl-3-[(a-methylphenethyl)amino] propionitrile
GLUTETHIMIDE 2-ethyl-2-phenylglutarimide
KETAMINE (±)-2-(2-Chlorophenyl)-2-
methylaminocyclohezanone
LEVAMPHETAMINE 1-a-methylphenethylamine
LEVOMETHAMPHETAMINE l-N, a-dimethylphenethylamine
MAZINDOL 5-(p-chlorophenyl)-2, 5-dihydro-3H-imidazo
[2, 1-a] isoindol-5-ol
MECLOQUALONE 3-(o-chlorophenyl)-2-methyl-4 (3H)-
quinazolinone
MEFENOREX dl-N-(3-chloropropyl)-a-
methylphenethylamine
MEPHENTERMINE N--trimethylphenethylamine
MEPROBAMATE 2-methyl-2-propyl-1, 3-propanediol
dicarbamate
MESOCARB 3-(-methylphenethyl)-N-phenylcarbamoyl)
sydnone imine
METHAMPHETAMINE (+)-2-methylamino-l-phenylpropane
M E T H A M P H E TA M I N E R A C E M AT E
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-piperidine-dione
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
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
TIANEPTINE 7 - [ ( 3 - C h l o r o - 6 , 11 - d i h y d r o - 5 , 5 - d i o x o - 6 -
methyldibenzo[c,f][1,2] thiazepin-11-yl)
amino] heptanoic acid
VINYLBITAL 5-(l-methyl-butyl)-5-vinylbarbituric acid
18 [ S.L.31.18 DRUGS (CONTROL)

ZIPEPROL -(-µ ethoxybenzl)-4-((ß-methoxphenethyl)-


1-piperazineethanol
CHLORMETHIAZOLE 5-(2-chloroethyl)-4-methyl-1,3-thiazole
AMINEPTINE (7 -[(10, 11-dihy dro-5Hdibenzo[ a,d,]
cyclohepten-5-y-5-yl) amino]heptanoic
acid)
TRAMADOL (±)-trans-2-Dimethylaminomethyl- 1-(3-
methoxyphenyl) cyclohexanol
ZOLPIDEM (N,N,6-trimethyl-2-ptolylimidazo[1,2-
α]pyridine-3-acetamide)
2C-B (4-bromo-2,5-dimethoxyphenethylamine)
GHB (γ-hydroxybutyric acid)
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.
And any salts or esters of the above.
DRUGS (CONTROL) [ S.L.31.18 19

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)

FOURTH SCHEDULE Amended by:


L.N. 426 of 2012;
(Regulation 13(4)) L.N. 380 of 2017.

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

Amended by: FIFTH SCHEDULE


L.N. 426 of 2012;
L.N. 380 of 2017. (Regulation 13(5))

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)

SIXTH SCHEDULE Amended by:


L.N. 426 of 2012.
(Regulation 13)

Name and address of patient .................................................................................


Legally valid Identification Document Number ........................................................
Date of prescription ..............................................................................................
Name of drug ........................................................................................................
Amount prescribed ...............................................................................................
Name of medical practitioner, dental surgeon or dentist who has prescribed the
drug .........................................................................................................................
DRUGS (CONTROL) [ S.L.31.18 25

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 .............................................................

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 DISPENSER Dispensary

To be filled by Coder DH Licence No.

Item No. Prescription Origin Date

Serial No.
26 [ S.L.31.18 DRUGS (CONTROL)

EIGHTH SCHEDULE

(Regulation 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.

FOR OFFICIAL USE

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.


DRUGS (CONTROL) [ S.L.31.18 27

Added by: NINTH SCHEDULE


L.N. 65 of 1986.
Amended by: (Regulation 9)
L.N. 34 of 1989;
L.N. 426 of 2012. DEPARTMENT OF HEALTH

CONTROL CARD FOR NARCOTIC/PSYCHOTROPIC DRUGS


Name and Surname of Patient .................................... Address ................................................
A legally valid Identification Document Number (where
available, or Passport No., in case of Non-Maltese
citizens who do not hold a legally valid identification
document):
................................................

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 Name of Amount Signature of Amount Date of Signature of D.H. Licence


Prescription Drug. Prescribed Medical Dispensed Dispensing Apothecary No. of
Form and Practitioner Dispensary
Dose and Medical
Council Reg.
No.
28 [ S.L.31.18 DRUGS (CONTROL)

TENTH SCHEDULE Added by:


L.N. 65 of 1986.
(Regulation 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.

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