DRUGS (CONTROL) _gS.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 and 103 of 1989, 173 of 1994, 78 of 1998 and 
183 of 1999. 
Title. 1. The title of these Regulations is Drugs (Control) 
Regulations. 
Interpretation. 2. In these Regulations, unless the context otherwise 
requires - 
Cap. 258. 
"identity card" means a valid identity card issued in accordance 
with the provisions of the Identity Card Act, and of any regulations 
made thereunder; 
"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. 
Importation, etc., 
of restricted drugs 
to be specially 
authorised. 
3. (1) No person may import, manufacture, export, purchase, 
sell, use or be in possession of any restricted drug without a special 
authorisation in writing by the Superintendent. 
(2) The Superintendent shall not grant a special authorisation 
to use any restricted drug except in special cases for scientific or 
very limited medical purposes inside medical or scientific 
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 
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

2 _gS.L.31.18 DRUGS (CONTROL) 
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 subregulations 
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 
regarding specified 
drugs to be 
registered. 
4. (1) Any person who is licensed or authorised to 
manufacture, import, sell, supply, distribute, or administer any 
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 
for any purpose other than of this regulation. 
(6) No entry in the register referred to in the preceding subregulations 
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

DRUGS (CONTROL) _gS.L.31.18 3 
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 followed and the details to be submitted in the relative 
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. 
Possession of 
specified drugs. 
5. (1) No person, unless duly authorised, may have in his 
possession any specified drug. 
Cap. 31. 
(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 
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. 
Safe keeping of 
restricted and 
specified drugs. 
6. Any person authorised to be in possession of specified 
drugs in accordance with the provisions of regulation 5 of these 
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. 
Use and contents 
of prescription. 
7. (1) Every prescription for a specified drug shall be written 
in ink or in other indelible material on the form set out in the 
Seventh Schedule to these Regulations. 
(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

4 _gS.L.31.18 DRUGS (CONTROL) 
signature in full and the date when the prescription was issued: 
Cap. 31. 
Provided that in the case of a medical practitioner 
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 identity card. 
(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. 
Cap. 101. 
(7) A medical practitioner shall use a separate form in respect 
of every drug prescribed by him 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. 
(8) 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

DRUGS (CONTROL) _gS.L.31.18 5 
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 and it shall not be lawful for a medical practitioner to 
use any prescription form from any booklet of forms issued to 
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. 
Dispensing of 
prescriptions. 
8. (1) No person other than an apothecary shall dispense a 
prescription for a specified drug. 
(2) No apothecary shall dispense a prescription for a specified 
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 
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 the identity card 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 identity card as well as his own 
identity card together with the prescription: 
Provided that the provisions of this sub-regulation and the 
relative part of the provisions of sub-regulation (4) of this 
regulation shall not apply in respect of a person who has not yet

6 _gS.L.31.18 DRUGS (CONTROL) 
been issued with an identity card. 
(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. 
Control card. 
Added by: 
L.N. 65 of 1986. 
Amended by: 
L.N. 34 of 1989. 
9.(1) (a) No medical practitioner may prescribe any specified 
drug to any person unless such person is in possession 
of a control card, as per Ninth Schedule to these 
R e g u l a t i o n s , i s s u e d f o r t h e p u r p o s e b y t h e 
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 
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 
effect, on the form set out in the Tenth Schedule to these 
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 subregulation 
(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) It shall be lawful for a medical practitioner to prescribe

DRUGS (CONTROL) _gS.L.31.18 7 
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. 
(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 
signature of 
prescription. 
10. (1) No medical practitioner, dental surgeon, dentist or 
veterinary surgeon shall prescribe any specified or restricted drug 
unless the 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 
specified drugs to 
licensed or 
authorised persons. 
11. (1) No person shall deliver any specified drug to any other 
person except against the presentation of a duly signed receipt 
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

8 _gS.L.31.18 DRUGS (CONTROL) 
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 
prescriptions, 
registers, records, 
and other 
documents. 
12. Saving the provisions of sub-regulation (6) of regulation 8 
of these Regulations, any dispensed prescription, register, invoice 
or other document relating to the manufacture, importation, 
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. 
Notification by 
prescriber and 
managing 
apothecary in the 
case of certain 
drugs. 
Amended by: 
L.N. 70 of 1988. 
13. (1) No medical practitioner may issue a prescription for 
any preparation consisting of or containing amphetamine, or any 
isomer of amphetamine, cathine, fenetylline, flunitrazepam, 
mecloqualone, methaqualone, methylphenidate, or phenmetrazine, 
or any salts or esters of any such drugs, or for any preparation 
consisting of secobarbital or amobarbital or of a combination of 
secobarbital and amobarbital, in either case in tablet or capsule 
form, or in sachet or 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 
f r o m t h e m e d i c a l p r a c t i t i o n e r s u c h i n f o r m a t i o n a s t h e 
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

DRUGS (CONTROL) _gS.L.31.18 9 
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 twentyfour 
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 
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, 
dental surgeon or dentist, or veterinary surgeon to supply, 
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.

10 _gS.L.31.18 DRUGS (CONTROL) 
Warning and 
cautions on label, 
etc. 
14. (1) The Superintendent may require all manufacturers, 
importers, exporters, and all other persons who trade or otherwise 
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 
manufacturer and 
by importer. 
Added by: 
L.N. 173 of 1993. 
15. (1) Any person who manufactures or imports any drug or 
any pharmaceutical preparation shall, within eight days of any 
m a n u f a c t u r e o r i m p o r t a t i o n , g i v e n o t i c e t h e r e o f t o t h e 
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 
S u p e r i n t e n d e n t m a y r e q u i r e i n r e s p e c t o f s u c h d r u g o r 
pharmaceutical preparation and the said manufacturer or importer, 
as the case may be, shall comply with such request within fifteen 
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 subparagraphs 
(i) and (ii) of paragraph (a) of this subregulation 
are produced: 
Provided that no such suspension or prohibition

DRUGS (CONTROL) _gS.L.31.18 11 
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, 
m a n u f a c t u r i n g p r a c t i c e s o r o t h e r t e c h n i c a l o r s c i e n t i f i c 
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. 
Exemptions. 16. (1) These Regulations shall not apply, in respect of any 
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. 
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.

12 _gS.L.31.18 DRUGS (CONTROL) 
Substituted by: FIRST SCHEDULE 
L.N. 70 of 1988. 
Amended by: 
L.N. 183 of 1999. 
(Regulation 2) 
And any derivatives, salts, or esters of the above. 
International or other nonproprietary 
name or other trivial name 
Chemical name 
CATHINONE (-)-a-aminopropiophenone 
DET N.N-diethyltryptamine 
DMA d 1 - 2 , 5 - d i m e t h o x y - a - 
methylphenylethylamine 
DMHP 3-(1,2-dimethylheptyl)-l-hydroxy-7, 8, 9, 
10-tetrahydro-6, 6, 9-trimethyl- 
6Hdibenzo _gb, 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 d l - 3 , 4 - m e t h y l e n e d i o x y - N , a - 
dimethylphenylethylamine 
METHCATHINONE 2-(methylamino)-1-phenylpropan-1-one 
MESCALINE, MESCAL 
BUTTON, PEYOTE, PEYOTL 
3, 4, 5-trimethoxyphenethylamine 
MMDA dl-5-methoxy-3,4-methylenedioxy-a 
methylphenylethylamine 
PARAHEXYL 3-hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro- 
6, 6, 9-trimethyl-6H-dibenzo _gb, d) 
pyran 
PCE, ETICYCLIDINE N-ethyl-l-phenylcyclohexylamine 
PHP, PCPY, ROLICYCLIDINE 1-(1-phenylcyclohexyl) pyrrolidine 
PMA 4-methoxy-a-methylphenylethylamine 
PSILOCINE, PSILOTSIN 3 - ( 2 - d i m e t h y l a m i n o e t h y l ) - 4 - 
hydroxyindole 
PSILOCYBINE 3-(2-dimethylaminoethyl)-indol-4-y1 
dihydrogen phosphate 
STP. DOM 2-amino-1-(2, 5-dimethoxy-4-methyl) 
phenylpropane 
TETRAHYDROCANNABINO-LS, ALL 
ISOMERS 
1 - h y d r o x y - 3 - p e n t y l - 6 a , 7 , 1 0 , 1 0 a - 
tetrahydro-6, 6, 9-trimethyl-6-Hdibenzo 
_gb, d) pyran 
TCP, TENOCYCLIDNE 1-_g1-(2-thienyl) cyclohexyl) piperidine 
TMA dl-3, 4, 5-trimethoxy-amethylphenylethylamine

DRUGS (CONTROL) _gS.L.31.18 13 
SECOND SCHEDULE Amended by: 
(Regulation 2) 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. 
International or other nonproprietary 
name or other trivial name 
Chemical 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-6Hthieno 
_g3,2-f_h-s-triazolo _g4,3-a_h _g1,4_h 
diazepine 
BUPRENORHINE 21-cyclopropyl-7-alpha-_g(S)-l-hydroxy- 
1 , 2 , 2 - t r i m e t h y l p r o p y l _h - 6 , 1 4 - 
e n d oe t h a n o - 6 , 7 , 8 , 1 4 - 
tetrahydrooripavine 
BUTALBITAL 5-allyl-5-isobutylbarbituric acid 
BUTOBARBITAL 5-butyl-5-ethylbarbituric acid 
CATHINE d - t h r e o - 2 - a m i n o - 1 - h y d r o x y - 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 
DIAZEPAM and other compounds 
containing the chemical structure of 
DIHYDRO-1:4 BENZODIAZEPINE 
or of DIHYDRO-1:5 
BENZODIAZEPINE substituted to 
any degree 
7-chloro-1, 3-dihydro-1-methyl-5-phenyl- 
2H-1, 4-benzodiazepine-2-one 
DRONABINOL delta-9-tetrahydrocannabinol 
and its stereochemical 
variants (This item refers to only 
one of the stereochemical variants 
of delta-9-tetrahydrocannabinol, 
n a m e l y ( - ) - t r a n s - d e l t a - 9 - 
tetrahydrocannabinol.) 
(6aR, 10aR)-6a7, 8, 10a-tetrahydro-6,6,9- 
trimethyl-3-penatyl-6H-dibenzo _gb,d_h 
pyran-1-o1 
ETHCHLORVYNOL ethyl-2-chlorovinylethynylcarbinol 
ETHINAMATE l-ethynylcyclohexanolcarbamate 
µ 
µ

14 _gS.L.31.18 DRUGS (CONTROL) 
FENCAMFAMIN dl-N-ethyl-3-phenylbicyclo (2,2,1)- 
heptan-2amine 
FENETYLLINE dl-3,7-dihydro-1, 3 dimethyl-7-(2-_g(lmethyl2-
phenylethyl) amino_h ethyl)- 
1H-purine-2, 6-dione 
FENFLURAMINE N-ethyl- -methyl-m(trifluoromethyl) 
phenethylamine 
FENPROPOREX d l - 3 - _g ( a - m e t h y l p h e n e t h y l ) a m i n o _h 
propionitrile 
GLUTETHIMIDE 2-ethyl-2-phenylglutarimide 
KETAMINE ( ± ) - 2 - ( 2 - C h l o r o p h e n y l ) - 2 - 
methylaminocyclohezanone 
LEVAMPHETAMINE 1-a-methylphenethylamine 
LEVOMETHAMPHETAMINE l-N, a-dimethylphenethylamine 
MAZINDOL 5-(p-chlorophenyl)-2, 5-dihydro-3Himidazo 
_g2, 1-a_h isoindol-5-ol 
MECLOQUALONE 3-(o-chlorophenyl)-2-methyl-4 (3H)- 
quinazolinone 
MEFENOREX d l - N - ( 3 - c h l o r o p r o p y l ) - a - 
methylphenethylamine 
MEPHENTERMINE N- -trimethylphenethylamine 
MEPROBAMATE 2-methyl-2-propyl-1, 3-propanediol 
dicarbamate 
MESOCARB 3 - ( - m e t h y l p h e n e t h y l ) - N - 
phenylcarbamoyl) sydnone imine 
METHAMPHETAMINE (+)-2-methylamino-l-phenylpropane 
METHAMPHETAMINE RACEMATE 
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-piperidinedione 
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 
µ 
µ
µ

DRUGS (CONTROL) _gS.L.31.18 15 
And any salts or esters of the above. 
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 
VINYLBITAL 5-(l-methyl-butyl)-5-vinylbarbituric acid 
ZIPEROL -( -µethoxybenzl)-4- 
( ( ß - m e t h o x p h e n e t h y l ) - 1 - 
piperazineethanol 
µ µ

16 _gS.L.31.18 DRUGS (CONTROL) 
THIRD SCHEDULE 
(Regulations 3 and 4)

DRUGS (CONTROL) _gS.L.31.18 17

18 _gS.L.31.18 DRUGS (CONTROL) 
FOURTH SCHEDULE 
(Regulation 13(4)) 
CONFIDENTIAL 
(Return in terms of regulation 13 - Prescriptions for amphetamine and its isomers, 
flunitrazepam, mecloqualone, methaqualone, methylphenidate 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 ............................................... 
............................................... 
IDENTITY CARD 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) _gS.L.31.18 19 
FIFTH SCHEDULE 
(Regulation 13(5)) 
CONFIDENTIAL 
(Return in terms of regulation 13 - Prescriptions for amphetamine and its isomers, 
mecloqualone, methaqualone, methylphenidate 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 ............................................. 
............................................. 
IDENTITY CARD 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 .............................................

20 _gS.L.31.18 DRUGS (CONTROL) 
SIXTH SCHEDULE 
(Regulation 13) 
Name and address of patient ................................................................................. 
Identity Card Number ........................................................................................... 
Date of prescription .............................................................................................. 
Name of drug ........................................................................................................ 
Amount prescribed ............................................................................................... 
Name of medical practitioner, dental surgeon or dentist who has prescribed the 
drug .........................................................................................................................

DRUGS (CONTROL) _gS.L.31.18 21 
SEVENTH SCHEDULE 
(Regulation 7) 
PRESCRIPTION FOR NARCOTIC AND PSYCHOTROPIC DRUGS 
(Only one item may be prescribed on this Form) 
Serial No. 
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

22 _gS.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. 
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. 
FOR OFFICIAL USE

DRUGS (CONTROL) _gS.L.31.18 23 
NINTH SCHEDULE 
(Regulation 9) 
DEPARTMENT OF HEALTH 
Added by: 
L.N. 65 of 1986. 
Amended by: 
L.N. 34 of 1989. 
CONTROL CARD FOR NARCOTIC/PSYCHOTROPIC DRUGS 
Name and Surname of Patient .................................... Address ................................................ 
Identity Card No. (where available, or Passport No., 
in case of non-Maltese citizens who do not hold an 
Identity Card): 
................................................ 
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 
Prescription 
Name of 
Drug. 
Form and 
Dose 
Amount 
Prescribed 
Signature of 
Medical 
Practitioner 
and Medical 
Council Reg. 
No. 
Amount 
Dispensed 
Date of 
Dispensing 
Signature of 
Apothecary 
D.H. Licence 
No. of 
Dispensary

24 _gS.L.31.18 DRUGS (CONTROL) 
Added by: TENTH SCHEDULE 
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.

