Second

Edition

GENERAL
GUIDELINE ON
APPLICATION FOR
POISONS LICENCE,
2nd PERMIT &
IMPORT/EXPORT
AUTHORISATION
FOR CONTROLLED
SUBSTANCES
PHARMACEUTICAL SERVICES DIVISION
MINISTRY OF HEALTH MALAYSIA

March 2013
CONTENTS

1.0 Type of licence, permit or authorisation Page 3

2.0 Licensing process Page 4
3.0 Who can apply Page 5
4.0 Criteria for approval of licence, permit & authorisation Page 8
5.0 Fees Page 9
6.0 Closing Page 10
7.0 Annex A: Page 11
Addresses of Pharmaceutical Services Division at
Head Quarter and State level
8.0 Annex B: Page 13
List of controlled substances required
Import / export e-permit
9.0 Annex C: Page 15
List of strategic items required export e-permit

Disclaimer:

No part of these guidelines may be reproduced in any means without the

permission from the Senior Director of Pharmaceutical Services Division,
Ministry of Health, Malaysia.

Dated: 1st March 2013

Page 2
1.0 TYPE of LICENCE, PERMIT or AUTHORISATION

No Type of licence, permit or Place to submit the application

authorisation

1 Poisons Licence Type A Pharmaceutical Services Division

at the State level
2 Poisons Licence Type B
(Refer Annex A for list of
3 Poisons Licence Type E addresses)
4 Permit to purchase and use
psychotropic substances

5 Permit to purchase, store and use

Sodium Hydroxide (NaOH)

6 Permit to purchase and use Application through online system

psychotropic substances www.myspikes.gov.my
(Buprenorphine dan Methadone)
Application processed by
Pharmaceutical Services Division
at the State level
(Refer Annex A for list of
addresses)

7 Wholesale Dangerous Drugs Application through online system

Licence www.myspikes.gov.my

8 Import / Export Authorisation for Application processed by

Dangerous Drugs and Pharmaceutical Services Division,
Psychotropics Substances Ministry of Health Malaysia, Lot
36, Jalan Universiti, 46350,
Petaling Jaya, Selangor

9 Import / Export Authorisation for test Pharmaceutical Services Division,

kit containing Dangerous Drugs or Ministry of Health Malaysia, Lot
Psychotropics Substances 36, Jalan Universiti, 46350,
Petaling Jaya, Selangor
10 Authorisation to export
Dextromethorphan preparations

11 Permit to import / export controlled Application through online system

substances (Refer Annex B for list www.epermit.dagangnet.my
of item)
Application processed by
12 Permit to Import medicine making Pharmaceutical Services Division,
machine Ministry of Health Malaysia, Lot
36, Jalan Universiti, 46350,
Petaling Jaya, Selangor

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 13 Permit to export strategic trade item Application through online system
under the Strategic Trade Act 2010) http://stapermit.dagangnet.com.my
(Refer Annex C for list of items) Application processed by
Pharmaceutical Services Division,
Ministry of Health Malaysia, Lot
36, Jalan Universiti, 46350,
Petaling Jaya, Selangor

2.0 LICENSING PROCESS

2.1 Manual application

- Manual application is provided for:

 Poisons Licence Type A,

 Poisons Licence Type B,
 Poisons Licence Type E,
 Permit to purchase and use psychotropic substances,
 Permit to purchase, store and use Sodium Hydroxide (NaOH),
 Import / Export Authorisation for test kit containing Dangerous
Drugs or Psychotropics Substances and
 Authorisation to export Dextromethorphan preparations

- The form and checklist for the supporting documents can be

downloaded from www.pharmacy.gov.my or collect it from the
nearest Pharmaceutical Services Division office.

- Only complete application form and supporting documents will be

processed.

2.2 Online application

An online application is provided for:

- Authorisation to import/export controlled substances and import of

medicine making machine, application shall be done through
online system www.epermit.dagangnet.com

- Permit to purchase and use psychotropic substances

(Buprenorphine dan Methadone), Wholesale Dangerous Drugs
Licence, Import/Export Authorisation for Dangerous Drugs and

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 Psychotropics Substances, application shall be done through
online system www.myspikes.gov.my

- Permit to export strategic item under the Strategic Trade Act 2010
application shall be done through online system
http://stapermit.dagangnet.com.my

2.3 Inspection of premises

- Inspection of premises will be conducted in the case of application

of poisons licence type A/B/E, Permit to purchase and use
psychotropic substances, permit to purchase, store and use
Sodium Hydroxide (NaOH), permit to purchase and use
psychotropic substances (Buprhenorphine dan Methadone) and
Wholesale Dangerous Drugs Licence.

- Inspection can be done via appointment or on the spot.

2.4 Interview

- Interview is mandatory for first time application of poisons licence

type B. The questions asked cover the aspect of storing, selling,
labeling and recording of poisons under the Poisons Act 1952.
Only applicants who pass the interview would be considered for
issuance of the licence.

3.0 WHO CAN APPLY

No Name of licence, permit or Applicant

authorisation

1 Poisons Licence Type A Pharmacist registered with the

Pharmacy Board of Malaysia or
Pharmacist with the qualification
recognized by the State health
Director of Sabah or Sarawak.

2 Poisons Licence Type B (i) Part II poisons

- Applicant preferably a Malaysian
citizen or permanent resident of
Malaysia
- Minimum qualification of Sijil

Page 5
Pelajaran Malaysia (SPM).

(ii) Application for precursors

chemicals, arsenic and
cyanides
- Applicant preferably a Malaysian
citizen or permanent resident of
Malaysia
- Applicant must have a minimum
qualification of Diploma in Science
based.

(iii) Application for Piperonal,

Safrole and Isosfrole
- Applicant preferably a Malaysian
citizen or permanent resident of
Malaysia
- Applicant must have a minimum
qualification of Diploma in Science
based.
- Applicant must submit written
documents to prove that the end
users are using the substances for
perfume or flavour industries or
for laboratory analysis.

(iv) Feed miller who used

antibiotics/poisons for the purpose
of to be added into the animal
feed.
- Applicant preferably a Malaysian
citizen or permanent resident of
Malaysia
- Minimum qualification of Sijil
Pelajaran Malaysia (SPM).

Page 6
3 Poisons Licence Type E Applicant wish to import NaOH in
large quantities for own factory
use. Applicant preferably a
Malaysian citizen or a permanent
resident of Malaysia.

4 Permit to purchase and use Applicant wish to purchase and

psychotropic substances
use psychotropic substances for
own factory use. Applicant
preferably a Malaysian citizen or a
permanent resident of Malaysia.
The psychotropic substances
must be purchase from locally
licenced source only.
(Psychotropic substances are
substances listed in the 3rd
Schedule of Poisons Act 1952)

5 Permit to purchase, store and use Applicant wish to purchase, store

Sodium Hydroxide (NaOH)
and use NaOH for own use.
Applicant preferably a Malaysian
citizen or a permanent resident.
The NaOH must be purchase
from locally licenced source
only

6 Permit to purchase and use Medical Officer (doctor) who wish

psychotropic substances to purchase and use
(Buprenorphine and Methadone) Buprenorphine and/or Methadone
for opiates drug replacement
therapy. Medical Officer (doctor)
must be registered with the
Malaysian Medical Council (MMC)

7 Dangerous Drugs Wholesale Pharmacist who wish to sell

Licence dangerous drugs by wholesale.
Pharmacist must possess poisons
licence type A.

8 Import / Export Authorisation for (i) Pharmacist must possess

Dangerous Drugs and poisons licence type A.
Psychotropics Substances
(ii) In the case of import (other
than for lab use) authorisation will
only be given to those having
valid import quota issued by the
Pharmaceutical Services Division,
Ministry of Health Malaysia.

Page 7
 9 Import / Export Authorisation for test Pharmacist must possess poisons
kit containing Dangerous Drugs or licence type A
Psychotropics Substances

10 Authorisation to export Pharmacist must possess poisons

Dextromethorphan preparations licence type A. Permission must
already being granted by the
Competent Authority of the
importing country.

11 Permit to import/export controlled Applicant wish to import/export

substances precursors or controlled
substances under the Custom
(Prohibition of Import and Export)
Order, as listed in Annex B.
Applicant must possess
poisons licence type A or B.

12 Permit to Import medicine making Applicant posses Manufacturing

machine Licence from drug Control
Authority (DCA) or written
approval from National
Pharmaceutical Control Bureau
(NPCB).

13 Permit to export strategic trade item Applicant wish to export strategic

under the Strategic Trade Act 2010
item which are Bismuth / Thionyl
Chloride / Hydrogen Fluoride /
Sodium Fluoride / Sodium
Cyanide / Arsenic Trichloride /
Hydrogen Cyanide. Applicant
must possess poisons licence
type A or B.

4.0 CRITERIA FOR APPROVAL OF LICENCE, PERMIT & AUTHORISATION

4.1 Applicant must comply to all provisions in the Poisons Act 1952 and its
Regulations.

4.2 Applicant comply to all the terms and conditions impose by the
authority.

4.3 Premise inspected found to be suitable :

i. premise must be a commercial building

ii. premise must be licenced by the Local Council
iii. premise must be registered with the Registration of Company
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 4.4 Obtained more than 50% marks in the interview.
(first time applying for poisons licence type B)

4.5 Complete the application form and supporting documents.

5.0 Fees

No Type of licence, permit or authorisation Fees

1 Poisons Licence Type A Free

2 Poisons Licence Type B RM 100.00

3 Poisons Licence Type E RM 100.00

4 Permit to purchase and use psychotropic substances RM 100.00

5 Permit to purchase, store and use Sodium Hydroxide RM 20.00

(NaOH)

6 Permit to purchase and use psychotropic substances RM 100.00

(Buprenorphine dan Methadone)

7 Wholesale Dangerous Drugs Licence RM 50.00

8 Import / Export Authorisation for Dangerous Drugs and RM 100.00

Psychotropics Substances

9 Import / Export Authorisation for test kit containing RM 100.00

Dangerous Drugs or Psychotropics Substances

10 Authorisation to export Dextromethorphan preparations Free

11 Permit to import / export controlled substances (Refer RM 5.00

Annex B for list of item) (online
service paid
12 Permit to Import medicine making machine to DegangNet
Technologies
Sdb Bhd)
13 Permit to export strategic trade item under the Strategic RM 5.00
Trade Act 2010 (online
service paid
to DegangNet
Technologies
Sdb Bhd)

Page 9
6.0 CLOSING

Any questions regarding the application could be directed to Pharmaceutical

Services Division office at head quarter or state level. (Please refer to Annex
A for list of addresses)

Page 10
Annex A: Addresses of Pharmaceutical Services Division office

Bahagian Perkhidmatan Farmasi Tel: 03-78413200

Kementerian Kesihatan Malaysia Fax: 03-79682251
Lot 36, Jalan Univesiti, 46350,
Petaling Jaya, Selangor.
(Head Quarter)

Bahagian Perkhidmatan Farmasi Negeri Perlis Tel: 04-9765033

Jabatan Kesihatan Negeri Perlis Fax: 04-9770548
Lot 217, Jalan Raja Syed Alwi,
Mukim Utan Aji, 01000,
Kangar, Perlis.

Bahagian Perkhidmatan Farmasi Tel: 04-7741000

Jabatan Kesihatan Negeri Kedah Fax: 04-7741014
Jalan Kuala Kedah
05400 Simpang Kuala, Kedah.

Pejabat Timbalan Pengarah Kesihatan Negeri Tel: 04-2292319

(Farmasi) Fax: 04-2280314
Tingkat 8, Bangunan Persekutuan,
Jalan Anson, 10400,
Pulau Pinang.

Cawangan Penguatkuasa Farmasi Tel: 05-2555994

Jabatan Kesihatan Negeri Perak Fax: 05-2532734
Tingkat 10, Bangunan Maybank Trust,
No 28, Jalan Tun Sambathan,
34000, Ipoh, Perak.

Bahagian Perkhidmatan Farmasi Tel: 03-55101051

Jabatan Kesihatan Negeri Selangor Fax: 03-55108977
Tingkat 15, Wsima MBSA,
Persiaran Perbandaran, 40000,
Shah Alam, Selangor.

Bahagian Perkhidmatan Farmasi Tel: 06-7664800

Jabatan Kesihatan Negeri Fax: 06-7646148
Jalan Rasah, 70300,
Seremban, Negeri Sembilan.

Bahagian Perkhidmatan Farmasi Tel: 06-2345979

Jabatan Kesihatan Negeri Melaka Fax: 06-2345975
Tingkat 3, Wisma Persekutuan,
Jalan Business City, Bandar MITC,
75450, Ayer Keroh, Melaka.

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Bahagian Perkhidmatan Farmasi Tel: 07-2272801 / 2272802
Jabatan Kesihatan Negeri Johor Fax: 07-2236146 / 2235021
10-02 Tingkat 10, Menara MSC Cyberport,
5 Jalan Bukit Meldrum,
80300, Johor Bharu, Johor.

Bahagian Perkhidmatan Farmasi Tel: 09-5707737

Jabatan Kesihatan Negeri Pahang Fax: 09-5707795 / 5707792
Jalan IM 4, Bandar Indera Mahkota
25582, Kuantan, Pahang.

Jabatan Kesihatan Negeri Trengganu Tel: 09-6222627 / 6301722

Bahagian Perkhidmatan Farmasi Fax: 09-6227486
Tingkat 8, Menara Yayasan Islam Trengganu,
Jalan Sultan Omar, 20300,
Kuala Trengganu, Trengganu.

Bahagian Perkhidmatan Farmasi Tel: 09-7730586

Jabatan Kesihatan Negeri Kelantan Fax: 09-7746817
Lot 125-128, Taman Maktab,
Pengkalan Chepa, 16100,
Kota Bharu, Kelantan.

Pejabat Pengarah Tel: 082-473200

Jabatan Kesihatan Negeri Sarawak Fax: 082-441815
Jalan Diplomatik, Off Jalan Bako
93050. Kuching, Sarawak

Jabatan Kesihatan Negeri Sabah Tel: 088-257258

Bahagian Perkhidmatan Farmasi Fax: 088-223024
Tingkat 6, Rumah Persekutuan,
Jalan Mat Salleh, 88590,
Kota Kinabalu, Sabah.

Bahagian Perkhidmatan Farmasi Tel: 03-22687333 /

Jabatan Kesihatan Wilayah Persekutuan 22687404
Kuala Lumpur & Putrajaya Fax: 03-26938776
Jalan Chenderasari,
50590 Kuala Lumpur.

Bahagian Perkhidmatan Farmasi Tel: 087-411702 / 411416

Jabatan Kesihatan Negeri Fax: 087-411298 / 412342
Jalan Tanjung Teras, 87007,
Wilayah Persekutuan Labuan

Page 12
 ANNEX B: List of controlled substances required import/export
e-permit

No Controlled chemical substances Import Export

(e-permit (e- permit
required) required)
(A) Precursors
1 Acetic Anhydride √ √

2 Ephedrine and its salts √ √

3 Pseudoephedrine and its salts √ √

4 Norephedrine and its salts √ √

5 Lysergic acid and its salts √ √

6 Piperonal √ √

7 Safrole √ √

8 Ergometrine (INN) and its salts √ √

9 Ergotamine (INN) and its salts √ √

10 Potassium Permanganate √ √

11 N-acetylanthranilic acid √ √

12 Isosafrole √ √

13 1-(1,3-Benzodioxol-5-yl) propan-2-one √ √
(3,4-methylenedioxy-phenyl-2-
propanone)
14 Phenylacetone (Phenylpropan-2-one) (1- √ √
phenyl-2-propanone)
15 Phenylacetic acid and its salts √ √

16 Anthranilic acid and its salts X √

17 Piperidine and its salts X √

18 Diethyl ether (ethyl ether) X √

Page 13
19 Hydrogen Chloride (Hydrochloric acid) X √

20 Sulphuric acid X √

21 Acetone X √

22 Toluene X √

23 Butanone (methyl ethyl ketone) X √

24 Medicaments containing Ephedrine / √ √

Pseudoephedrine
(B) Controlled chemicals/other controlled substances

25 Acetyl Bromide / Acetyl Chloride √ √

26 Arsenic Trichloride √ √

27 Caffeine and its salts √ X

28 Clenbuterol √ X
29 Formoterol √ X
30 Salbutamol / Salmeterol / Terbutaline √ X
31 Preparations of a kind used in animal Not Allowed √
feeding containing Salbutamol, to import
Clenbuterol, Salmeterol, Terbutaline or
Formoterol

Note: √ e-permit required

X e-permit not required

Page 14
ANNEX C: List of strategic trade items required export e-permit

No Controlled chemical substances

1 Arsenic Trichloride
2 Bismuth
3 Hydrogen Cyanide
4 Hydrogen Fluoride
5 Potassium Cyanide
6 Sodium Cyanide
7 Sodium Fluoride
8 Thionyl Chloride

Page 15