MINISTRY OF HEALTH MALAYSIA MALAYSIAN NATIONAL …

MINISTRY OF HEALTH MALAYSIA

MALAYSIAN NATIONAL MEDICINES POLICY

2nd Edition, 2012 DASAR UBAT NASIONAL (DUNas) EDISI KEDUA, 2012

Ministry of Health Malaysia

MALAYSIAN NATIONAL MEDICINES POLICY

2nd Edition, 2012

First print 2013 ? Malaysian National Medicines Policy (MNMP) 2013

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without prior permission in writing.

ISBN 978-967-5570-44-5

9 789675 570445

CONTENTS

MINISTRY OF HEALTH MALAYSIA

MALAYSIAN NATIONAL MEDICINES POLICY

CONTENTS

ACKNOWLEDGEMENTS

iii

PREAMBLE

1

INTRODUCTION

1

1. GOVERNANCE IN MEDICINES

4

1.1 AIM

5

1.2 STRATEGY

5

2. QUALITY, SAFETY AND EFFICACY OF MEDICINES

6

2.1 AIM

7

2.2 STRATEGY

7

2.2.1 LEGISLATION AND REGULATIONS

7

2.2.1.1 National Pharmaceutical Control Bureau (NPCB)

7

2.2.1.2 Regulating Premises that Supply Medicines

8

2.2.1.3 Effective Enforcement

8

2.2.1.4 Medicines Advertisement and Promotion

8

2.2.1.5 Counterfeit Medicines

8

2.2.2 PHARMACEUTICAL QUALITY ASSURANCE

9

2.2.2.1 Post-Marketing Surveillance

9

2.2.2.2 Management of Complaints about Medicines

9

3. ACCESS TO MEDICINES

10

3.1 AIM

11

3.2 STRATEGY

11

3.2.1 AVAILABILITY OF MEDICINES

11

3.2.1.1 Selection of Medicines

11

3.2.1.1.1 National Medicines Formulary

11

3.2.1.1.2 National Essential Medicines List (NEML)

12

3.2.1.1.3 Drug and Therapeutic Committee

12

3.2.1.1.4 Traditional and Complementary Medicines Formulary

12

3.2.1.1.5 Life-saving Medicines and Orphan Medicines

12

3.2.1.1.6 Halal Medicines

13

3.2.1.2 Supply of Medicines

13

3.2.1.2.1 Procurement

13

3.2.1.2.2 Distribution and Storage of Medicines

13

3.2.1.2.3 Disposal of Medicines

13

3.2.1.2.4 Medicines Supply in Emergency Situations and Medicines 13 Donations

i

MINISTRY OF HEALTH MALAYSIA

MALAYSIAN NATIONAL MEDICINES POLICY

MINISTRY OF HEALTH MALAYSIA

3.2.2 AFFORDABILITY OF MEDICINES

14

3.2.2.1 National Pricing Reference for Medicines

14

3.2.2.1.1 Transparency on Price Information

14

3.2.2.1.2 Monitoring of Price Information

14

3.2.2.1.3 Tariffs and Duties

14

3.2.2.2 Financing for Medicines

15

3.2.2.3 Generic Medicines Policy

15

4. QUALITY USE OF MEDICINES

16

4.1 AIM

17

4.2 STRATEGY

17

4.2.1 DEVELOPMENT AND IMPLEMENTATION OF MODELS OF BEST PRACTICE 17

4.2.2 EDUCATION AND TRAINING

18

4.2.2.1 Healthcare Providers

18

4.2.2.2 Consumers

18

4.2.2.3 Pharmaceutical Industry

18

4.2.2.4 Media

18

4.2.3 PROVISION OF TIMELY AND ACCURATE INFORMATION ON MEDICINES 18

4.2.3.1 Healthcare Providers

18

4.2.3.2 Consumers

19

4.2.3.3 Pharmaceutical Industry

19

4.2.3.4 Media

19

4.2.4 STRENGTHENING SEAMLESS CARE BETWEEN HEALTHCARE

19

PROVIDERS

4.2.5 RESEARCH AND DEVELOPMENT IN QUALITY USE OF MEDICINES

19

4.2.6 ENGAGEMENT OF PAYERS INVOLVED IN REIMBURSEMENTS FOR

19

MEDICINES USE

5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY

20

5.1 AIM

21

5.2 STRATEGY

21

5.2.1 HUMAN RESOURCE DEVELOPMENT

21

5.2.2 RESEARCH AND DEVELOPMENT

22

5.2.3 TECHNICAL COLLABORATION AND PARTNERSHIP

22

5.2.4 A VIABLE AND RESPONSIBLE PHARMACEUTICAL INDUSTRY

22

5.2.4.1 Domestic Pharmaceutical Manufacturing

23

GLOSSARY

24

ABBREVIATIONS

29

MINISTRY OF HEALTH MALAYSIA

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MINISTRY OF HEALTH MALAYSIA

MALAYSIAN NATIONAL MEDICINES POLICY

ACKNOWLEDGEMENTS

The Pharmaceutical Services Division (PSD) of the Ministry of Health would like to thank the World Health Organization (WHO) for its contribution in making the full-term review of the Malaysian National Medicines Policy a successful effort.

The PSD would also like to express appreciation to the following participants and stakeholders for their support and contribution in the preparation of this policy:

? Pharmaceutical Services Division, State Health Departments ? National Pharmaceutical Control Bureau ? Medical Practice Division, Ministry of Health ? Medical Development Division, Ministry of Health ? Planning and Development Division, Ministry of Health ? Finance Division, Ministry of Health ? Oral Health Division, Ministry of Health ? Procurement and Privatisation Division, Ministry of Health ? Family Health Development Division, Ministry of Health ? Traditional and Complementary Medicine Division, Ministry of Health ? Health Education Division, Ministry of Health ? Clinical Research Centre, Ministry of Health ? Policy and International Relations Division, Ministry of Health ? Human Resource Division, Ministry of Health ? Institute for Health System Research, Ministry of Health ? National Institute of Health, Ministry of Health ? Health Services Division of the Malaysian Armed Forces HQ, Ministry of Defence ? Educational Policy Planning and Research Division, Ministry of Education ? Ministry of International Trade and Industry ? Ministry of Science, Technology and Innovation ? Performance Management Delivery Unit, Prime Minister's Department (PEMANDU) ? University of Malaya (UM) ? Universiti Sains Malaysia (USM) ? National University of Malaysia (UKM) ? International Islamic University Malaysia (IIUM) ? University Technology MARA (UiTM)

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MINISTRY OF HEALTH MALAYSIA

MALAYSIAN NATIONAL MEDICINES POLICY

MINISTRY OF HEALTH MALAYSIA

? International Medical University (IMU) ? University of Nottingham Malaysia Campus ? Pharmacy Dean Council ? University Malaya Medical Centre (UMMC) ? UKM Medical Centre (UKMMC) ? Malaysian Medical Association (MMA) ? Malaysian Pharmaceutical Society (MPS) ? Malaysian Academy of Pharmacy ? Malaysian Organisation of Pharmaceutical Industries (MOPI) ? Pharmaceutical Association of Malaysia (PhAMA) ? Malaysian Association of Pharmaceutical Suppliers (MAPS) ? Association of Private Hospitals Malaysia (APHM) ? Consumer Association of Penang (CAP) ? Federation of Malaysian Consumers Associations (FOMCA) ? Malaysian Investment Development Authority (MIDA) ? Malaysia Competition Commission (MyCC) ? Intellectual Property Corporation of Malaysia (MyIPO) ? Forest Research Institute Malaysia (FRIM) ? Malaysia Biotechnology Corporation Sdn. Bhd. ? General Insurance Association of Malaysia (PIAM) ? Direct Selling Association of Malaysia (DSAM) ? Pharmacists and medical doctors from public and private hospitals

MINISTRY OF HEALTH MALAYSIA

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