Table of Contents
1. IRAQ ................................................................................................................................................... 1
2. LAOS................................................................................................................................................ 11
3. NORTH MACEDONIA.................................................................................................................. 22
4. TIMOR-LESTE(1) ......................................................................................................................... 42
5.TIMOR-LESTE(2) .......................................................................................................................... 58

1. Iraq

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2022）
Name: Mamand Rashid Mamand
Country: Iraq/ Kurdistan region
Organization/Department/Division: Ministry of health krg/ Kurdistan medical control agency① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.

1001

−Please briefly describe each role and responsibility on pharmaceutical administration.
1- administration department
this department covers both administrative and financial units to organize the affairs of the office andhuman resources, plays an important role for giving incentives to employees and organize expenditures
2- media and informative department
this department consist of three different units with different rolea/ technology and information unit, this unit is to provide and repair all electronic equipment’s of theorganizationb/ IT and Database unit is responsible for kmca system and online service which is available for all legalized
applicant.
c/ media unit, publishes the latest information on medicines and activities of KMCA and publish necessary
guidelines on medicines and pharmaceutical products to the community.
3-Registration department
Is the most important department in KMCA which is responsible for registration of manufactures and medicines
according to legal documents.
4-regulatory affairs
a/This department is responsible for issuing permits to pharmaceutical importing companies into the country after
insuring the status of manufacturing registration. Aplicants submit their documents online like COA, COO. Packing
list and invoiceb/Ensure compliance with international obligations assumed within the scope of pharmaceutical activities, namely
protocols relating to medicines and other potentially toxic, narcotic and psychotropic substances.
5-Laboratory department
a/ This department is responsible for evaluation all imported pharmaceutical products to decide which item isneeded to be tested and which item is getting quick release.
b/ printing KMCA stickers for all batches that has release decision or its comply after testingeach sticker has name of importer, name of item, kmca logo, and price.
6- Post marketing department

2002

a/Several teams of inspector pharmacists in working under this department in all cities and towns to monitor allplaces where pharmaceutical products are sold and in coordination with local polices to take action against whom
who do not obey rules of ministry of health and arrest those who is dealing fake medicines.
b/ controlling borders and airports for regular custom clearance※About the Hospital pharmacy only, if possible;−Please briefly describe the position and role of pharmacist in the medical institution and the medical caresystem in your country.
② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
2014

・

administered byministry of health・

administered by・administered by・administered by◆Local Level◆International Level:
・ PIC/S:

Yes

OR

No

If yes, joined when・ Others if any
by③ Regulatory /Administrative Services−Please describe pharmaceutical regulatory services of your country in response to each topic described below.
−It is recommended to add supplemental information such as systems, regulations, responsible administrators,
since you are expected to explain them to other participants.
◆Pharmaceutical Manufacturing
・Systems, Regulations, etc.
・NONadministered byadministered by・※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・ministry of healthadministered by

KMCA

administered by・◆Marketing Authorization
・Systems, Regulations, etc.
・nonadministered byadministered by

・
3

003

※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
non・

administered byadministered by・◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・

authorized by MOH

administered by

KMCA

administered by・※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
・

recalling medicines if there is any problem

administered by

KMCA

administered by・④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
There is a regulation on going to equalize and control pricing upon pricing procedure and install one system inall end user pharmacies connected directly with MOH⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of
your knowledge).
−Put the year of the presented data as well if it's available.
1.

Number of pharmacists

2150 pharmacist

2022

2.

Number of GMP inspector (National & Local)

3.

Number of pharmaceutical manufacturers / manufacturing sites 3 local manufacturer

2022

4.

Number of traditional medicine manufacturers / manufacturing sites

none(year)

5.

Number of pharmaceutical importers

350

2022

6.

Number of pharmaceutical wholesalers

around 75

none(year)(year)(year)(year)
2022(year)※About the Hospital pharmacy only, if possible;⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs: 1 pharmacist
b. Number of deputy chiefs: 1 pharmacist
c. Number of managers: 1（２） Number of staff
a. Number of pharmacists:
b. Number of clinical pharmacists:
4004

c. Number of technicians:（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:b. Injections:c. Medicines for external use:
（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:
b. For outpatients:（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?
If "Yes", how large is it?
Yes

b.

㎡

No

Does the pharmacy have a clean room or laminar flow hood?
Yes

/

No

If "Yes", please describe it in detail
Detail:c.

Does the pharmacy have computers?
Yes

/

No

If "Yes", what is the purpose of using them.
Purpose:d.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Yes

e.

/

no

Do you prepare TPN (Total Parental Nutrition)
Yes

f.

No

/ No

no

Can you use Internet at the pharmacy?
If "Yes", what is the purpose of using it.
Yes

/ No

no

Purpose:※All participants. Please describe the following general information as much as you know.

⑦

Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

6

years

Secondary

3

years

High school

3

years

5

005

（２） Number of years / weeks in the following categories during university or college
University / college:

5

Professional education:

years
2

years

Practical training:

years

Duration of training by each facility:

years

Hospital pharmacy:

weeks

Community pharmacy:

weeks

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:

23

years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

days

Clinical Exams

days

No
（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.

* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)（５）Number of pharmaceutical university or college graduates:
300

people/ per year

The alumni's placement rate (%)
a. Hospital:%b. Community Pharmacy:%c. Government Organization:%d. Enterprise:%e. Others:%⑧ ADR(Adverse Drug Reaction) report
Please describe the flow of reporting system (from a medical institution to an administrative agency), when asevere ADR is detected in a medical institution. Describe specifically the rule and responsibility of eachorganization (an administrative agency / a medical institution), and their collaboration/cooperation.

Not applicable yet
60062. Laos

Part I:INFORMATION SHEETRegulatory Systems on Ensuring Access to Quality Medicines （JFY 2022）
Name:

Mr Kongchack PHOMMACHACKCountry:

Laos

Organization/Department/Division:

Food and Drug Department① Organizational Chart−Please attach the organizational chart of pharmaceutical administration at national/state & local levels aboutpharmaceutical administration in your country.

−Please briefly describe each role and responsibility on pharmaceutical administration.
※About the Hospital pharmacy only, if possible;−Please briefly describe the position and role of pharmacist in the medical institution and the medical caresystem in your country.
② Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
・Drug and Medical Products Law No 07/NA, dated 21 December 2011; administered by・Regulation Governing Drug registration No.1441/MoH,

dated: 13 August 2003

administered by・Regulation on Business Establishment for Medicine and Medical Product Company
1820/MoH,

dated: 25 August 2017

administered by・Regulation on Drug and Medical Products Production,
2004

No

No 937/MOH, Dated

12 Julyadministered by
1011

◆Local Level・

administered by・administered by◆International Level:
・ PIC/S:

Yes

OR

No

If yes, joined when・ Others if any
by③ Regulatory /Administrative Services−Please describe pharmaceutical regulatory services of your country in response to each topic described below.
−It is recommended to add supplemental information such as systems, regulations, responsible administrators,
since you are expected to explain them to other participants.
◆Pharmaceutical Manufacturing
・Systems, Regulations, etc.
・Regulation on Drug and Medical Products Production,

No 937/MOH, Dated

12 July 2004

administered by
・PIC/S Good Manufacturing Practice PE 009-12 October 2015

administered by※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice◆Drug Import/Export
・Systems, Regulations, etc.
・Drug and Medical Products Law No 07/NA, dated 21 December 2011;

administered byadministered by・◆Marketing Authorization
・Systems, Regulations, etc.
・Regulation Governing Drug registration No.1441/MoH,

dated: 13 August 2003 administered by・administered by

FDD※Example: Good Quality Practice◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・AUCTION SYSTEM

administered by

Medical Product supply Center
administered by・◆Medicine Safety (post-marketing)・Systems, Regulations, etc.
・Lao Pharmacovigilance guideline

administered by

FDD

administered by・※Example: Good Pharmacovigilance Practice◆Relief System for Adverse Drug Reactions
・Systems, Regulations, etc.
・administered by・administered by
2012

④ Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.
⑤ Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of
your knowledge).
−Put the year of the presented data as well if it's available.
1.

Number of pharmacists>2000 (year) 2022

2.

Number of GMP inspector (National & Local)

13 (year) 2022

3.

Number of pharmaceutical manufacturers / manufacturing sites

124.

Number of traditional medicine manufacturers / manufacturing sites

2 (year) 2022

5.

Number of pharmaceutical importers

96

6.

Number of pharmaceutical wholesalers

11 (year) 2022

(year) 2022
(year) 2022

※About the Hospital pharmacy only, if possible;⑥

Information on your hospital pharmacy（１） Organization chart of the pharmaceutical department or the pharmacy to which you belong
a. Number of section chiefs:
b. Number of deputy chiefs:
c. Number of managers:（２） Number of staff
a. Number of pharmacists:
b. Number of clinical pharmacists:
c. Number of technicians:（３） Number of the kinds of drugs managed in your pharmacy or hospitala. Oral medicine:b. Injections:c. Medicines for external use:
（４） Number of prescriptions dealt in your pharmacy per day
a. For inpatients:
b. For outpatients:（５） Equipment of the pharmacy in your hospitala.

Does your hospital have a dispensary room?
If "Yes", how large is it?
Yes

b.

㎡

No

Does the pharmacy have a clean room or laminar flow hood?
Yes

/

No

If "Yes", please describe it in detail
Detail:
3

013

c.

Does the pharmacy have computers?
Yes

/

No

If "Yes", what is the purpose of using them.
Purpose:d.

Do you implement Therapeutic Drug Monitoring (TDM : Therapeutic Drug Monitoring) in yourHospital?
Yes

e.

/

Do you prepare TPN (Total Parental Nutrition)
Yes

f.

No

/ No

Can you use Internet at the pharmacy?
If "Yes", what is the purpose of using it.
Yes

/ No

Purpose:※All participants. Please describe the following general information as much as you know.

⑦

Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary

5

years

Secondary

7

years

High schoolyears（２） Number of years / weeks in the following categories during university or college
University / college:
Professional education:

3-5

years

3-5

years

Practical training:

years

Duration of training by each facility:

0.2

Hospital pharmacy:

years

3-4

weeks

Community pharmacy:

weeks

Pharmaceutical company:

weeks

Others:weeks

Age at graduation:

21-23

years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams

days

Clinical Exams

days

No
4

014

1. Introduction of the work
(2) Job tenure: 4 years(3) Regulatory services that you are engaged in- Evaluation on new drug registration- Evaluation on Renewal, Variation.

4

1. Introduction of the work(4) roles and position of pharmacists in Laos

1.Pharmacists in hospitals- Validate prescription and drug dispensation.
- Manage the supply chain of drug store
2. Pharmacists in Research-Carrying out in analytical research of drugs and clinical trial
3. QA,QC and Production staff, pharmacist license holder inpharmaceutical factories
4. Academic pharmacists (Faculty of pharmacy, UHS)
5. Sale, pharmacist license holder in pharmaceutical companies
6. In-charge in private pharmacies-Manage GPP and GSP of pharmacies
7. Regulators in food and drug department
8. GMP inspector
5018

2. Good Practice

Achievements-ACTD format submission for Drug registration-Reliance Pathway for evaluation-Initial GPP training to 100 pharmacies-GMP training

6

2. Good PracticeOn-going projects to deal with current
problems- Training on implementation the ACTD format
submission to local company- Establish SOP of each type of Product to beevaluated for regulators- Evaluate GPP implementation in 100
pharmacies

7019

3. Difficulties/Lessons Learned from Past Experience

which you have faced difficulties, or struggled;
1. Evaluation of Biological products
2. Site master file evaluation
3. On-site GMP inspection

8

4. My interests- In this section, please describe issues you
are expecting to this Program.
- At Maximum THREE issues!
(1) Major and minor variation(2) Evaluation of Biological products(3) Method validation

9020

Thank you

10

021

3. North Macedonia

Unit for medical devices
Department for inspection- Unit for inspection in the field of medicines and medical devices--

Unit for for licensing of medicines and medical devices

Health insurance fund of Republic of North Macedonia (HIFRNM)
Pharmacy department

Ministry of health, Department of pharmacy - Unit for determination of prices of medicines is in chargefor:
Determination of wholesale prices and retail prices for medicines that have an authorization for placing
on the market, issued by the MALMED for drugs and are issued on prescription.
Determination of wholesale prices and retail prices of medicines for which MALMED has issued an
import permit.
Agency for medicines and medical devices-MALMED is in charge for:1) issuing approvals for medicine manufacturing ;2) issuing approvals for manufacturing of medical devices;
3) issuing approvals for wholesale trade for medicines and medical devices;
4) issuing approvals for retail trade for medicines and medical devices;4a) issuing a marketing authorization for each batch of imported medicine;5) issuing approvals for placing medicines on the market, as well as changes, supplementation or renewalof the approval;
6) approval for advertising of medicines and medical devices;7) keeping a Register for medicines, for traditional herbal medicines, homeopathic medicines, and a
Register for medical devices in the Republic of North Macedonia;8) keeping a Register of medicine manufacturers and a Register of manufacturers of medical devices in the
Republic of North Macedonia;9) keeping a Register of entities for wholesale trade and a Register of entities for retail trade with medicinesand medical devices in the Republic of North Macedonia;
10) issuing approvals and / or notifications for clinical trials of medicines;10а) keeping Register for clinical trials;
11) issuing approvals and / or notifications for clinical examinations of medical devices;
11a) evaluation of the expected health benefit in relation to the potential risk of the respondents (assessment
document of pre-clinical and clinical documentation with evaluation of the benefit-risk ratio) for the
medicine which is subject to clinical trial;
12) issuing approvals for import, parallel import and for export of medicines;
13) issuing certificates of compliance with the principles of good practice;14) issuing certificates for the needs for export of medicines and medical devices;15) classification of products as medicines or medical devices;16) establishment and maintenance of a system for pharmacovigilance and materialovigilance;16a) preparation of an annual report on reported adverse reactions to medicines in the Republic of North024

Macedonia
17) establishment and maintenance of a database;18) inspection of medicines and medical devices;
19) inspection of entities for manufacturing, wholesale and retail;20) activities for ensuring the quality control of medicines and medical devices;
21) implements measures for monitoring of consumption of medicines;22) promotion the rational use of medicines and medical devices;
23) integration in the international network of information on drugs and medical devices;23-a) analyzes and evaluates the safety and side effects on the respondents in clinical trials;23-b) performs inspection supervision over the clinical trials, side effects and drug malfunction;23-c) analyze and evaluate the pharmacoeconomic data related to medicines;23-d) conducts an urgent procedure for withdrawal of the medicine and medical device from market;23-e) plans and implements activities in the field of systematic control of medicines;23-f) prepares and publishes professional publications related to the competencies of the Agency;23-g) conducts from its own funds a procedure for public procurement of medicines which are not on the
List of medicines covered by the Fund for health insurance of Republic of North Macedonia, at the requestof the Ministry of health and24) perform other activities related to medicines and medical devices in accordance with the
Law.
Health Insurance fund of Republic of North Macedonia- Pharmacy department is in charge for:Setting referent prices for medicines which are included in the List of medicines on burden of HIFRNM(Positive List).
Inspection of the work of retail pharmacies which has contract with Fund for issuing medicines on burdenof HIFRNM.
Monitoring consumption of medicines which are covered in Positive List.
Participates in the creation of health policies related to medicines covered in the Positive list.

② Legislation on pharmaceutical administration◆

National Level

・ Law on medicines and medical devices - administered by MALMED・ Law for health insurance - administered by Ministry of Health and HIFRNM
・ Law on health care – administered by Ministry of health◆ Local Level
・ Regulation for the network of health institutions - administered by MoH・ Methodology for determination of medicines prices - administered by MoH
025

・ Rulebook on the manner and procedure for clinical trials of medicines and the content
of the documentation - administered by MoH and MALMED
・ Rulebook on obtaining approval for placing a medicinal product on the marketadministered by MALMED
・ Rulebook on the detailed conditions for the manner of prescribing and issuing or
selling medicines - administered by MALMED
・ Rulebook on the manner and procedures for analytical examination of drugsadministered by MALMED
・ Rulebook on the manner and procedure for pharmacological-toxicological and clinicalexamination of medicines – administered by MALMED
・ Rulebook on the manner of quality control of medicines and the manner of recognitionof the analyzes of the batches of medicines- administered by MALMED
・ Rulebook on the manner of reporting, the content of the form for reporting adverse
drug reactions and the manner of organization of the pharmacovigilance systemadministered by MALMED
・ Rulebook on registration of traditional herbal medicines - administered by MALMED
・ Rulebook on the content of the request and the closer conditions regarding the space,equipment and staff for obtaining approval for wholesale of medicinal products administered by MALMED
・ Rulebook on the content of the request and the manner of obtaining approval for
import of drugs - administered by MALMED
・ Rulebook on the manner of prescribing and dispensing prescription medicines administered by MALMED
・ Rulebook on the manner and procedure for clinical trials of drugs and the content of
the documentation - administered by MALMED
・ Rulebook on authorizations and manner of work of the control of the Health Insurance
Fund - administered by HIFRNM
・ Rulebook for determining the criteria and procedure for determining the reference
prices of medicines - administered by HIFRNM◆ International Level:
・ PIC/S:

Yes

OR

No

If yes, joined when・ Others if any
/

by

/

③ Regulatory /Administrative Services◆Pharmaceutical Manufacturing
・ Guideline for the principles of Good Manufacturing Practice - administered by MoH
and MALMED
026

・ Guideline for the principles of Good Pharmaceutical Practice - administered by MoH
and MALMED
・ Guideline for the principles of Good Laboratory Practice - administered by MoH and
MALMED・ Guideline for the principles of Good Clinical Practice - administered by MoH and
MALMED・ Rulebook on the content of the request, documentation and detailed conditions
regarding the space, equipment and staff for obtaining approval for production of
medicine - administered by MALMED
・Rulebook on obtaining approval for wholesale trade - administered by MALMED
Pharmaceutical manufacturing- production of medicines is regulated with bylaw
administered by MALMED. The regulations related to the production of medicines provide
detailed information on what conditions need to be met and how to carry out the procedure
for approval of production and wholesale of medicines. This Rulebook contains detailed
information about conditions and requirements regarding the space, equipment and staff
which manufacturers should provide for obtaining approval for production of medicine.
Rulebook for obtaining approval for wholesale trade is consisted of detailed
description of the documentation that the manufacturer must submit in order to obtainapproval for the wholesale trade of medicinal products.
Guidelines for good production practice contains the basic principles of good
manufacturing practice as basic conditions for manufacturing of medicines; manufacturingof: sterile, biological, radiopharmaceuticals, medical gases, herbal medicines, liquid
pharmaceutical forms, creams and ointments, inhalations, computerized systems, use ofionizing radiation, medicines for clinical trials, medicines derived from blood and bloodplasm; qualification and validation; issuance of a certificate for placing a batch of a medicineon the market; parametric placing of a batch of drug on the market; reference and control
samples. This guidelines are in accordance with the European directives that prescribes theprinciples of GMP and are adopted by the European Commission.
Guidelines for principles for good laboratory practice - the principles of goodlaboratory practice are a quality system that is established for the laboratories in whichlaboratory and pharmacological-toxicological tests are performed.
The guidelines for the principles of good laboratory practice prescribes the principles fororganization of planning, conducting and monitoring of pre-clinical examinations, safe forhuman health and environment; Conditions for planning, conducting and monitoring preclinical examinations, safe for human health and the environment; Manner of reporting anddocumenting pre-clinical trials, safe for human health and the environment
The Principles of Good Clinical Practice cover international ethical and scientific027quality standards in the planning, implementation, monitoring and reporting of clinical trials
conducted on humans. Adherence to these standards provides public protection of the rights,
safety and best interests of the respondents in accordance with the principles set out in theHelsinki Declaration, as well as that the data obtained from the clinical trial are reliable. The
purpose of these ICH guides is to provide a single standard for the European Union (EU),Japan and the United States of America to facilitate mutual acceptance of clinical data by
the competent authorities of these countries.
The guidelines have been developed taking into account the current good clinicalpractices of the European Union, Japan and the United States, but also Australia, Canada,
the Nordic countries and the World Health Organization (WHO). These guidelines should
be followed when preparing the data from the clinical trials that are given for inspection to
the competent body (MALMED), ie the competent bodies (Commission for Clinical Trials
and Ethics Commission). These principles can be applied to other clinical trials that may
affect the safety and best interests of the respondents.
The guidelines for the principles of good clinical practice prescribe the principles for:- international ethical and scientific quality standards in the planning, implementation,
monitoring and reporting of clinical trials conducted on humans;- the composition, tasks and activities performed by the commission for clinical trials;- the tasks undertaken by the examiner during the clinical trial;- the tasks undertaken by the applicant for the clinical trial;- the clinical trial plan and its changes and additions;- brochure for the examiner and- basic documents for conducting the clinical trial◆Drug Import/Export• Rulebook on the content of the request and the manner of obtaining approval for
import of medicines –administered by MoH and MALMED• Rulebook on the form and content of the guarantee for imported medicine administered by MALMED
The Rulebook on the content of the request and the manner of obtaining approval for importof medicines determines the form of the request and the documents that the applicant should
submit to MALMED. The import request contains:- data on the applicant for import;- data on the manufacturer of the medicinal products that are subject to import;- data on the supplier of the medicines;- name of the medicine (brand name, INN or generic name);- pharmaceutical form, strength and package of the medicine;- tariff number of the imported medicines;- identification number of the applicant for import;- deadline within which the import of medicines will be performed.
028

An integral part of the request for import of medicines are:- specification for import of medicines with tariff codes, name of the medicine (brand name,
INN or generic name), pharmaceutical form, strength and package of the medicine,- pro-invoice or invoice for the medicines that are subject to import in three (3) copies,- quality certificate for the batch of medicine that is subject to import,- decision for registration of the medicine on the territory of the Republic of North
Macedonia,- decision - license for wholesale of medicines issued by the Ministry of Health.
Rulebook on the form and content of the import guarantee prescribes the form and content
of the guarantee that each batch of imported medicine complies with the conditions of themarketing authorization of the medicinal product or the marketing authorization for theimport of the medicinal product. This guarantee contains: Name of medicine; ATC code;
International nonproprietary name (INN); Pharmaceutical dosage form, strength and size of
packaging; Serial number; An Expiration Date; Quantity of imported medicine; Bar code /data matrix check; Visual inspection; Conclusion; Name of the importer; Employedprofessional; MP; Director of the importer.
◆Marketing Authorization• Rulebook for obtaining approval for placing a drug on the market – administered by
MALMED• Rulebook for registration of traditional herbal medicines - administered by
MALMED• Rulebook on the content of the request, the manner of registration of homeopathic
medicines, the form and the content of the documentation - administered by MoH
Rulebook for obtaining approval for placing a medicine on the market prescribes the content
of the request, the form and the content of the required documentation, the manner ofrecognition of the marketing authorization issued by the countries of the European Union,
as well as the manner of obtaining conditional marketing authorization for medicinal
products for use in human medicine.
Rulebook for registration of traditional herbal medicines prescribes the manner ofregistration of traditional herbal medicines, the form and content of the required
documentation and the manner of recognition of the registration in the countries of theEuropean Union.
◆Drug Distribution (including drug selection, procurement, sale)・Systems, Regulations, etc.
・administered by029

administered by・A rulebook for distribution of medicines is being prepared◆Medicine Safety (post-marketing)• Rulebook on the manner of reporting, the content of the form for reporting
adverse medicine reactions and the manner of organization of thepharmacovigilance system – administered by MoH, MALMEDThis Rulebook prescribes the manner of reporting, the content of the form for reporting
adverse drug reactions, as well as the manner of organization of the pharmacovigilancesystem.
MALMED publishes safety information on its website, following information from relevant
sources.
MALMED has signed a cooperation agreement with Uppsala Monitoring Center (UMC) a global electronic database on drug side effects of the World Health Organization based in
Sweden. All applications submitted to MALMED are processed and forwarded to the UMC
and become part of the documentation for the safety of the drug, on the basis of which
recommendations are issued for its safe use in terms of proper dosing, contraindications,special warnings, interactions with other drugs such as and measures to minimize theoccurrence of adverse reactions.
◆Relief System for Adverse Drug Reactions• Rulebook on the manner of reporting, the content of the form for reporting
adverse medicine reactions and the manner of organization of thepharmacovigilance system – administered by MoH, MALMED.
Organization and monitoring the manner of collection and assessment of adverse drug
reactions, processing and evaluation of the obtained data on drug safety is performed by the
MALMED, through the National Center for Monitoring Adverse Reactions of drugsNational Center for Pharmacovigilance.
The system for collecting new data on drug safety, assessing adverse reactions and events,
informing about drug interactions and abuse, and proposing appropriate measures to betaken during the period of validity of the marketing authorization or during theimplementation of the clinical trial of the drug is performed by the National Center for
Pharmacovigilance, which in accordance with the law establishes and maintains the systemof pharmacovigilance.
Data on adverse drug reactions may be submitted by the applicant for clinical trial.
Data on adverse drug reactions, suspicion of adverse drug reactions, can be reported by030

health care institutions and health professionals by submitting a report of adverse drug
reactions, on a form that is an integral part of the rulebook.
Data on adverse drug reactions can also be submitted by person responsible forpharmacovigilance designated by marketing authorization holder in accordance with the law
for implementation of the pharmacovigilance system.
Based on the data collected on adverse drug reactions during clinical trials of the drug, thefollowing measures may be proposed by the National Center for Pharmacovigilance:
1) change in the protocol of clinical trial of the drug;2) conducting control over the clinical trial of the drug;3) termination of the clinical trial of the drug.
Individual PSURs( Periodical Safety (six-month, one-year and three-year) are submitted
to the Agency by the person responsible for pharmacovigilance during the first renewal ofthe marketing authorization.
Each subsequent renewal of the marketing authorization for the medicinal product, theindividual PSURs should cover a period of five years, with cumulative data relating to theperiod from the first day of approval or to the period from the date of the last renewal of themarketing authorization for placing on the market (Summary Bridging Report), no later than
60 days from the date of expiration of the period to which it refers. Conclusion (it isnecessary to state the information on the safety of the medicine that changes the cumulative
experience with the drug so far, as well as the specific measures to be taken, with an
explanation of the same).
The latest version of the basic reference document for the safety of the drug from the drug
manufacturer (summary report on the properties of the drug, patient guide) is submitted to
the PSUR by the person responsible for pharmacovigilance.
Upon receipt of a report for a serious adverse reaction to a drug that may have serious
consequences for human health, the holder of the approval shall immediately submit to the
Agency a proposal for urgent safety measures which may be:1) withdrawal of the drug from the market;2) change in the summary report on the properties of the drug, such as the introduction ofcontraindications, warnings or precautions, reduction of the recommended dose, narrowingof the indication area and3) informing the health professionals and patients about the newly discovered risk during
the use of the medicine, without delay.

④ Drug Pricing
Drug prices are regulated by law.
There is a methodology that determines the way of forming wholesale prices andretail prices of medicines that have an authorization for placing on the market issued by the
Agency for medicines and medical devices and are issued on prescription.
This methodology also determines the manner of formation of wholesale prices andretail prices of medicines for which the Agency has issued an import permit, in accordance031

with the Law on Medicines and Medical Devices.
This methodology determines the manner of formation of wholesale prices and retail prices
of medicines for which the Agency has issued an approval for parallel import. Wholesale
and retail prices of medicines are formed on a comparative basis wholesale drug price inreference countries. Comparative wholesale price of the drug is determined on each
pharmaceutical form, strength and packaging, separately.
The comparative wholesale price of the drug in the reference countries is the average valueof all wholesale drug prices according to Article 5 of this methodology, with the same INN,
the same pharmaceutical shape, strength and packaging from different manufacturers. Basedon the methodology, the Ministry of Health determines the maximum price once a year. The
wholesale price of the medicine includes the costs of the wholesale sale of the medicine,
customs costs and other import costs, while a margin is added to the retail price dependingon the amount of the wholesale price. There are special provisions for medicines fromparallel import, original drugs and biosimilar drugs.
Health insurance fund of the Republic of North Macedonia also determines referent prices.
There is a Rulebook based on which are determined the manner and methodology for
determining reference prices of medicines which are on the List of medicines covered by
the Health Insurance Fund of the Republic of North Macedonia
The reference price of the medicine is the maximum amount that the Fund provides for acertain medicine.
The reference price of the medicine is determined at the level of wholesale price including
VAT. An integral part of the wholesale price is the margin for wholesale in accordance with
the Law on medicines and medical devices.
The basic criteria for determining the reference prices of medicines are the following:- The reference price (the comparative wholesale price of the medicine with VAT included)in the reference countries,- The average relative price of the medicine,- The level of the comparative price according to the purchasing power parity coefficient.
The comparative wholesale price of medicines is determined individually for each
pharmaceutical dosage, pharmaceutical form and strength.
If in the reference countries there is a drug of the same strength from different manufacturers
at different prices, the lowest price of the drug is taken into account, which is applied when
determining the comparative price for all drugs of that generic.
Average comparative price of the drug is the price calculated so that the sum of the two (2)lowest comparative drug prices in reference countries, divided by two.
The level of the relative price is the ratio of the reference price of the drug in the Republicof North Macedonia and the average relative price of the drug in the reference countries,
expressed as a percentage.
The comparative price level is adjusted to the purchasing power parity ratio.
Purchasing power parity ratio is a ratio expressed as a percentage of GDP per capita in
Republic of North Macedonia and the average of the values of the gross domestic productper capita in reference countries, according to the purchasing power parity methodology
established by the International monetary fund from Washington for the last year for which032

the International Monetary Fund has published final data.
Rference prices are reviewed at least once a year.

⑤ Statistic Data – No data available−Please answer the following questions (if the number is not applicable, please give ananswer to the best of your knowledge).
−Put the year of the presented data as well if it's available.
1. Number of pharmacists(year)
2. Number of GMP inspector (National & Local)(year)
3. Number of pharmaceutical manufacturers / manufacturing sites(year)
4. Number of traditional medicine manufacturers / manufacturing sites(year)
5. Number of pharmaceutical importers(year)
6. Number of pharmaceutical wholesalers(year)⑥ Education and License of Pharmacists in your country（１） Number of years in primary, secondary and high school education
Primary
9
years
Secondary
years
High school4years（２） Number of years / weeks in the following categories during university orcollege
University / college: 5 years for master degree/4 years for graduated pharmacist
Professional education:/
years
Practical training:
6 months to 1 year
Duration of training by each facility:
years
Hospital pharmacy:
1.5months
Community pharmacy with Galen laboratory:
2 months
Pharmaceutical company:/
weeks
Others: Pharmacoinformation 1 month and Clinical pharmacy 1 monthAge at graduation:
approximately 24/25 years old（３）Are there any national examinations for pharmacists in your country?
Yes
Academic Exams
Clinical Exams

days
days

No
033

（４）Which of the followings must you fulfill to obtain a pharmacist's license?
* If practical training is mandatory, give the subjects and training period.
6 months to 1 year
* If practical training is optional, give the reasons.
(i.e. Training is necessary to prepare for the national examination)（５）Number of pharmaceutical university or college graduates:

people / per year

The alumni's placement rate (%)
a. Hospital:%b. Community Pharmacy:%c. Government Organization:%d. Enterprise:%e. Others:%
According to the information given by Pharmaceutical chamber of RNM, in this moment in
the pharmaceutical chamber are registered 3484 graduated pharmacists/ master pharmacists.
Manufacturer 242
Representative offices 167
Education 10
Laboratory 36
Retail Pharmacy 1446
Hospital 10
Other 42
Drug depot 8
Wholesale 168
Hospital pharmacy 98
Not report 1257
Total 3484

⑦ ADR(Adverse Drug Reaction) report
Please describe the flow of reporting system (from a medical institution to an administrative
agency), when a severe ADR is detected in a medical institution. Describe specifically therule and responsibility of each organization (an administrative agency / a medical institution),and their collaboration/cooperation.
Health institutions and health professionals report to the National Center for
Pharmacovigilance:
1) adverse reactions to a new drug or in case of suspected adverse reactions, as well asreactions that are not serious;
0342) serious and unexpected, adverse reactions to a drug that has been in use for more than
five years or in case of suspicion of these reactions;3) information on the increased incidence of the manifestation of the expected reaction,clinically significant interactions, drug abuse, overdose, use during pregnancy and lactation,ineffectiveness, as well as information on medical error.
In the cases referred to in paragraph 1 item 3), it is sufficient only a suspicion that the drug
used may have caused an adverse reaction in the patient.
Adverse drug reactions, or suspicion of adverse drug reactions, by health care institutions
and health professionals are reported by submitting a report of adverse drug reactions, on aform that is an integral part of rulebook.
The report of adverse drug reactions contains data on:1) patient (initials, age and sex) and adverse reaction (start date of reaction, description ofclinical manifestation, outcome and possible treatment, association between adverse
reaction and suspected drug);2) the suspected drug (brand name and international unprotected name, pharmaceutical form,
strength, individual and daily dose, method / s of use, indication for use, date of therapy
from / to, duration of therapy) and the course of the adverse reaction upon discontinuation
and / or re-use of the suspected drug;3) concomitant use of another drug (s) with date of use and patient history;4) the manufacturer of the suspected drug (name and country, batch number) and theapplicant (date of application, source and type of application, name and surname, contact
telephone, occupation).
The National Center for Pharmacovigilance in performing the activities referred to therulebook implements the following activities:
1) collects, processes and evaluates data on adverse drug reactions and adverse events
related to the use of drugs during the clinical trial or in the marketing of the drug, or in the
post-marketing intervention clinical trial of the drug;2) processes and evaluates periodic reports on the safety of medicines, which it receives
from the holder of the marketing authorization;3) collects, processes and evaluates data from the post-marketing non-intervention clinical
trial of the medicine (pharmaco-epidemiological examination), which it receives from theholder of the marketing authorization;4) notifies the holder of the marketing authorization for serious adverse reactions to the
medicinal product immediately, no later than 15 days from the date of receipt of thisinformation;5) inform the Agency and the health professionals about the serious side effects of the
medicine and about the significant changes in the safety of the medicine immediately, andno later than 15 days from the date of receipt of this information;6) encourages health professionals to report adverse events and adverse reactions to drugs,
or suspicion of them;7) maintains a database of information collected in the pharmacovigilance system that isavailable to the public and to the competent authorities in the country and abroad;8) exchanges information collected in the pharmacovigilance system with the competent035

authorities for pharmacovigilance in other countries.
The National Center submits to the Agency a report on the reported adverse drug reactions
every three months and an annual report on the reported adverse drug reactions.

036

Republic of North Macedonia

Health Insurance Fund of North
Macedonia

Blerina Tushi

1. Introduction of the work

The HIFNM provides health services from the basic packageof services to the insured persons based on the principles ofcomprehensiveness, solidarity and equality.
Pharmaceutical sector as an independent sector in the
HIFRNM has been functioning since 2007 and performs duties
and activities related to medicines which are on the burden of
HIFRNM.
Currently nine graduated pharmacist work in the sector including thedirector of the sector.

1037

1. Introduction of the work

- As pharmacist
years.

inspector, I am part of this sector more than 15

Control/Inspection of services insured persons receives in pharmacies;
Monitoring consumption of medicines which are covered in Positive
List;
Participating in the creation of health policies related to medicines
covered in the Positive list;
Reference prices for medicines on the burden of HIFRNM.

2

1. Introduction of the work
Roles and position of pharmacists in your country
Most of the pharmacist work in:
Retail pharmacies;
Wholesalers and representative offices of pharmaceuticalcompanies;
Pharmaceutical manufactures;
Hospital pharmacies;
Public institutions as Ministry of health, Agency for
medicines and medical devices, HIFRNM, Institution for
public heath, etc.

3038

1. Introduction of the work
Pharmacist in RNM have different positions in the public andprivate sector and all of them have a role in the timely
provision of medicines to patients, access to quality and safe
medicines, rational use of medicines and prevention of
misuse of medicines

4

2. Good Practice
Ach evemen s
Republic of North Macedonia has established national framework ofquality standards and guidelines for: Good manufacturing practices,
Good pharmaceutical practices, Good laboratory practices, Good
Clinical practices. Guideline for good distribution practices is indevelop.
Changes and amendments on Law on Medicines and medical devices
are being made to be harmonized to European Union system.
So ut ons for past problems
Regulation of parallel import of drugs.
5039

2. Good PracticeOn- o ng p o ects to deal w th cu ent prob ems
Preparation of new rulebook for inclusion of new medicines in Positive
List.
Collaboration with WHO for antimicrobial consumption
Successfu co nter eas res aga nst prob ems
Collaboration and cooperation between public Institutions as well as
cooperation with the private sector in order to provide patients withdrugs especially new generations of drugs.
Regular inspections on pharmacies
6

2. Good Practice
Public awareness programsContinuous trainings and meetings with the controllers
from the regional offices
Continuous meetings with representatives of pharmacies
that have concluded an agreement with the HIFRNM

7040

3. Difficulties/Lessons Learned from Past
Experience
Unified medicine labeling system to facilitate tracking of
medicines use;
Strengthening of legal framework in the area of access toquality medicines
Raising the awareness of all participants in the healthsystem about the negative effects of the irrational use of
antimicrobial drugs and creating resistance to them;
Creating conditions for more medicines, especially newer
generations of medicines, to enter the drug market;
Providing patients and insured persons with new
innovative medicines.
8

4. My interests
1.To get acquainted with the Japanese regulatory system andidentify what best practice can be applied in RNM.

2. To explore for solutions of databases for managing and tracking
medicines to the last consumer (patient).
3. To explore for solutions for access quality and innovative
medicines in conditions of limited financial resources.

9041

4. Timor-Leste(1)REGULATORY SYSTEMS ON ENSURING ACCESS TO QUALITY MEDICINES(JFY 2022)

Inception ReportName: Ismenia Mateus da Costa Belo

Country: Timor-Leste

Organization/Department/Division : Serviços Autonomos de Medicamentos e
Equipamentos da Saude (SAMES)/Warehouse andDistribution Direction/Head of Department
Warehouse and Distribution.

PART I: INFORMATION SHEET
Why? To clarify and share the basic information on each country and yourself
among all participants
The best “Regulatory Systems On Ensuring Access to Quality Medicines” forcountries like Timor-Leste is prequalification. For the other country they can consider
a drug registration system. As we know that Timor-Leste does not have any
manufacture, and the all medical products are import from the outside country.

1042

Introduction
TIMOR-LESTE MAP

Timor-Leste or east Timor, a southeast Asian nation occupying half the island of Timor,
is ringed by coral reefs teeming with marine life.
Landmarks in the capital, Dili, speak to country’s struggles for independence from
Portugal in 1975 and then Indonesia in 2002. The iconic 27m-tall Cristo Rei de Dilistatue sits on a hilltop high over the city, with sweeping views of the surrounding bay.
Capital: Dili
Population: 1.370 million (2022)
Points of Interest: Atauro Island, Jaco Island, Tatamailau, Cristo Rei of Dili, Ramelau
Mountain, Koni Santana National Park and more
Official language: Portuguese and Tetun
The vision of Ministry of Health of Timor-Leste
2043

The Government is committed to a vision of ensuring safe, effective, reliable quality,
essential medicines to be available at affordable cost at all times to the entire
population of Timor-Leste. The national drug Policy there for recognizes that priorities
must be made in terms of selecting drug of supply, to meet the most important needsof the healthcare system, solving the most important health problems of the population.
MissionConsistent the vision statements, the mission of ministry of health is strive to ensure
the availability and affordability of health services to all the people of Timor-leste, toregulate the health sector and to promote community and stakeholders’ participation(including other sector).
1. Organizational Chart (Attach)
2. Legislation on Pharmaceuticals Administrationa. The Medicine Law; (Pharmaceutical Law, Drug Law).
An updated Drug Law of the Republic of Timor-Leste shall form the legal
basis and framework for regulatory control, matching objectives of the
National Drug Policy. It shall incorporate elements of existing rules andregulations which are in line with this policy Following enactment of the Law
by the relevant bodies, detailed regulations governing the standards andprocedures for carrying out the provisions of the law shall be formulated.
Scope of the Law, decrees and guidelines, forming a regulatory framework forthe pharmaceutical sector.
The Legal and regulatory framework shall include the following:Specifics; National Drug Regulatory Authority (synonym: National Drug
Administration)
1. The law shall pave the way for the establishment of a National Drug
Administration Syn. National Drug Regulatory Authority, in theorganization of the Ministry of Health

3044

2. Its duties and powers regarding the enforcement of the Drug Law,
with technical regulations for authority and authority, clearly
defined in the Drug Law.
3. The National Drug Administration shall be the focal point for
implementation of the National Drug Policy.
4. The National Drug Administration shall be advised by an advisory
body. (hereinafter called Advisory Board)
Access to Medicines and Pharmaceutical Supply
b. A centralized procurement and supply system has been established,
the SAMES with the aim to ensure availability and supply of medicines
to all levels of health care in a predictable manner. The Public Healthobjectives of the SAMES system shall be defined in the new Drug Law
of Timor Leste.
c. There is no local level legislation for pharmaceuticals, but Timor-Lesteis currently implementing a decentralization plan which will
implement responsibilities for the municipalities. At the National level,
DNFM

and

SAMES

have

different

responsibilities

for

the

Import-Departmentofpharmaceuticals supply chain.
3. Regulatory Services
Pharmaceutical

Manufacturing-

NA

drug

Pharmacy oversee registrations for local imports. SAMES can procure andimport medicines for use in the public system without registration.
Marketing authorization-NA Drug Distribution- SAMES have a five years’plan, procurement manual- SAMES also have a separate procurement law
to facilitate procurement of medicines. Adverse drug reactions- reportingat the department of pharmacy
A. Licensing of Importers, Wholesalers and Pharmacies

4045

The Ministry of Trade and Development is responsible for issuing a general
trade license for any corporation, before it can apply to the Drug Administration
for license to operate as medicine importer, wholesale or retail pharmacy.
Legislation shall require that importers, wholesalers, pharmacies and otherretail outlets:
Be licensed by the National Drug Administration, and Fulfill standard
requirements of the Ministry of Health in providing and maintaining
suitable premises and quality procedures including appropriate storage
conditions for medicines to preserve their quality and efficacy (GoodDistribution Practices) and that qualified personnel are available toendure good pharmacy practices Pharmaceutical personnel, andhealthcare personnel with right to prescribe, shall be licensed by the
National Drug Administration, and kept in updated recording database in
the Drug Administration, and in updated printed records over licensed
prescribers, provided to all pharmacies with 2 updates per year.
B. Medicine / Drug Registration and Marketing Authorization
Approval is required through Registration of a medicine for approved purpose(s)(indications) before a medicine can be imported, sold or used in Timor Leste.
Only medicines with adequate documentation about its efficacy and its safety,
in its use for the suggested indication(s) can be approved by registration. In
addition, import license and marketing authorization from the Drug
Administration is required before any product is allowed on the market.
Regulations for issuing or denying marketing authorizations shall be clearly
defined and shall be based on evaluation of safety, efficacy, quality and need.
approved byregistration. In addition, importlicense and marketing

authorization from the Drug Administration is required before any product isallowed on the market. Regulations for issuing or denying marketing
authorizations shall be clearly defined and shall be based on evaluation of safety,
5046efficacy, quality and need. approved by registration. In addition, importlicenseand marketing authorization from the DrugAdministration is required before
any product is allowed on the market. Regulations for issuing or denying
marketing authorizations shall be clearly defined and shall be based on
evaluation of safety, efficacy, quality and need.
Marketing Authorization shall be valid for a specified period of time and areview shall be required for renewal of registration. A registration fee shall becharged for pharmaceutical and other products as determined by Ministry of
Health. A database for registration and monitoring imports of pharmaceuticalproducts shall be developed.
C. Post Marketing Surveillance.
All marketed medicines shall be under vigilance to ensure constantconformity with the conditions and terms of the marketing authorizationand safety
4. Drug Pricing
Medicines are provided free of charge in all public health facilities. SAMES
Procure medicines at internationally competitive prices.
5. NA
6. NA
7. Education and License of pharmacist in Timor-Leste
1. Number of years in primary, secondary and high school education
Primary 6 years
Secondary 3 years
2. Category during university
University: 4 years

Professional education : 2 years
Practical training 2 or 4months (one month in warehouse, hospitals,
private clinics and the community)

6047

In Timor- Leste at the moment there is no any examination forpharmacist

7048

1. Organizational chart of ministry of health in Timor-Leste
Ministry of Health

Minister of HealthVise- Minister of HealthNational Hospital
Director General of
HealthReferrals Hospitals

Legal office
Office of protocol andNational Laboratory

Director of administration finance and logistics
services

Department of FinanceDirector of Health policy andDepartment of administration

Department of policy

Department of logistic andDistrict health services

Centre for drugs Supply andmedical equipment

Department of planning
Department of human resources
Department of health information system, monitoring and evaluation
049

TIMOR LESTE

Serviço Autonomo Medicamentos e
Equipamentos da SaudeSAMES IP
Ismenia Mateus da Costa Belo

TIMOR LESTE

1051

Servico Autonomu Medicamentos e Equipamentos da
Saude SAMES Timor Leste

VisionEnsure for complete access, equal and safe access to essential
drugs, consumables for the people of Timor Leste

MissionEstablishes management cycle system for purchase Medicines instrong resilient, fully adhering to national regulations and follow
International best practice

1. Introduction SAMES of Timor Leste
Servico Autonomo Medikamentos e Equipamentos da SaudeSAMES an only National Warehouse in Timor Leste
SAMES have a three (3) function important are ; Procurement,
Storage and Distribution for all product medicine available in
Health Facilities in Timor Leste
SAMES has three (3) Warehouses in three regions are Ainaro
regional warehouse, Baucau regional warehouse and Maliana
regional warehouse, aiming to bring pharmaceutical services
to the population
5053

2. Introduction of the work
1. Servico Autonomos Medicamentos e Equipamentos da
Saude(SAMES)/
Warehouse
andDistribution
Direction/Head of Department Central Warehouse andDistribution.

2. I am Head of Department Central Warehouse andDistribution, responsible for Inventory Management,
Distribution Management, Fleet Management system andHuman Resources Management
3. SAMES has regulation of Ministry of Health number
21/2016, 9 March which was recently changed to 36/2020,
8 March.
6

Continue Introduction of the work
4. Roles and Positions of Pharmacist in my Country Timor
Leste

Clinical Pharmacists (in hospitals)(Manage thesupply chain of drug store)
Pharmacists in Research (Carrying out inanalytical research of drugs and clinical trial)
Academic pharmacists
pharmacy)(inuniversities

ofSale managers (in pharmaceutical companies)
7054

2. Good Practice
Achievements

On-going projects
Implementation of Quality
Management System

Implementation of national
standardofGood
Manufacturing
Practice(European Commission - EC
GMP)

Establishment of national
electronic system namely
MSupply for the Inventory
Management system from
Municipality Health Service to
Health Post

Establishment of GMP
Inspectorate
Full membership of the
WHO Program forInternational Drug
Monitoring

Establishment of medicines
control laboratory
8

3. Difficulties/Lessons Learned from Past Experience

More than 99% of pharmaceutical imported
Low capacity of National Medicine Quality Control
Laboratory
Insufficient competent staff to perform regulatory
activities
Insufficient resources for implementation of laws andregulations
Insufficient capacity and resource to perform post
market surveillance assessments
9055

Continue Difficulties/Lessons Learned from Past Experience

MRP (Maximum Retail Price) system not
implemented
Limited pharmaceutical human resources against
pharmaceutical establishments
Illegal promotion of medicine and healthcare
products
GMP not implemented for manufacturing sites
Lack of standard quality control laboratories
inside the manufacturing companies
10

Your interests

The followings are my interests to learn fromthis program and to deal with mentioned
challenges:
1. How to standardized the local manufacturing
companies in Timor Leste and how to improve thequality of their products?
2. How to deal with existing and how to avoid more
smuggling and illegal medicine in the market of
Timor Leste?
3. How to implement normal and fast-track registration
system in Timor Leste by minimum use of sources?
11056

THANK YOU
ARIGATO - GOZAIMASOBRIGADO BARAK

12

057

5. Timor-Leste(2)REGULATORY SYSTEMS ON ENSURING ACCESS TO QUALITY MEDICINES(JFY2022)

Inception Report

Name:Angelica Brito Ribeiro

Country: Timor-Leste

Organization/Department/Division :SAMES is means: Servico Autonomo de Medicamentos e Equipamentos da
Saude/ Service Autonomous of medicines and Medical Equipment/
Warehouse and Distribution Direction/Head of Department Pharmaceutical
Information Management.

1058

PART I: INFORMATION SHEET
Why? To clarify and share the basic information on each country and yourself
among all participants
The best “Regulatory Systems On Ensuring Access to Quality Medicines” forcountries like Timor-Leste is prequalification. For the other country they can consider
a drug registration system. As we know that Timor-Leste does not have any
manufacture, and the all medical products are import from the outside country.

The vision of Ministry of Health of Timor-Leste
The Government is committed to a vision of ensuring safe, effective, reliable quality,
essential medicines to be available at affordable cost at all times to the entire
population of Timor-Leste. The national drug Policy there for recognizes that priorities
must be made in terms of selecting drug of supply, to meet the most important needsof the healthcare system, solving the most important health problems of the population.

MissionConsistent the vision statements, the mission of ministry of health is strive to ensure
the availability and affordability of health services to all the people of Timor-leste, toregulate the health sector and to promote community and stakeholders’ participation(including other sector).

2059

1. Organizational Chart (Attach)
2. Legislation on Pharmaceuticals Administrationa. The Medicine Law; (Pharmaceutical Law, Drug Law).
An updated Drug Law of the Republic of Timor-Leste shall form the legal
basis and framework for regulatory control, matching objectives of the
National Drug Policy. It shall incorporate elements of existing rules andregulations which are in line with this policy Following enactment of the Law
by the relevant bodies, detailed regulations governing the standards andprocedures for carrying out the provisions of the law shall be formulated.
Scope of the Law, decrees and guidelines, forming a regulatory framework forthe pharmaceutical sector.
The Legal and regulatory framework shall include the following:Specifics; National Drug Regulatory Authority (synonym: National Drug
Administration)
1. The law shall pave the way for the establishment of a National Drug
Administration Syn. National Drug Regulatory Authority, in theorganization of the Ministry of Health
2. Its duties and powers regarding the enforcement of the Drug Law,
with technical regulations for authority and authority, clearly
defined in the Drug Law.
3. The National Drug Administration shall be the focal point for
implementation of the National Drug Policy.
4. The National Drug Administration shall be advised by an advisory
body. (hereinafter called Advisory Board)
Access to Medicines and Pharmaceutical Supply
A centralized procurement and supply system has been established, the SAMES withthe aim to ensure availability and supply of medicines to all levels of health care in a
predictable manner. The Public Health3060

b. objectives of the SAMES system shall be defined in the new Drug Law
of Timor Leste.
c. There is no local level legislation for pharmaceuticals, but Timor-Lesteis currently implementing a decentralization plan which will
implement responsibilities for the municipalities. At the National level,
DNFM

and

SAMES

have

different

responsibilities

for

the

Import-Departmentofpharmaceuticals supply chain.
3. Regulatory Services
Pharmaceutical

Manufacturing-

NA

drug

Pharmacy oversee registrations for local imports. SAMES can procure andimport medicines for use in the public system without registration.
Marketing authorization-NA Drug Distribution- SAMES have a five years’plan, procurement manual- SAMES also have a separate procurement law
to facilitate procurement of medicines. Adverse drug reactions- reportingat the department of pharmacy
A. Licensing of Importers, Wholesalers and Pharmacies
The Ministry of Trade and Development is responsible for issuing a general
trade license for any corporation, before it can apply to the Drug Administration
for license to operate as medicine importer, wholesale or retail pharmacy.
Legislation shall require that importers, wholesalers, pharmacies and otherretail outlets:
Be licensed by the National Drug Administration, and Fulfill standard
requirements of the Ministry of Health in providing and maintaining
suitable premises and quality procedures including appropriate storage
conditions for medicines to preserve their quality and efficacy (GoodDistribution Practices) and that qualified personnel are available toendure good pharmacy practices Pharmaceutical personnel, andhealthcare personnel with right to prescribe, shall be licensed by the
4061

National Drug Administration, and kept in updated recording database in
the Drug Administration, and in updated printed records over licensed
prescribers, provided to all pharmacies with 2 updates per year.
B. Medicine / Drug Registration and Marketing Authorization
Approval is required through Registration of a medicine for approved purpose(s)(indications) before a medicine can be imported, sold or used in Timor Leste.
Only medicines with adequate documentation about its efficacy and its safety,
in its use for the suggested indication(s) can be approved by registration. In
addition, import license and marketing authorization from the Drug
Administration is required before any product is allowed on the market.
Regulations for issuing or denying marketing authorizations shall be clearly
defined and shall be based on evaluation of safety, efficacy, quality and need.
approved byregistration. In addition, importlicense and marketing

authorization from the Drug Administration is required before any product isallowed on the market. Regulations for issuing or denying marketing
authorizations shall be clearly defined and shall be based on evaluation of safety,
efficacy, quality and need. approved by registration. In addition, importlicenseand marketing authorization from the DrugAdministration is required before
any product is allowed on the market. Regulations for issuing or denying
marketing authorizations shall be clearly defined and shall be based on
evaluation of safety, efficacy, quality and need.
Marketing Authorization shall be valid for a specified period of time and areview shall be required for renewal of registration. A registration fee shall becharged for pharmaceutical and other products as determined by Ministry of
Health. A database for registration and monitoring imports of pharmaceuticalproducts shall be developed.

5062

C. Post Marketing Surveillance.
All marketed medicines shall be under vigilance to ensure constantconformity with the conditions and terms of the marketing authorizationand safety
4. Drug Pricing
Medicines are provided free of charge in all public health facilities. SAMES
Procure medicines at internationally competitive prices.
5. NA
6. NA
7. Education and License of pharmacist in Timor-Leste
1. Number of years in primary, secondary and high school education
Primary 6 years
Secondary 3 years
2. Category during university
University: 4 years

Professional education : 2 years
Practical training 2 or 4months (one month in warehouse, hospitals,
private clinics and the community)
3. In Timor- Leste at the moment there is no any examination forpharmacist

6063

Introduction of the work Continue2) Department Pharmaceutical Information Management guardianship in
the Directive of storage and distribution. (This is my Job now)
2) SAMES has regulation of Ministry of Health, Ministerial Diploma
Number. 36/2020 of 8 October. First amandament to ministerial
diploma Number 21/2016, 9 March which establishes the internal
regulations of SAMES.
4) Pharmacist hold multiple roles in Hospitals,SAMES,DNFM andPharmacies in Timor Leste.
DNFM Is means: Diresaun Nasional Farmacia e Medicamentos/
Direction National Pharmacy and Medicines2

2. Good Practice1)

At the SAMES especially in the direction of storage and distribution using
the electronic system mSupply to control the situation stock of the medicine
and medical Equipment.

2)

SAMES uses an electronic system mSupply to procure, receive,
store,distribute and reporting.

3)

SAMES brings and expands the electronic system mSupply to hospitals
and all health facilities in Timor Leste to help them manage stock of
medicine and medical equipment.

4)

SAMES has established three (3) warehouse in each region, the aim of
speeding up distribution medicine and medical equipment to hospitals andall health facilities in Timor Leste.

5)

SAMES already has a mini laboratory to test the quality of medicine, but

3067

3. Difficulties/Lessons Learned from Past Experience
Which is problematic for the Timor Leste Ministry ofhealth(DNFM),SAMES and all Pharmacies in Timor
Leste do not have a laboratory to test medicine
making it difficult for us/for Phamacies Timor Lesteto determine the quality of medicine.
SAMES already has a mini laboratory to test the quality of

Pharmacy Timor Leste (for me) still lacks knowledge of testing
the quality of medicine
The problem that often occours at SAMES is that the internet
signal take a long time to load, difficulties when we serve
emergengy distribution in the 4electronic system msupply.

4. Your interests

Provide a laboratory to test the quality of
medicine and adding equipment andreagents to test medicine (at SAMES).
Increase the knowledge of testing medicine
to the pharmacy Timor Leste (Specially for me).
Increase internet capacity in the area SAMES
to help speed up emergency services.

5068

Thank You

Obrigado Wain

6069

出典：2022 年度 JICA 課題別研修「適正な医薬品の供給・品質管理・使用に向けた薬事行政」カントリーレポート

Japan International Corporation of Welfare Services (JICWELS) was established with the sanction of
the Minister for Health, Labour and Welfare in July 1983 and implements international technicalcooperation programmes with purpose of contributing to the promotion of health and social welfare
activities in the friendly nations.
Japan International Corporation of Welfare Services (JICWELS)
Matsuoka Ginnana BLDG. 3F
7-17-14 Ginza Chuo-ku, Tokyo 104-0061 JAPAN
Tel: +81-(0)3-6206-1137
Fax: +81-(0)3-6206-1164
https://jicwels.or.jp
公益社団法人国際厚生事業団（JICWELS）は、国際的な保健・福祉分野の国際協力に貢献することを目的として、1983 年（昭和 58 年）7 月 7 日に厚生省（現厚生労働省）から社団法人の認可を受け設立されました。開発途上国の行政官研修や WHO フェローの受け入れ、調査企画や研究開発並びに情報の交換及び広報活動など、海外諸国との国際交流活動を推進し
ています。
発行日

2022 年 8 月 31 日
〒104-0061
東京都中央区銀座 7 丁目 17-14 松岡銀七ビル 3 階

広報チーム

電話 03-6206-1137 (国際協力チーム)
Fax 03-6206-1164
https://jicwels.or.jp