maldives food and drug authority guideline for registration...

Maldives Food and Drug Authority

Ministry of Health

Male', Maldives

Guideline for Registration of Alternative and Traditional Medicines

Medicine and Therapeutic Goods Division, Maldives Food and Drug Authority I Authorized by: Director General, MFDA Doc. No: MTG/RE-MD/GLN·TE 005 Doc. Name: Guideline for Regist rat ion of Alternative and Tradit ional Medicines

Issue No. 01 Issue Date: Prepared by: Director, Approved by· Deputy Copy Letter: MTG/Re 04.03.2020 Pharmaceuticals Director General, GLN003

Revision No: • Revised Date: • Verified by: Technical Pharmaceut icals Page No:Page 1 of 13

Committee of MTG

Guideline for Registration of Alternative and Traditional Medicines is released under the

authority of

Approved By:

Ms.Thooma Adam Deputy Director General


It is the property of: Maldives Food and Drug Authority

Male' Republic of M ldives

Prepared by: Mohamed Fazeen

Director, Pharmaceuticals

Aishath Mohamed Deputy Director General, Pharmaceuticals


Authorised by: ThoomaAdam

Deputy Director General, Laboratory Services


04.03.2020

04.03.2020

Medicine and Therapeutic Goods Division, Maldives Food and Drug Authority I Authorized by: Director General, MFDA Doc. No: MTG/RE·MD/GLN-TE 005 Doc. Name: Guldellne for Registration of Alternative and Tradltlonal Medicines

Issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy Letter. MTG/Re

04 03.2020 Pharmaceuticals Director General, GLN003

Revision No: - Revised Date: - Verified by: Technical Pharmaceuticals Page No:Page 2 of 13

Committee of MTG

CONTENTS

1 INTRODUCTION········-····-···-·-··-··-······-········----·--··--- ------····----- 4

2 PURPOSE ·····-···············-······-···-··················--·········--·--·-··--····--··---·-----·--·---·-· 4

3 SCOPE ·······--··-···-·-·-·--··-----··-··-······--··-··-·-·--·-······-·--·-----··-·-------·-----·-----------·----- 4

4 What are Alternative and Traditional medicines? --···--·-·-·------··----·-·--·------·--------- ·--------·- 4

5 Who should register a product? ·--·-··-······--------------------·---··--·-----·---·--·--·-·--·--··---------·-· 5

6 What do you have to do if you want to register a product?----------·------------------------·-- 5

6.1 Application Form/ Dossier submission: •··································· ··-·····················-·····-········- ·-· 5

6.2 Dossier Content •··········-····-·- ················-················-···- ············-·-·····················-···· ···-·-·· 5

6.3 What if you have to import a sample of alternative medicine? •······ ··········· ···-····-········ ·········-·-10

7 Dossier Evaluation -·---·-----·---------------·--------··-· ---·--··----·-------------·--------·-----·-·--·-··-··-10

7.2 Certification of registration:.•······-···---·-----------····-··-···-·· ···--···--·--··-··- --·· ········-·--·· ·-·-·--·--11

8 Re-registration: ------------·----------------·---------------------·---·-----------------------·-----------------------11

9 Approved Alternative/ Herbal Drug Ust----·----···--·-·----··--·-·---·--------·-------- --------·----- --------12

10 Changes to particulars of products authorized with full dossier submission-·-- - --·----···------12

11 Post-market suNelllance ------·--·--··-·---------··--------·---·-------·----------·--- ·------ --13

12 Annex----- ·-·--···-···-··--··---·--··--·-·-------·--·-··········-····-····-·--·-· ------------13

13 Reference documents: --··-·-·-·-·-------·-·---·----··----------······--·-·-····---····-------------13

Medicine and Therapeutic Goods Division, Maldives Food and Dru1 Authority I Authorized by: Director General, MFDA Doc. No: MTG/RE•MD/GLN·TE 005 Doc. Name: Guideline for Re1istration of Alternative and Traditional Medicines

Issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy l etter: MTG/ Re

04.03.2020 Pharmaceuticals Director General, GLN003

Revision No: · Revised Date: · Verified by: Technical Pharmaceuticals Page No:Page 3 of 13 Committee of MTG

Guideline for Registration of Alternative and Traditional Medicines

1 INTRODUCTION

Alternative (Complementary) Medicines and Traditional medicines sold in the Maldives should be

approved by the Maldives Food and Drug Authority (MFDA), to assure the quality and safety of the

medicines. Product registration and approvals facilitate the traceability of products for post market

surveillance activities as well as for product recalls if an incident warranting a recall occurs. MFDA

strives to achieve a balance between regulatory stringency towards protection of public health and

free market.

2 PURPOSE

This guideline is aimed at informing the public and stakeholders of the process, and requirements

for registration of Alternative and Traditional Medicines for sale in the Maldives.

3 SCOPE

The procedure outlined in this guideline is applicable for Alternative medicines, herbal, traditional

and complementary medicines that are imported, manufactured, and sold in the Maldives.

4 What are Alternative and Traditional medicines?

4.1.1 Herbal medicines are defined as "plant-derived materials or products with therapeutic or other

human health benefits which contain either raw or processed ingredients from one or more

plants."1

4.1.2 Traditional medicines are defined as knowledge, skills, and practices based on theories and

experiences indigenous to a local community or region. Traditional medicines are often used

synonymously with the terms alternative and complementary medicines. Hence, for the

1 WHO (World Health Organization).1988. Guidelines f or the Appropriate use of Herbal Medicines.

Medkine and Therapevtk Goods Division, Maldives Food and Drug Authority I Authorized by: Director General, M FDA Doc. No: MTG/ RE-MD/ GLN-TE 00S Doc. Name: Guideline for Registration of Alternative and Traditional Medklnes

Issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy Letter: MTG/ Re 04.03.2020 Pharmaceuticals Director General, GLN003

Revision No: - Revised Date: - Verif ied by: Technical Pharmaceuticals Page No:Page 4 of 13 Committee of MTG

Maldivian context, traditional medicines are the herbal medicines produced by local

practitioners and have been passed on for generations.

4.1.3 Herbal medicines are the most popular forms of traditional or complementary medicine.

S Who should register a product?

5.1.1 Alternative and Traditional Medicines can be registered by:

• An importer

• A Party assigned by the product Manufacturer (e.g.: marketing authorization holder)

• Product Manufacturer

6 What do you have to do if you want to register a product?

6.1 Application Form/ Dossier submission:

6.1.1 To register a product, an "Application Form for Registration of Alternative Medicine/Dhivehi

Beys" (MTG/RE-HP/Fo 0045) shall be completed with all the required documentation and

submitted to MFDA to register the required product. Dossier is a set of these documents

detailing the technical specifications of the product proposed to be registered and

documents related to the manufacturing facility.

6.1.2 The application form will be available from the Ministry of Health counter and MFDA or MoH

website (www.mfda.gov.mv, www.health.gov.mv).

6.1.3 Dossier applications will be accepted at MFDA reception, on Mondays and Thursdays between

10:00 am and 13:00 pm.

6.1.4 There is no difference in procedure for receiving application, processing the application, and in

issuing Certificate of Alternative/ Herbal medicine Certificate for any applicants irrespective of

the applicant being a foreigner, local, individual, private or public company.

6.2 Dossier Content

Medicine and Therapeutic Goods Division, Maldives Food and Dru1 Authority I Authorized by: Director General, MFDA Doc. No: MTG/RE-MD/GLN-TE 005 Doc. Name: Guideline for Reslstratlon of Alternative and Traditional Medicines

Issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy letter: MTG/Re 04.03.2020 Pharmaceuticals Director General, GLN003

Revision No: - Revised Date: - Verified by: Technical Pharmaceuticals Page No:Page 5 of 13 Committee of MTG

6.2.1 The application form/Dossier shall include the following information and documentation.

6.2.1.1 Applicant information:

a. Name and Address of Applicant, contact no., Fax no., email

b. Letter of appointment of applicant signed and stamped as the authorized representative of

the medicinal product in the Maldives.

6.2.1.2 Alternative/ Herbal Medicine product information: This includes the following

detailed information of the product for which the dossier is submitted for registration.

a. Brand name: Brand name is the name of the product submitted for registration.

b. Quantitative particulars of all the constituents of the medicinal product.

i. Active Ingredient: chemical or scientific name of the constituents, source of

ingredients.

ii. Non active ingredient: components other than the active ingredient used in the

production of the product

c. Primary use and therapeutic indications

d. Dosage form: physical form of the product (tablet, syrup, injection, etc.)

e. Route of administration: the route in which the medicine is to be administered

f. Contraindications and adverse reactions

g. Shelf life: period from date of manufacture to expiry date

h. Reasons for any precautionary and safety measures to be taken for the storage of the

medicinal product

i. Statement indicating whether the herbal medicinal product should be available for

prescription only, from pharmacy or on general sale: how medicine is sold.

j . Storage conditions: the condition in which the product shall be stored and kept

k. Proposed Dispensing category (Example: Over the Counter, Prescription Only Medicine,

etc.)

6.2.1.3 Manufacturer of the product: This shall include the information of the manufacturer

responsible to manufacture the product.

a. Manufacture's name, address, phone, fax, e-mail address

Medicine and Therapeutic Goods Division, Maldives Food and Dru1 Authority I Authorized by: Director General, MFDA Doc. No: MTG/RE-MD/GLN-TE 005 Doc. Name: Guideline for Re1lstratlon of Alternative and Traditional Medicines

Issue No. 01 Issue Date: Prepared by Director, Approved by. Deputy Copy Letter: MTG/ Re 04 03.2020 Pharmaceutocals Director General, GLN 003

Revision No· - Revised Date: · Verified by Technical Pharmaceuticals Page No Page 6 of 13 Committee of MTG

6.2.1.4 Brief Description of manufacturing steps: It includes all the steps used in manufacturing the

specific product.

6.2.1.5 Other documents

a. Manufacturing license issued by the relevant authority. The license shall have a minimum

period of 6 months validity from the date of submission. The license shall contain the following

information:

• Manufacturing company's Address and manufacturing site

• license Issuing Authority's details

• Issue and expiry date of the license (If expiry date is not specified, a

documentation providing the details should be submitted)

b. WHO-type Good Manufacturing Practice Certificate (GMP). This GMP certificate should have

a validity period of 6 months at the time of submission. The certificate submitted shall be a

certificate for the manufacturing site of the product of the Manufacturing Company. The

certificate should contain the following details:

• Certificate number

• Company/Manufacturer's Name and Address (site)

• Range of production types

• Certificate issuing Authority's details with full address

c. Valid "Certificate of registration of product" issued by competent authority. The

certificate should have a validity of 06 months at the time of submission) and should include

the following details:

• Certificate number

• Brand Name and Active ingredient

• Manufacturing Company's manufacturing site

d. Product registration certificate (For alternative medicines manufactured in countries other

than the Maldives) by a Competent Authority mentioned below or proof of import (invoice) to

a country mentioned below, other than the country of manufacture should be applied.

• Singapore

• Thailand

• Malaysia

Medicine and Therapeutic Goods Division, Maldives Food and Drug Authority I Authorl1ed by: Director General, MFDA Doc. No: MTG/RE·MD/GLN·TE 005 Doc. Name: Guideline for Registration of Alternative and Tradltlonal Medicines

Issue No. 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy letter: MTG/Re 04.03.2020 Pharmaceuticals Director General, GLN 003

Revision No: • Revised Date: • Verified by: Technical Pharmaceuticals Page No:Page 7 of 13

Committee of MTG

• India

• Srilanka

• China

e. Product Analysis certificate: refers to permissible limit of heavy metals in Ayurveda, Siddha

and Unani medicines with only herbal ingredients (Annex 1).

f. Evidence of traditional use of Dhivehi beys or evidence to support indications and safety (for

Traditional Maldivian medicines) (Refer to Annex 02). A medicine is considered a traditional

medicine in the Maldives if it has been used for 30 years in the Maldives. The active

ingredients, indications for use, strength and dosage, dosage form, and route of administration

shall have been unchanged during this period. If the amount of an ingredient has been reduced

overtime, the safety of the product after the change shall be proved with evidence from books,

statements from practitioners, or experts in the field. To prove a medicine is indeed a

traditional medicine, strong evidence from reference books or traditional medicine experts'

statements will suffice. However, if the practitioners are not very experienced or new to the

field, additional evidence shall be provided to support the claim that the medicine is a

traditional medicine. The practitioners shall be registered as Health Professionals at the

Ministry of Health. Evidence of traditional use can also include proof of sale of the product for

thirty years.

If the medicines are new products manufactured in the Maldives, with changes to ingredients

or composition of traditional medicines, or if you are unable to provide evidence of traditional

use, then the safety of the medicine has to be assured. In such cases, the rationale for

ingredients, effects of the active ingredients against its indication for use, identification of

active ingredients and excipients shall be provided along with the application form and dossier.

Applicants shall prove evidence of safety for traditional medicines that may show adverse

reactions or side effects. The benefits of the medicines shall outweigh the adverse effects. The

effects of the use of medicine shall be based on the indications for use, reports from doctors,

experience of traditional/ alternative medicine practitioners, and patient reports or feedback.

g. Sample, label, and insert information: Sample product submitted with the dossier shall

contain:

• Shelf life (production date and expiry date)

Medicine and Therapeutk Goods Division, Maldives Food and Drue Authority I Authorized by: Director General, M FDA Doc. No: MTG/RE-MD/GLN-TE 005 Doc. Name: Guideline for Registration of Alternative and Traditional Medicines Issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy Letter: MTG/Re

04.03.2020 Pharmaceuticals Director General, GLN 003 Revision No : - Revised Date: - Verified by: Technical Pharmaceuticals Page No:Page 8 of 13

Committee of MTG

• Storage condition of the finished product in detail

• Label shall be written in English or Dhivehi. The label shall be printed with an

ink that does not fade easily and shall be written in a typeface/font that is easy

to read . The label shall have the following information.

o Name of the product

o Ingredients and composition

o Date of manufacture

o Expiry date

o Indications for use

o Directions for use, and dosage

o Lot number or batch number

o Special precautions, side effects, or potential adverse reactions.

o Name and address of the manufacturer

o Storage conditions

• Copies of sample medicines should be attached with the dossier (including

packaged details)

h. Samples of the product (original sample) shall be submitted as follows and this sample is non-

returnable to the applicant:

•

•

•

Samples of finished product submitted for registration shall be taken at

random from an actual product batch

Samples submitted must be intact and it must be in final commercial pack

with original labels and package inserts.

Product sample size may vary depending on the type of packaging used .

o If the product is a tablet formulation or capsule, 60 tablets/capsules shall

be submitted with the dossier

o If the product is a syrup or any liquid oral preparation, 3 bottles shall be

submitted

o If the products are Injections, 3 vials or ampoules shall be submitted.

o If the product is a cream or lotion, 3 tubes or packs shall be submitted.

• Product samples submitted must have a remaining shelf-life of at least half of

Medicine and Therapeutic Goods Division, Maldives Food and Drug Authority I Authomed by: Director General, MFDA Doc. No: MTG/RE-MD/GLN-TE 005 Doc. Name: Guideline for Registration of Alternative and Traditional Medicines

Issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy letter: MTG/Re 04.03.2020 Pharmaceutteals Director General, GLN003

Rev1s1on No: - Revised Date: - Verified by: Technical Pharmaceutlcals Page No:Page 9 of 13 Committee of MTG

its shelf-life.

• If the product is without an out carton, the inner label should bare all the

information that is required.

• The color of the labels should be differentiated between strengths of products.

The label must be made from good quality material.

i. Product leaflet or insert shall be submitted and it shall be in English or Dhivehi language.

6.2.1.6 Price of the Product: Proposed Retail Price in the Maldives market in USO and MVR

6.3 What if you have to import a sample of alternative medicine?

6.3.1 Samples of medicines shall be submitted for product registration. An approval for import of

medicine sample will be required for health clearance at the ports of entry.

6.3.2 The request for approval to import medicine samples for registration shall be submitted in

the form of a letter.

6.3.3 The request 11etter shall contain the following information:

• • • • • •

The Brand name of the product

The Generic name of the product

Dosage form

Strength and volume

Manufacturer details with country of origin

Quantity to be imported

6.3.4 If the required information is complete, approval to import the medicine sample will be issued

within 3 ((three) working days.

6.3.5 The medicine samples imported for this approval shall be submitted to MFDA with the

application form or dossier for product registration.

7 Dossier Evaluation

7.1.1 Once a dossier is submitted to MFDA, required documentation check is done and incomplete

dossiers will be rejected, and complete dossiers will be accepted. The applicant/customer will be

Medklne and Therapeutk Goods Division, Maldives Food and Drug Authority J Authorized by: Director General, MFOA

Doc. No: MTG/RE-MD/GLN-TE 005 Doc Name: Guideline for Re&istration of Alternative and Traditional Medicines

issue No: 01 Issue Date: Prepared by: Director, Approved by: Deputy Copy letter: MTG/Re 04.03.2020 Pharmaceuticals Director General, GLN 003

Revision No: • Revised Date: • Verified by: Technical Pharmaceuticals Page No:Page 10 of

Committee of MTG 13

given a written notice of acceptance or rejection within 03 days.

7.1.2 Accepted dossiers will be evaluated for:

• Alerts, recalls,

• Validity of certificates and documents

• Safety against reference standards

7.1.3 Dossiers will be evaluated within 90 (ninety) working days and evaluations are done in the order

of submission.

7.1.4 If any issues are identified, the applicant will be informed in writing to resubmit the dossier with

the required amendments. Samples submitted along with the dossier are not returned. Samples

will be discarded within 3 (three) months if the dossier is not re-submitted.

7.1.5 Once a product is approved to be registered, "Certificate of Registration of a alternative/ herbal

medicine" (MTG/RE-2018/AP-HE) is issued to the applicant within 15 (fifteen) working days from

the date of approval. Following this, the products are uploaded to the Approved Alternative/

Herbal medicine List (MTG/RE-AH/Li 0018).

7.2 Certification of registration:

7.2.1 The registration of the product is valid for a period of 5 years and within this period the product

can be imported, sold and produced in the Maldives.

7.2.2 All registered products can be marketed as per the duration of the validity of the registration

certificate, which is for 5 years.

8 Re-registration:

8.1.1 An application for re-registration shall be filed at the expiry of the period. Any product not re-

registered will be deleted from the Approved Alternative/ Herbal medicine List (MTG/RE-AH/Li

0018).

8.1.2 In case of re-registration application by a local agent other than the previously registered agent,

Medicine and Therapeutic Goods Division, Maldives Food and Dru1 Authority I Authorized by: Director General, MFOA Doc. No: MTG/RE-MD/GLN·TE 00S Doc. Name: Guideline for lte&lstratlon of Alternative and Tradltlonal Medicines

Issue No: 01 Issue Date: Prepared by: o,reetor, Approved by· Deputy Copy Letter: MTG/Re

04.03.2020 Pharmaceuticals Director General. GLN003

Rl'voslon No: - Revised Date· - Venfled by: Technical Pharmaceuticals Page No:Page 11 of

Committee of MTG 13

priority should be given to the previously registered local agent.

8.1.3 For re-registration of an authorized product, the following documentation should be submitted

with the Dossier.

• Good Manufacturing Practice certificate

• Certificate of registration product/ proof of exporting

• Certificate of analysis

• Product Sample

8.1.4 If documentation is incomplete, the re-registration application will be rejected, and the

applicant will be informed in writing.

8.1.5 If all documentation is complete and compliant, the dossier evaluation shall be done within 60

(sixty) working days from the date of submission.

9 Approved Alternative/ Herbal Drug List

9.1.1 Approved Alternative/ Herbal medicine List (MTG/RE-AH/Li 0018) is the list of medicines

authorized to be imported, distributed, produced, and sold in the Maldives.

9.1.2 Approved Alternative/ Herbal medicine List (MTG/RE-AH/Li 0018) is updated monthly, uploaded

to Ministry of Health and MFDA website and an announcement of the upload will be published

in the gazette. Products are included in the list by registration through submission of full dossier.

9.1.3 The products in the list are divided into 2 categories.

• Alternative Medicine

• Traditional (Dhivehi beys)

10 Changes to particulars of products authorized with full dossier submission

10.1.1 Changes to a registered product shall be informed to MFDA.

10.1.2 If any change to a registered product is submitted in writing by the local agent to MFDA, the

following documentation shall be verified for these requests;

Medicine and Therapeutic Goods Division, Maldives Food and Drug Authority I Authorized by· Director General, M FOA Doc. No: M TG/ RE-MD/ GLN-TE 005 Doc. Name: Guideline for Registration of Alternative and Tradition.ii Medltines

Issue No: 01 Issue Date: Prepared by: Director. Approved by : Deputy Copy letter: MTG/Re

04.03.2020 Pharmaceuticals Director General, GlN 003

Revision No: • Revis~ Date: - Verllled by· Technical Pharmaceuticals Page No·Page 12 of Committee of MTG 13

• Certificate of registration of product

• Product Sample

• In case of registered manufacturer change, all relevant documentation on this regard.

• G.M .P certificate.

• Company Profile

• Manufacturing License

11 Post-market surveillance

11.1.1 For products authorized with submission of full dossier, post market surveillance of products will

be done each month according to the post-market surveillance plan.

11.1.2 In addition, for traditional medicines, Adverse Drug Reactions (ADR) monitoring will be done for

one year. Once a new product is registered, the applicant will be provided with the form for

monitoring the ADR for re-registration or renewal of traditional medicines.

12 Annex

• Annex 01: permissible limit of heavy metals in Ayurveda, siddha and unani medicines with only herbal ingredients

• Annex 02: Evidence of traditional use of Dhivehi beys or evidence to support indications and safety

13 Reference documents:

• Medicine Regulation 2014/R-46

• Guideline for Quality Defects and Product Recall

• Guideline for Pharmacovigilance and ADR reporting

Medklne and Therapeutic Goods Division, Maldives Food and Drug Authority I Authorized by: Director General, MF0A Doc. No. MTG/ RE-MD/GLN-TE 005 Doc. Name. Guideline for Rqlstratlon of Alternative and Traditional Medicines

Issue No: 01 Issue Date· Prepared by: Director. Approved by. Deputy Copy Letter: MTG/Re 04.03.2020 Pharmaceuticals Director General, GLN003

Revision No Revised Date • Verified by· Technical Pharmaceutlcals Page No:Page 13 of Committee of MlG 13

THE DRUGS AND COSMETICS ACT, 1940 AND RULES, 1945

Permissible Limit of Heavy Metals in Ayurveda, Slddha and Unani Medicines with Only Herbal Ingredients

I if.ilt@ -1.Lead {pb) 10 ppm 2. Cadmium ( Cd) 0.30 ppm

3. Arsenic (As) 10 ppm 4. Mercury {Hg) 1 ppm

• THESE ITEMS SHOULD NOT BE INCLUDED IN THE HERBAL PREPARATIONS.

TOXIC HEAVY METALS / TOXI ELEMNTS

a) Minerals

Actinolite

Alum

Arsenic Sulphide

Cinnabar

Lead Oxide

Mercurous Chloride

Pumice

Pyrite

Actinolitum

Alum Potash

Realgar

Mercuric Sulphide

lithargyrum

Calomelas

Pumice Stone

Pyitum

iMif&fu Yang Qi Shi

Ming Fan

Xiong Huang

Zhu Sha

Mi TouSeng

Qing Fen

Fu Hai Shi

Zi Ran Tong

Iii]

b) Red Lead Oxide

Simthsonit e

Sodium Sulphste

Sodium Tetraborate

c) Animal

Allolobaphora Caliginosa

Amyda Sinensis

Bombyx Mori

Bubalus Bubalis

Callorhinus Ursinus Penis Otoriae

Elphe Carinata Periostracum Serpentis

Endothelium Corneum Gigeriae Galli

Gekko Gecko

Hippocampus Kellogi

Plecenta Hominus

Smithsonitum

Mirabilatum

Borax

Trap Lumbricus Dried Earth Worm

Carapax Amyd Tortoise Shell

Silk Worm Feaces

Corn Bubali Buffalo Horn Shavings

Testicles And Penis Of Bear

Dried Epidermal Memebrane Of Snake

Chicken Gizzard Skins

Dried Body Of Geko

Hippocampus

Human Placenta

Lu Gan Shi

Mang Xiao

Peng Sha

Di Long

Bei Jia

Can She

Shu lniu Jiao

Hai Gou Shen

She Tui

Ji Nei Jin

GeJie

Hai Ma

Zi He Che

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MFDA/MTG-DBR/IF-001

maldives food and drug authority guideline for registration...

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