-
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
Maldives Food and Drug Authority
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
Maldives Food and Drug Authority
Authorised by: ThoomaAdam
Deputy Director General, Laboratory Services
Maldives Food and Drug Authority
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
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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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