Listed Health Products Regulatory Guidelines 

 

Version1 

2  

 

 

 

 

 

Listed Health Products Regulatory Guidelines 

 

Version 1  

 

 

     

Drug Sector 

Saudi Food & Drug Authority 

Kingdom of Saudi Arabia 

 

 

 Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug

for the latest update 

 

3  

Document Control 

 

Version  Date Author(s) Comments 

1.0  23/05/2012  Products Classification Committee Final 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4  

Table of Contents  

Introductuion………………………………………………………………………………..5  Scope……………………………………………………………………………………………5  Objective………………………………………………………………………………………5  General Criteria for Listed Health Products……………………………………6  Listing Process……………………………………………………………………………..7  Regulatory Requirements……………………………………………………………..8  List of crude Medicinal plants that can be used in listed products.....11  Health Product Listing Application Form…………………………………..…18  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5  

 

 

 

• Introduction: 

Most of the products can be easily classified Into drug, medical device, cosmetic or food supplement and subsequently  identifying which regulation these products should follow to get the marketing authorization. However, there are still many products which fall in the grey area or borderlines between these categories which makes it difficult to identify which marketing authorization scheme these products should follow. Therefore, the  SFDA  has  developed  this  document,  "Regulatory  Guidelines  For  Health  Products Subject for Listing" , to set regulations for this category of products. This is a simplified listing  scheme. Products are  required  to meet  specific  standards of  safety and quality and  be  accompanied  by  acceptable  indications  and  systematic  patient  information allowing the safe use of the product.  

 

• Scope: 

This guidelines explain  the  regulatory  requirements  for health products subject  for  listing  to  be  marketed  in  Saudi  Arabia.  The  classification  of  the products  as Health  product  subject  for  Listing  is  determined  by  The  Products Classification Committee. Listed health products should be  renewed every Five years. 

• Objective: 

The objective of this guidelines is to set regulations for this category of products to ensure their safety and quality. The efficacy of these products will not be evaluated. 

 

 

 

 

 

 

6  

General Criteria for Listed Health Products: 

To classify a product as health product subject for  listing,  it must meet one or more of the following criteria and/or type of products: 

• Products    not  in  a  pharmaceutical  dosage  form  containing  raw  herbal  substance (listed in table 1) e.g.: bags of senna leaf and ginseng root. 

• Products  not  in  a  pharmaceutical  dosage  form  containing  extract  of  raw  herbal substance (listed in table 1)  (not isolate of a herbal substance) known to provide to provide nutritional support  e.g. Ginseng, Royal Gelly, Propilis: table 1. 

     

o Herbal teas: consist exclusively of one or more herbal substance(s)

(listed in table 1) intended for oral aqueous preparations by means of decoction, infusion or maceration. The preparation is prepared immediately before use. Herbal teas are usually supplied in bulk form or in sachets.

o Herbal oil consist exclusively of one or more herbal substance(s) (listed in table 1) dissolved in water with no medicinal claim. 

• Medicated  throat  lozenges which  consist only of  volatile oils,  ascorbic  acid  (or  its 

salts)  and/or  menthol  with  no  unacceptable  claim.  The  concentration  of  the individual  ingredients  (menthol, eucalyptus oil and Ascorbic acid) must not exceed the maximum value as follows: 

o Menthol 1 ‐ 20 mg  o  Eucalyptus oil 0.2 ‐ 15 mg. o Ascorbic acid: 100 mg 

• Topical products containing organic acids (Alpha‐hydroxy acids (AHAs))  in total 

concentration of organic acids more than 10% . 

• Alcohol hand sanitizers.  

• Topical patches, creams, ointments and gels containing counter irritant ingredient as an externally  applied  substance  that  causes  irritation or mild  inflammation of  the skin for the temporary relieve of pain in muscles or joints by reducing inflammation in  deeper  adjacent  structures  (these  products  should  comply  with  the Counterirritant monograph). 

• Energy drinks products. 

N.B.: All extracts or isolated active substance(s) of herbal substance(s) in a pharmaceutical dosage form like capsules, pills, tablets and syrup are subject for registration as Herbal Product. 

7  

• Powder  products  to  provide  nutritional  support  to  athletes  and  persons  who exercise (“powder sports supplements”). 

• Medicated Skin Care Products containing urea  in a concentration greater  than  the concentration recommended by the GSO standards for cosmetic products. 

• Must not be an isolate of a medicinal herbal substance.  

• Must NOT be a type of product that needs to be sterile, such as eye drops. 

• Must NOT be in a pharmaceutical dosage form like capsules, pills, tablets and syrup. 

• Must  contain  only  permitted  excipient  including  coloring,  flavoring  and  fragrance ingredients 

• Must comply with the labelling requirements of listed products. 

• have not indication(s) inappropriate for Listed products.   

  

 

      

• Listing Process: 1. The applicant will submit his application along with the required documents. 2. The  herbal  and  health  products  licensing  department  will  review  the 

application for validity. 3. If  the  application  is  valid,  forward  the  application  to  the  Health  Products 

Listing  committee  for  their  recommendations.  Otherwise,  return  the application to the applicant with the deficiencies. 

4. If the Health Products Listing committee approved the product to be  listed, the applicant will be asked to pay the listing fee. 

5. Once the applicant paid the fee, the listing staff will enter the product in the database  and  issue  the  listing  certificate  with  labeling  information recommended by the committee. 

6. If the Health Products Listing committee did not approve the product to be listed, notify the company about the committee decision with justification.  

N.B.:  Listed products are low‐risk products. Therefore, they may not refer to serious forms of disease, disorders or conditions and, generally, must not  indicate  that  they  are  for  treatment,  cure,  management  or prevention of disease, disorders or conditions. However, sponsors of such  products  are  required  to  hold  evidence  to  support  the  claims made  for    their product and  to make  such evidence available  to  the SFDA if requested. 

8  

Listing Regulatory Requirements: 

Part 1 Administrative Information

1.1 Register the establishment in drug establishment national registry(DENR) 1.2 Cover letter

1.3 Application Form

1.4 Prove of paymet for Listing service fees (5000 SR for each product)

1.5 Product Information

1.3.1 Labeling or Artwork (Outer Package) should involve the following information:

1.5.1.1 Product name in Arabic and English.

1.5.1.2 Contents

1.5.1.3 Directions

1.5.1.4 Special warning and precautions

1.5.1.5 Manufacturing and expiry dates: Dates should be expressed with the month given as 2 digits or 3 characters and the year as 4 digits. e.g.: 02/2010, Feb 2010. Where applicable, the shelf life after reconstitution, dilution or after first opening the container should be included.

1.5.1.6 Storage conditions

1.5.1.7 Name and Address of the importing company

1.5.1.8 Batch No.

1.6 Sample

1.7 Certificates & Licenses

1.7.1 Free-sales Legalized from Saudi Embassy

1.7.2 Certificate of analysis – Finished Product Legalized from the Company if applicable.

1.7.3 Warehouse license issued from Ministry of Municipality.

1.7.4 Manufacture License issued from Ministry of Municipality (for Locally manufactured products

1.7.5 Manufacture license in the country of origin, Hazard Analysis & Critical Control Points (HACCP), Good manufacturing practice (GMP) .

1.7.6 Product classification letter stating that this products has been classified as health products subject for listing (if available).

9  

1.8 Declaration

1.8.1 Alcohol-free declaration

1.8.2 TSE-free declaration: For excipients obtained from sources that are at risk of transmitting Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE) agents (e.g., ruminant origin), a letter of attestation (with supporting documentation) should be provided confirming that the material is not from a BSE/TSE affected country/area.

1.8.3 Pork-free declaration

Part 2 Technical Information

2.1 Finished Product

2.1.1 Manufacture of the Finished Product:

2.1.1.1 Manufacturer(s)

2.1.1.2 Detailed Product Content

2.1.2 Microbiological Attributes

2.1.3 Finished product specifications sheet such as (Appearance, Identification, pH, Volume, ingredients assay, Preservative(S), Microbial limits…etc).

2.1.4 A letter of commitment from the manufacturer that the product is stable during the suggested shelf life. The shelf life for solid dosage form must not exceed two years unless justified.

2.1.5 Analytical procedure file (method of Analysis) should involve the following information: 1. Full Composition for active and inactive ingredients containing their

quantity and percentage in the finished product 2. Specification certificate includes Physical , Chemical and Microbial

(Upper and lower limit for physical and chemical , upper limit for microbial in the finished product )

3. Certificate of analysis for the product that covers item )٢( 4. Detailed Method of analysis for determination and detection of the

active and non-active ingredients in the final product . 5. the working Standards/or raw materials which the analytical method

demands 6. the copy from the chromatograms for sample & standard if the

analysis by chromatography

10  

6.1.1 Hard and soft –copy of the product file(CD/DVD) This guidance document may be reevaluated from time to time based on future regulatory or policy amendments.  

DEFINITIONS 

Herbal medicinal products: any medicinal product, exclusively containing as active substances one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. Herbal preparations: are obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates. Herbal substances: all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author). Herbal teas: consist exclusively of one or more herbal substance(s) intended for oral aqueous preparations by means of decoction, infusion or maceration. The preparation is prepared immediately before use. Herbal teas are usually supplied in bulk form or in sachets.  

Table 1: list of crude Medicineal plants that can be used in listed products  

- NOTE: this list is intended as a guide and is not necessarily all inclusive 

S.N. PLANT NAME COMMON NAME ARABIC NAME

Medicinal use

Food use

PARTS USED COMMENTS

1. Aesculus hippocastanum

Common horse chestnut

قسطل الحصان، آستناء الحصان

أو الخيلyes No Seed Raw seeds should not be used

2. Aloe ferox Cape aloes الصبر اآلسيوي yes no Gum Use only medicinally

3. Aloe vera Aloe Capensis الصبار yes yes latix Not to be confused with Aloe ferox

4. Althaea officinalis Marshmallow الخطمي ,الخبيزة المخزنية yes yes Leaf and

root

5. Ammi visnaga Bisnaga, Khella الخله yes no Ripe fruit

6. Angelica sinensis Chinese angelica, Danggui حشيشة المالك yes yes root Safe for short period

7. Arctostaphylos uva-ursi Bearberry عنب الدب yes yes Leaf

Fresh blossom & berries are reported to be eaten as foods.

Safe for short period

8. Aspalathus linearis

Red tea, Rooibosch tea المرامية yes yes Leaf, Stem

More food than medicine. Used as a tea (low tannin & caffeine

free)

9. Asparagus officinalis Common asparagus الهليون yes yes Rhizome,

root & shoot Fresh shoots used as food.

10. Astragalus membranaceus

Astragalus, Huangqi Membranaceus milk

vetch yes yes Root األستراجالس

11. Atractylodes macrocephala

Bai zhu, Baizhu, Largehead

atractylodes yes no Rhizome Safe for 7 weeks

12. Azadirachta indica Indian Neem النيم yes yes All parts of

plant Safe for 10 weeks

12  

13. Bacopa monnieri Water hyssop وطواط yes yes Leaf Safe up to 12 weeks

14. Ballota nigra Black hempnettle فراسيون أسود yes yes Aerial parts White horehound used as tea, in sweets and liqueurs

15. Betula alba Silver birch بتوال بيضاء , yes yes Leaf شجرة الثامول

16.

17. Boswellia carterii Frankincense آندر, لبان ذآر yes yes stem bark resin

18. Calamintha ascendens ريحان, قلمنت yes no Aerial parts A flavoured tisane can be made

from the leaves

19. Calendula officinalis

Calendula, Garden marigold

, أقحوان أصفر yes yes آحلة

Flower (dried or as source

of lutein)

Marigold flowers are used in the food industry as a

flavouring and colouring.

20. Calluna vulgaris Common heather سميسم yes yes Aerial parts Blossom used as an ingredient in teas.

21. Capsella bursapastoris Shepherd's purse آيس الراعي ,

yes yes Aerial parts قرملةThere are reported culinary

uses for the fresh leaves and seeds.

22. Frangula purshiana California buckthorn القشرة المقدسة yes no Dried bark Use for 1-2 weeks

23. Cassia angustifolia Fanxieye السنامكي yes no Leaf and fruit Use for 2 weeks only

24. Castanea sativa Spanish chestnut الكستناء yes yes Leaf Nut is used for food 25. Cedrus atlantica Atlas cedar األرز األطلسي yes no Oil Topical use only

26. Centaurium erythraea

Centaury, Small centaury القنطريون yes yes Aerial parts Can be used in 'bitters'

27. Centella asiatica Asiatic pennywort,

Centella Gotu kola, Jixuecao

قصعة الماء سرة , الهندية

البحر الهنديةyes yes Aerial parts Cause liver damage in certain

people

28. Cetraria islandica Iceland moss خرز الصخور yes yes Algae & fungus Use for short period

29. Chamaelirium luteum False unicorn root جذور

اليونيكورن yes no Rhizome, Root

13  

الكاذبة30. Chelone glabra Balmony yes no Aerial parts

31. Chimaphila umbellata

Bitter wintergreen, Ground ivy Pipsissewa, Pipsissiwa

yes yes Aerial parts Use for short period اللبالب

32. Chondrus crispus Carrageen األشنة االيرلندية yes yes Red algae or seaweeds

Use as a stabilizer E407 in the food and pharmaceutical

industry

33. Cichorium intybus Chicory الهندباء البرية yes yes Aerial parts & root

Fresh leaves have common use as a vegetable. Also used

in coffee

34. Cimicifuga racemosa Black cohosh

الكوهوش األقنتى , األسود

العنقوديةyes no Root &

Rhizome Large doses may cause

abortion

35. Cinnamomum camphora

Camphor laurel, Camphor tree الكافور yes yes Bark & wood

Careful classification is required with Cinnamomum species, do not confuse C.

Cassia with C. Zeylanicum from which cinnamon is produced.

Topical use only 36. Cistus ladanifer Labdanum yes no Aerial parts

37. Cnicus benedictus Blessed thistle

, الشوك المباركالقنطريون العنبري

yes no Flower top, leaf, upper stem & oil

Large doses strongly emetic

38. Cola acuminata Cola القيرو, الكوال yes yes Seed & leaf

39. Commiphora opobalsamum البشام yes no oleo-gum

resin

40. Commiphora molmol Myrrh مرة, المر yes yes oleo-gum

resin

41. Echinacea angustifolia

Echinacea, Black sampson

Coneflower & yes yes Root حشيشة القنفذ

Rhizome

14  

42. Echinacea pallida Echinacea, Purple cone flower --- yes yes Root &

Rhizome

43. Echinacea purpurea Echinacea --- yes yes Root &

Rhizome

44. Eclipta prostrata Mohanlian, Stinking

mayweed Yerbadetajo

yes no Whole plant

45. Eleutherococcus senticosus Ciwujia الجنسنج

yes yes Root السيبيري

46. Eucalyptus citriodora Lemon scented gum الكافور الليموني yes no Leaf, Oil Topical use for short period

47. Eucalyptus globulus

Anyou, Eucalyptus oil, Globulus,

Tasmanian blue gum yes no Leaf, Oil Large doses are toxic, may الكافور

cause hysteria & palpitation

48. Euphrasia officinalis Eyebright حشيشة الرمد yes no Whole plant

49. Ferula assa-foetida Asafetida الحلتيت yes yes Gum resin Use in minute quantities as a

food flavouring

50. Filipendula ulmaria Dropwort اآليلة المروج ,

yes no Aerial parts ملكة المروج

51. Fraxinus ornus Flowering ash, Manna ash المن yes yes Sap Use for short period, may

cause flatulence

52. Fumaria officinalis Fumitory بقلة الملك yes no Aerial parts Use for short period

53. Galium aparine Cleavers البلسكاء yes yes Aerial parts Roasted seeds used as coffee substitute

54. Ganoderma lucidum Reiishi mushroom فطر ريشي yes yes fruiting body

& mycellum Often supplied in powder form

55. Gaultheria procumbens Wintergreen

الغلطيرة شاي (المسطحة )آندا

yes yes Leaf, oil

56. Gelidium amansii Agar, Red algae yes yes Thallus 57. Ginkgo biloba Baiguo, Ginkgo الجنكة yes yes leaf, seed

15  

58. Glechoma hederacea Ground ivy اللبالب األرضي yes yes Whole plant Can have food uses as a

flavouring

59. Glycyrrhiza glabra Liquorice Root عرق السوس yes yes Root

Large doses may cause sodium retention and

potassium loss

60. Gossypium herbaceum Cotton plant القطن yes no Root bark No part of the plant should be

used internally

61. Guaiacum officinale Guaiac yes no Wood, resin

62. Gymnema sylvestre Gymnema yes no Leaf

63. Hamamelis virginiana Hamamelis

الهماميليس المشترآة (

)االفرنجية yes no leaf, Bark

64. Harpagophytum procumbens Devil's claw مخلب الشيطان yes no Tuber

65. Hedera helix Common ivy اللبالب المتسلق yes no Leaf Many different species used, usually Hedera helix

66. Helianthus annuus Sunflower دوار الشمس yes yes Flower, Leaf,

(seed)

67. Hieracium pilosella  hawkweed/Mouse ear 

أذن حشيشة /الفأر الغراب

yes  yes  Whole plant  An effective gargle

68.

Humulus lupulus  hops   yes حشيشة الدينار yes 

Strobiles (dried, female flowering part 

) 

69. Hydrangea arborescens 

Wild hydrangea  yes  no  Root, rhizome  Use for short period

70. Hydrastis canadensis 

Golden seal   yes خاتم الذهب no Rhizome & 

Rootshort-term use

71. Hypericum  St.John's wort   yes حشيشة القلب yes  Whole plant  Use for up to 8 weeks

16  

perforatum 

72. Hyssopus officinalis  hyssop   yes ُزوفا yes  Aerial parts  Leaves have culinary use as a flavouring

73. Ilex paraguariensis  mate   yes المته yes  Leaf  Use for short period

74. Impatiens balsamina 

Garden balsam/ Jixingzi 

 yes البلسم yes  Aerial parts  Other species of Impatiens are also used medicinally

75. Inula helenium  Elecampane   yes الراسن yes  Root, rhizome 

Some use in perfumery and as a flavouring. Roots can be candied. Banned by IFRA.

76. Juniperus commuis  Juniper yes  yes  Berry  Not to be used in pregnancies

77. Lavandula officinalis 

lavender   yes الخزامى no flower, leaf, 

and oil  

78. Ligusticum lucidum    yes  no  Fruit   79. Marrubium vulgare  horehound  زقومال yes  yes  Aerial parts  Flowers used as a flavouring

80. Melaleuca alternifolia 

tea tree   yes شجرة الشاي no  Leaf and oil 

81. Melilotus officinalis 

melilot/yellow sweet clover 

 yes إآليل الملك yes flowering branch and 

leaf 

It is reported that the dried herb can be used as a flavouring

82. Menyanthes trifoliata 

bog bean   yes أطريفل الماء yes  Leaf  Reportedly used as a flavouring in beer

83. Mitchella repens  Squaw vine عنب الهنود  yes الحمر no  Aerial parts 

84.

Mucuna pruriens  Cowhage/Mucuna  yes  no  bean or seed 

The bean pod hairs are strong irritants and can cause severe

itching, burning, and inflammation

85. Myristica fragrans  Mace   yes جوزة الطيب yes  oil  Restriction should be considered

86. Myroxylon balsamum 

tolu   yes بلسم البيرو no Resin balsam from trunk 

Use in aromatherapy restricted by IFRA

87. Nasturtium  watercress  yes  yes  Aerial Parts 

17  

officinale 

88. Nelumbo nucifera  Lotus   yes جذور اللوتس yes Flower, 

bean/seed 

89. Nepeta cataria  catmint   yes حشيشة الهر yes 

flowering tops 

Young leaves may reportedly be used for a tea and as

flavourings in sauces & stews

90.

Ocimum tenuiflorum 

Sacred basil   yes الباسل الحلو  The leaf, stem, seed and oil 

safe for 4 weeks.

91. Oenothera biennis  evening primose 

زهرة الربيع  yes المسائية yes  Leaf and Stem 

Oil is used in many food supplements and cosmetic

products 92. Ononis spinosa  Spiny rest‐harrow   yes الشبرق الفريش no  Root 

93. Origanum majorana 

majoram   yes المرقدوش yes flower, leaf and oil 

94. Origanum vulgare  Wild majoram  المرقدوش yes البري yes  leaf, Oil 

95. Paeonia lactiflora  peony   yes القبرية no  Root  Many different species used medicinally. short term use

96. Panax ginseng  Asian gensing   yes الجنسج   Root 

97. Parietaria diffusa  Pellitory‐of‐thewall 

سان ل/حريقة حشيش /الطير

الريحyes  no  Aerial parts  Can cause allergic rhinitis

98.

Passiflora incarnata 

passion flower زهرة االالم  yes الحمراء yes 

Aerial parts and flower 

The fruit of some species of Passion Flower is eaten as a

food. The usual medicinal plant is Passiflora incarnata

99. Peumus boldus  boldu   yes البولدو no  Leaf and Bark  Banned by IFRA, large doses cause vomiting

100. Picrasma excelsa  Quassia  yes  yes  Wood  Use for short period, large doses cause vomiting

101. Picrorhiza kurroa  picrorhiza  yes  no  Rhizome and 

18  

Root 

102. Pinus pinaster  Maritime pine الصنوبر  yes الساحلي yes  Bark 

103. Plantago ovata  isfagula   yes لسان الحمل yes the seed and seed husk 

104.Rhamnus catharticus 

Buckthorn   yes النبق   the berry  Safe for 10 days only

 

 

نموذج طلب إدراج مستحضر صحي

Health Product Listing Application

Form           

New Renewal

Listing No:

 

 

 

 

 

 

אא،אאאאאK

.

This form is used to request Listing a Health Product submitted to Saudi Food & Drug Authority (SFDA).

A separate application form is needed for each strength, flavor .

20  

1 Product information in the Country of Origin (COO)

1.1 Please provide the following information for the product:

Product information in the Country of Origin (COO):

Trade name:

Marketing Authorization holder:

o Name:

o Address :

Line 1:

Line 2:

Line 3:

Postal/Zip code:

City:

Country:

o Date of authorization (dd/mm/yyyy):

o Certifying Authority:

o Country:

21  

2 Marketing Authorization Application Details

2.1 Name(s): 2.1.1 Proposed trade name:

2.1.2 List the active substance(s) and the excipient(s):

Name of active substance(s)

Quantity

Unit

 

Name of excipient(s)

Quantity

Unit

22  

2.2 Product Information:

Manufacturer name:

Manufacturing site: City:

Country

Package Size:

Primary packaging Manufacturer:

Manufacturing site: City:

Country

2.3 Marketing Authorization Holder/Contact Person(s)/Company Details: 2.3.1 Proposed marketing authorization holder legally responsible for

placing the product on the market in KSA (Agent): Company Name:

Commercial Record Number:

Warehouse License number:

Address:

o Line 1:

o Line 2:

o Line 3

o Postal/Zip code:

o City:

Phone:

Fax:

E-Mail:

23  

2.3.2 Person authorized for communication in KSA on behalf of the applicant: Person Name:

o First name:

o Middle name:

o Family/last name:

Address:

o Line 1:

o Line 2:

o Line 3

o Postal/Zip code:

o City:

Phone:

Fax:

Mobile:

E-Mail:

2.4 Manufacturers: 2.4.1 Finished Product manufacturer:

Name of manufacturer Address1 Phone Fax Activity

                                                            1 Full address as Line 1, 2 & 3; Postal/Zip code, City & Country 

24  

2.4.1.1 For under-licensed manufactured product, do you have a manufacturing authorization from the marketing authorization holder?

Yes, specify: No

Not applicable

2.4.2 List and specify any material of animal source contained in any

component of the product, if applicable:

Material Animal Animal part Free from BSE/TSE

• Please note that any pork content has to be clearly specified. • It should be noted that all material used must be free from

BSE/TSE. If a certificate confirming that the product is free from BSE/TSE is available, it should be provided.

3 Status of the application in other regulatory agencies

Tick the appropriate box and fill the information.

Authorized

List all countries where the product is authorized for marketing:

Country Trade name

25  

Declaration:

I hereby certify that the submitted information is true and accurate and changes will not be made until they are approved by SFDA.

Company Director/CEO:

Signature:

Date: