Upload
truongmien
View
233
Download
3
Embed Size (px)
Citation preview
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