Islamic Republic of Iran
Ministry of Health and Medical Education
Food and Drug Organization
Title: Application form for registration of biological products
Type:
√
Finalized
Draft
No.:
Date of Issue
Document No.: 102-24-03
Name of Office: Biologic,Deputy for Drug
Application Form for Medicine Registration in Iran
Ministry of Health and Medical Education, Division of Pharmaceutical & Narcotic Affairs
Complete the form by typing legibly in the captions' language.
1. Drug name in Persian
2. Product Name (as on Label):
3-1 International nonspecific name of active ingredient in Persian:
4.1. INN Name (WHO format):
5.1. Strength:
6.1. Defined Daily Dose
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7.1. ATC code
8. Dosage form (Appendix 1):
9. Packing form (Appendix 2):
10. Route of Administration (Appendix 3):
11. Main Pharmacological Group:
12. Volume or Weight:
13. Barcode (EAN13):
14. Packaging (Full explanation):
15. License Holder (in Country of Origin):
16. Marketing Authorization Holder (in Country of Origin):
17. Manufacturing site(s) (Name and Address):
18. Packaging site(s) (Name and Address):
19. API producer:
20. Global registration
(Country/Organization):
Registered as (Medicine,
Natural/MD/…)
Date of registration
(yy/mm)
1.
2.
3.
21. Name of Reference Products (for Generic Drugs):
2
Patent Expiry date
(yy/mm)
22. International reference source:
Published Date
1.
2.
3.
23. Preference of drug form and active ingredient over other registered drugs in Iran with the same
active ingredient:
24. Consumer’s price for each drug unit in the following countries:
Spain
Dollars
Euros
Greece
Dollars
Euros
Turkey
Dollars
Euros
Manufacturing Country
Dollars
Euros
25. Consumer’s price for each drug unit with similar active ingredient, drug form and packaging in the
following countries:
Country
Specific name of generic Price- Euros
Specific name of
Price -Euros
product
original product
Spain
Greece
Turkey
Manufacturing
Country
26. Recommended sales price (in rials) by the license-holding company to pharmaceutical distributers:
27. Recommended consumer’s price (in rials) for each drug unit in Iran:
28. Durability period for the recommended consumer’s price (in rials) for each drug unit in Iran:
29. Date when the company is able to submit all documents completely:
30. Information and applicant company (license-holder in Iran)
31. Date of activity license:
32. Number of activity license:
33. Phone
34. Fax
35. Address
37. Full name of managing director
38. email of managing director
39. Full name of technical director
40. email of technical director
Confirmed by managing director (stamp and signature)
Confirmed by technical director (stamp and signature)
Guideline for completing drug registration questionnaire:
1) The drug name must be identical to that on packaging. There is no need to mention drug form, potency or
volume here. The name must be compatible with nomenclature rules expressed in regulations of registration and
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2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
20)
21)
22)
23)
24)
25)
is permissible after confirmation by committee of pharmaceutical nomenclature.
Act as in paragraph 1, in English.
International nonspecific name (INN) in accordance with nomenclature of the world health organization and, if
not available in that list, the nonspecific name available in American pharmacopeia (USAN) or England (BAN)
must be written in Persian. For drugs with more than one active ingredient, the table (items 3 through 7) must be
copied and completed for each substance separately. Those drugs are allowed for registration which molecule
and ATC are already confirmed by the council for study and preparation of drugs.
Act as in paragraph 4, in English.
Amount or concentration of the active ingredient in unit of drug form (in mg, IU, mg/mL, IU/mL, mg/5mL, etc.)
Defined daily doses (DDD) for adults have been determined by world health organization to harmonize drug
evaluating studies, and are accessible on website www.whocc.no/atcddd. It is mandatory to mention the
quantifying unit.
ATC based on the categorization of world health organization (www.whocc.no/atcddd) is a 7-digit number and its
information and method of encoding are available on the website. Some pharmaceutical molecules have several
ATC codes, and the right code must be selected according to the drug form and indication.
Mention drug form according to appendix 1. If the drug form is not available in that appendix, provide complete
explanations.
Mention drug packaging according to appendix 2. If the drug packaging is not available in that appendix, provide
complete explanations.
Mention route of administration according to appendix 3.
Mention the main pharmacologic group in English, in accordance with valid scientific sources.
Mention drug volume or weight, especially for liquid (with different modes of administration), semi-solid and
inhalational products.
The EAN13 bar code structure is provided by the center of goods and services numbering. Currently, there is a 16digit goods code defined in Iran which is compatible with EAN. Therefore, contact the aforesaid center and obtain
the 16-digit code to mention in this section.
Form and type of packaging, count per primary and secondary packaging, packaging supplements such as
brochure, spoon, applicator, syringe, etc. must be mentioned here in English.
Complete name and address of company holding registration permit of the drug in country of origin. In many
countries this is equivalent to section 16.
Complete name and address of company holding sales permit of the drug in country of origin. In many countries
this is equivalent to section 15.
Complete name and address of site of production of the drug
Complete name and address of site of packaging of the drug
Complete name and address of source of active ingredient of the drug
In column one, name country or countries (three countries in decreasing order of priority) where the drug is
registered. In column two, mention under which title the drug is registered (prescribed drug, OTC, orphan,
medical device, natural, etc.). In column three, mention date of registration.
For generic drugs (with multiple sources) the original brand name from which the current drug is copied and to
which all comparative bioequivalency studies have referred must be mentioned here, as well as the date of its
patent expiry.
Mention three valid pharmacy textbooks and their publication year which have mentioned the drug with similar
dosage, drug from and active ingredient (The list of references in decreasing order of priority is available in
appendix 4).
If no drug with similar form, amount of active ingredient or concentration is previously registered in Iran, it is
necessary to mention some reasons for preference of the dosage and form.
Mention consumer’s price for the drug with the same name and information per unit (the smallest consumable
unit) in Spain, Greece, Turkey and the manufacturing country in dollars and euros.
Mention consumer’s price per unit (the smallest consumable unit) of the original brand and one sample of other
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generic types registered in these countries.
26) Mention the price suggested by the sales permit holding company for selling to distributing companies (in rials)
27) Mention the suggested consumer’s price per unit (smallest consumable unit) in rials.
28) Mention the period of time during which the country can keep the price constant (in months) with regard to
fluctuations in currency exchange rates and the country’s inflation.
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Appendix 1
List of Dosage Forms
1. AEROSOL
2. AEROSOL, FOAM
3. AEROSOL, METERED
4. AEROSOL, POWDER
5. AEROSOL, SPRAY
6. BEAD
7. BEAD, IMPLANT, EXTENDED RELEASE
8. BULK
9. CAPSULE
10. CAPSULE, COATED
11. CAPSULE, COATED PELLETS
12. CAPSULE, COATED, EXTENDED RELEASE
13. CAPSULE, DELAYED RELEASE
14. CAPSULE, DELAYED RELEASE PELLETS
15. CAPSULE, EXTENDED RELEASE
16. CAPSULE, EXTENDED RELEASE, PELLETS
17. CAPSULE, FILM COATED, EXTENDED RELEASE
18. CAPSULE, GELATIN COATED
19. CAPSULE, LIQUID FILLED
20. CEMENT
21. CIGARETTE
22. CONE
23. CORE, EXTENDED RELEASE
24. CREAM
25. CRYSTAL
26. CULTURE
27. DIAPHRAGM
28. DISC
29. DOUCHE
30. DRESSING
31. DROPS, SOLUTION
32. DROPS, SUSPENSION
33. ELIXIR
34. EMULSION
35. ENEMA
36. EXTRACT
37. FILM
38. FILM, EXTENDED RELEASE
39. FILM, SOLUBLE
40. GAS
41. GEL
42. GEL, DENTIFRICE
43. GEL, JELLY
44. GENERATOR
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45. GLOBULE
46. GRAFT
47. GRANULE
48. GRANULE, DELAYED RELEASE
49. GRANULE, EFFERVESCENT
50. GRANULE, FOR SOLUTION
51. GRANULE, FOR SUSPENSION
52. GRANULE, FOR SUSPENSION, EXTENDED RELEASE
53. GUM
54. IMPLANT
55. INHALANT
56. INHALER
57. INJECTION
58. INJECTION, EMULSION
59. INJECTION, POWDER
60. INJECTION, POWDER FOR RECONSTITUTION
61. INJECTION, POWDER,
62. INJECTION, POWDER, LYOPHILIZED
63. INJECTION, POWDER, LYOPHILIZED,
64. INJECTION, SOLUTION
65. INJECTION, SOLUTION, CONCENTRATE
66. INJECTION, SUSPENSION
67. INJECTION, POWDER, EXTENDED RELEASE
68. INJECTION, SUSPENSION, EXTENDED RELEASE
69. INSERT, EXTENDED RELEASE
70. INTRAUTERINE DEVICE
71. IRRIGANT
72. KIT
73. LINER, DENTAL
74. LINIMENT
75. LIPSTICK
76. LIQUID
77. LOTION
78. LOZENGE
79. MOUTHWASH
80. NEBULISATION
81. OIL
82. OINTMENT
83. PACKING
84. PASTE
85. PASTE, DENTIFRICE
86. PATCH
87. PATCH, EXTENDED RELEASE
88. PELLET
89. PELLET, IMPLANTABLE
90. PELLETS, COATED, EXTENDED RELEASE
91. PILL
92. PLASTER
93. POULTICE
94. POWDER
95. POWDER, DENTIFRICE
96. POWDER, FOR SOLUTION
97. POWDER, FOR SUSPENSION
98. POWDER, METERED
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99. RINSE
100. SALVE
101. SHAMPOO
102. SHAMPOO, CREAM
103. SHAMPOO, LOTION
104. SHAMPOO, SUSPENSION
105. SOAP
106. SOLUTION
107. SOLUTION, CONCENTRATE
108. SOLUTION, FOR SLUSH
109. SOLUTION, GEL FORMING, EXTENDED RELEASE
110. SPONGE
111. SPRAY
112. SPRAY, METERED
113. SPRAY, SOLUTION
114. SPRAY, SUSPENSION
115. STICK
116. STRIP
117. SUPPOSITORY
118. SUPPOSITORY, EXTENDED RELEASE
119. SUSPENSION
120. SUSPENSION, EXTENDED RELEASE
121. SUSPENSION, NEBULISATION
122. SUTURE
123. SWAB
124. SYRUP
125. TABLET
126. TABLET, CHEWABLE
127. TABLET, COATED
128. TABLET, DELAYED RELEASE
129. TABLET, DISPERSIBLE
130. TABLET, EFFERVESCENT
131. TABLET, EXTENDED RELEASE
132. TABLET, EXTENDED RELEASE, DELAYED RELEASE
133. TABLET, FILM COATED
134. TABLET, FILM COATED, EXTENDED RELEASE
135. TABLET, FOR SOLUTION
136. TABLET, FOR SUSPENSION
137. TABLET, MULTILAYER
138. TABLET, MULTILAYER, EXTENDED RELEASE
139. TABLET, ORALLY DISINTEGRATING
140. TABLET, ORODISPERSIBLE
141. TABLET, SOLUBLE
142. TABLET, SUGAR COATED
143. TAMPON
144. TAPE
145. TINCTURE
146. TISSUE
147. TROCHE
148. UNKNOWN
149. WAFER
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Appendix 2
List of Packing Forms
1. AMPOULE
2. APPLICATOR
3. BAR
4. BLISTER
5. BOTTLE
6. BOTTLE WITH APPLICATOR
7. BOTTLE, DROPPER
8. BOTTLE, GLASS
9. BOTTLE, PLASTIC
10. BOTTLE, PUMP
11. BOTTLE, SPRAY
12. BOTTLE, UNIT DOSE
13. BOX
14. CAPSULE
15. CARTRIDGE
16. CONTAINER
17. COUNT
18. DISK
19. GALLON
20. INHALER
21. JAR
22. JUG
23. KIT
24. LOZENGE
25. PACKAGE
26. PELLET
27. PLASTER
28. Prefilled Disposable Pen
29. SACHET
30. SPRAY
31. STRIP
32. SUPPOSITORY
33. SYRINGE
34. SYRINGE, GLASS
35. SYRINGE, PLASTIC
36. TABLESPOON
37. TABLET
38. TABLET, DELAY RELEASE, EXTENDED RELEASE
39. TEASPOON
40. TUBE
41. TUBE WITH APPLICATOR
42. VIAL
43. VIAL, GLASS
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44. VIAL, MULTI DOSE
45. VIAL, PLASTIC
46. WAFER
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Appendix 3
List of Route of Administrations
1. BUCCAL
2. DENTAL
3. INTRAARTICULAR
4. INTRACAVITARY
5. INTRACORNEAL
6. INTRADERMAL
7. INTRAEPIDERMAL
8. INTRALESIONAL
9. INTRAMUSCULAR
10. INTRAOCULAR
11. INTRASPINAL
12. INTRATHECAL
13. INTRATRACHEAL
14. INTRAVENOUS
15. INTRAVENOUS BOLUS
16. INTRAVENOUS DRIP
17. INTRAVESICAL
18. IRRIGATION
19. LOCAL ORAL
20. MOUTHWASH
21. NASAL
22. NASAL & OPHTHALMIC
23. NOT APPLICABLE
24. OPHTHALMIC
25. OPHTHALMIC & OTIC
26. ORAL
27. OTIC
28. PARENTERAL
29. RECTAL
30. RESPIRATORY
31. SUBCUTANEOUS
32. SUBLINGUAL
33. TOPICAL
34. TRANSDERMAL
35. UNASSIGNED
36. UNKNOWN
37. VAGINAL
38. VAGINAL or RECTAL
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Appendix 4
List of Reference Books
1. Drug information health care professionals (USPDI)
2. British National Formulary (BNF)
3. Vidal
4. Drug Facts & Comparisons
5. Medicine Compendium (DATA Pharm)
6. Physician Desk Reference (PDR)
7. Rote List
8. Compendium Swiss Medicines
9. Martindale the complete drug reference
10. FASS
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Application form for registration of companies registering, manufacturing, and importing pharmaceutical products
1. Name of company
Province
Company registration number
Address
Phone
Website
2) Managing director
Full name
Father’s name
National code
City
Company registration date
Fax
Email
Education
Three last positions
123-
Birth certificate number
3) Directing board
3) Main investor and stock-holders
6) Size of investment
Surface area
Area of laboratory
Area of stores
Number of employees with Master’s degree or higher
Type of lines and their numbers
6) Type of activity
License holder
Importer
Area of administrative office
Area of manufacture sections
Number of separate manufacture lines
Number of other employees
Manufacturer
Packager
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