Saturday, August 16, 2008

Registration of Pharmaceutical Products in Iran

Documents required for registration of a pharmaceutical product in Iran after its addition to Iranian list of formulary

I- Certificate of Pharmaceutical Product according the specification of WHO
I I-A certificate/letter containing list of the countries where product (in any dosage form) is registered and their registration number
I II-A certificate/letter containing list and of the countries where product (any dosage form) is sold/used, and information regarding date of introduction in these markets.
IV-A certificate/letter has a factory/manufacturing unit in them and the address of factory containing list of the countries in which the company
V-Letter of agency for the product(s) to an Iranian company
VI-Complete form for price of product
VII-Complete Drug Importing Application
VIII-Samples of product including CoA and all analytical records

plus a comprehensive file (DMF = Drug Master File) containing following documents:

1-Company Profile
Including also (not limited to ) plant master file including also the machinery, and equipments used for production and analysis of the product.

2- Manufacturer
-Manufacturing authorization holder (name, address, country)
-Number and date of the first marketing authorization/renewal
-Manufacturer of finished product (name, address, country)
-Flow-chart indication the different sites involved in the manufacturing process, packaging and release of the medicinal product.
-Manufacturer of the active substance(s) (Name, address and country)

3-Formula/composition of the product
-Quantitative and qualitative composition in terms of the active substance(s)
-List of active substances separately form the excipient(s)
(Name of active substance (INN), name of excipients, function, quantity, unit, reference/pharmacopoeia)
-Incompatibilities of the excipients
-List of materials of animal and/or human origin contained or used in the manufacturing process of the medicinal product
-List of constitutes from other origins
-Coloring, flavoring and perfume compounds

4-Compostion of batch
-Complete composition of a trial batch
-Complete composition of batch for production at industrial level

S-Packaging material of the product
2-method of analysis
3-certificate of analysis
* 4-Samples of packaging material

6-Method of Preparation
a-manufacturing formula
b-manufacturing process*
c-manufacturing equipments

7-Control of starting materials
a-active ingredients
2-method of analysis
3-potential impurities and determination
4-certificate of analysis*
b-other ingredients
2-method of analysis
4-certificate of analysis*
5-the non-active substances not-remaining in the finished product

8-Control tests on finished products
b-batch analysis
c-certificate of analysis*
d-the non-active substances remaining in the finished product
e-the limitation for the potentially toxic substance(s) which may remain in the finished product and the method for their determination.

-Method of sampling
-Details of sampling plan
-Method of selection of samples for analysis
-Method of increasing or decreasing the number of samples
-Deviations and necessary actions needed to be taken based on statistical methods.

10-ln-process controls
-Details of physical, chemical, microbiological and other tests during the process of production
-Deviations in in-process tests and actions needed to be taken
-Statistical methods for combination of the result of tests on consecutive batches
-Method of analysis of in-process control as a feed-back for improving/adopting the production process

11-Pharmacopial specification of the product
-Acceptable range of physical, chemical, microbiological and other tests based on the relevant pharmacopeias
-Conformity of the product with specification of the pharmacopeias
-Pharmacopeias tests for guaranteeing the clinical, physical, chemical, microbiological characteristics of the product in the course of its shelf-life
-Comparisons/conformity of the release characteristics of the product
-Additional test compared to pharmacopeias specifications.
-Alternative tests to pharmacopeias tests

a-controlled batches
b-storage conditions
c-description of containers
d-analytical methods
e-stability schedule
g-interpretation of results h-shelf life*
i-validation of stability tests

13-Pharmacology and Toxicology report

14-Clinical trials

15-Bioequivalency, and pharmacodynamics

16-Patient information leaflet

17 -Labels and outer carton text

1S-Samples of the product with original certificate of analysis plus the required reference standard for testing the samples

-Documents "I" to "V" in above need to be original copy and need to be legalized by Iranian Embassy.
-Documents marked as "*" within the above list of "1" to "18" need to be an original copy and signed and stamped by the responsible person in the factory/company.

Number of samples required. Samples: -Large volume parenterals
-Small volume parenterals 1 and 2 cc -Small volume parenterals 5 to 10 cc -Drop, sterile ointment
-Oral solutions, syrups, suspensions -Topical ointment, cream, spray -Shampoo
-Tablets and capsules
-Injectable vials

20 200 100
60 20 20 15
10 50 50