Registration of drug producing plant in our department that did not registered Health Ministry of Federal Iraq.
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Registration should be made by Drug Importer Company that must be
registered in Ministry of health in Kurdistan region or by
representative of manufacturer.
-
Demand letter for registration should be represented to our
department, and in the letter the date and No. should be indicated.
- List of presented documents ( Index List)
- The form of factory registration (Form A1) should be filled, sealed
and signed by representative of drug producer factory and certified by
ministry of health, ministry of foreign in manufacturer country and
embassy of Iraq or Kurdistan Region’s representative in English
language.
- Valid GMP certificate, issued and certified by concerned parties and
foreign ministry of manufacturer country, embassy of Iraq or
Kurdistan Region’s representative in English language.
- Copy of Valid GMP certificate issued and certified or copy of CPP
certificate of Pharmaceutical product at least for two products ( but if
the factory produce one product one CPP is enough) according to
WHO standard in English language and certified by concerned parties
, foreign ministry of manufacturer country , embassy of Iraq or
Kurdistan Region’s representative and if issued by reference country
that mentioned below they don’t need test in contrary most be tested
by our test team in purpose of registration:
Reference country:
- USA (FDA)
- European Union or one of its countries
- UK ( MHRA)
- Health Products and Food Branch , therapeutic products Directorate
of Canada ( HPFB)
- Ministry of Health , Labor and Welfare / Pharmaceutical and
Medical Safety Bureau Japan ( MHLW)
- Australia ( TGA )
- Switzerland ( Swiss Medic )
- Gulf Countries Central Registration ( GCC)
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2-
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7- Copy of last factory test report that should be certified by concerned
parties.
8- Manufacturing license in Manufacturer country certified by concerned
parties , foreign ministry of manufacturer country , embassy of Iraq or
Kurdistan Region’s representative.
9- Authorization letter issued by manufacturer factory for demander for
registration in our department should be certified by chamber of
commerce , ministry of foreign affairs and embassy of Iraq or
Kurdistan Region’s representative in Manufacturer Country.
10- List of drug with date and number of registration in
Manufacturer Country.
11- Recommendation letter and copy ID of Pharmacists Syndicate
in Kurdistan for Demander.
12- Fee of factory registration
Registration of Drug Manufacture Factory that should be registered by
Health ministry of Iraq.
Registration should be made by Drug Company in our department that
registered by Ministry of health or through electing representative of
manufacturer in a formal way that most have Iraqi ID and an
occupation.
Required Documents:-
1- Demand letter for registration should be represented to our
department, and in the letter the date and No. should be
indicated.
2- Factory registration certificate in Iraqi Ministry of health.
3- Copy of valid GMP.
4- Authorization letter issued by manufacturer factory for
demander for registration in our department should be certified
by chamber of commerce, ministry of foreign affairs and
embassy of Iraq or Kurdistan Region’s representative in
Manufacturer Country.
5- Recommendation letter and copy ID of Pharmacists Syndicate
in Kurdistan for Demander.
