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Registration of the Pharmaceutical Companies

Iraqi MOH registration requirements for pharmaceutical companies:


Company registration form needs to be filled in one copy signed and stamped by the person responsible in the establishment.


GMP certificate published by legalized official authority.


Copy of CPP for at least two of the company products released from one of the following authorities :- (not required for companies producing general products)
I- FDA (USA) :Food AND Drug administration .
II- HPFB (Canada):Health products and food branch, therapeutic products directorate.
III- EMEA (Europe or any of its countries);European Union ,European Agency for evaluation of medical products.
IV- MHLW (Health authority of Japan ).Ministry of health, Labor and Welfare.
V- Pharmaceutical and medical safety Bureau.

Otherwise the company should be inspected by the registration department.


Certification letter regarding the boycott with Israel (i:e products do not comprise in any part ,raw materials ,labor or capital of Israeli origin ).It is acceptable to simply specify the country of origin for raw materials (this certificate should be signed and stamped by the company itself ).


Registration fee $ 1000


Marketing distributor and companies that are responsible for final packaging which do not have actual pharmaceutical manufacturer have no right to be registered .


Multinational companies are required to register any of their subsidiaries if they decide to supply any of their products from the said subsidiary.


(Additional request): To submit prices of any drug to be registered in Iraq and neighboring countries and European countries in US $.




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