Drug Product Registration (Medication Registration)

Description
It is a process of electronically requesting the registration of a new medication through Kurdistan Medical Control Agency (KMCA). This system is registered with the Federal Government of Iraq, and it is designed with care to utilize KMCA's process.
Responsible Entity Information

ناونیشانی سەردانی هاوڵاتی بۆ بەڕێوەبەرایەتی کۆنترۆلی جۆریی دەرمان

Office Hours
(٨:٠٠)ی بەیانی بۆ (٢:٣٠)ی دوا نیوەڕۆ.
بەڕێوەبەرایەتی کۆنترۆلی جۆریی دەرمان / هەولێر
شەقامی (١٠٠)م تەنیشت نەخۆشخانەی ڕاپەڕین
ئیمەیڵ: info@kmcakrg.org
Conditions
For preliminary registration:
Letter of the preliminary registration decision issued by the Iraqi Ministry of Health.
Certificate of Manufacturer Registration from the Directorate of KMCA.
Providing a sample of the medication (drug) that the request for registration is made for.
For final registration:
Letter of the ultimate registration decision issued by the Iraqi Ministry of Health.
Providing a sample of the medication (drug) that the request for ultimate registration is made for.
Certificate of Manufacturer Registration from the Directorate of KMCA.
Documents
For preliminary registration:
Legal pledge clarifying that the same information about the medication provided to the Iraqi Ministry of Health has been submitted to KMCA for the purpose of preliminary registration.
Documents required for the registration on a Compact Disc (CD).
Certificate of the Medication (Drug) Preliminary Registration from the Iraqi Health Ministry.
For final registration:
Legal pledge clarifying that the same information about the medication provided to the Iraqi Ministry of Health has been submitted to KMCA for the purpose of preliminary registration.
Documents required for the registration on a Compact Disc (CD).
Certificate of the Medication (Drug) Final Registration from the Iraqi Health Ministry.
Time
Fourteen (14) to thirty (30) working days
Price
Reference to administrative decree no. (4527) issued on 25/5/2014 the cost is:

- Seven hundred and fifty thousand (750,000) Iraqi Dinars for the Preliminary Registration.
- One million and five hundreds (1,500,000) Iraqi Dinars for the Final Registration.
Procedures
The requestor visits the Directorate of KMCA.
The requestor visits the public relations department for submitting the application.
After the application is processed, the requestor will be contacted from the Directorate to visit and complete the application.
The requestor visits the public relations department for referral to the accounting.
The requestor visits accounting to pay the relevant fees.
The requestor visits the public relations to collect the registration certificate.
Application Form
پێویستە فۆرمی داواکاری هاوپێچ بکرێت، ئەگەر هەبێت.
External Services
پێویستە خزمەتە پەیوەندیدارەکان دەستنیشان بکرێن، ئەگەر هەبن.
Signed by
پێویستە ئەم خزمەتە لەلایەن بەڕێزان وەزیر/سەرۆکی دەستە و بەڕێوبەری گشتی دیوان و لیژنەی خزمەت واژوو بکرێت.
Service ID
MOH - 35
Last updated08-01-2024

Feedback

Is this information helpful?

Please include your email if you want us to follow up with you.