Description
This service is to register pharmaceutical manufacturers, that are not registered with the Iraqi Ministry of Health, at the Directorate of KMCA.
Responsible Entity
Responsible Entity Information
ناونیشانی سەردانی هاوڵاتی بۆ بەڕێوەبەرایەتی کۆنترۆلی جۆریی دەرمان
Website
Office Hours
(٨:٠٠)ی بەیانی بۆ (٢:٣٠)ی دوای نیوەڕۆ.
بەڕێوەبەرایەتیی کۆنترۆڵی جۆریی دەرمان / هەولێر
شەقامی (١٠٠)م تەنیشت نەخۆشخانەی ڕاپەڕین
ئیمەیڵ: info@kmcakrg.org
ئیمەیڵ: info@kmcakrg.org
Conditions
The request must be made by a company registered at the KRG's Ministry of Health.
The Manufacturing Licence of must be certified by the relevant entity in the country of origin and by the Iraqi Embassy or KRG representative in the relevant country.
The requestor must hold an authorization letter from the Manufacturer, certified by the Chamber of Commerce at the Manufacturing Country and by the Iraqi Embassy to the manufacturing country, to register at the KMCA.
List of the pharmaceutical products (medications) including numbers and patented dates.
Support letter or a copy of the Syndicate of Kurdistan Pharmacist identity card of the requestor pharmacist.
Documents
The list of all submitted documents (Index list)
Valid, English version of "Good Manufacturer Practice Certificate" issued and certified by the relevant entity or foreign ministry of the manufacturer country and the Iraqi embassy.
A copy of the" Good Manufacturer Practice Certificate", certified by the Ministry of Health and Foreign Ministry of the manufacturing country as well as by the Iraqi Embassy to the manufacturing country or a copy of "Certificate of Pharmaceutical Product" at least for two of its products. However, if the manufacturer produces only one pharmaceutical product, only one Certificate of Pharmaceutical Product is required following WHO format, and it has to be certified by the relevant entities such as foreign ministry and the Iraqi embassy in the manufacturing country.
Time
(21) to (45) working days
Price
Reference to administrative decree no. (4527) issued on 25/5/2014 the cost is:
- (2,500,000) Iraqi Dinars each five (5) years for the registration of Pharmaceutical Manufacturing Factory.
- (25,000) Iraqi Dinars for the application form.
- (2,500,000) Iraqi Dinars each five (5) years for the registration of Pharmaceutical Manufacturing Factory.
- (25,000) Iraqi Dinars for the application form.
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
Legal Documantation
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 - 34
Last updated03-03-2024
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