Medicine registration Requirements at KMCA:
- Drug registration form (this form is provided by KMCA) filled by Manufacturer (signed and stamped), legalized by Ministry of health, Ministry of foreign affairs, Iraq embassy.
- Certificate of Pharmaceutical products (CPP) legalized by Health Authority, the Ministry of foreign affairs, Iraqi Embassy in the country of origin, this certificate should include the following:
- A statement that the product is freely sold and used in the country of origin with the registration number and date.
- Quantities of active and non active ingredient (s).
- Name and address of manufacturing company and marketing authorization holder.
- Certificate of analysis of finished product legalized by Ministry of Health, Ministry of foreign affairs, Iraqi Embassy in the country of origin.
- Price structure certificate Issued by Health authority clarifying the profit margins for the wholesaler and the pharmacist in the country of origin legalized by chamber of commerce, Ministry of foreign affairs, and Iraqi Embassy in the country of origin.
- Two samples of the package insert, inner label and outer pack (the outer pack should contains the bar code, storage conditions numerically and identical to what mentioned in the stability study, batch number, manufacturing date and expiry date, trade name if any , generic name , concentration Of active constituents, route of administration, storage conditions, warnings, name of manufacturer and full address and special instruction for use). The inner leaflets should be written in English .
- A sample of the following with its certificate of analysis of the same batch for the use of KMCA –Quality Control.
- Reference standard / official products.
- Working standard / non pharmacopoeia products, submit minimum (20grams) of active constituent(s).
- Degradation product (s) or related substance (s).
- Samples for registration and for analysis as follow:
||No. of Samples required for analysis (of the same Batch. no.) in the Quality Control Lab
||No. Of Samples required for registration (of the same Batch no.) in the Quality Control Lab
|1||Tablets & caps||150 tab or cap ||2 packs|
|2||Vials, Amp. Vol.>1 ml||50 vial or amp. ||2 packs|
|3||Vials, Amp. Vol. of 1 ml||100 vial or amp. ||2 packs |
|4||Vials, Amp. Vol.<1 ml|| 200 vial or amp. ||2 packs |
|5||Distilled water|| 1500 ml ||2 packs|
|6||Syrup|| 5 bottles ||2 packs|
|7||Oral Drops||5 containers ||2 packs|
|8||Eye drops || 20 containers ||2 packs|
|9||Eye ointment|| 50 tubes ||2 packs|
|10||Skin ointment|| 5 tubes ||2 packs|
|11||Suppositories||30 blister ||2 packs|
|12||Vaginal cream||5 tubes ||2 packs|
|13||Insulin ||20 vials ||2 packs|
|14||Heparin ||30 vials ||2 packs|
|15||Albumin ||25 vials ||2 packs|
|16||Factors ||25 vials ||2 packs|
|17||I.V Fluids||10 bottle ||2 packs|
- Method of analysis for the finished product.
- Method of validation for analysis methods.
- Stability studies of the product in the same formula and dosage form that will be submitted for registration:
- Stability study protocol should be provided
- Accelerated stability studies
- Long term stability studies for the whole shelf life.
- Test interval are 0,3,6,9,12,18,24,36,48 months.
- Results and conclusions report should be enclosed , clarifying the proper shelf life and the storage conditions a cording to the study conditions.
- Specifications of:
- Finished product
- Raw material for both active and non active ingredient
- Both the inner and outer packaging material
- Method of manufacturing and filling of the finished product.
- In process and finished product Q.C. test methods along with validation of that method unless the product is a pharmacopeias one.
- A certificate stating the safety of blood products from HIV, HAV, HDV, BCV, HBS.
- A certificate stating that the gelatin and other components of animal source are not of pork origin, and these components are free from contamination with BSE. (Issued by the health authority of country of origin of raw material)
- List of the countries where the product is registered and sold with registration number and date.
- In case of under license product, a letter of the manufacturer clarifying the responsibilities that the new manufacturer holds (manufacturing, repackaging, marketing….etc) also confirming its approval to export this item to Iraq.
- A certificate from regulatory authority of the manufacturer country confirming that raw materials for Oral Dosage Forms are not contaminated with di-ethylene Glycol.
- Registration Fee should be paid by the applicant company.
- When applicable, append details of any restriction applied to the sale, distribution or administration of the product that is specified in the origin country.
- If an application has been rejected or withdrawn in any country, give reasons.
- A dosage form in a separate strength and pharmaceutical form shall be considered as a drug and need separate application form.
- Bioequivalence study (for generics).
- Bioavailability study for originators.
- No bioavailability or bioequivalence study is required for OTC drugs, however dissolution profile to be submitted.
- Re registration is required after five years, and the requirements are:
- Sample of finished products.
- CPP issued by the health authority of the country of origin.
- Specification of finished product.
- Specifications of active and inactive ingredients.
- A letter from the manufacturer declaring that there are no changes made on the formula, manufacturing method and specification, signed and stamped by the manufacture.
- Re registration fee.
- The registration committee has the right to ask for any additional information or documents.
- Files to be submitted should be numerated and have a table of contents.
- Scientific data should be in English.