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I am writing this answer based on my practical exposure in MOH for conventional NDA
Step1 Appointment
Step2 Payment
Step3 Dossier submission
Step4 QC lab submissions
Location details:
Step:1
Appointment in MOH:
Appointment can be requested through mail with details in tabular column, Subject is critical you should mention conventional NDA or required details
1. Name of the product
2. Active ingredients list
3. Strength
4. Dosage form
5. Country of origin
6. Which all countries registered and marketed
7. Applicant Name and Address(Agent)
8. Applicant Authorized Representative
9. Appointment type
. Product Type
. Date of Application
Appointment date may be within one month or delay
Appointments in QC lab:
Wednesday: No need of appointment
Monday: require appointment
Tuesday: require appointment
Step:2 &3
Payment: Payment for registration was revised on.., for accepting file payment shall be as per official payment sheet. Here with i am elaborating step by step:
Payment sheet shall be prepared in-house it should contain details: product name, Company, Agent and fee. Fee structure like below
(Registration fee)
(QC)
(PV plan)
(QC Report)
(Application/appointment)
Note1: Payment shall be done only through eDirham card, you can buy eDirham card with4 AED in MOH counter itself
Note2: Always carry your emirates I.D to MOH
Note3: There is service charge (3 AED) for eDirham transactions keep extra money in eDirham card
Note4: Initial eDirham card will not accept transaction more than0 AED single day, you can extend upto0 AED only in banks
Note5: After eDirham recharge you need to pay in MOH account, you can do it in MOH itself
Note6: MOH Counter people are handling payments for different sections not only to drug registration department, they may don’t know what exactly you want to avoid any money transaction errors: here with i am providing main code and sub codes for payment
For AED: Main code subcode:
For AED: Main code subcode:
For AED: Main code subcode:
For AED: Main code subcode:
For AED: Main code subcode:
You will get2 payment receipt (signed) from the staff, one is copy and one is original, (please note that copy slip having black bands on top) you should always staple original to your check list and copy hand over to DRCD representative.
3 files should be in place:1 registration dossier, stability file and QC file
Regarding dossier file:You should prepare a file as per check list for receiving new conventional NDA if renewal as per renewal check list.
Stability file: stability file should contain your stability data important that you should submit this file in MOH along with dossier in MOH muhaisna
QC file: contains specifications, MOA and pack declarations you should submit in QC lab AL barsha Science Park
Samples: prepare with3 original samples2 at the time of registration and one in QC lab
After DRCD representative review on the day of appointment he/she will fill the check list and he will hand over your dossier file and filled check list back to you (After taking requirements).
NOTE: UAE MOH not keeping complete files with them they are taking application form and few declarations and CDs they will return file back to you no need to afraid.
Note: You need to take2 photocopies (Xerox machine available in MOH) of filled checklist and you need to handover to DRCD representative along with copy payment slips
QC lab: You need to submit QC file to QC lab located in Al barsha along with one original sample. They will give you analysis requirements.
Location details: MOH drug registration department muhaisnah2 for registration dossier submission and QC lab Al barsha science park for QC file submission
Regarding any noncompliance in procedure or any doubts please reach me on OR
1- Application form for registration
2- Certificate of Pharmaceutical Product (CPP)
3- Certificate of Analysis
4- Package insert for the product
5- three samples of product in its final package
6- Halal Certificate
7- Medical store license (for applicants)
8- Valid registration certificate
9- CD for product Artwork
10- Outer label, inner label and insert of the product
Requirements of the Drug Registration in the United Arab Emirates
A. For new submissions or re-registration (RR) The applicant shall fill the form DRS No: 52-A (to be filled by New Medical Centre) accompanied with the following arranged in a separate dossier with separate partitions numbered according to the following order: 1. Serial Number. 2. Statement covering letter on the company letter head stating: New product / or re-registration. 3. Product Name 4. Form 5. Pack 6. Patency - Certificate or information that the product is out of Patent. 7. Certificate Of Pharm. Product - authenticated by UAE Embassy in the country of origin. The certificate should mention the following; - Name and address of the manufacturer and the year of incorporation together with registration number - The manufacturer is licensed to manufacture the preparation the country of origin. - The manufacturer is permitted to sell freely the preparation the country of origin, mentioning the date of commencement of marketing. - Formula of the preparation of active and inactive ingredients with quantities in detail - Shelf life of the preparation - Validity of the preparation and storage conditions - Insert leaflet of the preparation - The preparation is fully conforming to the name, formula and specifications of the product marketed in the country of origin. In case the name of the product requested to be re-registered is different than its name in the country of origin, the certificate should mention two names, confirming that the formula and specification of both the names are same 8. Shelf life on the (C.P.P.) 9. Shelf life on the sample. 10. Pharmacology 11. Toxicology 12. Clinical Studies 13. Research 14. Date of introduction in the Country Of Origin. 15. Registration in the other countries (Photocopies to be attached) 16. Price Certificate authenticated UAE Embassy in the country of origin & should mention following details; - Ex-factory price in the country of origin. - Wholesale price in the country of origin. - Retail price in the country of origin - CIF price to U.A.E. - CIF price to GCC Countries (like Saudi Arabia, Kuwait) 17. Two Number of samples. (batch no, expiry date & Mfg date printed on both outer and inner pack. 18. Samples of outer and inner pack. 19. RemarksI. Requirements of Drug Control Lab. (D.C.L.):A. For new submissions & re-registration (RR) The applicant shall fill in the form DRS No: 53 (to be filled by New Medical Center) accompanied with the following arranged in a separate dossier with separate partitions numbered according to the following order: 1. Serial Number 2. Statement whether it is new product or re-registration (Covering letter) 3. Product Name. 4. Form 5. Pack 6. Number of samples submitted 7. Certificate Of composition 8. Shelf life of the sample 9. Finished product release specifications 10. Method Of analysis and specifications 11. Certificate Of Analysis of the finished product 12. Stability studies specifications. 13. Stability studies - studies more than 12 months. 14. Stability studies - undertaking letter for ongoing stability studies for climatic zone IV. 15. Bioavailability or bioequivalence studies. 16. Details of reference standards. - Active ingredient (s) along with a certificate of analysis 17. Preservative (s) along with a certificate of analysis 18. Colorant(s) along with a certificate of analysis. 19. Internal standards. 20. Degradation standards 21. Certificate Of Analysis (where applicable)Food Supplement Registration/Medicated cosmetic Documents required by Ministry of Health for Health Food or Food Supplementary Preparation Registration Requirement The local agent should submit to the 'Technical Affairs Division of the Medicine Control Department at the Ministry an application requesting to register the preparations having medical claim and the producer thereof, accompanied with the following documents: 1) Table of contents (Index) 2) Application form for registration duly filled (To be filled by New Medical Centre) 3) Copy of commercial licences granted for the applicant (local agent) by the Municipality, Chamber of Commerce and the Economy department (To be attached by New Medical Centre). 4) Copy of registration certificate of the agency of manufacturing company and its products for the applicant (local agent) in the Ministry of Commerce and Economy, U.A.E. 5) Certificate(s) issued by competent authority in the country of origin and attested by Embassy of UAE or any other GCC country, stating the following. - Name and address of the establishment of the manufacturer and any other information ----Capital and Annual turnover - Manufacturing Licence in the country of origin. (State the licence number and date) - Good Manufacturing Practice (GMP) Certificate - Free Sale Certificate, should also state the date of introduction of the product into the country of origin market. - The product intended for registration in UAE is marketed in the country of origin at least for the last two years with the same name, composition and other specifications. If the trade name of the product intended for registration in UAE is different from that in the country of origin, difference(s) should be explained clearly, and both names should be mentioned with confirmation of similarly in composition and other specifications. 6) Certificates issued from the countries where the product is being marketed mentioning the date of registration and marketing in those countries. 7) List of vademecum (catalogue) of the products manufactured by the manufacturer 8) Product information including: - Trade name of the product - Composition and scientific names of the active ingredient(s) (dietary ingredients in dietary supplements) and inactive ingredients with their quantities. - Indications - Method of preparation and analysis of the product - Dosage and direction of use - Contraindication & Precautions - Storage conditions - Validity (expiry date) - Weight and size of the pack 9) Insert leaflet duly authenticated 10) Dietary supplement must be devoid of hormones, heavy metals (minerals), antibiotics, Steroid, derivatives of pork meat and any natural or chemical ingredients' having harmful effects on human biological or behavioural functions. If the product contains any ingredient from animal source, the kind of animal and extract from it be specified. Percentage of alcohol, if any, must, be mentioned together with reasons thereof. 11) Six samples of the preparation in their original packets together with certificate of analysis of the same batch number. 12) Certificate confirming that the printed information on the outer and the inner label of the product and the leaflet (Arabic and/or English) are similar to that used in the country of origin. The art work in colour of the outlet and inner label should be attached. 13) The outer & inner label should include the following information: - Name of the product - Active (dietary ingredients) and inactive ingredients, with their quantities. - Dose and direction of use - Pack size - Batch Number - Date of expiry - Storage conditions - Name and address of manufacturing company in the country of origin 14) Any other additional information or documents required by the ministry. All the above mentioned documents of registration must be in Arabic language and/or English language used in the country of origin and attested by one of the embassies or consulates of GCC countries in the country of origin.
