Registration of veterinary product

  • Service Code D2-2-AAA-18-APH
  • Number of Users
    65 Companies
    0 Individuals
  • Number of Transaction
    1400 Companies
    0 Individuals
  • Target Audience
    Companies
  • Service Channels

Service Time

The Estimated time to submit a service request : 10 minutes / The time to obtain the service: 45 working days

Customer Happiness Centers

Call Center

Email

User manual

Service Description

Through this service, approved the registration of veterinary products through a licensed warehouse to allow its importation and circulation within the country after auditing the documents required by the Veterinary Products Registration Committee to ensure compliance with the terms and conditions

Service Procedures

To apply for a service over any of the service channels, you should register in the digital services system From here

  1. Fill out the electronic form
  2. E- Payment
  3. Study and review the documents
  4.  E- Payment fee for the analysis, if necessary
  5. Conducting a laboratory test
  6. Issuing the certificate electronically

Service Fees

2500 AED for five years for Request to issue or renew a certificate of registration of a veterinary preparation
3000 AED for Request for analysis or re analysis of a veterinary product

Required Documents

  • Certificate of CPP or valid free sale certificate in the country of origin issued by the responsible authorities, stating the following:
  1. Name and address of the manufacturer.
  2. Number and date of registration of the veterinary product in the country of origin.
  3. Details of the veterinary product indicating that the drug or product to be registered in the UAE is identical to the name, composition and specifications of the marketed product in the country of origin.
  4. If the trade name of the product to be registered is different from its trade name in the country of origin, it should be mentioned with reasons; provided that the certificate includes both names and that, the composition and other specifications of the two names are identical.
  5. Active and non-effective materials with their quantities.
  6. The shelf life of the medicine and storage conditions.
  7. Withdrawal period if available
  • Label / insert leaflet of the product in Arabic or English, should mention in the label for veterinary use only.
  • Certificate of analysis and specifications of the products from manufacturer.
  • Certificate of analysis from the accredited authority in the United Arab Emirates (Ministry of Health & Prevention), & the products used for horses need to submit extra sample for Central Veterinary Research Laboratory (CVRL) test
  • Certificate duly certified showing the prices of the preparation as follows:
  • Factory price in country of origin.
  • Wholesale price in the country of origin.
  • Selling price to the public in the country of origin.
  • CIF prices continued to UAE ports
  • Stability studies.
  • Specifications of raw materials
  • Manufacturing process and control during manufacturing.
  • Method of analysis.
  • Specifications of the final product.
  • Specifications of packing materials.
  • Studying bioequivalence (where required) in case the product is of similar species.
  • Safety study and efficiency study in the case of veterinary vaccines

In the case of product targeting dogs , cats and wild animals:

  • Certificate of CPP or valid free sale certificate in the country of origin issued by the responsible authorities
  • Label / insert leaflet of the product in Arabic or English, should mention in the label for veterinary use only.
  • Certificate of analysis and specifications of the products from the manufacturer

Pre-registered veterinary products:

https://www.youtube.com/embed/IUBk7CWJng4

Terms and Conditions

  • For the imported product:
  1. The applicant must be a licensed veterinary warehouse from the Ministry or a local veterinary product factory
  2. The manufacturer of the veterinary product shall be registered in the Ministry
  • For the locally manufactured product:
  1. The veterinary factory shall be licensed by the Ministry

 

Note: The use of colistin (polymyxin E) in the veterinary sector is prohibited