Registration of veterinary product

About the Service

Through this service, approved the registration of veterinary products through a licensed warehouse by Emirates Drug Establishment 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 Process

1. 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

Required Documents

1. • 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
     

Conditions & Requirements

1. For the imported product:

   1. The applicant must be a licensed veterinary warehouse from the Emirates Drug Establishment with valid license
   2. The manufacturer of the veterinary product must be registered in the Emirates Drug Establishment with valid license

   For the locally manufactured product

   1. The local manufacturer of veterinary products must be licensed by the Emirates Drug Establishment with valid license

   Note:

   • The use of colistin (polymyxin E) in the veterinary sector is prohibited
   • It is prohibited to import and trade all veterinary products that contain the active ingredient Metamizole / Dipyrone for food-producing animals