Products Registration in UAE

We Deal With following Categories in UAE:

Products Categories:

  1. Cosmetics Products
  2. General Sale Products
  3. Pharmaceutical / Conventional Products
  4. Medical Devices Products
  5. Herbal Products
  6. Veterinary Products
  7. Food Supplements

Government Authorities:

  1. United Arab Emirates Ministry of Health(MOH)
  2. Dubai Municipality
  3. Emirates Authority for Standardization and Metrology (Esma)
  4. Ministry Of Environment
Medspero Also Do Regulatory Consultancy Services in JORDAN, OMAN, SAUDI ARABIA, KUWAIT and QATAR Markets.!

Medspero Regulatory Support for Pharmaceutical Products:

  • Study product compliance to UAE MOH regulations.
  • Registration at UAE MOH.
  • CTD & eCTD Files preparation, revision and evaluation.
  • Pricing and Re-pricing.
  • Variations in in-active ingredients, outer package, and leaflet.

Additional Services Includes:

  • Converting NeeS to eCTD.
  • Ready eCTD dossiers for 184 Drugs.
  • e-Pharmacovigilance Upon request.
  • Preparing CTD/Technical writing Upon Request.

Medspero Responsibilities and Services

  • Study of Products And Modification of Products to comply with UAE MOH guidelines and doing necessary modifications.
  • Classification at MOH.
  • Preparing the dossier complying with UAE MOH guidelines.
  • Taking appointments for Classification Registration and QC Lab.
  • Submission of the Dossiers.
  • Followup with the for the Classification and Registration Certificates.
  • Modifying labels to comply with the guidelines.
  • CTD &eCTD files preparation, revision and evaluation.
  • Registration at UAE MOH.
  • Pre-notification step before shipments and clearance.
  • Pricing and Re-pricing.
  • Renewals and Minor Variations in in-active ingredients, outer package, and leaflet.