Certificate of registration of drugs

To ensure that medicines registered in Uganda meet national and internationally accepted quality, safety and efficacy standards.

  • All the general and specific information and documents relating to the product.
  • An application for registration of a product may be made by: the patent holder, a licensed person, the manufacturer, an agent authorized by the manufacturer or patent holder.
  • Approved generic name of the product.
  • Chemistry and pharmaceutical form and aspects of the product.
  • Complete index to the various appendices.
  • Description of the product.
  • Manufacturing license in case the applicant is not the manufacturer.
  • Name, physical address, email address, the telephone and fax number of the applicant.
  • Packaging specifications specified.
  • Particulars of the product.
  • Particulars relating to the toxicology and pharmacology of the product.
  • Proprietary name of the product.
  • Registration and licensing status of the product in other countries including the country of manufacture.
  • Safety and efficacy properties of the product.
  • Strength of the intended use of the product.
  • Studies undertaken in respect of the product.
  • Two samples of the product.
  • Where an applicant wishes to amend any part of a submitted application, the applicant shall pay the prescribed fees for each proposed amendment.
  • Where the original documents required are in a language other than English, the original documents shall be presented together with certified English translations.
  • Any other information as may be determined by the Authority.
  • Phone: +256 41 255665 / 347391/2
  • Physical Address: 46/48 Lumumba Avenue
  • Postal Address: P. O. Box 23096 Kampala, Uganda
  • Jurisdiction: National
  • Email Address: ndaug@nda.or.ug
  • Website: www.nda.or.ug
  • Operating Hours: Moday to Friday, 8:00am-5:00pm (excluding weekends and public holidays)
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  • Phone: +256 312261548
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