eRegistry:Licenses

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)
Directions: View Directions

Phone:+256 454445195
Physical Address:6 Busia Road South Bukedi Cooperative Building 3rd 453,Tororo Uganda
Postal Address:
Email Address:
Website:
Operating Hours:
Directions: View Directions