Clinical trials (Human) scientific trials on human drugs certificate

Regulatory

  • Proof of payment.
  • Applications for import and/or export of materials (if required).
  • Clinical Trial Application Form.
  • Trial Protocol.
  • Investigators Brochure.
  • Participant Information Leaflet and Informed Consent.
  • Certificate of GMP manufacture of the trial medicine or other evidence of manufacture
    quality, safety and consistency.
  • Package Insert/s for other trial medicines.
  • Certificate of GMP manufacture of the placebo - if appropriate.
  • Evidence of accreditation of the designated Laboratories or other evidence of GLP and
    assay validation.
  • Insurance Certificate specific for the trial in consultation with NDA.
  • Signed and completed Declarations by all Investigators.
  • Approval of Ethics Committees for the Protocol.
  • Full, legible copies of key, peer-reviewed published articles supporting the application.
  • Sample of the label for the imported products.
  • 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 312261548
  • Physical Address: Nakawa Central
  • Postal Address:
  • Email Address:
  • Website:
  • Operating Hours:
  • 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
  • Phone: +256 465440688
  • Physical Address: Old Fortportal Road, Hoima Uganda
  • Postal Address:
  • Email Address:
  • Website:
  • Operating Hours:
  • Directions: View Directions
  • Phone: +256 473420652
  • Physical Address: Erute road, Lira Uganda
  • Postal Address:
  • Email Address:
  • Website:
  • Operating Hours:
  • Directions: View Directions