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)
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  • Phone:+256 312261548
  • Physical Address:Nakawa Central
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  • Phone:+256 454445195
  • Physical Address:6 Busia Road South Bukedi Cooperative Building 3rd 453,Tororo Uganda
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  • Phone:+256 465440688
  • Physical Address:Old Fortportal Road, Hoima Uganda
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  • Phone:+256 473420652
  • Physical Address:Erute road, Lira Uganda
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