Application Fees: (a) Clinical trial for a registered drug - 2,500
USD
(b) Clinical trial for un registered drug - 4,000
USD
(c) Amend clinical trial application - 200 USD
License Fee: N/A
Maximum Processing Time: 1 Month for new applicants and 2 weeks for renewal
Related Websites: Validity: 1 Year
Contact Office: Renewal Fee: N/A
License Type: Certificate
Legal Basis: The National Drug Policy and Authority Act, Cap. 206
- 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 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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