- Format for application for variation to a registered pharmaceutical product
- Biowaiver Application Form – Additional Strength
- BiopharmaceuticaI Classification System (BCS) Biowaiver Application Form
- Registration of a pharmaceutical product for human use in Uganda
- Format for declaration by expert for registration of human pharmaceutical products
- Format for letters of access to APIMF and CEP for human pharmaceutical products
- Format for presentation of Bioequivalence trial information
- Format for quality overall summary – product dossier (QOS-PD) for Human Pharmaceutical Products
- Standard format for quality information summary (QIS) for Human Pharmaceutical Products
- Template for summary of product characteristics (SmPC) for Human Pharmaceutical products
- Registration of Human Vaccines
- Expert Declaration form for Human Vaccines
- Quality Overall Summary for Human Vaccines
- Summary information for Biotherapeutic Products
- Format for Application for Registration of Biotherapeutic Products
- Summary information for Similar Biotherapeutic Products
- Format for Application for Registration of Similar Biotherapeutic Products (SBPs)
- Registration of Surgical Instruments
- Essential principles checklist in registering of surgical instruments and appliances
- Application form for variation / alteration of a registered surgical instrument/appliances
- Application submission checklist
- Classification rules for surgical instruments and appliances
- Renewal of Authorization of a Clinical Trial
- Format of clinical trial report
- Application Form for Amendment of Conditions of a Clinical Trial
- Format of report for terminated clinical trial Regulation 12 (5)
- Labelling investigational drug products for clinical trial
- Format for investigators brochure
- Format for clinical trial protocol-Regulation 4
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- DIRECTORATES
- Directorate of Inspectorate & Enforcement Services
- Directorate of Product Assessment & Registration
- Directorate of Product Safety
- Directorate of Corporate Services
- Directorate of Laboratory Services
- Directorate of Human Resource & Administration
- Directorate of Veterinary Services
- Office of the Secretary to the Authority
- Public Relations Unit
- REGISTERS
- Contact Us
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