Application forms

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CTA Amendments Screening Form

2018-12-14

Initial CTA Screening Checklist

2018-12-14

CTA Renewal Screening Form

2018-12-14

Format of clinical trial report

2018-10-01

Application Form for Amendment of Conditions of a Clinical Trial

2018-10-01

Format of report for terminated clinical trial Regulation 12 (5)

2018-10-01

Letter of authorization from holder of patent of a drug, licensed person or manufacturer of drug

2018-10-01

Declaration by principal investigator

2018-10-01

Declaration by monitor

2018-10-01

Declaration by sponsor and principal investigator of funds of the clinical trial

2018-10-01

Pharmaceutical data on dosage form.

2018-10-01

Application for additional investigators

2018-10-01

Labelling investigational drug products for clinical trial

2018-10-01

Format for investigators brochure

2018-10-01

Format for clinical trial protocol-Regulation 4

2018-10-01

Application Form for Registration of Immunologial Veterinary Product_R0

2018-09-10

Application Form for Variations to a Registered Pharmaceutical Product

2018-09-10

Application Form for GMP Inspection_R2

2017-10-26

Authorization of Drug Promotion Materials

2017-08-17

Application for Publication or Advert for a Drug

2017-08-17

Application form for GMP inspection for finished pharmaceutical products and active pharmaceutical ingredients manufacturing facilities

2017-01-19

Application Form for EAC Joint GMP inspection for finished pharmaceutical products and active Pharmaceutical ingredients manufacturing facilities

2016-12-22

Application for a marketing authorization of a pharmaceutical product for human use submitted to National Drug Authority

2016-06-30