An application form to obtain a licence or renew/amend a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D read together with Regulation 23 and 24 of the General Regulations to the Medicines Act as the case...
Request For Use of An Unregistered Product In Terms of Section 21 of Act 101 of 1965...
This application form should be included in the South African Common Technical Document – Module 1 Administrative Information. The application form is to be used for an application for registration, variation or renewal of a medicinal product for Human or Veterinary use submitted to the South...
Owner Consent Form - Use of an Unregistered Veterinary Product...
This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...
Request For Use of an Unregistered Product In Terms Of Section 21 Of Act 101 of 1965...
The application form shall be used for an application for lot release of a human vaccine submitted to the South African Health Products Regulatory Authority....
This is the primary application form for applicants to use in case of an application for additional investigators or change of investigator(s)/sites and application for additional sites....
This is the primary application form for applicants to use for the purpose of amending an already approved study protocol....