Form Archives - SAHPRA

30 Mar Application Form: Rescheduling of a Substance or Medicine

Posted at 11:23h in

The applicant is to ensure that all relevant fields are completed on the application form and that all supporting documentation is attached. Incomplete applications will be identified as deficient, and the evaluation review will not be progressed until deficiencies are addressed. A completed application...

27 Mar Application for Certificate of Free Sale for Medical Devices

Posted at 09:31h in

03 Oct Signal Notification/ Follow-up Form

Posted at 10:08h in

The purpose of the form is to guide SAHPRA’s holders of certificates of registration about the details required and elements to be considered in the process of signal notification and follow-up. This form should be used to notify signals and Follow-Up information on signals according...

09 Sep Application for Clinical Investigation of Medical Devices

Posted at 10:44h in

20 Aug Sameness Declaration Form for Reliance-based Models

Posted at 16:24h in

23 Jul CTD Checklist

Posted at 10:39h in

The checklist must be included in submissions that include variations for CTD conversions. This checklist should also be included as an annexe to the cover letter for the baseline sequence when converting from eSubmission to eCTD....

23 Jul Z-Code Request Form

Posted at 10:37h in

Populate this information on a document that includes your company letterhead....

24 Apr Licence Application for the Importing and the Distribution Scheduled Substances

Posted at 11:21h in

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...

22 Mar Section 21 Emergency Medicines Bulk Application Form

Posted at 13:43h in

Request For Use of An Unregistered Product In Terms of Section 21 of Act 101 of 1965...

29 Feb Application Form of The Renewal of Authority to Acquire, Possess, Use, Convey and/or Distribute Radioactive Nuclides

Posted at 13:14h in

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