Key Contacts

Email: CEOOffice@sahpra.org.za

Ms Dusha Mashishi

salaminah.mashishi@sahpra.org.za

Dorothy Nkele

Email: dorothy.Nkele@sahpra.org.za

HR Enquiries

Email: HRenquiries@sahpra.org.za

Finance Enquiries

finance@sahpra.org.za

SCM Enquiries

scm@sahpra.org.za

PEM: Complementary Medicines Section 21

CMS21@sahpra.org.za

Veterinary Medicines Section 21 Requests

pervetS21@sahpra.org.za

Medical Devices Enquiries

mdqueries@sahpra.org.za

Application Related/Licensing Queries

mdadmin@sahpra.org.za

Email: recalls@sahpra.org.za

Email: mdvigilance@sahpra.org.za

Request for an eCTD/eSubmission identifier number (Application number)
applicationnumbers@sahpra.org.za

Pre- registration status updates:
Preregstatusupdates@sahpra.org.za

Request for an identifier number (application number) for Veterinary medicine:

vetmedicines@sahpra.org.za

Request for an identifier number (application number) for Complementary medicines:

camsmedicines@sahpra.org.za

Renewals Applications and Enquiries

renewals@sahpra.org.za

Queries relating to Business-As-Usual variation applications:
variationsuploadqueries@sahpra.org.za – For upload queries of applications that are not on the variations status checker

Submission of all Business-As-Usual variation registration certificate templates:
certificationvariations@sahpra.org.za

Email: inspectorate@sahpra.org.za

Dedicated Email Address for Licence Application for Pharmaceutical/GMP/Medicine  ONLY; of Manufacturers, Importers, Exporters and Wholesalers. Any other application will be automatically deleted.
gmplicensing@sahpra.org.za

Site Master File dedicated email address for submission of site master files and queries ( for pharmaceutical facilities only and NOT for Medical Device Establishments): smf@sahpra.org.za

Import And Export Permit Applications

Dedicated email address for import and export permit applications:

sec22a_permits@sahpra.org.za

Port Release

• OR Tambo International Airport
  Ms Aphiwe Mkula
  Cell: 063 382 6764
  Tel: 012 501 0419
  aphiwe.Mkula@sahpra.org.za

• Durban Harbour
  Mr Wandile Myeni
  Cell: 071 028 1585
  Wandile.Myeni@sahpra.org.za

• King Shaka International Airport (Durban)
  Ms Nwabisa Ndolo
  Cell: 067 232 0906
  Nwabisa.Ndolo@sahpra.org.za

• PE International Airport and Harbour
  Ms Tsakane Mashaba
  Cell: 071 443 3697
  tsakane.mashaba@sahpra.org.za

• Cape Town International Airport and Harbour
  Ms Lerato Mabinza
  Cell: 072 385 6695
  Lerato.mabinza@sahpra.org.za

Cannabis cultivation licence applications and any other cannabis related matters

Ramarumo Chepape

Tel: 012 015 5459
Cell: 082 492 4955
ramarumo.chepape@sahpra.org.za

Email: PEMPre-reg@sahpra.org.za

Ms Suraiya Suliman

Email: postregqualityvariations@sahpra.org.za

PEM: Complementary Unit Licensing

admin@sahpracm.org.za

Email: Biologicals@sahpra.org.za

Email: VETqueries@sahpra.org.za

Email: margaret.malatji@sahpra.org.za

For all clinical amendment queries:

variations@sahpra.org.za

For priority amendment application queries, USRN applications submission notifications and other priority notifications:

prioritycvariations@sahpra.org.za

New clinical trials application alert, Responses to new Clinical Trial applications and related queries:

ctcresponses@sahpra.org.za

Protocol amendments, responses to amendments and related queries:

ctcamendments@sahpra.org.za

Additional Investigators and Sites, responses to additional and related queries:

ctcinvestigators@sahpra.org.za

Bioequivalence studies, BE amendments, responses to BE studies and related queries:

ctcbeprotocols@sahpra.org.za

Notifications and related queries:

ctcnotifications@sahpra.org.za

Individual Patient Serious Adverse Events and related queries:

ctcsaes@sahpra.org.za

SAHPRA Guidelines, Forms and related queries:

CTCGuidelines@sahpra.org.za

For submission of:

• ADR reports in an e2b in an xml format: e2b@sahpra.org.za
• All other Adverse Drug Reaction (ADR) reports: adr@sahpra.org.za
• Pharmacovigilance-related queries:
  • pvqueries@sahpra.org.za
• Documentation relating to identified safety concerns, responses to PV recommendations, PSURs/PBRER, Risk Management Plans (RMPs): pvsubmissions@sahpra.org.za

Please refrain from sending one document to all email addresses as this create duplication of reporting and misuse of resources.

Email: namesandscheduling.variations@sahpra.org.za

General Enquiries

Email: radcon.enquiries@sahpra.org.za

Reporting of Radiation Incident:

Email: Radcon.incidence@sahpra.org.za

Status of applications after checking the tracker:

Tel: 012 501 0318
vetqueries@sahpra.org.za

Registration certificates for all new vet applications for registration:

Tel: 012 501 0318
newvetcertificates@sahpra.org.za

Request for Application Numbers:

Tel: 012 501 0318
vetmedicines@sahpra.org.za

Section 21s and Clinical Trial Applications:

Tel: 012 015 5449
pervetS21@sahpra.org.za

Submissions of Special Requests and Projects:

Tel: 012 501 0426
pervetqueries@sahpra.org.za: