Key Contacts

Simphiwe Mabusela

Tel: 012 501 0413
Email: Simphiwe.Mabusela@sahpra.org.za

Vacant

CEOOffice@sahpra.org.za

Communications and PR

media@sahpra.org.za

Ms Dusha Mashishi

Tel: 012 501 0415
salaminah.mashishi@sahpra.org.za

Dr Gontse Moutloatse

Tel: 012 501 1234
gontse.moutloatse@sahpra.org.za

Ms Lillian Kwinika

Tel: 012 501 0373

Email: lillian.kwinika@sahpra.org.za

Simphiwe Matsabe

Tel: 012 015 5474
finance@sahpra.org.za

Naazneen Babamia

Tel: 012 5010323
finance@sahpra.org.za

Malose Teffo

Tel: 012 501 0327
Malose.Teffo@sahpra.org.za

Precious Mnguni

Email: Precious.Mnguni@sahpra.org.za

Takalani Sinyosi

Tel: 012 015 5426
Takalani.Sinyosi@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

COVID-19 Enquiries

MDcovid@sahpra.org.za

TBC

Application Related/Licensing Queries

mdadmin@sahpra.org.za

TBC

Omphile Mokwena

Tel: 012 015 5499
Email: mdvigilance@sahpra.org.za

Luyanda Mahlanza

Tel: 012 501 0401
luyanda.mahlanza@sahpra.org.za

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

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

Edmond Shalang

Tel: 012 501 0318
edmond.shalang@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 Manager

Ntombi Mthembu

Tel: (012) 501 0352
ntombi.mthembu@sahpra.org.za

Renewals Applications and Enquiries

renewals@sahpra.org.za

Ketshepile Serumula

Tel: TBC
ketshepile.serumula@sahpra.org.za

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

Roxanne Noble

Tel: 012 501 0388
roxanne.noble@sahpra.org.za

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

Inspectorate Manager

Samu Motshitela

Tel: 012 015 5465
samu.motshitela@sahpra.org.za

Acting Pharma Licensing Manager

Naven Naidoo

Tel: 012 501 0395
naven.naidoo@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

Pharma Licensing Support

Dikeledi Yvonne Motepe

Tel: 012 501 0360
Email & Microsoft Teams call: dikeledi.motepe@sahpra.org.za

Khotso Bokaba

Tel: 012 501 0475
Email & Microsoft Teams call: khotso.bokaba@sahpra.org.za

Naven Naidoo

Tel: 012 501 0395
Email & Microsoft Teams call: naven.naidoo@sahpra.org.za

Regulatory Compliance Manager

Mokgadi Daphney Fafudi

Tel: 012 015 5434
Cell: 066 301 1878
Mokgadi.fafudi@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 Thandokazi Juqula
  Cell: 068 640 9629
  Thandokazi.Juqula@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

Product-related quality complaints and recalls

Mokgadi Daphney Fafudi

Tel: 012 015 5434
Cell: 066 301 1878
mokgadi.fafudi@sahpra.org.za

Section 36 exemptions

Daphney Mokgadi Fafudi

Tel: 012 015 5434
Cell: 066 301 1878
mokgadi.fafudi@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

Daphney Mokgadi Fafudi

Tel: 012 015 5434
Cell: 066 301 1878
mokgadi.fafudi@sahpra.org.za

Mr Mphako Ratlabyana

Tel: 012 015 5440
Cell: 073 015 9543
mphako.ratlabyana@sahpra.org.za
PEMPre-reg@sahpra.org.za

Ms Suraiya Suliman

Cell: 079 626 7974
Tel:  012 015 5477

suraiya.suliman@sahpra.org.za

Ms Fikile Mokgabudi

fikile.mokgabudi@sahpra.org.za
postregqualityvariations@sahpra.org.za

Kaizer Thembo

Tel: 012 501 0408
kaizer.thembo@sahpra.org.za

PEM: Complementary Unit Licensing

admin@sahpracm.org.za

Biological Medicines

Vacant
biologicals@sahpra.org.za

Veterinary Medicines

Alice Sigobodhla

Cell: 079 400 5796
Tel: 012 501 0426
alice.sigobodhla@sahpra.org.za

General Enquiries

Boitumelo Mahlangu

Tel: 012 501 0344
boitumelo.mahlangu@sahpra.org.za

Clinical Evaluation – Pre-registration

Mahlodi Moropa

Cell: 083 297 2866
Tel: 012 501 0349
mahlodi.moropa@sahpra.org.za

Clinical Evaluation – Post-Registration

Luleka Dhlamini

Cell: 078 855 0154
luleka.dhlamini@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

Kedibone Malatji

Cell: 076 510 8083
Tel: 012 501 0330
kedibone.malatji@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

Pharmacovigilance

Florah Matlala

Cell: 083 387 3358
Tel: 012 501 0497
mafora.matlala@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.

Names and Scheduling

Asia Maluleke

Cell: 083 424 4889
Asia.Maluleke@sahpra.org.za

Deputy Manager: Mr Thabo Nkuna

Tel: 012 501 0486
Email: Thabo.Nkuna@sahpra.org.za

Deputy Manager: Fakazi Nhachissambe

Tel: 031 015 5832
Email: fakazi.nhachissambe@sahpra.org.za

Deputy Manager: Mr Phineas Mahlangu

Tel: 012 015 5413
Cell: 082 817 8732
phineas.mahlangu@sahpra.org.za

Pretoria

Assistant Manager: Ms Mosidi Matjila

Tel: 012 015 5458
mosidi.matjila@sahpra.org.za

Cape Town

Chief Radiation Control Officer: Mr Malcolm April

Tel: 021 015 5508
malcolm.april@sahpra.org.za

Durban

Assistant Manager: Mrs Nyawedzeni Tshinaiwe

Tel: 031 307 2111
nyawedzeni.tshinaiwe@sahpra.org.za

NON-IONISING RADIATION MEDICAL DEVICES (NirMed)

Deputy Manager: Mr Colbert Ditsepu

colbert.ditsepu@sahpra.org.za

General Enquiries: Mr Dithole Seepamore

Tel: 012 501 0451
radcon.enquiries@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:

Veterinary Medicines Technical Requirements:

Tel: 012 501 0426
alice.sigobodhla@sahpra.org.za