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

To facilitate resolving your query, please send an email to all of these email addresses before you call. Your email must include essential information such as the application number, a description of your query, screenshots and your contact number.

Medical Devices Enquiries

mdqueries@sahpra.org.za

COVID-19 Enquiries

MDcovid@sahpra.org.za

Email: recalls@sahpra.org.za

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:
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 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

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

Nokuthula Edith Mayela

Tel: 012 015 5447
Nokuthula.mayela@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.

To facilitate resolving your query, please send an email to all of these email addresses before you call. Your email must include essential information such as the application number, a description of your query, screenshots and your contact number.

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