KEY CONTACTS

OFFICE OF THE CHIEF EXECUTIVE OFFICER

Chief Executive Officer

Dr. Boitumelo Semete-Makokotlela

Boitumelo.Semete@sahpra.org.za

Tel:

Office Manager: Office of the CEO

Ms Mukona Mphidi

mukona.mphidi@sahpra.org.za 

CEOOffice@sahpra.org.za

Tel: 081 381 2763

Chief Regulatory Officer

Portia Nkambule

Tel:078 820 0781
portia.nkambule@sahpra.org.za

Assistant Director

Ms Setlola Molepo
Tel: 071 605 1508
setlola.molepo@sahpra.org.za

Website Related Inquiries

Yuven Gounden
Tel: 066 120 2669
yuveng@sahpra.org.za

FINANCE & ADMINISTRATION

Chief Financial Officer

Molatlhegi Kgauwe

082 930 7090

Financial Manager

Simphiwe Matsabe
Tel:073 654 7680
finance@sahpra.org.za

MEDICAL DEVICES

Senior manager : Medical Devices and Radiation Control

Andrea Julsing Keyter
Tel:
082 062 2594
andrea.julsing@sahpra.org.za

For all medical device queries related to COVID-19: MDcovid@sahpra.org.za

June Searela

june.searela@sahpra.org.za

072 828 2416 – General licensing queries

 

Matlapeng Shabalala

Matlapeng.Shabalala@sahpra.org.za

071 302 0409 – Applications for licences (for medical devices related to COVID-19)

 

Khanyisile Nkuku

Khanyisle.Nkuku@sahpra.org.za

081 854 7109 – Applications for licences (for medical devices related to COVID-19)

 

HEALTH PRODUCTS AUTHORISATION

New medicine applications

Santhani Chetty
071 386 0867
santhani.chetty@sahpra.org.za

Request for an eCTD/eSubmission identifier number (Application number)
applicationnumbers@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

Queries relating to all Business-As-Usual variation applications, specifically requiring certification.
Submission of all Business-As-Usual variation registration certificate templates
certificationvariations@sahpra.org.za

Project Office

Buhle Binta

Queries relating to all Business-As-Usual new medicines applications
newmedicines@sahpra.org.za

Queries relating to all Business-As-Usual variations applications
variations@sahpra.org.za

INSPECTORATE & REGULATORY COMPLIANCE

Senior Manager: Inspectorate and Regulatory Compliance

Deon Poovan
Tel: 065 683 9783

deon.poovan@sahpra.org.za

Pharma Licensing Manager

Jerry Molokwane

076 422 4934
jerry.molokwane@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

GMP/CPP Certificates: dedicated email address is  gmplicensing@sahpra.org.za

Contact person

Mr Bafana Malaza

072 529 9555

Queries and Follow Up on GMP Pharma Licence applications only : jerry.molokwane@sahpra.org.za  and dikeledi.motepe@sahpra.org.za

 

Queries and Follow Up on GMP/CPP certificates  only: bafana.malaza@sahpra.or.za and ella.tshabangu@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

Contact Person is

Mr Laurence Moakamela

072 395 3288

Pharma Licensing Support:

Ms Dikeledi Yvonne Motepe

Microsoft Teams call dikeledi.motepe@sahpra.org.za

Email: Dikeledi.motepe@sahpra.org.za

IMPORT AND EXPORT PERMIT APPLICATIONS

Dedicated email address for import and export permit applications:

sec22a_permits@sahpra.org.za

PORT HEALTH RELEASE

Daphney Mokgadi Fafudi

Tel: 066 301 1878

mokgadi.fafudi@sahpra.org.za

Inspectorate

Enos Motshitela
Tel: 082 462 3727
samu.motshitela@sahpra.org.za

INSPECTORATE ACTING DEPUTY DIRECTOR

Susan Khoza

064 870 8702

Susan.khoza@sahpra.org.za

Naming & Scheduling

Momeena Omarjee
Tel:
082 524 1348
momeena.omarjee@sahpra.org.za

Regulatory Compliance Acting Deputy Director

Mlungisi Wondo
Tel: 082 256 2626
mlungisi.wondo@sahpra.org.za

Product-related quality complaints and recalls

Mlungisi Wondo
Tel: 082 256 2626
mlungisi.wondo@sahpra.org.za

Section 36 exemptions

Daphney Mokgadi Fafudi
Tel: 066 301 1878
mokgadi.fafudi@sahpra.org.za

Cannabis cultivation licence applications and any other cannabis related matters

Ramarumo Chepape
Tel: 082 492 4955
ramarumo.chepape@sahpra.org.za

 

Daphney Mokgadi Fafudi
Tel: 066 301 1878
mokgadi.fafudi@sahpra.org.za

PHARMACEUTICAL EVALUATION

Senior Manager: Pharmaceutical Evaluation

Silverani Padayachee

082 688 9955

silverani.padayachee@sahpra.org.za

Pre-registration

PEMPre-reg@sahpra.org.za

073 851 2416

Post-registration Amendments

Themba Nukeri

Tel:081 307 6910

themba.nukeri@sahpra.org.za

Fikile Mokgabudi

fikile.mokgabudi@sahpra.org.za

PriorityQvariations@sahpra.org.za

Complementary Medicines

Kaizer Thembo
Tel:
071 134 3709

kaizer.thembo@sahpra.org.za

 

PEM: Complementary medicines Section 21
Tel:

CM21@sahpra.org.za

 

PEM: Complementary unit Licensing

admin@sahpracm.org.za

Contact telephone number: 0711343709

Biological Medicines

Khamusi Mutoti
Tel:
071 302 2135
khamusi.mutoti@sahpra.org.za

biologicals@sahpra.org.za

Veterinary Medicines

Alice Sigobodhla
Tel:
079 400 5796

alice.sigobodhla@sahpra.org.za

 

Veterinary medicines Section 21 requests
Tel:

pervetS21@sahpra.org.za

CLINICAL EVALUATION & MANAGEMENT

Senior Manager: Clinical Evaluation
Management

Tohlang Sehloho
Tel:
082 302 0222
tohlang.sehloho@sahpra.org.za

Clinical evaluation – Post-registration

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

For all other queries or urgent queries:

Ntombi Mthembu
ntombi.mthembu@sahpra.org.za

or

Hitekani Mabunda

hitekani.mabunda@sahpra.org.za

New Clinical Applications

Mahlodi Moropa
Tel:
mahlodi.moropa@sahpra.org.za

newmedicines@sahpra.org.za for new clinical applications queries

Clinical Trials

Kedibone Malatji
Tel:
kedibone.malatji@sahpra.org.za

or

Ms Dominicah Thosago

dominicah.thosago@sahpra.org.za

ctcresponses@sahpra.org.za for Responses to new Clinical Trial applications and related queries

ctcamendments@sahpra.org.za for Protocol amendments, responses to amendments and related queries

ctcinvestigators@sahpra.org.za for Additional Investigators & Sites, responses to additional Investigators & Sites and related queries

ctcbeprotocols@sahpra.org.za for Bioequivalence studies, BE amendments, responses to BE studies and related queries

ctcnotifications@sahpra.org.za for Notifications and related queries

ctcsaes@sahpra.org.za for Individual Patient Serious Adverse Events and related queries

ctcguidelines@sahpra.org.za for Clinical Trials conduct guidelines and related queries

Pharmacovigilance

Florah Matlala
Tel:
083 387 3358
mafora.matlala@sahpra.org.za

 

adr@sahpra.org.za for ADR reporting

pvqueries@sahpra.org.za for Vigilance queries

Section 21 Orthodox Medicines for Human Use

Shyamli Munbodh
Tel:
Cell: 072 134 4546
shyamli.munbodh@sahpra.org.za

Adelaide Molatoli
Cell: 063 771 8906
adelaide.molatoli@sahpra.org.za

For Section 21 enquiries:

Email: section21@sahpra.org.za
Tel:

Section 21 for Veterinary Medicines – see section Veterinary Medicines

Section 21 for Complementary Medicines – see section Complementary Medicines

RADIATION CONTROL

Senior manager : Medical Devices and Radiation Control

Andrea Julsing Keyter
Tel:
082 062 2594
andrea.julsing@sahpra.org.za

Acting Director

Emma Snyman
Tel: 021 957 7444
Cell: 082 3199 173
emma.snyman@sahpra.org.za

Licensing queries

Debbie Coetzee
021 957 7443 Debbie.coetzee@sahpra.org.za

Licensing queries

Yusuf Trichardt
Tel: 021 975 5441
yusuf.trichardt@sahpra.org.za

Inspectorate (Pretoria)

Esther Matabane
Tel:
076 402 8179
Esther.matabane@sahpra.org.za

Inspectorate (Cape Town)

Malcolm April
Tel: 021 957 7469
Malcolm.april@sahpra.org.za

Inspectorate (Durban)

Manigai Chetty

Tel: 031 307 2111

Deputy-director: Non-ionizing radiation and Medical Devices

Leon du Toit
Tel: 021 957 7483
leon.dutoit@sahpra.org.za

Andrea Julsing Keyter

Tel: 012 8427585

082 062 2594

andrea.julsing@sahpra.org.za

BACKLOG PROJECT

Programme Manager: Backlog Clearance Project

MS Lorraine Danks

082 337 7972

lorraine.danks@sahpra.org.za

backlog@sahpra.org.za