| Submissions to SAHPRA |
| New Medicine, Variation, License, Renewal Applications |
Applications/submissions via sFTP will continue, however, applications received after 19 December 2025 will only be processed from 05 January 2026. |
| Lot Release Applications |
Lot release applications must reach SAHPRA by 10 December 2025 at 13:00 to allow for the administrative processing and samples to be sent to the laboratory this year. Samples must reach the South African National Control Laboratory for Biological Products (SANCLBP) on or before 12 December 2025. |
| Submission of Section 22A permit applications |
Permits required by 15 December 2025 must be submitted to SAHPRA by 12December 2025. Section 22A permits sec22a_permits@sahpra.org.za |
| Ports of Entry |
SAHPRA Border Medicines Control Technicians will be operating at the legislated ports of entry during the administrative closure. |
| Detained Complementary Products at the Ports of Entry |
Queries related to detained complementary products at the ports of entry should be sent to: CMDetained@sahpra.org.za. Requests submitted between 23 December 2025 and 04 January 2026, will only be processed from 05 January 2026. |
| Pharma Licensing |
Dedicated proxy mailbox for submission of licence applications: gmplicensing@sahpra.org.za |
| Veterinary Medicines Section 21 |
Queries related to veterinary medicines should be sent to: pervetS21@sahpra.org.za (up to 24 Dec 2024 only and from 05 January 2026 onwards). |
| Complementary Medicines Section 21 |
Queries related to complementary medicines should be sent to: CMS21@sahpra.org.za. Requests submitted between 23 December 2025 and 04 January 2026, will only be processed from 05 January 2026. |
| Renewal (Medicines) |
Queries related to the renewal of the certificate of registration for medicines should be sent to: renewals@sahpra.org.za. |
| Key Contacts during December 2025 |
| Health Products Authorisations (HPA) |
HPA queries should be sent to: pratibha.sobrun@sahpra.org.za (01 – 24 Dec 2025) santhani.chetty@sahpra.org.za (01 – 12 Dec 2025) ntombi.mthembu@sahpra.org.za (01 – 24 Dec 2025) |
| Clinical Evaluation Management (CEM) |
Acting Senior: CEM – Dr Shyamli Munbodh Shyamli.munbodh@sahpra.org.za (01 – 24 Dec 2025) Post Reg queries should be sent to: luleka.dhlamini@sahpra.org.za (01 – 24 Dec 2025) N&S queries should be sent to: Asia.Maluleke@sahpra.org.za (01-19 Dec 2025) Tarryn.Thaver@sahpra.org.za 01 – 24 Dec 2025) S21 queries should be sent to: section21@sahpra.org.za Manager: Dr Shyamli Munbodh Shyamli.munbodh@sahpra.org.za Duduzile Rapodile duduzile.rapodile@sahpra.org.za Ebenezer Minlah ebenezer.minlah@sahpra.org.za Pre-reg unit queries should be sent to: Acting Manager: Ms Esmerelda Jassen (01 – 24 Dec 2025) Esmerelda.Jassen@sahpra.org.za Acting Manager: Ms Siphokazi Sibisi (05 January to 14 January 2026) Siphokazi.Sibisi@sahpra.org.za PV queries should be sent to: pvqueries@sahpra.org.za |
| Pharmaceutical Evaluation Management (PEM) |
PEM post reg queries should be sent to: Postregqualityvariations@sahpra.org.za (01-24 Dec 2025) Biologicals Pre-reg- status enquiries should be sent to preregstatusupdate@sahpra.org.za and for technical queries to nokuthula.mayela@sahpra.org.za Variation status enquiries should be sent to variations@sahpra.org.za , and for technical queries nokuthula.mayela@sahpra.org.za Z codes to Biologicals@sahpra.org.za |
| Clinical Trials |
Clinical Trials queries should be sent to: Manager – Kedibone Malatji (01 – 12 Dec 2025) kedibone.malatji@sahpra.org.za Cell: 076 510 8083 Dominicah Thosago (15 – 19 Dec 2025) Dominicah.thosago@sahpra.org.za Tel: 012 501 0331 Ms Ayanda Sam (22 – 24 Dec 2025) Ayanda.Sam@sahpra.org.za Tel: 012 501 0417 |
| Inspectorate and Regulatory Compliance |
Licence Enquiries for Regulatory compliance: – mokgadi.fafudi@sahpra.org.za (066 3011878) Inspectorate Enquiries: Samu.motshitela@sahpra.org.za (012 015 5465)- (01-12 Dec 2025) Inspection reports, resolution letters & responses Enquiries: inspectorate@sahpra.org.za IRC Enquiries: lebohang.mazibuko@sahpra.org.za (012 015 5713) (01 -18 Dec 2025) Variations Enquiries: variations.inspectorate@sahpra.org.za (01-24 Dec 2025) GMP Certificate/CPP Enquiries: inspectcert@sahpra.org.za (012 015 5467) (01-19 Dec 2025) PITE Enquiries: PITEapplications@sahpra.org.za Once Off: onceoffdeviations@sahpra.org.za (012 501 0449) (01-18 Dec2025) |
| Pharma Licensing |
Pharma Licensing Enquiries: naven.naidoo@sahpra.org.za (012 501 0395) – (01 – 19 Dec 2025) |
| Ports of Entry |
OR Tambo International Airport
Ms Khutso Mehlape (01-19 Dec 2025) Cell: 068 491 0320 Khutso.mehlape@sahpra.org.za Ms Thandokazi Juqula (01 Dec 2025-13 Jan 2026)
Cell: 068 640 9629
Thandokazi.Juqula@sahpra.org.za Durban Harbour
Mr Wandile Myeni (01-12 Dec 2025 & 29 Dec 2025-13 Jan 2026)
Cell: 071 028 1585
Wandile.Myeni@sahpra.org.za Ms Lulamela Mlindazwe (01 Dec 2025-13 Jan 2026) Cell: 0659496190 Lulamela.Mlindazwe@sahpra.org.za King Shaka International Airport (Durban) Ms Nwabisa Ndolo (01-15 Dec 2025 & 05- 13 Jan 2026)
Cell: 067 232 0906
Nwabisa.Ndolo@sahpra.org.za Ms Lulamela Mlindazwe (17 Dec 2025-02 Jan 2026) Cell: 0659496190 Lulamela.Mlindazwe@sahpra.org.za PE International Airport and Harbour
Mr Lunika Gobeni (01-19 Dec 2025 & 29 Dec 2025-13 Jan 2026)
Cell: 071 443 3697
Lunika.Gobeni@sahpra.org.za Ms Lerato Mabinza (22-24 Dec 2025 remote, no inspections)
Cell: 072 385 6695
Lerato.Mabinza@sahpra.org.za Cape Town International Airport and Harbour Ms Lerato Mabinza (22-31 Dec 2025 & 02-05 Jan 2026)
Cell: 072 385 6695
Lerato.Mabinza@sahpra.org.za Ms Bongiwe Taboshe(01-12 Dec 2025 & 18 Dec 2025-13 Jan 2026) Cell: 076 624 4650 Bongiwe.Taboshe@sahpra.org.za For all escalations contact Educate Sebotsi@sahpra.org.za (01-24 Dec 2025) Cell- 081 036 4739 |
| Radiation Control and Medical Devices |
Medical Devices (New, Amendment, Renewal Applications) Applications: mdadmin@sahpra.org.za Payments: MDNotification@sahpra.org.za General Enquiries: Omphile.Mokwena@sahpra.org.za (01-24 Dec 2025) June.Searela@sahpra.org.za (01-24 Dec 2025) Medical Devices Registration Subunit All applications (registration, clinical, RUO section 36, CFS): mdreg@sahpra.org.za Queries: mdreg@sahpra.org.za Individual contact availability: lydia.motlogelwa@sahpra.org.za (01 – 24 Dec 2025) khanyisile.nkuku@sahpra.org.za (01 – 15 Dec 2025) Thamar Gudza (01-23 Dec 2025) Portia Motsoeneng (01-17 Dec 2025) Mahlori Mkhabele (01-24 Dec 2025) NirMed – Remotely Colbert Ditsepu (01 Dec 2024 to 04 Jan 2025): colbert.ditsepu@sahpra.org.za Mercy Nawa (01 Dec 2024 to 04 Jan 2025): mercy.nawa@sahpra.org.za Robyn Nimmerhout (01 Dec 2024 to 04 Jan 2025): robyn.nimmerhout@sahpra.org.za Enquiries: Nirmed.equiry@sahpra.org.za Radionuclides fakazi.nhachissambe@sahpra.org.za dithole.seepamore@sahpra.org.za boitshoko.diale@sahpra.org.za molatudi.koena@sahpra.org.za Enquiries: radionuclides@sahpra.org.za X-Ray Licensing mqondisi.maphophe@sahpra.org.za debbie.coetzee@sahpra.org.za lazola.nobecu@sahpra.org.za natalie.dekoker@sahpra.org.za Applications: rcdealer.xrays@sahpra.org.za rcdent.xrays@sahpra.org.za import.xrays@sahpra.org.za |
