Update on November 2nd New Submissions SAHPRA.

Importance: High

Update dated: 1st November:

Continued closure of Civitas building and on-going work activities at SAHPRA.

Please find in this link here, the change of the name of the MCC bank account to SAHPRA.

The MCC bank account has been transferred to SAHPRA - same account number, just change in name. Applicants need not be concerned about payments already made to MCC - these will automatically be reflected for SAHPRA.

Continued closure of Civitas building and on-going work activities at SAHPRA.

Communication released can be downloaded here.

The Director-General of Health issued a communication to all employees that the prohibition notice must be adhered to and employees have to vacate the building with immediate effect.

We are urgently exploring options for interim office space to allow for the continuation of essential services while the process to procure new premises for SAHPRA is in progress.

Please note the following regarding deliveries to SAHPRA:

• The delivery of paper documents to SAHPRA this week, initially arranged for 01 November 13h00 – 14h00, will not be possible.

The new submission date for clinical trial applications, initially scheduled for 02 November 2018, will be communicated in due course.

Applicants will be contacted regarding the collection of registration certificates, and individual arrangements will be made at the time.

• Please refer to the communication 9.113 for the submission procedure for Section 21 authorisations (orthodox medicines for human use only), and communication 9.114 regarding the submission of post marketing pharmacovigilance correspondence.

• With regard to the submission of Type B pharmaceutical amendments (communication 9.115), the alternative arrangements for submission will also be communicated shortly.

The emergency contact numbers are the following:

Ms Portia Nkambule (Acting CEO): 078 802 0781

Mrs Estelle Taute – Submissions (other than Section 21): 079 528 7755

Mrs Santhani Chetty – Registration certificates: 071 386 0867

Dr Dorah Diale – Clinical Trials: 060 548 4332

Dr Shyamli Munbodh – Section 21 Orthodox medicines for human use only: 072 134 4546

Ms Adelaide Molatoli – Section 21 Orthodox medicines for human use only: 063 771 8906

Mr Tohlang Sehloho – Safety notifications: 082 302 0222

Ms Florah Matlala – Pharmacovigilance: 083 387 3358

NADEMC – 021 447 1618

Mr Khamusi Mutoti – Biological Medicines - Vaccines: 071 302 2135

Dr Alice Sigobodhla – Section 21 Veterinary medicines: 074 379 1178

Mr Griffith Molewa – Permits, Section 36 exemptions: 071 604 7751

Mr Jerry Molokwane – GMP, WHO CPP certificates and any other Inspectorate related activities: 076 422 4934

Mr Mlungisi Wondo – Product Quality Related Complaints and Possible Recalls: 082 256 2626

Ms Daphney Mokgadi Fafudi – Section 36 Exemptions: 066 301 1878

Dr Kaizer Thembo – Section 21 Complementary medicines: 071 134 3709

Ms Andrea Julsing Keyter – Medical devices & IVDs: 082 062 2594

SAHPRA will offer continued guidance to stakeholders while attempts to resolve the situation regarding office space continue.

Ms P Nkambule

Acting Chief Executive Officer