Application for SAHPRA GMP (Good Manufacturing Practice) Certificate
Documents required
- Business Cover Letter containing the following information (where applicable):
- The name and physical address of the applicant /HCR
- Name of the foreign site requiring the GMP certificate
- The name and physical address of the manufacturer / packer of the pharmaceutical product
- A copy of the licence(s) issued to the applicant or the local manufacturer/ packer and in terms of the provisions of section 22C (1) (b) of Act 101 of 1965
- Date of the last inspection
- Activity(ies) of the company
- Dosage forms manufactured at the site
- Active Pharmaceutical Ingredients manufactured at the site
- Name of the importing country, if required
- Documents included in the application and reasons for any excluded
- Date of Payment
- Amount paid
- Number of copies requested
- Copy of current SAHPRA License (with activities)
- Copy of current Inspectorate resolution (not older than 3 years)
- Copy of current/expired GMP Certificate (for renewal only)
- Proof of payment, as per SAHPRA latest fees gazette
Application Submission
- All Documents and queries should be submitted to inspectcert@sahpra.org.za
Additional information
- GMP Certificates are issued with a 12 month validity so as to take into account the current GMP status of the site at the time of the GMP certificate application and any enforcement actions that may have been taken against the site that will affect the reissuing of the GMP certificate
- Applicants are advised to apply for a GMP certificate one month (30 days) before the current certificate expires
- For South African GMP requirements, please refer to the SA Guide to Good Manufacturing Practice Guidelines
Application for Certificate of Pharmaceutical Product (CPP Certificate)
All WHO Certificates of Pharmaceutical Products will be issued in accordance with the approved procedure as prescribed by the World Health Organization Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. The objective of the Scheme is to provide importing countries with assurances (i) that a given product has been authorized to be placed on the market in the exporting country, (ii) that the manufacturing plant in which the product is manufactured is subject to inspections at suitable intervals and conforms to requirements for cGMP as recommended by the World Health Organization.
Documents required
The applicant shall attach the following documents to the application:
- Business Cover Letter containing the following information (where applicable):
- Name of the applicant
- Address of the company
- Product name being applied for
- Name of the importing country if required
- Documents included in application and reason for any excluded
- Payment reference number
- Date of payment
- Amount paid
- Number of copies requested
- Application Form (Module 1.2.1)
- Package Insert Module 1.3.1.1 (PI)
- Patient Information Leaflet (PIL) Module 1.3.2
- Current approved Container Label (or facsimile) of the pharmaceutical product Module 1.3.3
- Batch Formula 3.2.P.3.2 (Description & Composition)
- SAHPRA Registration Certificate 1.5.2.2.2 (if not registered – SAHPRA letter stating OLD MEDICINE)
- Fees; Proof of payment, as per SAHPRA latest fees gazette
Application Submission
All Documents and queries should be submitted to inspectcert@sahpra.org.za
Additional information
CPP Certificates are valid for 12 months
Applicants are advised to apply for a CPP certificate one month (30 days) before the current certificate expires.
INSPECTORATE KEY CONTACTS
Senior Manager: Inspectorate and Regulatory Compliance
Deon Poovan
Tel: 012 501 0419
Cell: 065 683 9783
deon.poovan@sahpra.org.za