Services
PHARMACEUTICAL & BIOLOGICAL MEDICINES
Pharmaceutical and Biological Medicines are subject to registration in terms of The Medicines and Related Substances Act; Act 101 of 1965, as amended.
There are particular requirements and processes involved during the registration process for medicines in South Africa and other African Territories.
We offer the following services:
- Due Diligence and guidance related to registration dossiers for New Chemical Entities (NCE’s), Multisource Medicines, Biologicals and Biosimilars
- Dossier compilation for applications for registration
- Dossier amendments/variations, updates & maintenance
- Professional Information/Summary of Product Characteristics, Patient Information Leaflets and Labels – writing and review
- Guidance and advice on current Good Practice (cGxP) expectations
- Self-Inspections & 3rd-Party Compliance Audits
- Design and Implementation of Quality Management Systems
- Writing of Standard Operating Procedures
- Writing of Site Master Files
- Licensing applications
- Dossier Conversions from Legacy formats including creation of eCTD Baselines
- Creating Variation (Amendment) applications
- Compilation of registration dossiers for submission into Africa and, or the various joint review initiatives (Zazibona | WHO)
COMPLEMENTARY MEDICINES
We assist our clients to comply with the current requirements for their individual needs. Our clients have come to rely on our expert advice and prompt service.
On 15 November 2013 and on 25 August 2017, amendments to the General Regulations pertaining to the Medicines Act were published, which defined Complementary Medicines and specified requirements for the South African Packaging: Labels, Package Inserts and Patient Information Leaflets.
The compliance requirements for licensing of facilities importing, exporting, manufacturing and selling Complementary Medicine products and Health Supplements were recently reiterated by the SAHPRA in their Roadmap and Labelling Annexure [https://www.sahpra.org.za/].
WE CAN ASSIST WITH THE FOLLOWING:
Product Classification
Labelling requirements
Data Due Diligence
Dossier compilation
Regulatory authoring for data not available in CTD format
eCTD publishing
Licensing of Facilities
Quality Management System development & implementation
Vigilance expectations
MEDICAL DEVICES & IVDS
The medical device industry encompasses a wide variety of products including In Vitro Diagnostics. The South African Health Products Regulatory Authority (SAHPRA) has issued several guidelines that relate to the regulations published on 9 December 2016 and qualify the compliance expectations.
Companies wishing to sell MDs & IVDs in South Africa are required to be licensed in terms of the Medicines and Related Substances Act (Act 101 of 1965, as amended). The Quality Management expectations are governed by ISO 13485:2016, which was also adopted as a South African National Standard [SANS 13485:2017].
In terms of product registration:
- SAHPRA is currently reviewing comments received on the registration guidelines and forms. Call-ups for registration of MDs and IVDs are awaited as soon as the final guidances are communicated.
- SAHPRA has also been tasked with the responsibility of managing Electromedical Devices in terms of the Hazardous Substances Act (Act 15 of 1973, as amended).
We can assist with the following:
- Product Classifications
- License Applications & Updates
- Design and Implementation of Quality Management Systems, including the creation of Quality Manuals
- Development and Implementation of Standard Operating Procedures
- Collation of Standard Technical Documents
- Review of Labels and IFUs
VETERINARY MEDICINES, FARM FEEDS AND STOCK REMEDIES
Veterinary medicines, like human medicines, are subject to registration.
There are two sets of legislation that govern Health Products for animal use: The Medicines and Related Substances Act [Act 101 of 1965, as amended] and The Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act [Act 36 of 1947, as amended].
Product Classification:
- Determination of regulatory and legal status of your product
- Compliance requirements to meet in terms of the classification of the product
Act 101 – Veterinary Medicines:
- Review of product information for registration dossiers
- Dossier compilation for registration
- Dossier updates & maintenance
- Professional Information and label compilation and review
Act 36 – Farm Feeds, Stock Remedies and Agricultural Remedies
- Review of product information for registration dossiers
- Dossier compilation for registration
- Dossier updates & maintenance
- Free Sale Certificates
COSMETICS
Cosmetics are the subject of the Foodstuffs, Cosmetics and Disinfectants Act, Act 54 of 1972.
The industry in South Africa currently self-regulates using the CTFA (Cosmetic, Toiletries and Fragrances Association) guidance documentation, which is based upon the EU Cosmetic Directive.
Draft regulations, Regulations Relating to the Labelling, Advertising and Composition of Cosmetics, were published for comment on 22 December 2017. The final regulations are awaited.
WE CAN ASSIST WITH THE FOLLOWING:
- Ingredient evaluation
- Labelling requirements
- Permitted claims
- Advertising compliance
FOODSTUFFS
All foodstuffs are controlled through the Foodstuffs, Cosmetics and Disinfectants Act, Act 54 of 1972, which controls the manufacture, importation, marketing and sale of foodstuffs.
There are regular updates to, and new standards for, foodstuffs published in terms of the Standards Act (Act 8 of 2008). These standards guide the quality and other expectations for foodstuffs and food ingredients.
WE CAN ASSIST WITH THE FOLLOWING:
- Ingredient evaluation
- Labelling requirements
- Permitted claims
- Advertising compliance
LICENSING & COMPLIANCE
The varied and dynamic requirements related to compliance for Health Products and the related expectations that pertain to Good Practices (GxP) pose challenges to the implementation strategies and maintenance of systems.
All companies involved in the manufacture, sale and supply of Health Products in South Africa require approvals in the form of licences/permits to conduct their operations.
WE ASSIST WITH THE FOLLOWING:
Preparing & reviewing:
- Site Master Files
- Quality Manuals
- Standard Operating Procedures
- Licence Applications
- Licence Renewals
Conducting:
- Self-Inspections
- Acquisition Due Diligence
- Local & Foreign Manufacturer Audits
- Warehouse & Distribution Facility Audits
Advising during planning stages of activities and envisaged growth or diversification.
Training and Mentoring
We provide project based mentoring for regulatory personnel and bespoke training for your regulatory affairs team.
Training in compliance requirements related to current Good Practice (cGxP) expectations for healthcare products is also offered for:
- Company Executives & Board Members
- (Pharmaco)Vigilance Officers
- GxP for Applicants / Holders of Certificates of Registration
- Regulatory Documents | Authoring & Editing
- Registrations for Africa
- Regulatory Affairs Departments:
- Managers & Responsible Pharmacists
- Pharmacists / Scientists
- Assistants