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Legal
Only a South African entity can be the applicant to be a
registration holder for all products.
The successful
registration of a medicine lies mainly in the ability to prevent unnecessary
delays during the process. This is achieved by understanding the process
pitfalls. We aim to present a quality submission that will avoid undue hold-ups
during the registration process.
Our clients enjoy the regulatory assistance required to ensure a smooth
registration process.
- Protect your Intellectual Properties and
Copyrights
- Protect your company with confidentiality
agreements
- Use By-laws, Shareholders Agreement &
Articles of Incorporation to setup your business
- Better negotiate your office lease
- Sublease extra space
- Review of product
information for registration dossiers for New Chemical Entities (NCE's) and
generic products
- Dossier compilation for
medicine registration
- Dossier updates &
maintenance
- Package inserts, patient
information leaflets and label compilation and review
- Guidance and advice on
cGMP/cGDP/cGWP
- Vendor audits
- Compilation of Standard
Operating Procedures
- Compilation of
Site/Applicant/HCR Master Files
- Licensing applications
- Advertising and Marketing
Code compliance
We can assist with the following:
- Ingredient evaluation
- Labelling requirements
- Permitted claims
- Advertising compliance
We assist with the following:
- Site Master Files
- Quality Manuals
- Standard Operating
Procedures
- Licence Applications
- Conducting and assisting
with:
- Self-Inspections
- Inspections of 3rd
party suppliers
- Local & Foreign
Manufacturer Audits
- Warehouse & Distribution
Facility Audits
Capabilities
Consulting during planning stages of
activities and envisaged growth or diversification.
Veterinary medicines, like human medicines, are
subject to registration in terms of The Medicines and Related Substances Act;
Act 101 of 1965, and The Fertilizers, Farm Feeds, Agricultural Remedies and
Stock Remedies Act; Act 36 of 1947, as amended.
There are particular requirements and processes
involved during the registration process in South Africa and we offer the
following services:
- Act 101 -Orthodox & Veterinary
Medicines:
- Review of product
information for registration dossiers
- Dossier compilation for
medicines registration
- Dossier updates &
maintenance
- Package inserts, patient
information leaflets and label compilation and review
- Guidance and advice on
cGMP/cGDP/cGWP
- Vendor audits
- Compilation of Standard
Operating Procedures
- Compilation of
Site/Applicant Master Files
- Licensing applications
- Advertising and
Marketing Code compliance
- Act 36 - Farm Feeds, Stock
Remedies and Agricultural Remedies
- Registration
applications
- Maintenance of
registrations (renewals)
- Registration amendments
- Advertising compliance
and assistance with development of promotional materials
- Free Sale Certificates
- Import Permits & Master
Permits
- Legalisation of
documents
- Policy development with
regulatory authorities
- Expertise in
interpretation of regulations
- Determination of
regulatory and legal status of your product
Cosmetics are currently self-regulated through
South Africa’s CTFA (Cosmetic, Toiletries and Fragrances Association) guidance
documentation, which is based upon the EU Cosmetic Directive. The statutory
regulations are awaited.
We can assist with evaluation of ingredients,
claims, advertisements and labelling, taking into account the ASA (Advertising
Standards Authority) Code of Advertising Practice.
All foodstuffs are controlled by the
Foodstuffs, Cosmetics and Disinfectants Act, Act 54 of 1972, which controls the
sale, manufacture and importation of foodstuffs.
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