RegiPharm

  • Orthodox / Allopathic Medicines

    There are particular requirements and processes involved during the registration process for medicines in South Africa and we offer the following services...

  • Complementary Medicines

    Our aim is to clarify the often confusing issues surrounding the complementary medicines industry. 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.

  • Cosmetics

    We can assist with evaluation of ingredients, claims, advertisements and labelling, taking into account the ASA (Advertising Standards Authority) Code of Advertising Practice.

  • Foodstuffs

    All foodstuffs are controlled by the Foodstuffs, Cosmetics and Disinfectants Act, Act 54 of 1972, which controls the manufacture, importation, marketing and sale of foodstuffs.

  • Veterinary Medicines, Farm Feeds and Stock Remedies

    There are particular requirements and processes involved during the registration process in South Africa we can assist with the following...

  • Licensing of Facilities and GMP

    Depending on the business and its intended activities, all pharmaceutical companies in South Africa require licensing with both the Medicines Control Council and the Department of Health.

Veterinary Medicines, Farm Feeds and Stock Remedies

Veterinary medicines, like human medicines, are subject to registration in terms of The Medicines and Related Substances Act; Act 101 of 1965, or 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 - Veterinary Medicines:
    • Review of product information for registration dossiers
    • Dossier compilation for medicines registration
    • Dossier updates & maintenance
    • Package inserts 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
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