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:
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Act 101 - Veterinary Medicines:
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Review of product information for registration dossiers
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Dossier compilation for medicines registration
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Dossier updates & maintenance
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Package inserts and label compilation and review
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Guidance and advice on cGMP/cGDP/cGWP
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Vendor audits
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Compilation of Standard Operating Procedures
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Compilation of Site/Applicant Master Files
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Licensing applications
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Advertising and Marketing Code compliance
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Act 36 - Farm Feeds, Stock Remedies and Agricultural Remedies
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Registration applications
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Maintenance of registrations (renewals)
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Registration amendments
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Advertising compliance and assistance with development of promotional materials
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Free Sale Certificates
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Import Permits & Master Permits
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Legalisation of documents
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Policy development with regulatory authorities
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Expertise in interpretation of regulations
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Determination of regulatory and legal status of your product
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