With the need for converting old format submissions to CTD format comes the opportunity for Market Authorization Holders (MAH) to plan and be ready for electronic submissions. From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines). In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African common technical document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format. Regulatory Operations Submissions Publishing The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.Īpplications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country. The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application. 101 of 1965 and the Regulations and Guidelines published in terms thereof.Ī written notification from the Minister to the effect that the medicine is considered essential to national health an expert report (which is not more than 2 (two) years old a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application. Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council’s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved.The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers.Under Section 22C of the Act, all South African manufacturers should be licensed.Medicines Control Council’s (MCC) general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP). The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken.Regular periodic or rolling quality reviews of all registered medicinal products, including export only products are conducted. Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.
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