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Category SelectSelect Medical Product Dossier Evaluation and Registration Good Manufacturing Practices and Inspections Clinical Trials, Pharmacovigilance and Medicines Safety Quality Control Laboratories Quality Management Systems Information Management Systems Policy, Legislation and Regulation

Abstract This guidance document is technically and structurally inspired by the World Health Organisation’s Variation Guideline (TRS 981 Annex 3) on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. It is intended to provide supportive information on how to present an application to implement a change to a product. An applicant is responsible for the safety, efficacy and quality of a product throughout its life-cycle. Therefore, the applicant is required to make changes to the details of the product in order to accommodate technical and scientific progress, or to improve or introduce additional safeguards for the registered product. Such changes, whether administrative or substantive, are referred to as variations and may be subject to acceptance by WAHO prior to implementation. Technical requirements for the different types of variations are set out in these guidelines in order to facilitate the submission of appropriate documentation by applicants and their assessment by WAHO and to ensure that variations to the medicinal product do not result in health concerns. The procedure for submitting variation applications is provided as an Annexure to this guideline lines.

Document Status Select Active Inactive Archived

Document Type Select Guideline Manual