guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical Producta variation can be approved by NDA. Four categories of changes that requireapplication for variations have been provided in the <strong>guidelines</strong>. These includenotifications, minor changes, major changes and changes that make a newapplication.Changes are classified as major only in those instances where the level ofrisk is considered to be high and it is deemed necessary to provide NDA withadequate time for an assessment of the supporting documentation. Decisionson such changes shall be made by the NDA Licensing and Amendments ReviewCommittee (LARC).Particular circumstances are identified where lower reporting requirements (AN,IN or Vmin) are possible.The change categories are organized according to the structure of the CommonTechnical Document (CTD). Specific CTD sections have been identified forindividual data requirements in order to assist in the filing of documentation.In addition, the guideline assists in understanding the possible consequencesof the listed changes, and may be useful as a risk management tool to promoteor enhance best practices within organizations.The Guideline is an administrative instrument and allows for flexibility inapproach. Alternate approaches to the principles and practices described inthis document may be acceptable provided they are supported by adequatejustification. Alternate approaches should be discussed in advance with NDAto avoid the possible finding that applicable regulatory requirements have notbeen met.As a corollary to the above, it is equally important to note that NDA reservesthe right to request information or material, or define conditions not specificallydescribed in this guideline, in order to allow for adequate assessment of safety,efficacy or quality of the pharmaceutical product. NDA is committed to ensuringthat such requests are justifiable and that decisions are clearly documented.Doc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 2 of 70
Guidelines on Variations to a Registered Pharmaceutical Product2. BACKGROUNDThe requirements specified in the Guidelines have been adapted from the currentWHO Guidance on Variations to a Prequalified Product, the European UnionInstitutions and Bodies Commission’s Guideline on the details of the variouscategories of variations to the terms of marketing authorizations for medicinalproducts for human use and veterinary medicinal products and Health Canada’sGuidance Document Post-Notice of Compliance (NOC) Changes: Quality. It isintended to provide supportive information on how to present an application toimplement a change to a product.An applicant is responsible for the safety, efficacy and quality of a productthroughout its life-cycle. Necessarily, therefore, the applicant is required tomake changes to the details of the product in order to accommodate technicaland scientific progress, or to improve or introduce additional safeguards for theprequalified product. Such changes, whether administrative or substantive, arereferred to as variations and may be subject to acceptance by NDA prior toimplementation.Technical requirements for the different types of variations are set out in thisguideline in order to facilitate the submission of appropriate documentation byapplicants and their assessment by NDA and to ensure that variations to themedicinal product do not give rise to public and animal health concerns.1.1 Objectives1.2 ScopeThis guideline is intended to:a) assist applicants with the classification of changes made to a registeredFPP;b) provide guidance on the technical and other general data requirements tosupport changes to the quality, safety and efficacy attributes of the activepharmaceutical ingredient (API) or FPP.This guideline applies to applicants intending to make changes to the differentsections of product dossiers for an API or an FPP of a registered pharmaceuticalproduct. This guideline should be read in conjunction with other applicable<strong>guidelines</strong> including the Guidelines on submission of Documentation forDoc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 3 of 70
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