Post-approval Changes


Post-approval changes can arise throughout the lifecycle of a drug product and must be addressed appropriately.  After the product approval and during the commercialization of drug products, manufacturers may propose certain changes to a product and/or active substance for many reasons such as optimising operational costs, increasing productivity, administrative reasons, etc.  

Evaluation of such changes must determine whether a submission to the relevant health authorities is necessary, and if it is, a variation package must be prepared.  The submission required might be a Type IA, IA, IB or Type II variation package, depending on the categorization of change in accordance with the relevant variation guidelines.   

Changes requiring prior to health authority approval must only be implemented after this has been granted, and in many cases, the implementation may be required within a defined period following the approval.  Robust post-approval submission strategies and accurate change categorization are critical to minimize health authority questions and to avoid rejections.

In order to maintain compliance, timely submission of changes is essential during the lifecycle of drug products.

Freyr’s Regulatory affairs team has extensive experience in handling post-approval changes and the required submissions to European health authorities in alignment with the relevant requirements and guidelines.

Freyr Expertise

Freyr’s team has experience and expertise in handling post-approval changes including the following:

  • 01

    Change addition/deletion in manufacturing site.

  • 02

    MAH transfers

  • 03

    Change in formulation and batch size

  • 04

    Optimization of manufacturing process/change in route of synthesis/change in equipment

  • 05

    Addition/change of active substance supplier/CEP updates/New CEP

  • 06

    Additional source for active substance starting material

  • 07

    Pharmacopoeia monograph updates

  • 08

    Specifications and analytical method changes

  • 09

    Changes in container closure system and suppliers

  • 10

    Shelf-life extension/reduction

  • 11

    Administrative updates/Changes in contact details

Freyr offers following services to medicinal product manufacturers:

  • 01

    Change control support and change evaluation

  • 02

    Consulting on submission strategy for proposed changes

  • 03

    Implementation strategy and timelines

  • 04

    Guidance on supporting documents/data

  • 05

    Preparation of variation submission documentation

  • 06

    Health Authority interactions for approval and implementation

  • 07

    CMC Regulatory compliance of legacy dossiers and submissions

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