Post-Approval Life Cycle Management

Having full proof strategy is very important and in order to overcome unnecessary delays due to rejection or delay in the approval of proposed changes, Fervor is adept at handling post-approval changes and streamlining the changes in formulation, batch size, synthesis route and other important Post-approval activities.

Post-Approval Submissions

Post approval for Product Marketing authorization in EU, manufacturers might consider some changes for various commercial reasons (minimize costs, time or other reasons) which must be notified to HAs.

Any variation proposed shall be informed to HAs as per following categories:

Major Changes: Substantial potential w.r.t adverse effect on the identity, strength, quality, purity, or potency of product relating to safety and / or effectiveness.
Moderate Changes: Moderate potential w.r.t adverse effect on the identity, strength, quality, purity, or potency of product relating to safety and/or effectiveness.
Minor Changes: Minimal potential w.r.t adverse effect on the identity, strength, quality, purity, or potency of product relating to safety and/or effectiveness.

Once approval received, any variation (administrative/ quality) impacting process or product shall be informed HAs by filing supplements or variations or amendments seeking approval.

Based on the impact, these changes are categorized into:

Major Changes, which should be filed as prior approval supplement/Type II/Type C submission and require approval.
Moderate Changes, which should be filed as Changes Being Effected (CBE) – 30/Changes Being Effected/ Type IB/Type IAIN/Type B submissions and require approval
Minor Changes, which should be filed in Annual Report/Type IA/Type A submissions and these changes, in general, do not require prior approval.

Post-Approval
Changes

CMC and Life Cycle Management

Any Change related to manufacturing process
Marketing Authorization Holder (MAH) transfers
Certification of Suitability (CEP) updates/new CEP
Monograph updates i.e., Compliance to Pharmacopoeia
Shelf-life extension/reduction
eCTD/CTD dossier preparation and Re-registration dossiers
Drug license renewal applications and Pharma variations filing