Variations

For most MAHs the number of variations of the MAs held exceeds by far the number of new product filings. As variation applications are procedures intended for both ensuring compliance and Regulatory instruments of product life-cycle management, usually these represent the biggest challenge for Marketing Authorization Holders’ Regulatory staff.

The legal basis for variations is provided in Regulation 1234/2008/EC, which classifies these into several categories (Types IA, IA_IN, IB and II), with different time schedules, documentation needs and regulatory implications. Although not a variation per se, the Notification procedure provided by Article 61(3) Directive 2001/83/EC as amended, and procedures allocated under national competence (i.e. MAH transfers, final sample approvals, etc.) come to complete the series of procedures available for product maintenance.

AccepTher advises its clients on regulatory requirements on compliance, procedures and documentation needed for regulatory product life-cycle management, reviews or prepares and submits to national Competent Authorities and follows-up, as requested, all types of variation applications.