Marketing Authorisation Transfer: Whitepaper Overview
A marketing authorisation transfer (MAT) is a procedure by which the marketing authorisation is transferred from the currently approved MAH to a new MAH, which is a completely different person/legal entity. The implementation date/effective date for transfer of all rights pertaining to the product must be scheduled prior to submitting the MAT as a part of transfer agreements between both the entities.
Transfer of Marketing Authorisation Holder: Highlights
A marketing authorisation holder (MAH)/applicant has the right to sell the product in the market for which they have taken approval from the health authority. Challenges pour in when any legal entity/company becomes an MAH for the first time, especially if the company is taking over all the rights of the product that has already been marketed. This process is crucial for pharmaceutical companies undergoing mergers, acquisitions or licencing agreements. Some of the key challenges that are faced by an organisation while a MAT is planned are as follows:
- Administrative challenges include coordination between multiple stakeholders (e.g., regulatory agencies, distributors and local agents), potential disruption in market supply, maintaining market share during transfer
- Technical challenges include transfer of technical documentation including approved dossier, details on lifecycle management, post-approval commitments and pharmacovigilance responsibilities.
- Regulatory challenges are those associated with ever-changing regulatory landscapes, e.g., complexity of transfer procedures across globe, differing regulatory requirements across countries
Understanding the diverse requirements, procedures and timelines for different regulatory authorities streamlines the MAT submission process. For some countries, the regulations are clear and concise; however, for some geographies, the regulatory framework is still evolving.
This paper provides an overview of the Pre-MAT activities in the following countries, which must be completed by the MAH before planning the submission of the MAT:
- Europe, United Kingdom and United states
- ASEAN Countries
- Latin American Countries
APCER’s Regulatory Affairs Capabilities & MAH transfer
APCER’s team has a dedicated and highly experienced regulatory affairs professional skilled in preparing and submitting MAT applications to regulatory bodies. Our experts possess a deep understanding of the specific requirements across various regional markets, ensuring that all necessary documentation is prepared, organized, and submitted in full compliance with the applicable guidelines.