Marketing Authorization Maintenance

Marketing authorization maintenance refers to the ongoing responsibilities and activities that a pharmaceutical company or a manufacturer must undertake after receiving initial regulatory approval to market a medicinal product.

Key elements of marketing authorization maintenance include:

Compliance with Regulations: Ensuring continued adherence to regulatory requirements and standards stipulated by the regulatory authorities that granted the initial marketing authorization.

Pharmacovigilance: Continuous monitoring and reporting of the safety profile of the drug, including adverse reactions and side effects. This involves collecting and assessing safety data from various sources and promptly reporting any significant safety issues to regulatory authorities.

Lifecycle Management: Managing changes and updates related to the product over time, such as variations in manufacturing processes, label updates, changes in formulation or packaging, and post-approval clinical studies. These changes often require regulatory submissions and approvals.

Renewals and Periodic Reviews: Marketing authorizations typically have an expiration date, requiring renewal at specified intervals. Periodic reviews or re-evaluations by regulatory authorities may also be necessary to assess the continued safety and efficacy of the product.

Regulatory Reporting: Timely submission of required reports, including annual reports, safety updates, and any other requested information to regulatory authorities.

Quality Assurance: Maintaining high manufacturing and quality standards to ensure consistency and compliance with Good Manufacturing Practices (GMP) and other quality requirements.