Business Imperatives

A German multinational pharmaceutical and life sciences company sought expert Regulatory support to switch a topical product to an Over-the-Counter (OTC) classification in Brazil. The project required compliance with ANVISA’s RDC 98/2016 and Normative Instruction No. 11/2016, ensuring alignment with Brazil's non-prescription drug list (LMIP).

Objectives

To facilitate the successful OTC market switch application in Brazil by ensuring compliance with ANVISA regulations, addressing Regulatory complexities, and leveraging global safety data to justify the classification change, enabling a seamless and timely submission.

Problem Statement

The client faced challenges in justifying the market switch request due to stringent ANVISA requirements. Establishing the product’s safety profile and gathering relevant data from global markets where the switch had been approved were critical hurdles. Additionally, Regulatory complexities surrounding labeling compliance and dossier compilation posed potential delays.

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr conducted a comprehensive evaluation of safety data and compiled necessary documents to support the market switch request.
  • The team ensured that labeling adhered to ANVISA’s classification criteria, aligning with therapeutic class indications.
  • A structured dossier was prepared, reviewed, and compiled, incorporating a strategic approach to mitigate documentation gaps.
  • Safety data from other regulated markets with prior OTC approvals were leveraged to strengthen the justification for classification change.
  • Freyr provided post-submission follow-up and query resolution to ensure a smooth Regulatory process.
  • Efficient pre-assessment of the Regulatory submission process.
  • Timely completion of dossier development, compilation, and submission.
  • Effective resolution of post-submission queries, ensuring a seamless Regulatory pathway.

Freyr’s Regulatory expertise facilitated the successful submission of the OTC switch application, ensuring compliance with ANVISA regulations.