The Regulation on Market Surveillance of Medicinal Products for Human Use and Foods for Special Medical Purposes Has Been Published

The Regulation on Market Surveillance of Medicinal Products for Human Use and Foods for Special Medical Purposes, published in the Official Gazette dated November 21, 2024, and numbered 32729, comprehensively addresses market surveillance activities concerning medicinal products, active substances, and foods for special medical purposes.

The new regulation comprehensively addresses market surveillance activities concerning medicinal products, active substances, and foods for special medical purposes, aiming to standardize these processes. It seeks to establish a more comprehensive and risk-based framework for the market surveillance of medicinal products and active substances, with the overarching goal of protecting public health. Transparency, inspection efficiency, and compliance with international standards constitute the core principles of the system. In this process, both manufacturers and license holders bear significant responsibilities and face severe sanctions in cases of non-compliance with the regulations.

The Market Surveillance Planning Board stands out as a central body responsible for coordinating these activities. The Board considers numerous criteria to determine the risk status of products. These criteria include national or international notifications and pharmacovigilance data related to the product, the compliance of the manufacturing site with Good Manufacturing Practices (GMP), whether a recall process has previously been initiated, issues identified during the licensing procedures and inspection recommendations, the pharmaceutical form of the product, its biological or biotechnological structure, and usage data.

Within the scope of the program, product samples are obtained from various points along the legal distribution chain, while active substances can be collected directly from manufacturing sites. Analyses are conducted using internationally recognized and harmonized methods. The quality, safety, and efficacy parameters of medicinal products for human use and foods for special medical purposes are evaluated in alignment with their shelf life, stability studies, and intended use.

In the event that non-compliance is identified in the analysis results, the provisions of the Regulation on the Recall of Medicinal Products for Human Use and Foods for Special Medical Purposes will apply. A recall decision can be issued for non-compliant products or active substances. If the defective production of products persists or if actions contrary to the provisions of the regulation are undertaken, more severe sanctions can be imposed. Furthermore, in cases where the rules regarding the market control process are not adhered to, a decision can be made to prohibit the marketing of the product or active substance.

You can access the relevant Regulation through this link.