Reference source : Official Gazette
The market for specialized medical purpose foods in Turkey is undergoing a significant regulatory transformation. The Turkish Medicines and Medical Devices Agency (TİTCK) has published sweeping amendments to the "Regulation on Licensing Special Medical Purpose Foods," introducing stricter technical standards, new scientific oversight mechanisms, and critical compliance deadlines for all manufacturers and importers.
These changes, detailed in the Official Gazette dated July 2, 2026, aim to elevate the safety profile and scientific rigor of products claiming therapeutic benefits within Turkey's licensed pharmacy sector. Industry professionals are advised that proactive internal audits are necessary to ensure continuous market access following these mandates.
The Core Changes: Pesticide Residue Testing Overhaul
One of the most impactful technical changes concerns pesticide residue testing. Previously, regulations used a broader term for residue limits. Under the amended framework (Article 1), this has been clarified and tightened significantly.
The focus shifts from assessing the "total residue limit of pesticides" to mandating compliance with the "residue limit of each pesticide." This semantic shift is critical: manufacturers can no longer rely on an aggregate total allowance. Instead, product data must now prove that every single pesticide detected meets its Maximum Residue Level (MRL) individually.
Increased Scientific Scrutiny and Oversight
Recognizing the complexity of modern nutritional science, TİTCK has strengthened its regulatory backbone by formalizing specialized scientific review processes. The amendments empower the Agency to establish expert Scientific Commissions during product evaluations. This means that companies preparing regulatory dossiers should anticipate a higher level of technical scrutiny, potentially requiring validation or input from these newly empowered scientific bodies.
Critical Timeline Adjustments and Compliance Risk
Perhaps the most urgent takeaway for industry stakeholders involves the compliance timeline. While the initial notice period was set for July 1, 2026, the key reference date has been officially extended to July 1, 2027.
However, this extension comes with a severe warning: failure to submit a full license application by the new deadline of July 1, 2027, will result in existing permits being automatically considered invalid, potentially leading to withdrawal from the Turkish market.
Next Steps for the Industry
The amendments mandate action across three key areas:
These revisions underscore a definitive tightening of compliance standards across the sector. Companies operating in Turkey must treat these changes as mandatory updates to their global regulatory strategy to maintain uninterrupted market supply.