Amendment to the Regulation on Licensing Foods for Special Medical Purposes
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This regulation changes licensing rules for foods for special medical purposes, mainly by extending the transition period for existing permitted products until 1 July 2027. Products that apply for a license by that date may stay on the market under their existing permits until the licensing process is completed. It also clarifies pesticide residue wording so limits apply to each pesticide separately, and allows the Turkish Medicines and Medical Devices Agency to set up scientific commissions or seek expert advice when reviewing these products. Companies should check whether their products need a license application before the new deadline, because permits for products with no application by then will become invalid.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Extends the transition deadline for existing permitted foods for special medical purposes from 1 July 2026 to 1 July 2027.
- Allows products with a license application filed by the deadline to remain on the market under existing permits until the application is decided.
- Clarifies that pesticide residue limits apply to each pesticide individually and allows the agency to use scientific commissions in product reviews.
Obligations
What this law requires
Companies with existing permits for foods for special medical purposes must submit a licensing application to the Turkish Medicines and Medical Devices Agency by 1 July 2027 if they want those products to remain validly permitted after the transition period.
Products for which a licensing application is submitted by 1 July 2027 may continue to be placed on the market under their existing permits until the licensing procedure is completed.
Existing permits for foods for special medical purposes will become invalid if no licensing application is submitted for the product by 1 July 2027.
Residue limits must be assessed separately for each pesticide in foods for special medical purposes, rather than by using the total residue limit of multiple pesticides.