Digital Transformation In Packaging: Compliance Deadlines For E-Leaflets, QR Codes, And Anti-Tampering

I. Introduction and Scope of the Updated Guideline

The Turkish Medicines and Medical Devices Agency ("TİTCK") has updated its Guideline on Packaging Information and Patient Information Leaflets for Medicinal Products for Human Use ("Guideline"), with its latest revision dated August 11, 2026. Issued under the Regulation on Packaging Information, Patient Information Leaflets and Tracking of Medicinal Products for Human Use ("Regulation"), the Guideline sets out requirements concerning pharmaceutical packaging, patient information, and product safety.

A significant development concerns the mandatory introduction of electronic patient information leaflets ("e-KT") for most medicinal products as of January 1, 2027. Alongside this transition, the Guideline addresses anti-tampering measures, risk warning symbols, and optional multimedia QR codes. Marketing authorization holders must assess these requirements against their existing packaging arrangements and regulatory obligations.