To harmonize the standards of packaging and labeling of medicinal products for human use with those of the EU, the Ministry of Health recently adopted the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use (the “Regulation”).
The Regulation is adopted based on EC Directive No. 2001/83/EC and EU Directive No. 2011/62/EU, effectively repealing the previous Regulation on the Packaging and Labeling of Medicinal Products for Human Use. The Regulation was published in the Official Gazette and entered into force on April 25, 2017.
What the New Regulation Says
The Regulation tightens the obligations regarding the packaging and labeling of medicinal products for human use and introduces a new requirement of notification to the Medicine Tracking System. The Regulation provides in general that:
- All medicinal products for human use must be provided with a manual containing the minimum mandatory content required under the Regulation. The names of certain medicinal products for human use should be provided in braille alphabet on the outer packaging.
- Pharmaceutical warehouses must immediately inform the Turkish Medicines and Medical Devices Agency (TITCK) and the relevant licensees upon suspicion or identification of a product as falsified.
- The stakeholders must notify certain transactions related to medicinal products for human use to the Medicine Tracking System, such as purchase, sale, return, import and export. A “stakeholder” is defined as “a real or legal person, institution or organization capable of performing any action in the supply chain related to medicinal products for human use, such as production, import, export, purchase, sale and use.” In this scope, stakeholders include licensees, pharmaceutical warehouses and pharmacies.
The Regulation also provides a transition period for compliance with the provisions. In this regard, medicinal products for human use for which the license applications are in review, or which are already licensed before the effective date of the Regulation, should be made compliant with the Regulation until September 9, 2017. The products that are manufactured before December 31, 2017 can be kept in the market in their present packages until the expiration of their shelf lives.
The new Regulation introduces significant changes to packaging and labeling requirements and a new notification obligation regarding medicinal products for human use. Pharmaceutical companies should carefully review the new Regulation and take the necessary steps to ensure compliance within the transition periods specified in the Regulation.