Recent developments
The Turkish Medicines and Medical Devices Agency (the “TITCK”) recently announced a list of pharmaceutically similar products to be used as a base for the pricing of medicinal products for human use.
The list is accessible through this link (in Turkish).
Background
“Pharmaceutically similar products” are products determined by the TITCK for products that do not have reference products due to their pharmaceutical forms. Pharmaceutically similar products contain the same or different amounts of the same active substance in different pharmaceutical forms.
Pursuant to the Communiqué on the Pricing of Medicinal Products for Human Use, in the event that a reference product is not available in Turkey or in the reference countries for the same active substance, the price may be determined based on the pharmaceutically similar products instead of reference products.
The list classifies pharmaceutically similar products into separate groups and pharmaceutical forms, and provides that the product with the lowest price within the same group should be utilized in the pricing of a product.
Conclusion
The TITCK continues to provide pharmaceutical companies detailed guidelines on the pricing process of medicinal products for human use. Pharmaceutical companies should take note of the recently announced list and follow the future announcements to be made by the TITCK.
