AIFD PROPOSALS FOR PRODUCTS WITHOUT PRESCRIPTION
The list for non-prescription pharmaceuticals has been made available for consultation by the Turkish Medicines and Medical Devices Agency at the end of 2017, however, after the communication of the opinions and recommendations, the list has been removed from the website. The cooperation and collaboration of all stakeholders are critical in this sector. It is believed that by reviewing the current regulations in line with the recommendations listed below, the legislation for non-prescription pharmaceuticals could be implemented in Turkey.
- Classification of non-prescription pharmaceuticals should be prepared with mutual agreement between industry and health authorities in line with the classification criteria in the EU and the world.
- The licensing process for non-prescription products should be lean, and GMP evaluation of these products has to be managed separately. In case the manufacturing is conducted in a facility that was authorized/audited by another reference authority, GMP audit process for non-prescription products should proceed without placing barriers to licensing and marketing of the product.
- The pricing guidelines for manufactured and imported non-prescription medicines should be kept as is; a tailor-made non-prescription products legislation based on the EU and the world examples should be promulgated and implemented.
- Advertisement of non-prescription products to the general public should be permitted under well-defined rules. Advertisement and communication materials could be developed under self-regulation or pre-evaluation rules.
- Products should be dispensed from pharmacies only.
