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The Turkish Medicines and Medical Devices Agency ("Agency") published the Guideline on License Application for Homeopathic Medicinal Products (“Guideline on Licensing”) and the Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products (“Guideline on Packaging”)  on March 15, 2022. Both Guidelines are based on Homeopathic Medicinal Products Licensing Regulation (“Regulation”). Within the scope of the Guidelines, the Agency has started accepting license applications for homeopathic medicinal products through the website www.ebs.titck.gov.tr, as of April 1, 2022. 

In January 2022, the new Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union of 15 December 2021 on health technology assessment (the "HTA Regulation") entered into force on the territory of the European Union. The HTA Regulation aims to harmonize (but not to fully centralize) the currently fragmented procedure for assessing the health technologies of innovative medical therapies entering the European Union market in different European countries. The HTA Regulation shall begin to apply in stages from 12 January 2025 and the European Commission has already approved an implementation plan until that date, which includes mainly the establishment of the information resources needed for its operation, the creation of new supranational bodies to participate in the application of the Regulation and training of the competent national authorities.

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