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Category: MA | Gazette Edition 144: 29 August 2024

Devices Agency has updated the Guideline on the Scheduling Processes for Marketing Authorization Applications of Medicinal Products for Human Use, the Guideline on Biosimilar Medicinal Products, and the Guideline on the Importation of Medicines from Abroad

29 Aug 2024

One of the most significant updates in the Guideline on the Scheduling Processes for Marketing Authorization Applications of Medicinal Products for Human Use (“Scheduling Guideline”) is the new regulations regarding hybrid applications. Firstly, the Scheduling Guideline has been updated […]

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The Regulation Amending the Medical Devices Regulation and the Regulation Amending the In Vitro Diagnostic Medical Devices Regulation have been published in the Legal Gazette

29 Aug 2024

“The Regulation Amending the Medical Devices Regulation” (“Regulation“) has introduced detailed amendments to Article 10 titled “General Obligations of the Manufacturer.” The Regulation on notified bodies has been amended to provide for an assessment 5 years after notification and […]

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The Regulation Amending the Regulation on Contracts Established Outside the Workplace Has Been Published

29 Aug 2024

The Regulation Amending the Regulation on Contracts Established Outside the Workplace (“Amendment Regulation“), prepared by the Ministry of Trade (“Ministry”) has been published in the Official Gazette dated 23 August 2024 and numbered 32641, and entered into force as […]

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