The amendments introduced by the “Communiqué on Amendments to the Social Security Institution Health Implementation Communiqué” (“Communiqué”) published in the Official Gazette on September 25, 2024, have brought about several changes regarding the provision and financing of health services. Furthermore, TMMDA has published a new regulation draft and several guidelines.
This article will outline the main elements of these regulations.
1. Amendments to the Social Security Institution Health Practice Communiqué (“HIC”)
With the changes made in the Communiqué, the Social Security Institution has decided to remove references to the pandemic from specific articles. Accordingly, “diagnosis and treatments related to pandemic cases during the pandemic period” have been excluded from the scope of emergencies, services for which no additional fees will be charged, and emergency health services specified in the HPC.
The reimbursement conditions for certain medical supplies, treatments, and medicinal products for human use have also been modified.
2. New Regulations Published by TMMDA
a. Draft Regulation on Promotional Activities for Human Medicinal Products and Dietary Foods for Special Medical Purpose
As is well known, the TMMDA submitted the “Draft Regulation on Promotional Activities of Medicinal Products for Human Use and Foods for Special Medical Purposes” (“Draft Regulation”) for public consultation on May 27, 2024. In a previous Information Note, we comprehensively addressed the changes introduced in the shared draft for public opinion. You can access this Information Note through this link.
On September 23, 2024, TMMDA announced on its website that the Draft Regulation had been updated based on the feedback received and that these updates would hold a new public consultation. Accordingly, stakeholders can submit their opinions on the Draft Regulation to TMMDA by the close of business on October 4, 2024.up olmadığına ilişkin doğru kararlar alınmasının sağlanması amaçlanmaktadır.
b. Packaging Guidelines
On September 18, 2024, TMMDA announced on its website that it had updated and published guidelines regarding the packaging information and instructions for using medicinal products for human use. Accordingly, the following guidelines have been updated and released:
Guideline on Packaging Information and Instructions for Use of Medicinal Products for Human Use
Guideline on the Readability of Packaging Information and Instructions for Use of Medicinal Products for Human Use
Guideline on Auxiliary Materials in Packaging Information and Instructions for Use of Medicinal Products for Human Use
c. Guidelines for the Classification of Diversification Applications and Variation Applications
On September 18, 2024, TMMDA announced on its website that the “Guidelines for the Classification of Diversification Applications and Variation Applications” has been updated and published in accordance with the “Regulation on the Licensing of Human Medicinal Products,” published in the Official Gazette on December 11, 2021, and the “Regulation on Variations for Licensed Human Medicinal Products,” published in the Official Gazette on December 18, 2021. This update aims to facilitate the correct distinction between diversification and variation applications for new applications planned for licensed products by administrative requirements.
TMMDA designed the guideline to ensure accurate decisions regarding whether an application is for diversification or variation.
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