Our latest article “Strict Procedures vs Urgent Needs: Is it possible to be equal to the occasion?” by Nihan Bacanak, Can Aksoy ve Bengüsu Güvendi is published on Lexology.
As known, pharmaceutical products for human use can in principle only be placed on the market upon obtaining a licence for the specified indications for which the product is allowed to be used. On the other hand, as experienced during the COVID-19 pandemic, not being able to access pharmaceutical products particularly in cases of emergency where a licensed product is unavailable can lead to aggrievements and the lengthiness of the process of obtaining a licence for a pharmaceutical product can cause additional problems. Hence it is of utmost importance to properly set a balance between satisfying the urgent needs of patients in an efficient manner and safely placing the products on the market. Various methods enabling patients to access unlicensed products are available under Turkish law. Amongst these methods which are briefly described below, named patient programme and off-label use have enabled rapid actions to be taken in particular during the COVID-19 pandemic.
You may reach the article here.
Share
Related persons
You can contact us for detailed information.
Legal Information
This briefing is for information purposes; it is not legal advice. If you have questions, please call us. All rights reserved.
You May Be Interested In
10 September 2024
Turkish Data Protection Authority and Turkish Ministry of Trade sign cooperation protocol on targeted advertising and dark patterns
The Turkish Personal Data Protection Authority and the Turkish Ministry of Trade General Directorate of Consumer Protection and Market…
16 August 2024
Turkish Competition Law Newsletter – 2024 Summer Issue
We are pleased to share our quarterly newsletter on recent developments under Turkish Competition Law.
16 August 2024
New Regulatory Framework Unfolded for Establishment of Crypto Platforms
Following the July 2, 2024, introduction of the crypto asset regulation law under the Capital Markets Law No. 6362, the Capital Markets…
7 August 2024
Key Changes in the Local Tax Legislation
Paksoy legal briefing: “Key Changes in the Local Tax Legislation”
24 July 2024
Amendments on the Communiqué on Principles Regarding Real Estate Investment Funds
The Communiqué Amending the Communiqué on Principles Regarding Real Estate Investment Funds (III- 52.3) (“Amendment Communiqué”) has been…
18 July 2024
Turkish Data Protection Authority issues new regulation on cross-border data transfers
Paksoy legal briefing: “Turkish Data Protection Authority issues new regulation on cross-border data transfers”