On 14 March 2023, the Presidential Decree numbered 6932 Amending the Decision on Pricing of Medicinal Products for Human Use (Turkish Language) (Decision) was published in the Official Gazette numbered 32132. The Decision introduces a new calculation for the real source price of products where the source price cannot be determined with the Presidential Decree numbered 6365 Amending the Decree on Pricing of Medicinal Products for Human Use that was introduced in November 2022…
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On 17 February 2023, the Turkish Medicines and Medical Devices Agency (Agency) made an announcement (Turkish language) on its official website that it had published a Guideline on Human Medicinal Products that are Co-marketed (Guideline). The Guideline came into force on the day of its publication.
The Guideline aims to provide guidance on licensing of co-marketed human medicinal products, cancellation or suspension of the main product's marketing authorisation and…
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On April 7, 2016, the Law on the Protection of Personal Data (“Law”) came into force in Turkey as a special law regarding the protection of personal data.
The Law is a step towards harmonising Turkish legislation with EU legislation, and it was prepared based on Directive 95/46/EC on data protection (“Data Protection Directive”). Although the Law is very similar to the Data Protection Directive, certain principles of the General Data Protection Regulation (“GDPR”) were also…
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Personal data can be processed based on the following legal grounds:
If explicit consent of the data subject is obtained.
If processing is clearly proposed.
If processing is mandatory for the protection of life or to prevent the physical injury of a person in cases where that person cannot express consent or whose consent is legally invalid due to physical disabilities.
If processing is necessary for and directly related to the establishment or performance of a contract and…
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Explicit consent has been defined as consent that relates to a specified issue, declared by free will, and based on information.
As the definition suggest, the Law stipulates that no kind of “blanket consent” of not limited to a specific subject or transaction will be valid. For example, consent such as "I allow all kinds of data processing activities", will not suffice under the Law. The data subject must know for what s/he is giving consent and must clearly express his/her…
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Sensitive and non-sensitive personal data may be transferred to third parties if the data subject’s explicit consent is obtained or if one of the additional legal grounds is applicable for such transfer.
The Law does not define a third party; therefore, any individual or entity (other than the data controller and the data subject) may be considered a third party. This creates a problem, especially about transfers between data controllers and data processors, as there is no…
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