Insights
Transfer of Data Abroad
Sensitive and non-sensitive personal data can be transferred abroad if the explicit consent of the data subject is obtained. Furthermore, other legal grounds will also apply to the transfer of personal data to the foreign country. However, the destination country must have “sufficient protection” in order to conclude the transfer abroad based on legal grounds (except for having obtained explicit consent). A list of jurisdictions that provide sufficient protection is to be… »
Renewal of EC Certificates After Brexit
On 15 January 2021, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) on the deactivation of Product Tracking System registrations of notified bodies located in the UK following the end of the UK-EU transition period. The registrations were deactivated on the date of the publication of the announcement, although affected medical device companies will have a 60-day period to update the system with valid EC certificates (issued by the… »
Product List For Compassionate Use Programme Published
On 31 December 2020, the Medicines and Medical Devices Agency published the 2021 list of the products to be supplied through Compassionate Use Programme (Turkish language). In the published list, products are referred to by the sponsor firm, the firm that supplies the product, required diagnosis, active ingredient of the product and the maximum number of patients to whom the product can be delivered. The updated list can be followed from the website of the Agency. »
Processing of Personal Data in COVID-19 Outbreak
The world is struggling with an unprecedented crisis seen in recent human history. Governments have taken serious measures to combat the outbreak and Covid-19 was declared to be a "pandemic" by the World Health Organization. Within the scope of the measures taken, data controllers, public authorities or private companies, are in need of processing personal data with different methods to protect health and limit the spread of the infection through contact tracing and requiring… »
Precautions to Be Taken in Clinical Trials Due to COVID-19
Due to COVID-19 pandemic, precautions needed to be taken in the field of clinical trials where it is requisite to ensure the protection of the rights, safety and wellbeing of trial participants. In this regard, European Medicines Agency published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic on 20 March 2020 and released revised Version 2 on 27 March 2020 and recently updated Version 3 (“EMA Guidance”) on 30 April 2020. The EMA… »
Patient Support Program
Through Circular numbered 2016/4 published by the Turkish Medicines and Medical Device Agency (“TITCK”) an obligation for marketing authorization holders to apply to TITCK and obtain permission for training and support programs for patients / healthcare professionals for the purpose of the rational use of drugs was regulated. With the program, the marketing authorization holder signs a contract with an organization that has been licensed within the framework of the… »
“New Normal” After COVID-19 - Immunity Certificates
We are in new era with the affect of Covid 19 and we feel it all over the world. Incentives and aid packages offered in efforts to reduce the negative impact of the crisis on countrys’ economies during this period, many ideas are proposed to provide smooth return to normal life and revive the economy as soon as possible. Issuance of immunity certificates has been on the agenda of some countries to certify persons deemed safe to return to normal life. In this respect, it is… »
Localization of Imported Products
Following the announcement of the Structural Transformation Program Action Plan for Healthcare Industries on 7 November 2014, Turkey commenced adopting measures to localize the production of a substantial number of pharmaceutical products sold in Turkey. On 10 December 2015, the 64th Government announced the 2016 Action Plan (64th Government Action Plan), which included a statement that measures would be taken to prioritize domestically produced medical supplies and medical… »
Lawful Data Processing
Processing Personal Data In principle, personal data can be processed with the explicit consent of the data subject. On the other hand, personal data can be processed without explicit consent in the following circumstances: If processing is clearly proposed under the laws; 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… »
Key Developments and Predictions for Trademark Law in Turkey - 2020
Trademark law has continued to evolve at a slow pace within the course of the last year, while January, 2020, marks the completion of the third year of Industry Property Code No. 6769 (“the IP Code”). The Turkish Patent and Trademark Office (“TÜRKPATENT” or “the Office”) issued guidelines in an aim to bring clarity on absolute grounds examination, and a new guideline is to be announced within the first half of 2020. The decisions of TÜRKPATENT in opposition and appeal phases… »
Judicial Remedy Against Decisions Issued by Turkish Data Protection Board
Under the Personal Data Protection Law No. 6698 Article 18 ("DPL") the Personal Data Protection Board (“Board”) has the authority to impose administrative fines on data controllers due to failure to comply with their various obligations regulated under the DPL, i.e. failure to comply with the obligation to inform data subjects, obligations related to data security, the decisions issued by the Board and registration and notification obligations to the Data Controllers’… »
Is Digital Service Tax Dead Already? Legal Barriers in the Way of Collecting Digital Service Tax in 2020
New taxes entered into our lives with the Act numbered 7194 which was published in the Official Gazette on 7 December 2019. One of these taxes is Digital Service Tax. The law provides that digital service providers are liable for this tax at a ratio of 7,5% over the revenue they generate from their digital services. The examples of such digital services include games, software, applications, music, video, online advertisement and online market place services. If tax payers… »