06/11/2018
Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications and any other medicinal products that are used to treat, diagnose, and prevent diseases to be released at the market. The registration process is outlined under the Regulation on the Registration of Medicinal Products for Human Use. Unlicensed or unregistered drugs and other medicinal products cannot be released or marketed (Article 5, Licensing Regulation on Human Medicinal Products). Real and legal entities of Turkish residency must apply to the Ministry…
The legal framework for regulatory reforms in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? No…
Patents and trademarks in Turkey – an overview. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? Both…
An insight about product liability in Turkish Pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? Medicinal product liability arises…
The lowdown on the situation regarding traditional medicines and OTC products in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal,…
Preclinical and clinical trial requirements in Turkey – a legal guide. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition…
An intro to the legal situation for regulatory, pricing and reimbursement in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the regulatory authorities with jurisdiction over…
11/10/2018
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