The Turkish pharmaceutical law is the fundamental component of Turkish medicinal regulations, controlling the manufacturing, distribution, sale, and use of pharmaceuticals and medical equipment. Its primary object is to ensure the safety, efficacy, and quality of pharmaceutical products and medical devices available in the Turkish market.
As a Turkish law firm, Istanbul Lawyer Firm, we will give you all the necessary information about this regulation. You can contact our Turkish lawyer firm to get more information about Turkish pharmaceutical law and help from a successful and experienced legal practitioner in this field.
The Structure of Turkish Pharmaceutical Law
Pharmaceutical production and consumption in Turkey are increasing day by day, and the pharmaceutical industry is developing gradually. For this reason, Turkish Pharmaceutical Law should be regulated to establish its structure and provide order in this field. It also contributes to the shape of Turkey's pharmaceutical sector.
Turkish pharmaceutical law governs several aspects of the pharmaceutical sector, including licensing, marketing authorisation, pricing, reimbursement, and pharmacovigilance. These rules should be in line with general competition principles, even though they primarily address the unique needs and demands of the pharmaceutical industry. Therefore, competition law becomes part of this legislation, too.
Laws and Regulations
Laws and regulations made under Turkish pharmaceutical law shape the structure of this field. Thus, there are several rules and regulations governing this legislation. For instance, under patent law in the pharmaceutical industry, all rights related to the production and sale of a new medicine belong to the person or company that invents that medicine for a certain period.
Furthermore, the Turkish Pharmaceuticals and Medical Devices Law No. 1262, governs drug regulations.
Responsible Authorities in Pharmacy
Several authorities are responsible for different aspects of pharmacy regulation in Turkey. They work together to shape Turkish pharmaceutical law. The Ministry of Health is the main governmental authority that regulates the pharmaceutical sector in Turkey. In terms of healthcare, drugs, and patient safety, it establishes policies, rules, and guidelines. Through the independent Turkish Pharmaceutical Product and Medical Device Agency, the Ministry of Health regulates the pharmaceutical industry.
Implementation of Pharmaceutical Law in Turkey
The implementation of pharmaceutical law in Turkey aims to protect the regulations and legislations made within Turkish pharmaceutical law and create order in this field. The way it’s enforced comprises several factors, like the licencing process, monitoring compliance, and penalties.
Also, since the pharmaceutical field in Turkey is open to change and innovation, patents play a crucial role in the implementation of pharmaceutical law in Turkey, especially in the protection of intellectual property rights and the promotion of innovation in the pharmaceutical sector.
With the relationship between patent law and the pharmaceutical industry, exclusive rights are given to the inventor or patent holder and prevent others from manufacturing, using, or selling the patented invention without their consent. For instance, penalties may be applied in cases such as the sale of a patented medicine by someone else.
To get help with the licensing process and monitoring compliance and penalties, you need pharmaceutical lawyers in Turkey. Our legal practitioners at the Istanbul Lawyer Firm are experts in this field. By consulting our firm, you can get the necessary legal advice you need in the best way possible.
Licensing Process
No medical product for human use that has not been licenced by the Agency may be placed on the market, according to the Regulation on the Registration of Medical Products for Human Use. To obtain a license to market a medicinal product for human use, real or legal people with residence in Turkey must submit an application to the Agency under the regulation. To apply for a license, real people or legal entities residing in Turkey must submit the documents which are listed in Licensing Regulation to the Ministry of Health.
Monitoring Compliance and Penalties
The Turkish Medicines and Medical Devices Agency is responsible for monitoring compliance with pharmaceutical regulations in Turkey. In this context, it may, without prior notification, inspect and visit the manufacturing facility for medications both before and after granting the permit.
As a result of the inspection, it will compile a report on the manufacturing site's compliance with legal requirements. Also, the inspectors can gather samples of the products and active ingredients, relevant documents, and records, if necessary.
FAQ About Pharmaceutical Law in Turkey
For a more comprehensive understanding of pharmaceutical law in Turkey, let’s take a look at the frequently asked questions about this field. If you have more questions about Turkish pharmaceutical law, you can contact Istanbul Lawyer Firm. With our qualified and English-speaking lawyers in Turkey, we can assist you with your legal cases.
What Laws and Guidelines Govern Online Dispensing, Sale, and Supply of Medicinal Products and Medical Devices?
Several rules and norms govern the online dispensing, sale, and supply of pharmaceuticals and medical devices in Turkey. Mainly, by establishing the fundamental legal framework for the regulation of pharmaceuticals and medical devices in Turkey, the Turkish Pharmaceutical and Medical Device Law is responsible for governing.
Are There Special Rules Governing the Dispensing or Sale of Particular Types of Medicinal Products or Medical Devices?
Some rules in Turkey govern the dispensing or sale of particular types of medicinal products or medical devices. For instance, to dispense and sell prescription-only medications, a doctor's valid prescription is required. These items can only be purchased with a prescription written by a licensed healthcare professional and are not available without a prescription.
Besides, control procedures are in place to carry out regulations regarding medications and guarantee compliance. TITCK (Turkish Medicines and Medical Devices Agency) performs inspections of pharmacies, drugstores, and other entities involved in the pharmaceutical industry. In the event of non-compliance, sanctions may be applied.
What regulations govern the promotion and advertising of pharmaceutical products in Turkey?
In Turkey, the advertisement and promotion of pharmaceutical products are subject to strict regulations. To not mislead or deceive consumers, the advertisement and promotion of pharmaceutical products are regulated by the Pharmaceuticals and Medical Preparations Law No. 1262. Before allowing marketing authorization,it outlines the standards for the evaluation of safety, and effectiveness.
