Turkish Pharmaceutical Law and Regulations in Turkey

In today’s world, pharmaceuticals are very important in every field and have turned into a very big sector economically. The preparation of drugs by industrial methods, not by pharmacists, and the use of chemical synthetic substances rather than natural substances have caused drugs to become an increasing danger for humans. Because, as a result of all treatments done today, drugs are prescribed to people. The concept of “medical product” can be used as a parent concept to express all products used in the field of medicine. This includes drugs, medical supplies and all products related to medicine. Pharmaceutical law, on the other hand, is the field of law that deals with all legal issues and questions related to pharmaceuticals. Istanbul Pharmaceuticals Law Advocate provides full support to its clients in all possible problems related to pharmaceutical law.

Pharmaceutical law relies heavily on technical legislation and also covers a wide variety of fields. On the one hand, it has an aspect that concerns administrative law in terms of the license process, while it concerns private law and criminal law in terms of liability, and commercial law and intellectual property law in terms of patents. For this reason, it is very important to get support from an Istanbul Pharmaceuticals Law Attorney and to ask for legal opinion on pharmaceutical law. We provide full support to our clients with our expert lawyer staff.

The basic distinction between drugs is prescription and over-the-counter medicine. However, it is necessary to focus on the original drug and the generic drug. Original drug is an international term used for new drugs that have been proven to have a positive effect on a particular disease as a result of long studies and clinical studies, based on a patented molecule and previously unique. After the legal protection period of the original drug expires, similar drugs can be put on the market by pharmaceutical companies. These drugs are called generic drugs.

The drug manufacturer must obtain permission from the regulatory authority to put the drug on the market. In order to obtain this permission, it has to submit data on the effectiveness, safety and quality of the drug to the regulatory authority. Pharmaceutical manufacturers produce these data with their own clinical trials. In other words, the data showing that the drugs are effective, safe and of high quality are not provided by the administration; produced by the drug manufacturer. Licensing of drugs is an administrative law enforcement activity in terms of its nature, since it is in question to prevent and prevent the placing of drugs that do not have the necessary qualifications on the market with the licensing of drugs. According to special legislation, the Ministry of Health is authorized to carry out licensing, permitting and pricing. The production, import, sale of drugs and preparations for which permission or license has not been obtained according to special legislation, and the use of drugs and compounds on humans for scientific research purposes without the consent of the Ministry of Health and the person concerned, even if a license or permit has been obtained, is prohibited. Istanbul Pharmaceuticals Law Advocate provides legal support and consultancy to foreign and Turkish companies in registration application procedures, issuance and delivery of documents for the licensing of drugs whose clinical trials have been completed. We provide full support to our clients with their expert legal staff and their experience in pharmaceutical law.

Advertising for drugs is prohibited in our legislation. Because the fact that drug advertising is completely free may also negatively affect the physician-patient relationship, because the patient may be affected by advertisements and put pressure on the physician to prescribe a certain drug. Advertising of non-prescription drugs is not permitted, except in medical journals. In terms of drugs that can be sold without a prescription, it is promoted by placing an advertisement; Provided that it is limited to the description and newspapers, the opportunity is provided depending on certain form conditions. Istanbul Pharmaceuticals Law Advocate provides legal support and consultancy to Turkish and Foreign Company clients on the prohibition of advertising in pharmaceutical law.

Istanbul Pharmaceuticals Law Advocate works with a team of experts on the compensation and criminal liability of pharmaceutical manufacturers, physicians, pharmacists, clinical researchers, clinical research ethics committees and members, hospitals and the Ministry of Health. We provide full support to our Turkish and Foreign Clients. Damages caused by the drug cause both compensation and criminal liability. For this reason, it is very important to get support from an Istanbul Pharmaceuticals Law attorney, seek legal advice and get legal advice.