Vaistų registravimo tvarkos ypatumai Lietuvoje

Abstract

The legislation of drugs’ registration is a result of a long development period. The pharmaceutical industry abroad is one of the most severely controlled and most state-supported sectors of economy. This is due to the fact, that medical product have a direct impact on public health and thereby on social and economical welfare. The master’s paper analyzes the specifics of drugs’ registration procedure in Lithuania. A drug’s registration is its including into the state’s drug registry by a responsible institution via evaluating its quality, safety, effectiveness and its informational material. In order to prove a drug’s quality, safety and effectiveness, the applicant needs to present the required documentation. Only registered drugs can legally enter the market. The paper analyzes the regulation of drugs’ registration in Lithuania before and after joining the EU. In the earlier period, the registration procedure was regulated by the Pharmaceutical activity law and the Medicin law. After entering the EU, a new period began, and the Lithuanian laws had to correspond the EU’s judicial documents of the same area. The new judicial documents that have been implied after entering the EU caused numerous discussions and debates, which revealed several advantages and disadvantages of the new order. The paper consists of four main parts. The firs three present the conclusions that were achieved via the research which is presented in the fourth part. While successfully implementing the EU requirements to the drug registration system, Lithuania must assure that the pharmaceutical industry conducts its activities only in accordance with these requirements, and the market must be supplied only with high-quality and safe drugs, and the system of pricing and compensating must be in constant development. Therefore, the drugs’ registration procedures’ correspondence with the EU laws is a perpetual process. It cannot end with the application of the required laws for the given period, since the procedures of drugs’ registration are directly related to the further processes: moving the product into the market, sales, sales’ control, advertising etc.