Registration of drugs and medical devices ŠUKL

A natural person and a legal entity may handle medicines and medical devices only on the basis of a permit issued in accordance with the Act on Medicines and Medical Devices.

Registration of the drug

The registration of the medicine and its entry in the list of registered medicines is a basic prerequisite for the introduction of the medicine on the pharmaceutical market in the Slovak Republic. By the registration of a medicine, we mean the permission to put the medicine on the market and its entry into the list of registered medicines. All mass-produced medicines are subject to registration. Decisions on registration, change, extension, suspension, cancellation and transfer of the registration of the medicinal product are issued by:

• The State Institute (ŠÚKL), if it concerns human medicines,
• The European Commission (EC), if it concerns human medicinal products registered under special regulations (Regulation of the EP and Council (EC) No. 726/2004)
• The State Institute assesses the documentation and prepares an evaluation report.

Registration of medical devices

Regarding the distribution of medical devices, the permit is not enshrined in any legal regulation for the area of ZP, distribution is carried out on the basis of trade.

In the case of the production of a medical device, the manufacturer, authorized representative, importer or distributor who made the medical device or in vitro diagnostic medical device available on the market in the Slovak Republic in accordance with a special regulation shall notify the state institution in writing within 14 days of making it available to the market by submitting a standardized form, EU declaration of conformity, conformity assessment certificates, outer packaging and instructions for use your name or title, address of the place of business or registered office address, name and registered office address of the manufacturer, name and registered office address of the authorized representative and name, class of medical device or diagnostic medical device in vitro made available on the market in the Slovak Republic; documentation and information must be provided to the state institute in the state language upon request.

After notification, the state institute will assign a code to a medical device and an in vitro diagnostic medical device without undue delay, if such a medical device and an in vitro diagnostic medical device enters the process of categorizing medical devices and special medical material.

Our lawyers will help you with the registration of medicines and medical devices at the State Institute for Drug Control (ŠUKL) by:

• It advises on all requirements and requirements that must be met for the registration of a drug or medical device at ŠUKL.
• It will help in the preparation and control of the registration application, which must accurately and completely state the data on the drug or medical device.
• It will help with the preparation of all the necessary documents and certifications, which are necessary for the registration of the drug or medical device at ŠUKL.
• He will represent you in all communications with authorities and regulatory bodies that are involved in the process of registering a medicine or medical device.
• It will help in solving any problems or questions that arise during the process of registration of a drug or medical device.

Using the services of a lawyer when registering medicines and medical devices at ŠUKL can ensure that the process goes smoothly and that the medicine or medical device will be successfully registered.