The proposed legislative and regulatory amendments concern pharmaceuticals, medical devices and hospital pharmacies, including their branch offices and dispensaries.

Draft government proposal to Parliament on amending the Medicines Act and related legislation, and as part of the same legislative package, draft Government Decree amending the Medicines Decree with a draft explanatory memorandum

It is proposed to lay down procedures to regulate the decision-making and implementation of international assistance concerning medicinal products in the Medicines Act. A provision would be introduced to the Act concerning the duties of the National Institute for Health and Welfare regarding pharmaceutical preparedness. It is proposed to amend the regulation of hospital pharmacies and dispensaries to establish it through the wellbeing services counties’ responsibility for organising services. It is proposed to clarify the definition of wholesale trade in medicines, and to define the general distribution of medicines and medicinal products in national law. On that basis, provisions would be laid down regarding the right of hospital pharmacies, dispensaries and branch offices of hospital pharmacies to supply medicinal products
The Ministry of Social Affairs and Health would be given the right to decide on exceptional arrangements for the distribution of medicines in certain disruptions of normal conditions and states of emergency. It is proposed to introduce provisions to the Medicines Act concerning the right of emergency medical service vehicles and military units to import and export medicines for their own operations. Amendments are proposed to the regulations governing the preparation of medicines in pharmacies, relating to hospital pharmacies, military pharmacies and medicinal gases. It is proposed to amend the Act on Medical Devices to allow for the reprocessing and reuse of single-use medical devices, subject to the conditions laid down in the Act. It is proposed to make amendments to the Medicines Decree as a result of the legislative changes. The Acts and Decree are intended to enter into force on 1 January 2027.