Deadline: 23-Jul-25
The European Commission (EC) has launched the call for proposals to support the establishment of the State Control Authority for Medicines and Medical Devices.
Objectives
- The overall objective of this Twinning project is to support strengthen Ukraine’s health sector and protect patients’ interests by ensuring access to quality, safe, effective, and innovative medicines, medical devices, and cosmetic products.
- The specific objective of this Twinning project is to build the State Control Authority (SCA) as a regulatory body capable of functioning within the network of the EU competent authorities. This is to be achieved by establishing and strengthening the administrative capacity of the State Agency for Medical Devices as an independent body with a special status that implements the state policy on the development, registration, quality control, safety and efficacy of medicinal products, medical devices and medical devices for in vitro diagnostics; cosmetics; trafficking and countering illicit trafficking in narcotic drugs, psychotropic substances and precursors; SoHO, including blood and blood component donation; and the functioning of the blood system, the organisational structure, working methods and financing of which will comply with EU best practices.
Funding Information
- The maximum budget available is EUR 1 500 000.
Duration
- The project’s implementation period is 18 months.
Eligible Activities
- This support will cover the following activities, in particular:
- reforming the system of state authorities in the field of medicines circulation; establishing a European-standard state competent authority; and establishing proper communication of the newly established authority with the relevant EU entities;
- streamlining the approaches to licensing and inspection of activities related to the circulation of medicines, mandatory application of the relevant good practices (GxP) at all key stages of the medicine’s circulation;
- bringing the state marketing authorisation procedure and liability of marketing authorisation holders for medicines in line with the European directives;
- mandatory introduction of approaches to pharmacovigilance, promotion and advertising of medicines adapted to the EU requirements;
- fine-tuning of requirements for the operation of pharmacies as healthcare facilities;
- introducing mechanisms for technical regulation of the circulation of medical devices that will be compliant with the European regulations.
Eligibility Criteria
- Only Public Administrations and Mandated bodies as per Twinning Manual of European Union Member State may apply through European Union Member States’ National Contact Points.
For more information, visit EC.