High Representative Christian Schmidt strongly points out that a “Law on Pharmaceuticals and Medical Devices of RS” constitutes a severe challenge to the competencies and the unimpeded functioning of the BiH Agency for Pharmaceuticals and Medical Devices.

Under the Constitution of B&H, entities are obliged to comply fully with the Constitution and decisions of state institutions such as the Law on Pharmaceuticals and Medical Devices of B&H.

It is said that the B&H Agency is the only institution in B&H authorized, capable and equipped to ensure that pharmaceuticals and medical devices in use in B&H are safe, of high quality and efficient.

- It is also the only such agency established and operating in accordance with EU Acquis as a requirement for B&H in the EU accession process. Any rollback on this reform is a direct act against public health safeguards and with that, a dangerous and unnecessary risk to the lives and the wellbeing of all B&H citizens - announced the OHR.

The High Representative calls on every single RS National Assembly representative to uphold their obligations under the Constitution of B&H, demonstrate their responsibility towards public health and wellbeing and not proceed with the adoption of the Proposed RS Law on Pharmaceuticals and Medical Devices.