‘‘Suspend all activities on the establishment of the Agency for Medicines and Medical Devices at the level of Republika Srpska(RS), which will lead to market disruptions and affect patients and health care, ” pointed out the director of the Directorate for Neighborhood and Enlargement Negotiations in the European Commission, Maciej Popowski in a letter to high officials of RS.
A few days ago, the letter was sent to the President of the RS, Zeljka Cvijanovic, the President of the National Assembly of RS (NARS), Nedeljko Cubrilovic, the Prime Minister of the RS, Radovan Viskovic, and the Chairman of the BiH Council of Ministers, Zoran Tegeltija.
“The establishment of the RS Agency for Medicines and Medical Devices would create legal uncertainty in the market of medicines and medical devices with inevitable harmful effects on citizens and the economy while undermining the single economic space in our country,” Popowski noted.
He claims that the BiH constitutional framework does not provide a legal basis for the unilateral withdrawal of entities from established BiH institutions, nor a ban on the application of BiH legislation in the entities, emphasizing that the entities and their units must fully comply with the decisions made by BiH institutions.
“For pharmaceutical manufacturers, the RS law would mean that they have to obtain two different licenses for placing drugs on the market, which are not mutually recognized. This could cause the supply chain of medicines from abroad to collapse. In order to trade in RS and throughout BiH, companies will have to be under the control of laboratories, the RS Agency, and BiH-level agencies, which can apply different regulations, “ Popowski emphasized.
To recall, on October 20th, the NARS adopted the Law on Medicines and Medical Devices of the RS, which defines the establishment of the entity Agency for Medicines. The law enters into force six months from the day of its publication in the Official Gazette of the RS.