Cease all activities on the establishment of the Republika Srpska (RS) entity Agency for Medicines and Medical Devices, which will lead to market disruptions and affect patients and health care, said Maciej Popowski, director of the European Commission's Neighborhood and Enlargement Directorate in a letter to the highest officials of the Bosnia Serb-dominated entity, web portal Capital wrote.

The letter was sent to the RS President, Zeljka Cvijanovic, RS National Assembly Speaker, Nedeljko Cubrilovic, RS Prime Minister, Radovan Viskovic, and the Chairman of Bosnia’s 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 the country,” Popowski said in a letter obtained by Capital.ba.

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 state legislation in the entities, emphasizing that the entities and their units must fully comply with BiH institutions.

“For pharmaceutical manufacturers, the RS law would mean that they have to obtain two different marketing authorizations, which are not mutually recognized,” Popowski said.

He added that the expiration of the marketing authorization could lead to a medium- and long-term shortage of medicines and medical devices in the RS, and potentially in the whole of BiH.

The EU official also recalled that the Opinion of the European Commission on BiH’s application for EU membership states that BiH, among other things, should simplify and harmonize business registration and licensing procedures between the entities in order to improve the business environment and create a single economic space.

On October 20 2021, the RS National Assembly 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.