Due to the inaction of the Expert Council of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina (BiH), patients could soon suffer directly due to the unavailability and impossibility of diagnostics with medical devices from well-known manufacturers, it was found out.
Namely, the proposal of the Rulebook on Amendments to the Rulebook on Medical Devices, for which the Agency for Medicinal Products and Medical Devices of BiH received the consent of the Directorate for European Integration at the end of November 2021, was not adopted at the Expert Council sessionsbecause there was no entity majority for adoption during the voting process.
“Members of the Serb people were against and abstained,” the BiH Agency for Medicines and Medical Devices told.
The proposed changes should have enabled the registration of medical devices that are in line with the new regulations of the European Union (EU). The Agency has been receiving requests of this type since September 2021, and they cannot be resolved due to the mentioned issues.
As the state agency explained, the mentioned changes refer to the classification of “in vitro” medical devices, where new classes are introduced, completely different from the existing ones. For example, some “in vitro” medical device that was classified as list D, according to the new regulation is class A. Analogous to this, there are changes on other lists.
“Besides, the mentioned Rulebook envisages the possibility of registering a class of medical devices intended for multiple uses– Ir, which we cannot do now,” they state in the answer.
That date is May 26th, 2022. So, after that date, we can certainly expect that applications for registration of in vitro medical devices will be submitted to this Agency in accordance with the provisions of this Regulation, evidence documentation, and classification of in vitro medical devices, which differs somewhat from the previous classification.
Who makes up the Expert Council?
The Expert Council, as the expert, regulatory, advisory, and control body of the Agency, consists of Chairman Vedran Marcinko and members Harun Avdagic, Branko Nikolic, Lazar Prodanovic, Slobodan Prtilo, and Admir Alagic.
As it is known, the government in Republika Srpska (RS) passed the Law on Medicines of RS, which envisages the establishment of the entity Agency for Medicines and Medical Devices, and then the amendment to the Law on Republic Administration, by urgent procedure, voted the establishment of that agency.
Because of these moves, the EU warned the RS authorities that these actions lead to a collapse in the market of medical products and complete confusion of pharmaceutical companies, which will directly affect the citizens of BiH.
E.Dz.
Source: Klix.ba
