The European Commission has approved Romania's request for the urgent approval of a temporary suspension of the distribution outside the country of certain drugs in the category of oral antibiotics and antipyretics, the Health Ministry reported on Thursday.
"The measure is a temporary measure to be applied for a period of three months amid the current epidemiological situation, and is intended to secure continuity in the availability of these medicines for Romanian patients," the ministry says.
It is about the common international names of the antibiotics Amoxicillinum, Amoxicillinum + Acidum Clavulanicum, Azithroycinum, Cefuroxinum, Clarithromycinum, Phenoxymethylpenicillinum, Sulfamethoxazolum + Trimethoprium, as well as antipyretics Ibuprofenum and Paracetamolum for children, told Agerpres.
According to the ministry, the measure does not affect the export of medicines manufactured by Romanian manufacturers, as it only regards halting intra-Community distribution of medicines allocated to the Romanian market.
In January 2023, Romania notified the European Commission about a draft order regarding the approval of a list of oral antibiotics and antipyretics whose distribution outside Romania is temporarily suspended for a period of three months, and requested the urgent adoption of the document in line with Article 6 (7) of Directive (EU) 2015/1535.
After examining the draft order, the Commission said that the request for urgent adoption is justified.