The Minister of Health made an extremely important decision for Romania, one that can have a big impact on a considerable number of Romanians, and this is because it was decided to add a new one to the list of medicines derived from human blood, or human plasma, which he was expected by some of the Romanians who need him.
The Minister of Health decided to add the medicine human tetanus immunoglobulin, with the ATC code number J06BB02, to the list of those derived from human blood, or human plasma, so that soon it will be made available to the people who need to use it, so if count yourself among them, you can talk to your doctor about their possible use.
"Considering the address CNAS address no. P6004/04.08.2022, registered at the Ministry of Health under no. Reg1/17257/11.08.2022, by which steps are requested to include medicines with DCI HUMAN TETANUS IMMUNOGLOBULIN - ATC code J06BB02, in the Annex to the Order of the Minister of Health no. 402/2018 on the approval of the list of medicines derived from human blood or human plasma.
The CNAS request was submitted as a result of the notification of PRISUM HEALTHCARE SRL, as the holder of the Authorization for the supply of medicines for special needs issued for the medicine with the trade name TETAGAM P (DCI TETANIC IMMUNOGLOBULINĂ UMANĂ – ATC code J06BB02).
Considering address no. 60885E/12.08.2022, registered at the Ministry of Health under no. Reg1/17257/19.08.2022, by which ANMDMR sent the confirmation of the classification of the drug TETAGAM P (DCI HUMAN TETANIC IMMUNOGLOBULIN) in the category of drugs derived from human blood or human plasma, Annex to the Order of the Minister of Health no. 402 of 28.03.2018 regarding the approval of the list of medicines derived from human blood or human plasma, will be completed in the sense of adding to position no. 18 the medicine with the international common name HUMAN TETANIC IMMUNOGLOBULIN.
Following the above and according to the provisions of art. 7 para. (4) from Government Decision no. 144/2010 regarding the organization and functioning of the Ministry of Health, the Pharmaceutical and Medical Devices Department has developed this Draft Order regarding the completion of the Annex to the Order of the Minister of Health no. 402/28.03.2018.
Regarding the approval of the list of medicines derived from human blood or human plasma, which, if you agree, please approve it, in order to publish it on the website of the Ministry of Health, under the heading Transparency of decision-making, in accordance with the provisions of Law no. 52/2003 on decision-making transparency in public administration, republished."
