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prawo_farmaceutyczne
refundacja
2016-07-12

Ministry of Health announced amendment of the reimbursement act

According to the information, which Krzysztof Łanda the deputy of Minister of Health, gave to the Polish Press Agency, it appears that the Ministry of Health drafted an amendment of the Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Purposes and Medical Devices (the reimbursement act). Below you can find the draft decision of the amendment: 
•    facilitating reimbursement procedure of orphan medicines. In the procedure of acquiring the reimbursement decision for these kind of medicines, instead of an economic analysis, only price justification will be required.

•    introduction of "compassionate use" rule allowing application of medicine that has not been registered for patient who is not taking in a clinical trial.
•    publishing reimbursement lists every three months, not every two months, as it is now.
•    enabling reimbursement of registered medicinal products in direct import procedure, which are authorized, but are unavailable on the territory of Poland.
•    publishing the reimbursement application, which aims to strengthen transparency of  the reimbursement procedure.

•    introduction of the possibility of quick removal of medicinal product from the reimbursement list, when this particular medicine does not fulfill any reimbursement criteria anymore.
The draft decision (amendment) is to be relisted for consultations in July.

Source: http://www.rynekzdrowia.pl/Polityka-zdrowotna/Landa-w-noweli-ustawy-refundacyjnej-m-in-zmiany-dla-osob-z-chorobami-rzadkimi,163424,14.html

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