New Hungarian Government Decrees introduced temporary measures relating to the supply and use of medicinal products during the state of emergency ordered in response to the COVID-19 pandemic. These measures entered into force on 27 March and 10 April 2020.
Based on the Government Decree having entered into force on 27 March 2020, during the state of emergency, the existence of patient care interest deserving special consideration shall be presumed in the administrative proceedings to be carried out in relation to COVID-19 coronavirus diseases in connection with the treatment of the epidemic. This measure could facilitate the provision of certain exceptional authorizations and permissions by the government body for pharmaceuticals (OGYÉI).
Further, OGYÉI may establish the shortage of medicinal product or the risk thereof based on any information made available to it, even without the respective notification of the marketing authorization holder or the distributor under the Hungarian Medicines Act.
The requests for permission for prescription of a medicinal product for an unauthorized indication related to the COVID-19 pandemic are examined by OGYÉI in priority proceedings. OGYÉI shall also publish on its website the list of active substances of medicinal products covered by the permissions granted for prescription for an unauthorized indication to treat COVID-19. Contrary to the original rules of the Hungarian Medicines Act, to treat COVID-19, no permission is required for prescribing and using a medicinal product containing an active substance included in such list for an indication which is not included in the SmPC. Such prescription and usage shall be posteriorly notified to OGYÉI within 90 days from the end of the state of emergency by the treating physician.
Based on the Government Decree having entered into force on 10 April 2020, the preconditions necessary for granting OGYÉI’s permission for the compassionate use of investigational medicinal products and medicinal products not having a marketing authorization are temporarily alleviated by certain measures.
These measures include, inter alia, that the medicinal product in question shall already be tested by at least a phase I clinical trial (or such clinical trial shall be in progress) instead of a phase II clinical trial as originally requested by the Hungarian Medicines Act. Further, the scope of possible requestors is also extended to healthcare service providers and the request for permission can be submitted even for a specific group of diseases. Finally, the rules of the Hungarian Medicines Act based on which the manufacturer has to give consent for compassionate use, agree to supply the product free of charge for the duration of the treatment (or until the admission of the product into the social security subsidy system) and guarantee the quality of the product in accordance with the GMP shall not be applicable.
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