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Regulation provisions to the Act on Reimbursement

🔵Regulation provisions to the Act on Reimbursement

🔸Draft regulation of the Minister of Health on the level of payment for submitting an application for covering with reimbursement a medicine, a foodstuff for special nutritional use, a medical device or a dietary supplement.

🔸The preparation of a new draft regulation on the amount of payment for submitting an application for covering with reimbursement a medicine, a foodstuff for special nutritional use, a medical device or for their supplement results from the change in the wording of Article 32(3) of the Act, introduced by the Act of 17 August 2023 amending the Act on reimbursement of medicines, foodstuffs for special nutritional use and medical devices and some other acts, in which it was indicated that when determining the amount of fees, the type of application, its complexity, workload and costs related to its examination should be taken into account.

🔸The amount of fees for submitting individual applications will remain unchanged in relation to the existing regulation of the Minister of Health of 20 January 2021 on the amount of fees for submitting an application for covering with reimbursement a medicine, a foodstuff for special nutritional use, a medical device or a dietary supplement.

🔸If, in the course of the formal analysis of the application, it is found that there is no confirmation of payment of the application fee in the amount specified in the regulation, the applicant will be called upon to supplement it. In connection with the above, a transitional provision has been introduced to the proposed regulation, according to which the fees for submitting an application for covering with reimbursement a medicine, a foodstuff for special nutritional use and a medical device or for their supplementation, paid before the date of entry into force of the proposed regulation, are considered to have been paid correctly if the applications to which these fees pertained were submitted before the date of entry into force of this regulation.

🔸The date of entry into force of the proposed regulation has been set for 1 November 2023 and is correlated with the entry into force of the amendments comprising the authorisation to issue this regulation, introduced by the Act of 17 August 2023 amending the Act on reimbursement of medicines, foodstuffs for special nutritional purposes and medical devices and some other acts.

🔴The deadline for comments is 28 September this year, i.e. 14 days from the date of publication of the draft.

🔸Would you like us to submit comments on your behalf: send information with your comments to: legislacja@banaszewska.pl by 26 September this year.

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