CORRECTION of drug prices COST VOLUME (art.24-OMS no.368/2017)*
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The procedure is addressed to holders of marketing authorization (MAH) or their legal representatives.
It refers exclusively to products that are subject to cost-volume or cost-volume-outcome contracts and which fall under art. 24 para. (4), (5), and (6) of the Order of the Minister of Health no. 368/2017, with subsequent amendments and completions.
- art. 24 " (4) In the situation where, during the interval mentioned in para. (2), the negotiation process is resumed for a medicine for which there are no longer eligible patients subject to the clauses of the cost-volume or cost-volume-outcome contract/contracts concluded based on the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015, with subsequent amendments and completions, the annual correction procedure provided in paragraphs (5) and (6) applies.
(5) In the situation where the medicines provided in paragraph (1) are subject to the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 735/976/2018 regarding the contract model, negotiation methodology, conclusion and monitoring the implementation and conduct of cost-volume/cost-volume-outcome contracts, the holder of the MAH/representative will submit the documentation for correction at least 90 days before the expiry of the contractual period. At least 45 days before the expiry of the price validity in Canamed, the Ministry of Health communicates to the National Health Insurance House (CNAS) and the MAH the internal price notice for the resumption of the negotiation process.
(6) The maximum price levels provided in paragraph (5) are included in Canamed and come into force starting on the 1st of the month following the expiry of the existing prices in Canamed."
- art. 24 para. (2)" In the situation where the medicines provided in paragraph (1) are subject both to the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015 (...), and to the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 735/976/2018 (...), the annual correction procedure does not apply for 12 months from the termination of the validity of the last cost-volume or cost-volume-outcome contract concluded based on the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015, with subsequent amendments and completions. "
This procedure can be accessed by following the link below and then pressing the button "for the online service apply here":
http://www.ms.ro/organizare/directia-politica-medicamentului-si-a-dispozitivelor-medicale/#tab-id-7
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In the event of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.
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