CORRECTION drug price COST VOLUME (art.24-OMS no.368/2017)*
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The procedure is addressed to marketing authorization holders (MAHs) or their legal representatives.
It refers exclusively to products that are the subject of cost-volume or cost-volume-result contracts and which fall under Article 24, paragraphs (4), (5), and (6) of the Order of the Minister of Health no. 368/2017, with subsequent amendments and completions.
- art. 24 " (4) In situations where, during the period mentioned in para. (2), the negotiation process is resumed for a medicine for which there are no more eligible patients subject to the clauses of the cost-volume or cost-volume-result contract(s) 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 for in para. (5) and (6) shall apply.
(5) In situations where the medicines provided for in para. (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 of the implementation and running of cost-volume/cost-volume-result contracts, the MAH/representative shall submit the documentation for correction at least 90 days before the contractual term expires. 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 approval for resuming the negotiation process.
(6) The maximum price levels provided for in para. (5) are included in Canamed and come into effect starting with the 1st of the month following the cessation of the validity of the existing prices in Canamed."
- art. 24 para. (2)" Where the medicines provided for in para. (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 date of the last cost-volume or cost-volume-result 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 case of a dispute between the beneficiary and the competent authority, common law provisions shall apply.
Competent entities
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