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 that fall under the provisions of art. 24 para. (4), (5), and (6) of the Minister of Health Order no. 368/2017, with subsequent amendments and additions.

- art. 24 " (4) In the situation where, within the period 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(s) concluded under the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015, with subsequent amendments and additions, the annual correction procedure provided in para. (5) and (6) applies.

(5) In the situation where the medicines provided 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, methodology for negotiation, conclusion, and monitoring of the implementation and running of cost-volume/cost-volume-outcome contracts, the MAH holder/representative will submit the documentation for the correction at least 90 days before the end of the contractual period. At least 45 days prior to the expiration of the validity of the price in Canamed, the Ministry of Health communicates to the National Health Insurance House (CNAS) and the MAH internal price approval for the resumption of the negotiation process.

(6) The maximum price levels provided in para. (5) are included in Canamed and come into effect starting from the 1st of the month following the end date of the existing prices in Canamed."

- art. 24 para. (2)" In the situation where the medicines provided in para. (1) are subject to both the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015 (...), and 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 expiration of the validity of the last cost-volume or cost-volume-outcome contract concluded under the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015, with subsequent amendments and additions. "

This procedure can be accessed via the link below and then by clicking 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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