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  3. CORRECTION drug prices COST VOLUME (art.24-OMS no.368/2017)*

CORRECTION drug prices COST VOLUME (art.24-OMS no.368/2017)*

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Procedure
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National
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The procedure is addressed to holders of marketing authorization (DAPP) or their legal representatives.

It refers exclusively to products that are subject to cost-volume or cost-volume-result contracts and which fall under the incidence of art. 24 para. (4), (5), and (6) of the Order of the Minister of Health no. 368/2017, with subsequent amendments and additions.

- art. 24 " (4) In the situation where, within the interval mentioned in para. (2), the negotiation process is resumed for a medication for which there are no longer eligible patients subject to the clauses of the cost-volume or cost-volume-result 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 additions, the annual correction procedure provided for in para. (5) and (6) shall apply.

(5) In the situation where the medications 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 execution of cost-volume/cost-volume-result contracts, the MAH holder/representative shall submit the documentation for the correction at least 90 days before the expiration of the contractual period. At least 45 days before the expiration of the price validity in Canamed, the Ministry of Health communicates to the National Health Insurance House (CNAS) and the MAH holder the internal price approval for the resumption of the negotiation process.

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

- art. 24 para. (2)" In the situation where the medications 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 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 cessation of the validity 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 additions. "

This procedure can be accessed by following the link below and then pressing the button "for online service, apply here":

http://www.ms.ro/organizare/directia-politica-medicamentului-si-a-dispozitivelor-medicale/#tab-id-7

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*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Copy of the MA or the decision of the European Commission issued under the centralized procedure*
Descarcă
Scanned document
- the document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility of the APP holder or representative - Annex 2 from the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 of the Rules regarding the calculation method and the approval procedure of the maximum prices of human-use medicines approved by Order of the Ministry of Health no. 368/2017, with amendments and completions - the document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the APP holder or representative - Annex 3 from the Norms*
Descarcă
Formular tipizat
In the case of innovative medicines for which price approval is requested. The declaration is provided in Annex 3 of the Rules regarding the calculation method and procedure for approving the maximum prices of medicines for human use approved by Order MS no.368/2017, with amendments and additions - the document is uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Standard request - annex no. 1 from the Norms + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex no. 1 to the Norms regarding the calculation method and approval procedure of the maximum prices of human use medicines approved by Order of the Ministry of Health no. 368/2017, with amendments and completions. The request will be accompanied by the electronically generated receipt following the selection from the reference countries' catalogues - the document is uploaded signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy from the annexes of the APP or from the decision of the European Commission issued within the centralized procedure*
Descarcă
Scanned document
- the document is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Communication*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
90
Calendar days
Case filling duration:
45
Calendar days
Notification deadline:
5
Calendar days
Appeal routes

In the case of a dispute between the beneficiary and the competent authority, the common law provisions shall apply.



*
Additional information
More info:
Links
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Last updated: 
28 April 2023
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institution responsible with document: 
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Ministry of Health Pharmaceutical and Medical Devices Directorate*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
Ministry of Health Pharmaceutical and Medical Devices Directorate*
Str. Cristian Popisteanu, nr.1-3, Sector 1
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
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Serviciul Preturi si Politica Medicamentului

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