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Procedure regarding the establishment of prices for medicines needed for PUBLIC HEALTH REASONS*
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Procedure
Online
Companii
National
Cross-border
The procedure is addressed to holders of marketing authorization (DAPP) or their legal representatives who request the approval of the prices of medicines authorized on the basis of Order of the Minister of Health no. 1540/2021 for the approval of the Application Norms of the provisions of art. 883 of Law no. 95/2006 regarding the reform in the field of health concerning the authorization of the marketing of certain medicines required for public health reasons.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Copy of the Authorization on public health grounds*
Descarcă
Scanned document
- the document is uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the authorization holder - annex no.2 to the Regulations*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 to the Rules on the method of calculation and procedure for approval of prices for human medicinal products approved by Order of the Minister of Health no. 368/2017, as subsequently amended and supplemented - the document is to be uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Power of attorney from the pharmaceutical company for companies/individuals who submit/register the files*
Descarcă
Scanned document
- the document is uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
ANMDMR confirmation regarding the classification of the medicine*
Descarcă
Scanned document
- the document is uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Standard request - annex no. 1 from the Regulations + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 to the Rules on the calculation method and approval procedure of 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 receipt generated electronically following the selection from the reference countries’ catalogs - the document will be uploaded signed with extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the holder of the authorization - Annex 3 from the Rules*
Descarcă
Formular tipizat
The declaration is provided in Annex 3 of the Rules regarding the calculation method and the procedure for approving the maximum prices of human medicinal products approved by Order of the Ministry of Health no. 368/2017, with subsequent 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
Copy of the communication to ANMDMR regarding the actual market release date of the medicinal product - Annex no. 4 from the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex no. 4 of the Norms regarding the calculation method and the approval procedure of the maximum prices of human use medicines approved by Order of the Minister of Health no. 368/2017, with subsequent amendments and completions. The communication will bear the registration number from ANMDMR - the document will be uploaded signed with an extended electronic signature.*
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:
40
Calendar days
Notification deadline:
5
Calendar days
Legislation
None
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the common law provisions apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
16 January 2026
Publicat de către:
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a particular point or idea. Paragraphs are usually an expected part of
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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 Directorate of Pharmaceuticals and Medical Devices*
*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 Directorate of Pharmaceuticals and Medical Devices*
Str. Cristian Popisteanu, nr.1-3, Sector 1, Sector 1, RO
Telefon:
0213072500
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Serviciul Preturi si Politica Medicamentului
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