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Procedure regarding the establishment of prices for medicines needed for PUBLIC HEALTH REASONS*
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The procedure addresses marketing authorization holders (MAH) or their legal representatives who request the approval of prices for medicinal products authorized under Order of the Minister of Health no. 1540/2021 for the approval of the Rules for the application of the provisions of art. 883 of Law no. 95/2006 regarding health sector reform concerning the authorization of placing on the market certain medicinal products required for public health reasons.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Copy of the Authorization on grounds of public health*
Descarcă
Scanned document
- the document is uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on Own Responsibility of the Authorization Holder - Annex No. 2 to the Regulations*
Descarcă
Formular tipizat
The statement is provided in Annex 2 to the Rules regarding the calculation method and the approval procedure of prices of medicines for human use, approved by Order of the Minister of Health no. 368/2017, as amended and supplemented – the document is uploaded signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Authorization 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
Confirmation from ANMDMR regarding the classification of the medicinal product*
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 Rules + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 to the Norms regarding the method of calculation and the procedure for approving the maximum prices of human use medicines approved by Order MS no. 368/2017, as amended and supplemented. The request will be accompanied by the electronically generated receipt following the selection from the catalogues of the reference countries - the document is to be uploaded signed with an 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 Regulations*
Descarcă
Formular tipizat
The declaration is provided in Annex 3 of the Rules regarding the method for calculating and the procedure for approving the maximum prices of human medicines approved by Order MS 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
Copy of the communication to ANMDMR regarding the actual placing on the market date of the medicinal product - Annex no. 4 from the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex no. 4 of the Rules regarding the calculation method and the procedure for approving the maximum prices of human use medicines approved by the Order of the Minister of Health no. 368/2017, with amendments and completions. The communication will bear the registration number from ANMDMR - the document is 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 case 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:
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
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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 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
Table of contents
Competent entities
Serviciul Preturi si Politica Medicamentului
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