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Procedure regarding the setting of prices for human use medicines in Romania*
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Procedure
Online
Companii
Cetateni
National
ROEID
The procedure is addressed to marketing authorization holders (MAH) or their legal representatives in situations where price approval is requested for a medicinal product authorized for marketing that does not have a price registered in CANAMED/Public Catalogue
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Copy of the MA or of the European Commission decision issued within the centralized procedure*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy from the annexes of the APP or of the decision of the European Commission issued within the centralized procedure*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility by the APP holder or representative - Annex no.2 from the Norms*
Descarcă
Formular tipizat
- the document is uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Self-declaration of the APP holder or representative - Annex no. 3*
Descarcă
Formular tipizat
The application is provided in Annex 3 to the Rules regarding the calculation method and the approval procedure of the maximum prices of human medicines, approved by Order of the Ministry of Health no. 368/2017, with subsequent amendments and completions. In case the medicine is NOT classified as innovative or assimilated according to the rules, any other document (even a "blank sheet") can be submitted, since the procedure requires documents to be uploaded in all fields, so the request can be generated. - the document must 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
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
ANMDMR confirmation regarding the classification of the medicine*
Descarcă
Scanned document
The ANMDMR confirmation will be signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request type - Annex no. 1 from the Norms + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 of the Rules regarding the calculation method and approval procedure for the maximum prices of human use medicines approved by Order MS no.368/2017, with amendments and additions. The request will be accompanied by the receipt generated electronically following the selection from the reference countries' catalogs – the document is uploaded 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 amendments and additions.
The communication will bear the ANMDMR registration number - the document must 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:
120
Calendar days
Case filling duration:
45
Calendar days
Notification deadline:
5
Calendar days
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
21 April 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
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 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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