Single digital gateway for public services
Procedure regarding the establishment of prices for human use medicines in Romania*
favorite_border
Add favorite
Procedure
Online
Companii
Cetateni
National
ROEID
Details
The procedure is addressed to holders of marketing authorization (DAPP) or their legal representatives in the situation where approval of prices is requested for a medicinal product authorized for marketing that does not have a price registered in CANAMED/Public Catalog
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Copy of the APP or of the decision of the European Commission issued within the centralized procedure*
Descarcă
Copy from the appendices of the APP or from the European Commission decision issued within the centralized procedure*
Descarcă
Declaration on own responsibility by the APP holder or representative - Annex no.2 from Rules*
Descarcă
- the document is uploaded signed with an extended electronic signature*
Statement on own responsibility by the APP holder or representative - Annex no. 3*
Descarcă
The request is provided in Annex 3 to the Rules regarding the calculation method and procedure for approving the maximum prices of medicinal products for human use, approved by Order MS no. 368/2017, with subsequent amendments and additions. In the situation where the medicinal product is NOT classified as innovative or assimilated to it according to the rules, any other document (even a "blank sheet") may be submitted, since documents must be uploaded during the procedure, at absolutely all positions, so that the request can be generated. - the document is uploaded signed with an extended electronic signature*
Authorization from the pharmaceutical company for legal entities/individuals who submit/register the files*
Descarcă
ANMDMR confirmation regarding the classification of the medicine*
Descarcă
ANMDMR confirmation will be signed with extended electronic signature*
Request type - annex no. 1 from Norms + RECEIPT*
Descarcă
The request is provided in Annex 1 of the Rules regarding the calculation method and approval procedure of maximum prices for human medicinal products approved by Order MS no. 368/2017, with amendments and additions. The request will be accompanied by the electronically generated receipt following selection from the reference country catalogs - the document is uploaded signed with an extended electronic signature.*
Copy of the communication to ANMDMR regarding the actual date of placing the medicine on the market - Annex no. 4 of the Regulations*
Descarcă
The declaration is provided in Annex no. 4 of the Rules regarding the calculation method and the approval procedure of the maximal prices of human medicines approved by the Order of the Minister of Health no. 368/2017, with amendments and completions.
The communication will bear the ANMDMR registration number – the document is uploaded signed with an extended electronic signature.*
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 case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
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.
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
Share your opinion
Provide your opinion about the content of this page. You can leave acomment about what we can improve. You will not receive a response toyour comment. Use the contact form to clarify any questions regardingthe information and services available on this portal.
Did you find what you were looking for?
Help us improve