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
National
Cross-border
The procedure is addressed to the marketing authorization holders (DAPP) or their legal representatives in situations where the approval of prices is requested for a medicine authorized for marketing which 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 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 APP annexes or from the decision of the European Commission issued within the centralized procedure*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility of the holder of the APP or the representative - Annex no. 2 from Norms*
Descarcă
Formular tipizat
- the document is uploaded signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility by the APP holder or representative - Annex no. 3*
Descarcă
Formular tipizat
The request is provided in Annex 3 to the Rules regarding the method of calculation and the procedure for approving the maximum prices of human use medicines approved by Order MS no. 368/2017, with amendments and completions. In the situation where the medicine is NOT classified as innovative or assimilated to it according to the regulations, any other document (even a "white sheet") will be submitted, since documents must be uploaded at every position in the procedure, so that the request can be generated. - the document is 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 form - annex no. 1 from Rules + RECEIPT*
Descarcă
Formular tipizat
The application is provided for in Annex 1 of the Rules on 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 additions.
The application will be accompanied by the electronically generated receipt following the selection from the reference countries’ catalogues – the document must be 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 date of placing the medicinal product on the market - 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 medicinal products for human use approved by Order of the Minister of Health no. 368/2017, with amendments and completions. The communication will bear the registration number at ANMDMR - the document is to 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:
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 are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
01 February 2024
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
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