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Procedure for approving prices for medicines authorized for the supply of medicines for special needs (ANS)*
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Procedure
Online
Companii
Cetateni
National
ROEID
The procedure is addressed to holders of authorization for the supply of medicines for special needs or their legal representatives.
This procedure can be accessed by following the link below and then by pressing the button "for the online service apply here"
http://www.ms.ro/organizare/directia-politica-medicamentului-si-a-dispozitivelor-medicale/#tab-id-7
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request type - annex no. 1 from Norms + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 to the Rules regarding the calculation method and the approval procedure of 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 electronically generated receipt following the selection from the reference countries' catalogs - the document is uploaded signed with an advanced electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the authorization regarding the supply of medicines for special needs.*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the summary of product characteristics and the leaflet in the language of the country in which it is authorized, and the translation into Romanian*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility of the holder ANS - Annex no. 2 to Rules*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 to the Rules regarding the method of calculation and the procedure for approving prices of medicinal products for human use approved by Order of the Minister of Health no. 368/2017, as subsequently amended and supplemented - the document is uploaded signed with advanced 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:
15
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:
22 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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