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The procedure for approving prices for medicines that have changed their CIM code / DAPP / trade name*
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Procedure
Online
Companii
Cetateni
National
ROEID
Details
The procedure is addressed to holders of marketing authorization (MAH) or their legal representatives – in the case of changing/maintaining the CIM code of the medicine, changing the MA holder, the brand name, for the same package size (number of therapeutic units) and the same price.
This procedure can be accessed by following the link below and then clicking the "for the online service apply here" button
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*
Descarcă
The standard request is provided in Order no. 368 of 2018 for the approval of the Rules regarding the method of calculation and the approval procedure of the maximum prices of medicines for human use*
Copy of the MA or of the European Commission decision issued within the centralized procedure to which is added MA Modification or Decision attesting the change of the CIM code.*
Descarcă
Copy from the APP annexes or from the European Commission decision issued in the context of the centralized procedure*
Descarcă
Declaration on own responsibility of the APP holder or representative, according to annex no.2*
Descarcă
The declaration will be signed with an electronic signature.*
Power of attorney from the pharmaceutical company for companies/individuals who submit/register the files*
Descarcă
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:
22 April 2026
Publicat de către:
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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 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
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