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Approval of prices for medicines that have changed/maintained the CIM/DAPP/trade name code*
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Procedure
Online
Companii
National
The procedure is addressed to marketing authorization holders (MAH) or their legal representatives - changing/maintaining the CIM code of the medicinal product, in the case of the change of the MAH, the trade name, in the same package size (number of therapeutic units) and the same price.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request - annex no. 5 of the Norms*
Descarcă
Formular tipizat
The request is provided in Annex 5 to the Rules regarding the calculation method and the approval procedure of the maximum prices of human medicines approved by Order MS no.368/2017, with amendments and additions - the document is uploaded signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Extract details of the medicine according to the Nomenclature of human use medicines published on the ANMDMR website*
Descarcă
Scanned document
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
Legislation
None
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:
15 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
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