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Approval of prices in the case of a request to increase an already approved price*
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Procedure
Online
Companii
National
The procedure is addressed to holders of marketing authorization (MAH) or their legal representatives who request approval for increasing the prices of medicinal products for human use under the conditions of art. 12 para. (2) and para. (2^1) of the Rules approved by the Order of the Minister of Health no. 368/2017, with amendments and additions.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request form - annex no. 1^2 from Norms*
Descarcă
Formular tipizat
The request is provided in Annex 1^2 to the Rules regarding the calculation method and approval procedure of the maximum prices of medicinal products for human use approved by Order MS no. 368/2017, with amendments and additions. The request shall be accompanied by the electronically generated receipt following the selection from the reference countries' catalogs - the document shall be uploaded signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility of the APP holder or 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
Electronic receipt of the selection from source catalogues for comparison countries*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the communication to ANMDMR regarding the actual date of placing the medicine on the market - Annex no. 4 of the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex no. 4 of the Norms regarding the calculation method and approval procedure of 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 uploaded signed with extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the MAH/representative by which the necessary data are made available to the Ministry of Health, including details on the changes that have occurred since the approval of the last price of the medicine and which, in his/her opinion, justify the requested price.*
Descarcă
Scanned document
- the document is 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
Legislation
None
Appeal routes
In the case of a dispute between the beneficiary and the competent authority, the common law provisions apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
04 March 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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