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Procedure for the approval of prices for medicines authorized for the supply of medicines for special needs (ANS)*
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Procedure
Online
Companii
National
Cross-border
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 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 - annex no. 1 from Rules + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 to the Rules regarding the calculation method and the approval procedure for the maximum prices of human use medicines approved by Order of the Ministry of Health 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 to be uploaded signed with an extended 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 in Romanian*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the ANS holder - Annex no. 2 to the Rules*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 to the Rules regarding the calculation method and approval procedure of prices for human use medicines approved by Order of the Minister of Health no. 368/2017, as subsequently amended and supplemented - 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:
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 shall apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
27 April 2023
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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