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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
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 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
-
Standard request - annex no. 1 from the Regulations + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 to the Norms regarding the calculation method and the approval procedure of the maximum prices of human use medicines approved by Order of the Ministry of Health no. 368/2017, with subsequent amendments and completions. The request will be accompanied by the electronically generated receipt following the selection from the reference countries' catalogs – the document must 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 into Romanian*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on Own Responsibility of the ANS Holder - Annex no. 2 to the Regulations*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 to the Rules on the method of calculation and the procedure for approving the prices of medicines for human use approved by Order of the Minister of Health no. 368/2017, with subsequent amendments and completions—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 common law provisions 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 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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