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Procedure for approving medicine prices in case of extending the validity of the authorization for the supply of medicines for special needs*
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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, in the event that the quantity provided in the authorization regarding the supply of medicines for special needs is not exhausted before its expiry date, the holder may request only once, 30 days before expiration, the extension of the validity of the approved price.
This procedure can be accessed by following the link below and then clicking on 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*
Descarcă
Formular tipizat
The standard application is provided in Order no. 368 of 2018 for the approval of the Rules regarding the method of calculation and the procedure for approving the maximum prices of medicines for human use*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the authorization for the supply of medicines for special needs (initial), issued by ANMDM*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the document proving the extension of the validity of the Authorization for the supply of medicines for special needs, issued by ANMDM*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the APP holder or representative, according to annex no.2*
Descarcă
Formular tipizat
The declaration will be signed with an electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Power of attorney from the pharmaceutical company for companies/individuals who submit/register the files.*
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:
15
Calendar days
Notification deadline:
5
Calendar days
Appeal routes
In the case of a dispute between the beneficiary and the competent authority, common law provisions are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
26 October 2023
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.
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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