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Approval procedure for medicine prices in the case of extending the validity of the authorisation for the supply of medicines for special needs*
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Procedure
Online
Companii
National
Cross-border
The procedure is addressed to the holders of the authorization for the supply of medicines for special needs or their legal representatives, in the situation where the quantity provided in the authorization regarding the supply of medicines for special needs is not exhausted until the validity period expires, 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 by pressing 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
-
Standard request*
Descarcă
Formular tipizat
The standard application is provided in Order no. 368 of 2018 for the approval of the Norms regarding the method of calculation and the procedure for approving the maximum prices of medicinal products 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 holder of the APP or of the 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
Of course! Please provide the Romanian text you would like me to translate into English.*
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 event of a dispute between the beneficiary and the competent authority, the provisions of common law apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
26 October 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
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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 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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