Single digital gateway for public services
Procedure for approving medicine prices in case of extension of validity of the authorization for supply of medicines for special needs*
favorite_border
Add favorite
Procedure
Online
Companii
Cetateni
National
ROEID
The procedure is addressed to holders of authorization for the supply of medicines for special needs or their legal representatives, in the situation where the quantity provided in the authorization for 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 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
-
Request type*
Descarcă
Formular tipizat
The standard application is provided in Order no. 368 of 2018 for the approval of the Rules regarding the calculation method and the approval procedure of 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 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
Authorization 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:
120
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:
22 April 2026
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
Share your opinion
Provide your opinion about the content of this page. You can leave acomment about what we can improve. You will not receive a response toyour comment. Use the contact form to clarify any questions regardingthe information and services available on this portal.
Did you find what you were looking for?
Help us improve