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Procedure regarding the setting of prices for medicines marketed based on the PARALLEL IMPORT AUTHORIZATION or based on the PARALLEL DISTRIBUTION AUTHORIZATION (THE ORIGINAL MEDICINE DISTRIBUTED DIRECTLY HAS THE APPROVED PRICES IN CANAMED)*
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Procedure
Online
Companii
Cetateni
National
ROEID
The procedure is addressed to DAPP/representatives who request price approval for medicines that can be marketed in Romania based on the parallel import authorization or based on the parallel distribution authorization in the situation where the original medicine, distributed directly, has the producer, wholesale, and retail prices approved in Canamed.
This procedure can also be accessed by following the link below and pressing the button "for the online service apply here":
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request type - Annex no. 1.1 from the Norms*
Descarcă
Formular tipizat
The standard application is provided in Annex 1.1 of the Rules regarding the calculation method and approval procedure of the maximum prices of medicinal products for human use, approved by Order MS no.368/2017, with amendments and additions – the document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the MA or copy of the parallel distribution authorization*
Descarcă
Scanned document
- the document is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility by the APP holder or representative - Annex 2 from Regulations*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 of the Rules on the calculation method and approval procedure of the maximum prices for human medicines approved by Order MS no.368/2017, as amended and supplemented - the document is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Extracted "Medication details" from the ANMDMR site*
Descarcă
Scanned document
- the document is uploaded to the platform, signed with extended electronic signature*
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 case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*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
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