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Procedure regarding the determination of prices for medicines marketed based on the PARALLEL IMPORT AUTHORIZATION or based on the PARALLEL DISTRIBUTION AUTHORIZATION (THE ORIGINAL MEDICINE DIRECTLY DISTRIBUTED HAS APPROVED PRICES IN CANAMED)*
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Procedure
Online
Companii
Cetateni
National
ROEID
Details
The procedure is addressed to DAPP/representatives who request the approval of prices for medicines that may be marketed in Romania based on a parallel import authorization or based on a parallel distribution authorization in situations where the original medicine distributed directly has the manufacturer, wholesale, and retail prices approved in Canamed.
This procedure can also be accessed by following the link below and pressing the button "to apply for the online service apply here":
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request - annex no. 1.1 from the Rules*
Descarcă
The standard request is provided in Annex 1.1 of the Rules regarding the method of calculation and the approval procedure of the maximum prices of human use medicines approved by Order MS no.368/2017, with amendments and completions - the document is uploaded to the platform, signed with extended electronic signature*
Copy of AIP or copy of the parallel distribution authorization*
Descarcă
- the document is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility of the APP holder or representative - Annex 2 from the Regulations*
Descarcă
The statement is provided in Annex 2 of the Rules regarding the calculation method and the approval procedure of the maximum prices of human medicinal products approved by Order MS no.368/2017, with amendments and completions - the document is uploaded to the platform, signed with extended electronic signature*
”Drug Details” extract from the ANMDMR website*
Descarcă
- the document is uploaded to the platform, signed with an advanced electronic signature*
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 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
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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.
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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