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Procedure regarding the establishment of prices for medicines marketed on the basis of the PARALLEL IMPORT AUTHORIZATION or on the basis of the PARALLEL DISTRIBUTION AUTHORIZATION (THE ORIGINAL MEDICINE DIRECTLY DISTRIBUTED HAS THE APPROVED PRICES IN CANAMED)*
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Procedure
Online
Companii
National
The procedure is addressed to DAPP/representatives who request the approval of prices for medicines that can be marketed in Romania based on the parallel import authorization or based on the parallel distribution authorization in situations 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 "for the online service apply here" button:
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request - annex no. 1.1 from the Norms*
Descarcă
Formular tipizat
The standard application is provided in Annex 1.1 of the Norms regarding the calculation method and approval procedure of the maximum prices of human use medicines approved by Order MS no.368/2017, with subsequent amendments and completions - 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 AIP or copy of parallel distribution authorization*
Descarcă
Scanned document
- the document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility of the APP holder or representative - Annex 2 from Norms*
Descarcă
Formular tipizat
The statement is provided in Annex 2 of the Rules regarding the method of calculation 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
Drug Details*
Descarcă
Scanned document
- the document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
60
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 shall apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
10 January 2022
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 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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