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Procedure regarding the setting of prices for human-use medicines in Romania that have the status of: orphan, immunological, blood and human plasma-derived medicines, medicines notified regarding discontinuation.*
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Procedure
Online
Companii
National
Cross-border
The procedure is addressed to holders of marketing authorization (MAH) or their legal representatives.
This procedure can be accessed by following the link below and then pressing the button "for the online service apply here"
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 form - Annex no. 1 from the Norms + RECEIPT*
Descarcă
Formular tipizat
The application is provided in Annex 1 to the Rules on the method of calculation and procedure for the approval of maximum prices of human use medicines approved by Order of the Ministry of Health no. 368/2017, with amendments and additions The application will be accompanied by the receipt generated electronically following the selection from the reference countries' catalogs – the documents are uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy of the MA or of the decision of the European Commission issued within the centralized procedure*
Descarcă
Scanned document
- the document is uploaded signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Copy - Annexes APP/annexes European Commission decision centralised procedure*
Descarcă
Scanned document
- the documents are uploaded signed with an extended 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 the Regulations*
Descarcă
Formular tipizat
The declaration is provided in Annex 2 of the Rules regarding the method of calculation and the procedure for the approval of the maximum prices of medicinal products for human use, approved by Order of the Ministry of Health no. 368/2017, with subsequent 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
Statement on own responsibility of the APP holder or representative - Annex 3 from the Rules*
Descarcă
Formular tipizat
The declaration is provided in Annex 3 to the Rules on the calculation method and approval procedure of the maximum prices of medicinal products for human use approved by Order of the Ministry of Health no. 368/2017, as amended and supplemented - the document is to be uploaded signed with an extended 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
- the document is uploaded signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Confirmation from ANMDMR regarding the classification of the medicine*
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
Copy of the communication to ANMDMR regarding the actual marketing date of the medicinal product - Annex no. 4 of the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex no. 4 of the Rules regarding the method of calculation and the procedure for approving the maximum prices of human use medicines approved by Order of the Minister of Health no. 368/2017, with subsequent amendments and completions. The communication will bear the registration number from ANMDMR - the document is uploaded 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:
90
Calendar days
Case filling duration:
15
Calendar days
Notification deadline:
5
Calendar days
Appeal routes
In case of a dispute between the beneficiary and the competent authority, the common law provisions shall apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
11 July 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
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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