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Procedure regarding the establishment of prices for human use medicines in Romania that have the status of: orphan, immunological, medicines derived from blood and human plasma, medicines notified regarding discontinuity.*
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Procedure
Online
Companii
National
Cross-border
The procedure is addressed to marketing authorization holders (MAH) or their legal representatives.
This procedure can be accessed by following the link below and then by clicking 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
-
Standard request - annex no. 1 from the Norms + RECEIPT*
Descarcă
Formular tipizat
The request is provided in Annex 1 to the Rules on the method of calculation and the procedure for approval of the maximum prices of human medicinal products approved by Order of the Ministry of Health no. 368/2017, as amended and supplemented. The request will be accompanied by the electronically generated receipt following the selection from the reference countries' catalogues – 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 decision European Commission centralized procedure*
Descarcă
Scanned document
- the documents are uploaded signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration 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 Norms regarding the calculation method and the procedure for approving 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 an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the APP holder or representative - Annex 3 from the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex 3 to the Rules regarding the calculation method and the approval procedure of the maximum prices of human-use medicines approved by Order MS no.368/2017, with amendments and additions – the document is uploaded signed with an extended 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
- the document is uploaded signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
ANMDMR confirmation 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 date of placing the medicinal product on the market - Annex no. 4 from the Norms*
Descarcă
Formular tipizat
The declaration is provided in Annex no. 4 of the Norms regarding the method of calculation and the approval procedure of the maximal prices of medicinal products for human use approved by Order of the Minister of Health no. 368/2017, with amendments and completionsThe 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 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:
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 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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