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  3. Payment forms for the settlement of the fee and charge for applications for authorization/renewal of marketing authorization for medicines*

Payment forms for the settlement of the fee and charge for applications for authorization/renewal of marketing authorization for medicines*

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Procedure
Online
Companii
National
Cross-border

The purpose of this procedure is the submission and processing of payment forms for the payment of the fee and charge for marketing authorization/renewal requests of medicinal products.

Useful links:
https://www.anm.ro/medicamente-de-uz-uman/legislatie/legi-ordonante-si-hotarari-de-guvern/

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Payment authorization form national procedure*
Descarcă
Formular tipizat
- the document is downloaded, completed, and then uploaded to the platform*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Payment form for renewal, national procedure*
Descarcă
Formular tipizat
- the document is downloaded, completed, and then uploaded to the platform*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Invoice*
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

Any person who considers themselves harmed in one of their rights or in a legitimate interest by ANMDMR through an administrative act or by the failure to resolve a request within the legal term may address the competent administrative court under the conditions established by the Administrative Litigation Law no. 554/2004.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
13 April 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.
National Agency for Medicines and Medical Devices of Romania*
*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.
National Agency for Medicines and Medical Devices of Romania*
Str. Aviator Sănătescu 48
Telefon: +40213171100
Fax: +40213163497
Email: secretariat@anm.ro
www.anm.ro
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