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Notifications from Marketing Authorization Holders regarding discontinuation*
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Procedure
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Companii
National
Cross-border
The purpose of this procedure is to inform ANMDMR regarding medicine shortages, received from the Marketing Authorization Holders by completing the form attached to it.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Notification form for medication discontinuity*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents
Denumire
Tip document
Descarcă
-
None
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
5
Calendar days
Case filling duration:
0
Calendar days
Notification deadline:
0
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 through failure to resolve a request within the legal deadline, may address the competent administrative court under the conditions established by the Administrative Litigation Law no. 554/2004.
In the event of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*Additional information
More info:
Links
Assistance and problem-solving services
None
Last updated:
02 August 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
Table of contents
Competent entities
Serviciul Registratură și Arhivă
Direcția Generală Inspecție Farmaceutică
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