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  3. Correction of material errors entered on the Operating Authorization or within the mentions in the Annex to the authorization (UF-MS)*

Correction of material errors entered on the Operating Authorization or within the mentions in the Annex to the authorization (UF-MS)*

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units and targets situations where there are errors in the content of the Operating Authorization or in the annex (mentions) to it in relation to the documents submitted by the applicant.

The applicant will upload to the platform a request for the correction of incorrectly entered data, the Operating Authorization or its annex, as applicable, as well as the document supporting the correction of the material error.

IMPORTANT!!! The uploaded request must be compulsorily named as follows "pharmacy name_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf


*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Request for correction of material error + AF or annex + supporting document*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature Only one scanned and electronically signed document (.pdf) is uploaded, which should contain the items mentioned in the Name section*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Operating permit or appendix (mentions) with correct data*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
5
Calendar days
Appeal routes
In the case 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 June 2025
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 Units Authorization and Monitoring Department*
*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 Units Authorization and Monitoring Department*
Intr. Cristian Popisteanu, nr. 1-3
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
Table of contents

Competent entities

Compartimentul Autorizare și Monitorizare Unități Farmaceutice

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