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

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Procedure
Online
Companii
Cetateni
National
ROEID

Details

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

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

IMPORTANT!!! The uploaded request must be named in the following format: "pharmacy name_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest city district 1), MARIAFARM_BV.pdf


*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Request for material error correction + AF or annex + supporting document*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature. A single scanned and electronically signed document (.pdf) is uploaded, which must contain the items mentioned in the Name section*
Issued documents

Denumire

Tip document

Descarcă


-
Operating authorization or annex (mentions) with correct data*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Fees

Title

Payment method

Value

Currency


Taxă fixă
OP
50
RON
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 are applicable.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
10 July 2026
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 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.
Intr. Cristian Popisteanu, nr. 1-3, Sector 1, RO
Telefon: 0213141912
Fax:
Email: relatii.publice@ms.ro
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Competent entities

Compartimentul Farmaceutic si Dispozitive Medicale
A.D.R.
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