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Voluntary suspension of the operating authorization of the pharmaceutical unit for a period longer than 30 calendar days (UF-MS)*

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Procedure
Online
Companii
Cetateni
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where suspension of the operating authorization is requested for justified reasons or for objective reasons invoked by the holder of the authorization, for a period of time between 30 days and 180 days (calendar days). The request for suspension of the authorization must be notified to the Ministry of Health - Pharmaceutical Directorate and Medical Devices within 5 working days before the interruption of activity.

IMPORTANT!!! All uploaded documents must be named obligatorily in the form pharmacy name_county name_**. (** represents a very brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Standard request*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 4 annex from the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, completed, and then uploaded to the platform, signed with advanced electronic signature.*
The reasoned request of the authorization holder*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The operating permit or the duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with extended electronic signature*
Proof of payment of the fee required by law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with an extended electronic signature*
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, of the notification according to model no. 7 from the annex to the Norms*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
REVISAL extract or another document showing the change of position of chief pharmacist or chief pharmacy assistant (at a drugstore, only in the situation where there is no chief pharmacist), when their absence justifies the suspension request*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
In the situation where the reason for the suspension request is not found in this case, a statement from the company's administrator must be uploaded, stating that the suspension is not due to the absence of the chief pharmacist/chief pharmacy medical assistant. - it is uploaded to the platform, signed with an advanced electronic signature*
The lease contract or another supporting document of space possession when its absence justifies the suspension request*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
In the situation where the reason for the suspension request is not found in this situation, a declaration by the company administrator will be uploaded, stating that the suspension is not caused by the lack of space in which the pharmaceutical unit operates - it is uploaded to the platform, signed with an extended electronic signature*
Issued documents

Denumire

Tip document

Descarcă


-
Mention on Annex to the operating license*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Fees

Title

Payment method

Value

Currency


Taxă fixă
OP
50
RON
Deadlines
Resolution time:
30
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 common law provisions shall apply.

*
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
Table of contents

Competent entities

Compartimentul Farmaceutic si Dispozitive Medicale
A.D.R.
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