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  3. Voluntary suspension of the operating license of the pharmaceutical unit for a period of more than 30 calendar days (UF-MS)*

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

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Procedure
Online
Companii
National

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

IMPORTANT!!! All uploaded documents must be obligatorily named as follows: "pharmacy name_county name_**." (** represents the most concise 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
According to Model no. 4 annex from the Rules regarding the establishment, organization, and functioning of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, filled in, and then uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The substantiated request of the authorization holder*
Descarcă
Scanned document
- it is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating authorization or duplicate issued by the Ministry of Health in case of loss of authorization*
Descarcă
Scanned document
- is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the fee provided by law*
Descarcă
Scanned document
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity of the notification according to model no. 7 from the annex to the Norms*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
REVISAL excerpt or another document proving the change of classification of chief pharmacist or chief pharmacy assistant (in the drugstore, only in the situation where there is no chief pharmacist), when their absence justifies the suspension request*
Descarcă
Scanned document
In the situation where the reason for the suspension request is not found in this situation, a statement from the company administrator will be uploaded, showing that the suspension is not caused by the absence of the chief pharmacist/chief pharmacy medical assistant. - it is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The lease agreement or other supporting document evidencing possession of the space when its absence is the reason for the suspension request*
Descarcă
Scanned document
In the situation where the reason for the suspension request is not found in this list, a statement from the company's administrator must be uploaded, from which it results that the suspension is not caused by the lack of space where the pharmaceutical unit operates - it is uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Annex to the operating permit, with recorded mentions*
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:
20
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: 
31 March 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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