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

Voluntary suspension of the operating license of the pharmaceutical unit for a period longer 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 authorization holder, for a period of time between 30 days and 180 days (calendar days). The suspension request must be notified to the Ministry of Health - Directorate for Medicine Policy, Devices and Medical Technologies within 5 working days before the interruption of activity.

IMPORTANT !!! All uploaded documents must obligatorily be named as follows: "pharmacy name_county name_**." (** represents a 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
According to Model no. 4 annex from the Norms regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 444/2019. - Download the document, fill it in and then upload it 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
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an extended 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 an 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 where 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 showing the change in the position of chief pharmacist or chief pharmacy assistant (at the drugstore, only if there is no chief pharmacist), when their absence justifies the request for suspension*
Descarcă
Scanned document
In the event that the reason for the suspension request is not found in this situation, a statement from the company's administrator must be uploaded, indicating that the suspension is not due to the absence of the chief pharmacist/chief pharmacy 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 another document proving possession of the space when its absence justifies the request for suspension*
Descarcă
Scanned document
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 lack of space in which 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 authorization, with registered 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 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: 
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, Sector 1, RO
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
Table of contents

Competent entities

Compartimentul Autorizare și Monitorizare Unități Farmaceutice
A.D.R.
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