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  3. Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - SAME ADDRESS OF HEADQUARTERS/WORKING POINT (UF-MS)*

Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - SAME ADDRESS OF HEADQUARTERS/WORKING POINT (UF-MS)*

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in situations where the addition of the mention regarding resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at the same address of the headquarters/work point. Documents must be submitted 30 working days before the legal suspension period expires.


IMPORTANT !!! All uploaded documents must be named in the following mandatory format "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 - appendix from the Rules 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 an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The operating authorization or duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
- 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 Rules*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility that no changes have occurred compared to the last mention on the appendix to the operating license*
Descarcă
Scanned document
- 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 required 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
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:
30
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 provisions of common law 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
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
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Competent entities

Compartimentul Autorizare și Monitorizare Unități Farmaceutice

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