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

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in situations where registering the mention of resuming activity within the suspension period or upon its expiration is requested. The resumption of activity takes place at the same address of the headquarters/working point. The documents must be submitted 30 working days before the expiration of the legal suspension period.


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


-
Request type*
Descarcă
Formular tipizat
According to Model no. 4 - annex of the Regulations regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, filled out, and then uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The operating permit or duplicate issued by the Ministry of Health in case of loss of the permit*
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 sending to the College of Pharmacists of Romania, to the territorial branch corresponding to the county where the pharmaceutical unit carries out its activity, the notification according to model no. 7 from the appendix to the Norms*
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
Statement on own responsibility that no changes have occurred compared to the last mention on the annex to the operating authorization*
Descarcă
Scanned document
- is uploaded to the platform, signed with 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
Issued documents

Denumire

Tip document

Descarcă


-
Annex to the operating license, with registered 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 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.
Ministry of Health Pharmaceutical and Medical Devices Department*
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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