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Change of authorization conditions - CHANGES IN THE TRADE NAME, REGISTERED OFFICE ADDRESS, WORK POINT ADDRESS ACCORDING TO THE STREET NOMENCLATURE (UF-MS)*

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for the issuance of the operating authorization in the following situations (these are not cumulative):

- change of commercial name (brand) of one or more pharmacy points of sale

- change of registered office address without business activity

- modification of postal address name in the situation where the Local Council changes the street name plan.

- change of registration number in the Trade Register

IMPORTANT !!! All uploaded documents must be named obligatorily in the format "pharmacy name_county name_**." (** represents the briefest possible 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 to the Norms regarding the establishment, organization, and functioning of pharmaceutical units - it 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
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of registration mentions regarding the new name of the workplace/new address of the registered office/new name of the sales point address, issued by ONRC*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of facts with the new name of the work point/new address of the registered office/new name of the sales location address, issued by ONRC*
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 appropriate notification.*
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 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
Street nomenclature certificate issued by the City Hall of the locality*
Descarcă
Scanned document
It is submitted only in the case of updating the WORK POINT ADDRESS ACCORDING TO THE STREET NOMENCLATURE - 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 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 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 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
Table of contents

Competent entities

Compartimentul Farmaceutic si Dispozitive Medicale
A.D.R.
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