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  3. Modification of authorization conditions - CHANGES OF TRADE NAME, REGISTERED OFFICE ADDRESS, WORKING POINT ADDRESS ACCORDING TO NOMENCLATSTRADAL (UF-MS)*

Modification of authorization conditions - CHANGES OF TRADE NAME, REGISTERED OFFICE ADDRESS, WORKING POINT ADDRESS ACCORDING TO NOMENCLATSTRADAL (UF-MS)*

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Procedure
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Companii
National

The procedure addresses pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating license in the following cases (not cumulative):

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

- change of registered office address without business activity

- change of postal address name in cases where the local council changes the street naming plan.

- change of registration number in the Trade Register

IMPORTANT!!! All uploaded documents must be named strictly as follows: "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

-
Standard request*
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 license or the duplicate issued by the Ministry of Health in case of loss of the 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
Certificate of registration for mentions regarding the new name of the place of business/new address of the registered office/new name of the address of the point of sale, issued by the 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 registration with the new name of the place of business/new address of the registered office/new name of the address of the point of sale, issued by the 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 in which the pharmaceutical unit carries out its activity of the relevant 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 an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Street nomenclature certificate issued by the Local City Hall*
Descarcă
Scanned document
It is submitted only in the case of updating the ADDRESS OF THE PLACE OF BUSINESS 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 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 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
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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