Home
Home
Single digital gateway for public services
favorite_border

Modification of initial authorization conditions - Change of authorization holder and CHANGE OF HEADQUARTERS/WORKING POINT - Legal entity THROUGH DIVISION (UF-DSP)*

favorite_border
Add favorite
Procedure
Online
Companii
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for issuing the operating license - change of holder of the Operating License by modifying the legal entity (through division) and changing the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate for Drug Policy and Medical Devices within 5 working days from the date of the modification.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration regarding the registration of the beneficiary company's work point, issued by ONRC*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Certificate attesting the exact address of the workplace of the beneficiary company, issued by ONRC*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Proof of publication of the Division Project in the Official Gazette of Romania*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of mentions, issued by ONRC, in accordance with the Resolution which records the division of the company as a divided company and the newly created/beneficiary company, according to the Division Project, published in the Official Gazette*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility of the administrator of the divided company regarding the existence or non-existence of any disputes involving the operating authorization concerning the divided company*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use over the space designated as a pharmaceutical unit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with extended electronic signature*
Space sketch*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The employment contract or proof of exercising the profession in a liberal form, for a full-time position with a working duration of 8 hours, for the chief pharmacist, registered in the name of the new authorization holder*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
In the case of drugstores - the employment contract or proof of exercising the profession in a liberal form for a full-time position for the new pharmaceutical unit manager is uploaded - it is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee provided by law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with extended electronic signature*
Proof of compliance with the provisions of Article 20 of the Pharmacy Law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
Law no. 266/2008 - the pharmacy law, republished - the document attesting to the situation provided by the law, signed with an extended electronic signature, is uploaded to the platform*
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Request type*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 10 annex from the Regulations 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.*
Issued documents

Denumire

Tip document

Descarcă


-
Compliance decision for the space designated as a pharmaceutical unit*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Inspection report*
obligatoriu cu semnatură digitală disponibil și 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 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: 
15 September 2026
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.
Vrancea Public Health Directorate*
*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.
Bdul Garii nr. 14, Focsani, RO
Telefon: 0237225979
Fax: 0237225732
Email: dspvn@gmx.net
Table of contents

Competent entities

Compartiment Farmaceutic
A.D.R.
This site is managed by the Romanian Digitalisation Authority and is an official website of the Romanian Government
Public Institutions
Need assistance?
EU Institutions
Info
Your Europe
PNRR
PNRR. Finanțat de Uniunea Europeană
UrmătoareaGenerațieUE
© 2024 roepas.ro