Home
Home
Single digital gateway for public services
favorite_border
  1. Home > 
  2.  > 
  3. Modification of initial authorization conditions -ANY MODIFICATION TO THE SPACE - Does not include relocating the headquarters/work location (UF-DSP)*

Modification of initial authorization conditions -ANY MODIFICATION TO THE SPACE - Does not include relocating the headquarters/work location (UF-DSP)*

favorite_border
Add favorite
Procedure
Online
Companii
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating authorization - any other modification made to the space of the pharmaceutical unit, except for relocating the headquarters/working point. The modifications must be notified to the Ministry of Health - Drug Policy and Medical Devices Directorate within 5 working days from the date of 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
*
The document certifying the right of use of the premises by the pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
*
The outline of the space before the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
*
The layout of the space after modifications have been made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
*
Technical memorandum*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
*
Proof of payment of the fee provided by law*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
art. 42 - Law no. 266/2008 - Pharmacy Law, republished*
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. 7 from the annex to the Norms*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
*
Request type applicant*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
*
Request form to DSP*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
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:
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: 
01 July 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.
Brăila 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.
Brăila Public Health Directorate*
Str. Constantin Dobrogeanu Gherea .2 bis nr. 2 bis, Braila, RO
Telefon: 0339401175
Fax: 0339401178
Email: dspj.braila@dspbr.ro
www.dspbr.ro
Table of contents

Competent entities

Compartiment Avize autorizari
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