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

Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include moving the headquarters/working point (UF-DSP)*

favorite_border
Add favorite
Procedure
Online
Companii
Institutii
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where changes occur regarding the conditions that formed the basis for issuing the operating authorization - any other change affecting the space of the pharmaceutical unit, except for relocating the headquarters/branch. Changes must be reported to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the change.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
The operating license or the duplicate issued by the Ministry of Health in case of loss of the license*
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
- it is uploaded to the platform, signed with an extended electronic signature*
The outline of the space prior to the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The layout of the space after modifications have been made*
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
- is uploaded to the platform, signed with extended electronic signature*
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 - is uploaded to the platform, signed with extended electronic signature*
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which 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
- it is uploaded to the platform, signed with an extended electronic signature*
Request to DSP*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 2 appendix from the Norms regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 484/2025 - The document is downloaded, filled in, and then uploaded to the platform, signed with an extended electronic signature.*
Applicant Request*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 3 annex from the Norms regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 484/2025 - Download the document, fill it in and then upload it 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:
30
Calendar days
Case filling duration:
15
Calendar days
Notification deadline:
Calendar days
Appeal routes

​In the event 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: 
02 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.
Sibiu 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.
Sibiu Public Health Directorate*
Str. Gh. Baritiu, nr. 3
Telefon:
Fax: 0269217092
Email: secretariat@dspsibiu.ro
www.dspsibiu.ro
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