Single digital gateway for public services
favorite_border
  1. Home > 
  2. Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
     > 
  3. Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include the relocation of the headquarters/working point (DSP-MS)*

Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include the relocation of the headquarters/working point (DSP-MS)*

favorite_border
Add favorite
Procedure
Online
Companii
National

The procedure is addressed to County Public Health Directorates, and the Bucharest municipality in situations where there are changes to the conditions upon which the operating authorization was issued - any other modification made to the pharmaceutical unit's space, except for changing the headquarters/working point location - transmission of documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The resolution time (3 calendar days) represents the period for transmitting all documents to the Ministry of Health.
IMPORTANT !!! The uploaded documents must mandatorily be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, Sector 1), MARIAFARM_BV.pdf

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Compliance decision for a space designated as a pharmaceutical unit*
Descarcă
Scanned document
The document will be uploaded with the extended electronic signature of DSP*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Inspection report*
Descarcă
Scanned document
The document will be uploaded with the DSP's extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant type request*
Descarcă
Formular tipizat
According to the template Annex no. 3 to the Norms approved by OMS no. 444/2019. - uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
None
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
30
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
1
Calendar days
Appeal routes

In the event of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
10 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
Table of contents

Competent entities

Compartimentul Autorizare și Monitorizare Unități Farmaceutice

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
PNRR. Finanțat de Uniunea Europeană
UrmătoareaGenerațieUE
© 2024 roepas.ro