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  3. Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (DSP-MS)*

Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (DSP-MS)*

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Procedure
Online
Companii
National

The procedure is addressed to County Public Health Directorates, as well as the Bucharest municipality in the event of changes in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/point of work - sending documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate.

The resolution time (3 calendar days) represents the deadline for sending all documents to the Ministry of Health

IMPORTANT !!! Uploaded documents must 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 of the space intended for a pharmaceutical unit*
Descarcă
Scanned document
The document will be uploaded with the extended electronic signature of the DSP*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Inspection report*
Descarcă
Scanned document
The document will be uploaded with the extended electronic signature of the DSP*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant type request*
Descarcă
Formular tipizat
According to model no. 3 from the Norms approved by OMS no. 444/2019 – The document will be uploaded with the advanced electronic signature of the applicant for the issuance of the Authorization/Annex to the Authorization*
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:
15
Calendar days
Notification deadline:
1
Calendar days
Appeal routes

In 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: 
11 June 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

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