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  3. Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/workplace (DSP-MS)*

Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/workplace (DSP-MS)*

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Procedure
Online
Institutii
National
ROEID

Details

The procedure is addressed to County Public Health Directorates, as well as Bucharest Municipality in situations where there are changes in the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/working point - the transmission of documents to the Ministry of Health - Pharmaceutical Directorate and medical devices. The processing period (3 calendar days) represents the period for sending all documents to the Ministry of Health
IMPORTANT!!! The uploaded documents must be named, without exception, as follows: "pharmacy name_DSP_county name" ex.: 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 with the purpose of pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The document will be uploaded with the extended electronic signature of the DSP*
Inspection report*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The document will be uploaded with the extended electronic signature of DSP*
Applicant type request*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to the model Annex no. 3 to the Regulations approved by OMS no. 444/2019. - it is uploaded to the platform, signed with extended electronic signature*
Operating permit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
New sketch of the space + technical report*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The old draft of the space*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
None
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
45
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
Calendar days
Appeal routes

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

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
20 August 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.
Ministry of Health Pharmaceutical and Medical Devices 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 and Medical Devices Department*
Intr. Cristian Popisteanu, nr. 1-3, Sector 1, RO
Telefon: 0213141912
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
Table of contents

Competent entities

Compartimentul Farmaceutic si Dispozitive Medicale
A.D.R.
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