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

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

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Procedure
Online
Companii
National

The procedure is addressed to the County Public Health Directorates, and the Bucharest Municipality Directorate in situations where there are changes to the conditions that formed the basis for the issuance of the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/branch - forwarding the documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The processing timeframe (3 calendar days) represents the deadline for forwarding all documents to the Ministry of Health.
IMPORTANT!!! The 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 designated as 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 the template Appendix no. 3 to the Rules approved by OMS no. 444/2019. - it is 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 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: 
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, Sector 1, RO
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
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Compartimentul Autorizare și Monitorizare Unități Farmaceutice
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