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  3. Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. Changes must be notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the change.

*
Details

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. Changes must be notified 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

-
Request type*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
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
Updated certificate of findings with the new address of the pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The document attesting the right of use over the space designated for a pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Sketch of the space*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Technical memorandum regarding the new space of the pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Certificate regarding the demographic criterion*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit carries out its activity, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Proof of payment of the fee stipulated by law*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Standard request to DSP*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Request Applicant type*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
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

Value

Currency

None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
5
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: 
22 April 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.
Botosani 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.
Botosani Public Health Directorate*
Str. Col.Tomoroveanu Nr.1
Telefon:
Fax: 0231515112
Email: djspbotosani@yahoo.com
www.dspbt.ro
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