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

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in the event of changes in the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal 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


-
Standard request to DSP*
Descarcă
Formular tipizat
There is no Romanian text to translate. Please provide the text you want translated.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating permit or duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
Scanned document
Nu există niciun text în mesajul tău pentru a fi tradus. Te rog să introduci textul pe care dorești să-l traduc din română în engleză.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Updated certificate of attestation with the new address of the pharmaceutical unit*
Descarcă
Scanned document
Sure, please provide the Romanian text or HTML you want to translate.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The document attesting the right of use over the premises by the pharmaceutical unit*
Descarcă
Scanned document
Desigur! Vă rog să furnizați textul în limba română pe care doriți să îl traduc în engleză.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The outline of the space*
Descarcă
Scanned document
There is no Romanian text to translate.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical memorandum regarding the new space of the pharmaceutical unit*
Descarcă
Scanned document
Nu ai oferit niciun text în limba română de tradus. Te rog să postezi textul pe care dorești să-l traduc.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate regarding the demographic criterion*
Descarcă
Scanned document
- According to art. 20 of Law no. 266/2008 - the Pharmacy Law, republished - In the event that the address of the pharmaceutical unit is in the same locality, a declaration stating this fact is to be uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity, of the notification according to model no. 7 from the annex to-norms*
Descarcă
Scanned document
Of course! Please provide the Romanian text you want translated into English.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the fee provided by law*
Descarcă
Scanned document
art. 42 - Law no. 266/2008 - The Pharmacy Law, republished*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant request form*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă


-
Decision of compliance of the space designated as a pharmaceutical unit*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Inspection report*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency


None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
5
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: 
27 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.
Braila 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.
Braila Public Health Directorate*
Str. Constantin Dobrogeanu Gherea nr.2 bis
Telefon: 0339401175
Fax: 0339401178
Email: dspj.braila@dspbr.ro
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