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

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

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in cases where changes occur in the conditions that formed the basis for issuing the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for relocating the headquarters/working point. The modifications must be notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the modification.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
The operating license or the duplicate issued by the Ministry of Health in case of loss of the license*
Descarcă
Scanned document
Of course! Please provide the Romanian text you want translated to English.*
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
Of course! Please send the Romanian text you want translated.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The sketch of the space prior to the changes made*
Descarcă
Scanned document
Desigur! Vă rog să furnizați textul în limba română pe care doriți să îl traduc în limba engleză.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The layout of the space after changes have been made*
Descarcă
Scanned document
Sure! Please provide the Romanian text you want translated into English.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The technical memorandum*
Descarcă
Scanned document
Desigur! Vă rog să trimiteți textul în limba română pe care doriți să îl traduc.*
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 - Pharmacy Law, republished*
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 the Rules*
Descarcă
Scanned document
Desigur! Vă rog să furnizați textul în limba română pe care doriți să îl traduc.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant form*
Descarcă
Formular tipizat
Of course! Please provide the Romanian text you want translated into English.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Template request to DSP*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Compliance decision of the space intended for use 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 case of a dispute between the beneficiary and the competent authority, the common law provisions 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
www.dspbr.ro
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