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  3. Modification of initial authorization conditions -ANY MODIFICATION REGARDING THE SPACE - Does not include relocation of headquarters/branch (UF-DSP)*

Modification of initial authorization conditions -ANY MODIFICATION REGARDING THE SPACE - Does not include relocation of headquarters/branch (UF-DSP)*

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Procedure
Online
Companii
Institutii
National
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Details

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

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use over the space intended for a pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The outline of the space prior to the modifications made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The outline of the space after changes have been made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
Proof of payment of the fee provided by law*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
art. 42 - Law no. 266/2008 - Pharmacy Law, republished - is uploaded to the platform, signed with extended electronic signature*
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. 9 from the annex to the Norms*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Request to DPSJ BN*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 2 annex from the Regulations regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 484/2025 - The document is downloaded, completed and then uploaded to the platform, signed with an extended electronic signature.*
Request to MS*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 3 annex from the Rules regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 484/2025 - The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature.*
Issued documents

Denumire

Tip document

Descarcă

-
Decision of compliance of the space with the purpose of pharmaceutical unit*
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Inspection report*
 obligatoriu cu semnatură digitală disponibil și 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 authorities, the provisions of common law shall apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
01 July 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.
Public Health Directorate of Bistrita-Nasaud County*
*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.
Public Health Directorate of Bistrita-Nasaud County*
Granicerilor nr. 5, Bistrita, RO
Telefon: 0263232601
Fax: 0263231137
Email: dspj.bistrita_nasaud@dspbn.elcom.ro
https://dspbn.ro/
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