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

Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include moving the headquarters/work point (UF-DSP)*

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Procedure
Online
Companii
National

The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating permit - any other modification made to the space of the pharmaceutical unit, except for changing the headquarters/place of business. Modifications must be notified to the Ministry of Health - Policy Directorate for Medicines and Medical Devices within 5 working days from the date of the modification.

*
Details

The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating permit - any other modification made to the space of the pharmaceutical unit, except for changing the headquarters/place of business. Modifications must be notified to the Ministry of Health - Policy Directorate for Medicines 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 authorization or 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
The document certifying the right of use over the space designated as a pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The outline of the space prior to the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The outline of the space after modifications have been made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Technical memorandum*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Proof of payment of the fee provided by law*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Proof of submission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, 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
Request to DPSJ BN*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Request to MS*
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 case of a dispute between the beneficiary and the competent authorities, 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.
Bistrita-Nasaud 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.
Bistrita-Nasaud Public Health Directorate*
Telefon:
Fax:
Email: dspj.bistrita_nasaud@dspbn.elcom.ro
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