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

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

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating license - any other change made to the pharmaceutical unit's space, except for relocating the headquarters/branch. The 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 changes occur in the conditions that were the basis for issuing the operating license - any other change made to the pharmaceutical unit's space, except for relocating the headquarters/branch. The 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

-
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 to use the space intended for a pharmacy unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The sketch of the space before the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The sketch 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 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 appendix to the Norms*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Request form to DSP*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Applicant type request*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Decision of compliance of the space with the designated purpose 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 event 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: 
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.
Bacau 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.
Bacau Public Health Directorate*
Str. Vasile Alecsandri nr.45 cod 600011
Telefon:
Fax: 0234/524875
Email: dspjbacau@aspjbacau.ro
www.aspjbacau.ro
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