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

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

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Procedure
Online
Companii
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - any other change made to the space of the pharmaceutical unit, except for moving the headquarters/work point. Changes must be notified to the Ministry of Health - Policy Directorate for Medicinal Products 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 permit 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
- is uploaded to the platform, signed with an extended electronic signature*
The document attesting the right of use over the premises designated as 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 changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The layout of the space after modifications 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 extended electronic signature*
Proof of payment of the fee required by law*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
art. 42 - Law no. 266/2008 - the Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Proof of transmission 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
- is uploaded to the platform, signed with an extended electronic signature*
Request type*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 2 from the annex to the Rules regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature.*
Standard request / application
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Request form no.3*
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

Payment method

Value

Currency

None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
Calendar days
Appeal routes

In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
07 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.
Buzau 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.
Buzau Public Health Directorate*
Str. Grigore Bastan Nr. 3
Telefon: 0238725690/1
Fax: 0238721539
Email: medprev@dspbz.ro
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