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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 situations where changes occur to the conditions that formed the basis for granting the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/place of business. 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 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
- is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The document attesting the right of use over the space intended for a pharmacy unit*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The layout of the space before the modifications made*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The layout of the space after the modifications have been made*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The technical memo*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the fee required by law*
Descarcă
Scanned document
art. 42 - Law no. 266/2008 - the Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
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. 9 from the annex to the Norms*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant type request*
Descarcă
Formular tipizat
-*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Standard 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 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 provisions of common law are applicable.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
26 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.
Bihor 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.
Bihor Public Health Directorate*
Str. Libertăţii nr.34
Telefon: 0259434565
Fax: 0259418654
Email: secretariat@dspbihor.gov.ro
www.dspbihor.gov.ro
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Competent entities

Compartiment autorizare farmacie

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