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  3. Modification of initial conditions for authorization - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

Modification of initial conditions for authorization - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

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Procedure
Online
Companii
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions on which the operating authorization was granted - relocation of headquarters/working 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 the change.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Request type*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 10 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, filled out, and then uploaded to the platform, signed with an extended electronic signature.*
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*
Updated certificate of findings with the new address of the pharmaceutical unit*
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 for the space 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*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The technical memorandum regarding the new premises of the pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Certificate regarding the demographic criterion*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- According to art. 20 of Law no. 266/2008 - the Pharmacy Law, republished - In the situation where the address of the pharmaceutical unit is in the same locality, a declaration proving this fact must be uploaded. - it must be uploaded to the platform, signed with an extended electronic signature*
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
- it is uploaded to the platform, signed with an extended 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*
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 event of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
02 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.
Salaj 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.
Salaj Public Health Directorate*
Str. Corneliu Coposu nr. 1, Zalau, RO
Telefon: 0260 66 25 50
Fax: 0260 66 25 50
Email: secretariat@aspsalaj.ro
www.aspsalaj.ro
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