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Change of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

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Procedure
Online
Companii
Cetateni
Institutii
National
ROEID

Details
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for the issuance of the operating authorization - relocation of 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 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
- it is uploaded to the platform, signed with an extended electronic signature*
Updated certificate of attestation 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 attesting the right to use the premises designated as a 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 layout of the space*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded on the platform, signed with an extended electronic signature*
Technical memorandum regarding the new space 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 referring to 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 event that the address of the pharmaceutical unit is in the same locality, a declaration proving this fact is uploaded. - it 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 in which 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 - the Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
REQUEST DSP MODEL*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
MODEL MS REQUEST*
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

Payment method

Value

Currency


None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
Calendar days
Legislation
- Law number 
444
 dated year 
2019
ORDER no. 444 of March 25, 2019 for the approval of the Rules regarding the establishment, organization and operation of pharmaceutical units ISSUED BY Ministry of Health PUBLISHED IN Official Gazette no. 270 of April 9, 2019*
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: 
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.
Calarasi 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.
Str. Prelungirea Bucuresti Nr. 24, BL M19
Telefon: 0242311462
Fax: 0242312680
Email: DSP_JUD_CLS@YAHOO.COM
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