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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORK POINT - Legal entity BY ABSORPTION (UF-DSP)*

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Procedure
Online
Companii
National

Details

The procedure applies to pharmaceutical units in situations where there are changes in the conditions that formed the basis for issuing the operating authorization - change of holder of the Operating Authorization by changing the legal entity (by absorption) and change of the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of 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


-
AGA Resolution and Company Decision regarding the absorption, published in the Official Gazette, Part IV;*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
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*
Certificate of registration mentions regarding the registration of the working point of the absorbing company, issued by ONRC*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of attestation with the exact address of the place of business of the absorbing company, issued by ONRC*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of entries recording the merger by absorption between the absorbing company and the absorbed company*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of mentions regarding the deregistration of the absorbed work point*
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 publication of the merger by absorption project in the Official Gazette, Part IV*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility by the administrator of the absorbed company regarding the existence or non-existence of any litigations involving the operating authorization concerning the absorbed company*
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 over the space 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*
Space sketch*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it 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*
The employment contract or proof of exercising the profession in a liberal form, for a full-time schedule with a working time of 8 hours, for the chief pharmacist, registered in the name of the new holder of the authorization*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
In the case of drugstores - the employment contract or proof of exercising the profession in a liberal form for a full-time position for the new head of the pharmacy unit is uploaded - 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
Law no. 266/2008 - the pharmacy law, republished - 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. 10 annex from the Norms 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.*
Proof of compliance with the provisions of art. 20 of the Pharmacy Law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
Law no. 266/2008 - the pharmacy law, republished - the document certifying the situation provided by the law, signed with an extended electronic signature, is uploaded to the platform*
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*
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:
5
Calendar days
Appeal routes

In the case 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: 
29 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.
Ialomita 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. AL. COSMINULUI, NR. 4
Telefon: 0243/230280
Fax: 0243/232384
Email: dsp.ialomita@dspialomita.ro
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