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

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Procedure
Online
Companii
National

Details

The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for the issuance of the operating license - change of holder of the Operating License by modifying the legal entity (through adjudication) and change of the address where the pharmaceutical unit operates. 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


-
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 advanced 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 work point of the purchasing 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 buyer company's place of business, 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*
Deed of adjudication or Minutes of adjudication concluded between the judicial administrator, the representative of the selling company, and the adjudicator*
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 adjudication document or the adjudication report by the selling company*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an advanced electronic signature*
Certificate of registration mentions regarding the registration of the award deed or the minutes of award by the purchasing company*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Extended certificate of findings of the selling company showing the deregistration of the working unit with activity, which was the subject of the sale*
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 of the administrator of the selling company regarding the existence or non-existence of litigations involving the operating authorization concerning the selling company*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The document attesting the right to use 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
- 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 practicing the profession in a liberal form, for a full-time schedule with a working time of 8 hours, for the head pharmacist, registered in the name of the new authorization holder*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
In the case of drugstores - the employment contract or proof of practicing the profession in a liberal form for a full-time position for the new pharmaceutical unit manager is uploaded - 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
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with extended electronic signature*
Proof of submission to the College of Pharmacists of Romania, the territorial subsidiary corresponding to the county where the pharmaceutical unit operates, of the notification according to model no. 9 from the annex to the Rules*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Proof of compliance with the provisions of Article 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 law, signed with an extended electronic signature, is uploaded to the platform*
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 common law provisions apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
27 October 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.
Botosani 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. Col.Tomoroveanu Nr.1
Telefon: 0231513525
Fax: 0231515112
Email: djspbotosani@yahoo.com
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