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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORKING POINT - Legal entity BY MERGER (UF-DSP)*
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Procedure
Online
Companii
National
Details
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for granting the operating authorization - change of the holder of the Operating Authorization by modifying the legal entity (through absorption) and change of the address where the pharmaceutical unit operates. The modifications are to be notified to the Ministry of Health - Directorate of medicines policy and medical devices within 5 working days from the date of the modification.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
AGA Resolution and Company Decision regarding the merger, published in the Official Gazette, Part IV;*
Descarcă
- is 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
- 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
- it 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
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of mentions recording the merger by absorption between the absorbing company and the absorbed company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration mentions regarding the deletion of the absorbed work point*
Descarcă
- 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
- it is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility of the administrator of the absorbed company regarding the existence or inexistence of any litigation involving the operating license concerning the absorbed company*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The document attesting the right of use over the space intended for a pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Space sketch*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
- 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 chief pharmacist, registered in the name of the new authorization holder*
Descarcă
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 manager of the pharmaceutical unit is uploaded - it is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee provided by law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with extended electronic signature*
Request type*
Descarcă
According to Model No. 10 annex from the Rules 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 Article 20 of the Pharmacy Law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - the document attesting 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 in which the pharmaceutical unit operates, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
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 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:
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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