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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORKING POINT - Legal entity THROUGH ABSORPTION (UF-DSP)*
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Procedure
Online
Companii
National
ROEID
Details
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization by modifying the legal entity (through absorption) and changing 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 modification.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
General Meeting Resolution and Company Decision regarding the merger, published in the Official Gazette, Part IV;*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The operating permit or the duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
- it 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
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of attestation with the exact address of the workplace of the absorbing company, issued by ONRC*
Descarcă
- it 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
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration mentions regarding the removal 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 non-existence of any litigations involving the operating license concerning the absorbed company*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use over the space designated for a pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Space sketch*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
- it 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 duration 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 exercising the profession in a liberal form for a full-time position for the new pharmaceutical unit manager is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee stipulated by law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with an extended electronic signature*
Request type*
Descarcă
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
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 Romanian College of Pharmacists, the territorial branch corresponding to the county where the pharmaceutical unit operates, of the notification according to model no. 9 from the appendix to the Norms*
Descarcă
- 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 case of a dispute between the beneficiary and the competent authority, the common law provisions are applicable.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
20 August 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.
Satu Mare 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. Avram Iancu nr. 16
Telefon:
0261-768101
Fax:
0261-768103
Email:
office@dspjsm.ro
Table of contents
Competent entities
Biroul Avize si Autorizatii
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