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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORKING POINT - Legal entity BY ABSORPTION (UF-DSP)*
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Procedure
Online
Companii
National
ROEID
Details
The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions that formed the basis for the issuance of the operating authorization – change of holder of the Operating Authorization through modification of the legal entity (through absorption) and change of address where the pharmaceutical unit operates. The modifications must be notified to the Ministry of Health – Directorate of Medicinal 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 the Company's 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 mentioning the registration 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 confirming the exact address of the work point of the absorbing company, issued by ONRC*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of amendments 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 cancellation of the absorbed work point*
Descarcă
- 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
- is uploaded to the platform, signed with an extended electronic signature*
Declaration on own responsibility of the administrator of the absorbed company regarding the existence or non-existence of any disputes involving the operating license regarding the absorbed company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The document attesting the right to use the space designated as a pharmacy 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 exercising the profession in a liberal form, for a full-time position 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 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 required 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 Regulations 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 submission 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
- is uploaded to the platform, signed with an extended electronic signature*
Fees
Title
Payment method
Value
Currency
Taxă variabilă
OP
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
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:
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.
Giurgiu 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. Bucuresti bloc 114, scara A
Telefon:
0246/214176
Fax:
0246/217251
Email:
secretariat@dspgiurgiu.ro
Table of contents
Competent entities
Biroul pentru Avize si Autorizatii Sanitare
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