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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 is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating authorization -change of the 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 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
-
General Meeting Resolution and the Company's Decision regarding the absorption, published in the Official Gazette, Part IV;*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The operating authorization or duplicate issued by the Ministry of Health in case of loss of authorization*
Descarcă
- is uploaded to the platform, signed with 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 work location of the absorbing company, issued by the ONRC*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of mentions registering 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 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
- 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 litigations involving the operating authorization concerning the absorbed company*
Descarcă
- it is uploaded to the platform, signed with an advanced electronic signature*
The document certifying the right of use over the space intended for 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 exercising the profession in a liberal form, for a full 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 head 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 an extended electronic signature*
Request type*
Descarcă
According to Model no. 10 annex from the Rules regarding the establishment, organization and functioning of pharmaceutical units approved by Order of the Minister of Health no. 444/2019. - Download the document, fill it in, and then upload it 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 is uploaded to the platform, signed with an extended electronic signature*
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
- 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 case 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:
07 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.
Arad 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. Andrei Şaguna nr. 1-3, Et. 4, Arad, RO
Telefon:
0257 254 438
Fax:
0257 230 010
Email:
secretariat@dsparad.ro
Table of contents
Competent entities
Compartiment Supraveghere Epidemiologica si Controlul Bolilor Transmisibile
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