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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORKING POINT - Legal entity BY DIVISION (UF-DSP)*
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Procedure
Online
Companii
National
ROEID
Details
The procedure addresses pharmaceutical units in situations where there are changes to the conditions underlying the issuance of the operating authorization - change of the Holder of the Operating Authorization by modifying the legal entity (through division) and change of the address where the pharmaceutical unit operates. 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 change.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
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 beneficiary company's place of business, issued by ONRC*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of attestation with the exact address of the beneficiary company's place of business, issued by the ONRC*
Descarcă
- is uploaded to the platform, signed with extended electronic signature*
Proof of publication of the Division Project in the Official Gazette of Romania*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of mentions, issued by ONRC, in accordance with the Resolution that registers the division of the company as a divided company and of the newly created/beneficiary company, according to the Division Project, published in the Official Gazette*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility by the administrator of the divided company regarding the existence or non-existence of any disputes involving the operating permit regarding the divided company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The document attesting the right to use the space designated for a pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Sketch space*
Descarcă
- is uploaded to the platform, signed with 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 position 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 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
Law No. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with 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 confirming 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 in which the pharmaceutical unit carries out its activity, 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*
Request template to DSP*
Descarcă
According to Model no. 2 annex from the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019, updated. - Download the document, fill it in, and then upload it to the platform, signed with an extended electronic signature.*
Request template to the Ministry of Health*
Descarcă
According to Model no. 4 from the annex to the Rules regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019 updated. - The document is downloaded, filled in, and then 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:
Calendar days
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.
Dolj 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. Tabaci, nr. 1
Telefon:
0251310067
Fax:
0251310071
Email:
dspdolj17@gmail.com
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