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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORK POINT - Legal entity THROUGH DIVISION (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 formed the basis for the issuance of the operating license - change of holder of the operating license by modifying the legal entity (through division) and the change of address where the pharmaceutical unit operates. Changes must be reported to the Ministry of Health - Directorate of Pharmaceutical 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 license or duplicate issued by the Ministry of Health in case of loss of the license*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration regarding the registration of the beneficiary company's place of business, issued by ONRC*
Descarcă
- it is uploaded to the platform, signed with extended electronic signature*
Certificate attesting the exact address of the working point of the beneficiary company, issued by ONRC*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Proof of publication of the Division Project in the Official Gazette of Romania*
Descarcă
- is uploaded to the platform, signed with 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 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 of the administrator of the divided company regarding the existence or non-existence of any disputes involving the operating license concerning the divided company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use over the space designated as a pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an advanced electronic signature*
Space sketch*
Descarcă
- it 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 pharmaceutical unit manager is uploaded - it is uploaded to the platform, signed with an advanced 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*
Proof of compliance with the provisions of Article 20 of the pharmacy law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - the document certifying the situation provided for 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 where 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*
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.*
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:
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
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Competent entities
Biroul Avize si Autorizatii
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