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Modification of initial authorization conditions - Change of authorization holder and MOVE OF HEADQUARTERS/WORKING POINT - Legal entity BY DIVISION (UF-DSP)*
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Procedure
Online
Companii
National
Details
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating authorization - change of holder of the Operating Authorization by changing the legal entity (through division) and change of address where the pharmaceutical unit operates. 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
-
The operating authorization or 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 mentions regarding the registration of the beneficiary company's work point, issued by ONRC*
Descarcă
- is uploaded to the platform, signed with extended electronic signature*
Certificate of attestation with the exact address of the place of business of the beneficiary company, issued by the ONRC*
Descarcă
- it 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 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 the newly created/beneficiary company, according to the Division Project, published in MOf*
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 disputes involving the operating authorization concerning the divided company*
Descarcă
- it is uploaded to the platform, signed with extended electronic signature*
The document attesting the right of use over the space designated for a pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with extended electronic signature*
Space sketch*
Descarcă
- is uploaded to the platform, signed with an advanced 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 position with a working time duration of 8 hours, for the chief pharmacist, registered in the name of the new license 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 manager of the pharmaceutical unit 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*
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 stipulated by the law, signed with 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 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*
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, filled in, 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 event 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:
25 September 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.
Timis 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.
Nicolaus Lenau nr. 10, Timisoara, RO
Telefon:
0256 494 667
Fax:
0256/272743
Email:
dspj@dsptimis.ro
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