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Modification of initial authorization conditions - Change of authorization holder - Legal entity BY AWARD (WITHIN THE ENFORCEMENT PROCEDURE) - SAME ADDRESS (UF-MS)*
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Procedure
Online
Companii
National
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 amending the legal entity through adjudication (WITHIN THE FORECLOSURE PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named in the mandatory format “pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The operating license or its duplicate, issued by the Ministry of Health in case of loss of the license, with all notations and annexes*
Descarcă
Scanned document
- is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of registration of mentions, issued by the National Trade Register Office (ONRC), regarding the registration of the headquarters and/or the work point of the new legal entity whose name is requested to be entered by the Ministry of Health by mention on the old operating authorization and the issuance of a new operating authorization as a result of the change of the legal entity*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of attestation, issued by ONRC, with the exact address of the space in which the new company requesting the Ministry of Health to change the legal entity carries out its pharmaceutical activity*
Descarcă
Scanned document
- is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
STANDARD REQUEST*
Descarcă
Formular tipizat
The document is downloaded, completed, and then uploaded to the platform, signed with extended electronic signature The standard request is according to Model no. 4 annex from the Rules regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 444/2019*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of adjudication, Report of the conduct and completion of the enforcement proceedings, and the Act of delivery of the asset, drawn up by the bailiff under the conditions established by the Code of Civil Procedure*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of registration mentions regarding the registration of the adjudication act of the purchasing/adjudicating company*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Extended certificate of findings of the buyer/creditor company showing the registration of the operational working point, which was the object of the sale within the forced execution*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the administrator of the selling company regarding the existence or non-existence of any litigations involving the operating authorization, regarding the selling company*
Descarcă
Scanned document
It is uploaded to the platform, signed with an extended electronic signature In the event that there is a dispute involving the operating permit, the Ministry of Health will not approve the change of the permit holder - legal entity and will not register the mention on the annex to the operating permit*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The document attesting the right of use over the premises designated as a pharmaceutical unit*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
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 authorization holder*
Descarcă
Scanned document
is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the fee provided by law*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of sending the Notification to the College of Pharmacists of Romania (CFR), the territorial branch corresponding to the county in which the pharmaceutical unit operates*
Descarcă
Scanned document
It is uploaded to the platform, signed with an extended electronic signature. The Notification to CFR is according to Model no. 7 (annex) from the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility that no changes have occurred compared to the last mention on the annex to the operating permit*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
5
Calendar days
Legislation
None
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the provisions of administrative litigation law shall apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
31 March 2025
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.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
*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.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
Intr. Cristian Popisteanu, nr. 1-3
Telefon:
0213072500
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartimentul Autorizare și Monitorizare Unități Farmaceutice
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