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Modification of initial authorization conditions - Change of authorization holder - Legal entity THROUGH 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 case there are changes in 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 adjudication (WITHIN THE ENFORCEMENT PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Pharmaceuticals and Medical Devices within 5 working days from the date of the change.
IMPORTANT !!! All uploaded documents must be obligatorily named as follows: "pharmacy name_county name_**." (** represents the briefest possible 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 permit or its duplicate, issued by the Ministry of Health in case of loss of the permit, with all notes and annexes*
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 of mentions, issued by 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 through mention on the old operating license and the issuance of a new operating license as a result of the change of legal entity*
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
Certificate of findings, issued by the ONRC, with the exact address of the premises where the new company requesting the Ministry of Health to change the legal entity carries out its pharmaceutical activity*
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
STANDARD REQUEST*
Descarcă
Formular tipizat
The document is downloaded, completed and then uploaded to the platform, signed with an extended electronic signature The standard request is according to Model no. 4 annex from the Rules 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
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 judicial executor under the conditions established by the Civil Procedure Code*
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 registration of the buyer/creditor company showing the registration of the operating work point, which was subject to sale within the forced execution*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an advanced 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 disputes involving the operating license, concerning the selling company*
Descarcă
Scanned document
It is uploaded to the platform, signed with an extended electronic signature. In the event of a dispute involving the operating authorization, the Ministry of Health will not approve the change of authorization holder - legal entity, and will not register the mention on the annex to the operating authorization.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The document attesting the right of use over the space 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 exercising the profession in 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
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
- it 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 where 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 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
Statement 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, Sector 1, RO
Telefon:
0213072500
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartimentul Autorizare și Monitorizare Unități Farmaceutice
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