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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 there are changes to the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization by modification of the legal entity through adjudication (WITHIN THE ENFORCEMENT PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. 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 mandatorily be named as follows: "pharmacy name_county name_**." (** stands for 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 authorization or its duplicate, issued by the Ministry of Health in case of loss of the authorization, with all mentions and annexes*
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 registration of amendments, issued by ONRC, regarding the registration of the headquarters and/or working point of the new legal entity whose name is requested to be entered by the Ministry of Health as an amendment on the old operating license and the issuance of a new operating license following 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 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
- 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, filled in, and then uploaded to the platform, signed with an extended electronic signature. The standard application is according to Model No. 4 annex from the Regulations 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, Record of the conduct and completion of the enforcement proceedings and Deed of delivery of the asset, drawn up by the judicial 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 deed 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 the purchaser/creditor company from which the registration of the workplace with activity, which was the subject of the sale within the forced execution, shall be evident*
Descarcă
Scanned document
- 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 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 license, the Ministry of Health will not approve the change of the license holder - legal entity - and will not record the note on the annex to the operating license.*
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 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 an 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 transmission of the Notification to the College of Pharmacists of Romania (CFR), the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity*
Descarcă
Scanned document
It is uploaded to the platform, signed with an extended electronic signature. The Notification to CFR is in accordance with 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
Declaration on own responsibility that no changes have occurred compared to the last mention on the annex to the operating license*
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
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 case of a dispute between the beneficiary and the competent authority, the provisions of administrative litigation law are applicable.
*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 and Medical Devices 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 and Medical Devices Department*
Intr. Cristian Popisteanu, nr. 1-3, Sector 1, RO
Telefon:
0213141912
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartimentul Farmaceutic si Dispozitive Medicale
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