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The procedure is addressed to pharmaceutical units in cases where there are changes to the conditions that formed the basis for issuing the operating authorization - change of holder of the Operating Authorization by modifying the legal entity through award (WITHIN THE ENFORCEMENT PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. Changes must be notified to the Ministry of Health - Directorate of Pharmaceutical and Medical Devices within 5 working days from the date of modification.

IMPORTANT!!! All uploaded documents must be named in the following format "pharmacy_name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf

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Entitled persons

Regulated professions

Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

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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

obligatoriu cu semnatură digitală disponibil și prin OOTS

- is uploaded to the platform, signed with an extended electronic signature*

Certificate of registration of amendments, issued by ONRC, regarding the registration of the headquarters and/or the working point of the new legal entity whose name is requested to be entered by the Ministry of Health by 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

obligatoriu cu semnatură digitală disponibil și prin OOTS

- it is uploaded to the platform, signed with an extended electronic signature*

Certificate of attestation, issued by 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

obligatoriu cu semnatură digitală disponibil și prin OOTS

- it is uploaded to the platform, signed with an extended electronic signature*

STANDARD REQUEST*

Descarcă

Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature. The standard application 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.*

Certificate of adjudication, Record of the conduct and completion of forced execution, and the Act of delivery of the asset, drawn up by the judicial executor under the conditions established by the Code of Civil Procedure*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- it is uploaded to the platform, signed with an extended electronic signature*

Certificate of registration mentions regarding the registration of the adjudication act of the purchasing/adjudicating company*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- is uploaded to the platform, signed with an extended electronic signature*

Extended certificate of the purchasing/crediting company from which the registration of the operational workplace, which was the subject of the sale during the enforcement proceedings, should result*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- is uploaded to the platform, signed with an extended electronic signature*

Statement on own responsibility of the administrator of the selling company regarding the existence or non-existence of any litigations involving the operating authorization, concerning the selling company*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

It is uploaded to the platform, signed with an extended electronic signature. In case there is a dispute involving the operating license, the Ministry of Health will not approve the change of the license holder - legal entity and will not register the mention on the annex to the operating license.*

The document certifying the right to use the premises designated as a pharmaceutical unit*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- 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 duration of 8 hours, for the chief pharmacist, registered in the name of the new authorization holder*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

is uploaded to the platform, signed with an extended electronic signature*

Proof of payment of the fee provided by law*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- is uploaded to the platform, signed with an extended electronic signature*

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

obligatoriu cu semnatură digitală disponibil și prin OOTS

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 functioning of pharmaceutical units approved by OMS no. 444/2019*

Declaration on own responsibility that no changes have occurred compared to the last mention on the annex to the operating permit*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- is uploaded to the platform, signed with an extended electronic signature*

Issued documents

Denumire

Tip document

Descarcă

-

Annex to the authorization submitted for change of legal entity, with registered mentions and subsequently a new Operating Authorization*

obligatoriu cu semnatură digitală disponibil și prin OOTS