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The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for issuing the operating authorization -change of holder of the Operating Authorization through modification of the legal entity (by division) and maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Pharmacy and Medical Devices within 5 working days from the date of the modification.

IMPORTANT!!! All uploaded documents must be named obligatorily in the format "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf

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Entitled persons

Regulated professions

Required documents

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Descriere

Obligatoriu

Semnătură digitală

Tip document

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Standard request*

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Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

According to Model no. 4 in the annex to the Regulations regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, completed and then uploaded to the platform, signed with an extended electronic signature.*

Operating permit or duplicate issued by the Ministry of Health in case of loss of the permit*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- 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 litigations involving the operating license concerning the divided company*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

The document attesting the right of use for the space 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*

Declaration on own responsibility that no changes have occurred compared to the last entry on the appendix to the operating authorization*

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 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 transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity, of the notification according to model no. 7 from the appendix to the Norms*

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*

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Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with an extended electronic signature*

Certificate regarding registration mentions about the registration of the headquarters and/or the work point of the beneficiary company, issued by ONRC*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Certificate of acknowledgment with the exact address of the place of business of the beneficiary company, issued by the ONRC*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- 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

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 of mentions, issued by the ONRC, in accordance with the Resolution which registers the division of the company as a divided company and the newly created/beneficiary company, according to the Division Project, published in the Official Gazette.*

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

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Annex to the operating authorization, with registered mentions*

obligatoriu cu semnatură digitală disponibil și prin OOTS

Fees