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Details

The procedure applies to pharmaceutical units in situations where changes occur to the conditions on which the operating authorization was issued - change of holder of the Operating Authorization by modifying the legal entity (through division) and change of the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Drug Policy and Medical Devices Directorate within 5 working days from the date of the change.

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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 the duplicate issued by the Ministry of Health in case of loss of the authorization*

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 regarding the registration of the company's work point, issued by ONRC*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Certificate of findings with the exact address of the place of business 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 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

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

Certificate of registration of amendments, issued by ONRC, in accordance with the Resolution that registers the division of the company as a divided company and of the newly created/beneficiary company, according to the Division Project published in MOf*

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 of the administrator of the divided company regarding the existence or non-existence of disputes involving the operating license concerning the divided company*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

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

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Space sketch*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Technical memorandum*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

- it 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

In the case of drugstores - the employment contract or proof of practicing the profession in a liberal form for a full-time position for the new head of the pharmaceutical unit is uploaded - it is uploaded to the platform, signed with an extended electronic signature*

Proof of payment of the fee required by law*

Descarcă

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*

Proof of compliance with the provisions of Article 20 of the Pharmacy Law*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

Law no. 266/2008 - the pharmacy law, republished - the document certifying the situation provided by the law, signed with an extended electronic signature, is uploaded onto the platform*

Proof of submission 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. 9 from the annex to the Norms*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Request type*

Descarcă

Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

According to Model no. 10 annex from the Norms regarding the establishment, organization, and functioning 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.*

Issued documents

Denumire

Tip document

Descarcă

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Decision of compliance of the space with the purpose of pharmaceutical unit*

obligatoriu cu semnatură digitală disponibil și prin OOTS

Inspection report*

obligatoriu cu semnatură digitală disponibil și prin OOTS

Fees

Title

Payment method