title

Details

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating license - change of holder of the Operating License by modifying the legal entity (through adjudication) 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_**.pdf" (** 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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Request type*

Descarcă

Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

According to Model no. 4 from the annex to the Norms 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.*

The operating license or duplicate issued by the Ministry of Health in case of loss of the license*

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 mentioning the registration of the headquarters and/or the working point of the purchasing company, issued by ONRC*

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 with the exact address of the buyer company's place of business, issued by the ONRC*

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 selling company regarding the existence or non-existence of disputes involving the operating authorization concerning the selling 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 space designated as a pharmaceutical unit*

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 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*

The employment contract or proof of exercising the profession in a liberal form, for a full-time position with a working 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

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

Act of adjudication or Adjudication report concluded between the judicial administrator, the representative of the selling company, and the adjudicator*

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 mentions regarding the registration of the award document or the award minutes by the selling company*

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 mentions regarding the registration of the adjudication deed or the adjudication report by the purchasing company*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Extended ascertainment certificate of the selling company showing the deregistration of the operational unit that was the subject of the sale*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Proof of transmission to the Romanian College of Pharmacists, the territorial branch corresponding to the county where the pharmaceutical unit carries out its activity, of the notification according to model no. 7 from the annex to the Regulations*

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 permit, with registered mentions*

obligatoriu cu semnatură digitală disponibil și prin OOTS

Fees