Establishment of separate spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate spaces for outpatient dispensing within the PNS, located at the same address or at a different address from that of the hospital (UF-DSP)*

Details

The procedure is addressed to pharmaceutical units that wish to establish closed-circuit pharmacies at an address different from the hospital or at the hospital's address, being coordinated by the pharmacy in the healthcare unit. It is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is provided.

*

Entitled persons

Regulated professions

Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-

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*

Employment contracts for the pharmacists designated to ensure the working schedule of the distinct area and appointment decision for the activity in the distinct area*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Sketch and data regarding the distinct space and its location within the premises of the healthcare unit in the structure within which it operates*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Technical memorandum*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

List of furniture, utensils and equipment inventory*

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 membership of the College of Pharmacists of Romania for pharmacists designated to ensure the work schedule of the distinct space*

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 College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, 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

- 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

art. 42 - Law no. 266/2008 - The Pharmacy Law, republished - is uploaded to the platform, signed with extended electronic signature*

Standard application*

Descarcă

Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

According to Model no. 16 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.*

Document from which the address of the section or pavilion of the sanitary unit and, respectively, the address of the distinct space (the certificate of fiscal registration) should be evident*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

The working schedule of the distinct space and the coordinating pharmacy, specifying the pharmacists who ensure this schedule*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

The sanitary operating authorization of the healthcare unit accompanied by the annex in which the distinct space is specified*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

The approval/endorsement document of the structure of the healthcare unit in which the distinct space is provided*

Descarcă

Scanned document

obligatoriu cu semnatură digitală disponibil și prin OOTS

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

Request form to DSP*

Descarcă

Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

According to Model no. 2 from the annex to the Norms regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, filled in, and then uploaded to the platform, signed with an extended electronic signature.*

Applicant Type Request*

Descarcă

Formular tipizat

obligatoriu cu semnatură digitală disponibil și prin OOTS

According to Model no. 3 from the annex to the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. The request is addressed to the Ministry of Health and will be communicated to it by the Public Health Directorate. The document is downloaded, filled in, and then uploaded to the platform, signed with an extended electronic signature.*

Issued documents

Denumire

Tip document

Descarcă

-

Decision of compliance of the space designated for a pharmaceutical unit*

obligatoriu cu semnatură digitală disponibil și prin OOTS

Inspection report*

obligatoriu cu semnatură digitală disponibil și prin OOTS

Fees

Title

Payment method