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

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units that wish to establish closed-circuit pharmacies at an address different from that of the hospital, or at the hospital’s address but coordinated by the pharmacy within the healthcare unit; the operating authorization of the healthcare unit must be submitted compulsorily, accompanied by the annex in which the pharmacy is specified.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
The operating license or the duplicate issued by the Ministry of Health in case of loss of the license*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Employment contracts for pharmacists designated to ensure the working hours of the distinct area and appointment decision for the activity in the distinct area*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The layout and data regarding the distinct space and its location within the healthcare unit in whose structure it operates*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical memorandum*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The list of furniture, utensils and equipment*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The certificate of membership of the College of Pharmacists of Romania for the pharmacists designated to ensure the working schedule of the distinct space*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of submission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit operates, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the fee required by law*
Descarcă
Scanned document
art. 42 - Law no. 266/2008 - The Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Standard request*
Descarcă
Formular tipizat
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. - Download the document, fill it in, and then upload it to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Document showing the address of the department or pavilion of the healthcare unit and, respectively, of the distinct space (the tax registration certificate)*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The working schedule of the distinct space and the coordinating pharmacy, specifying the pharmacists who ensure this schedule*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The sanitary operating authorization of the healthcare unit accompanied by the annex in which the distinct space is specified*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The approval/endorsement document of the structure of the healthcare unit in which the distinct space is provided*
Descarcă
Scanned document
- is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant type request*
Descarcă
Formular tipizat
According to Model no. 3 from the annex to the Rules regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. The application is addressed to the Ministry of Health and will be communicated to it by the Public Health Directorate (DSP). - The document is downloaded, filled out, and then uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă


-
Decision of compliance of the space intended as a pharmaceutical unit*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Inspection report*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency


None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
5
Calendar days
Appeal routes

In the event of a dispute between the beneficiary and the competent authority, the provisions of common law apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
21 March 2025
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institution responsible with document: 
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Mehedinti Public Health Directorate*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
Mehedinti Public Health Directorate*
Str. Traian Nr. 115
Telefon: 0252323638/0252317381
Fax:
Email: DSPMH@DSPMH.RO
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