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Establishment of a closed-circuit pharmacy (UF-DSP)*

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Procedure
Online
Companii
National

The procedure is addressed to the establishment of closed-circuit pharmacies that serve medical units and/or outpatient clinics; the manager of the medical unit submits the application accompanied by the required documentation. The applicant will submit on the platform the documents provided in Order MS 444/2019 - submission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the inspection report and the compliance or non-compliance decision, and their submission on the platform.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Request form to the DSP*
Descarcă
Formular tipizat
According to Model no. 2 from the annex to the Rules 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 obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The approval/endorsement document of the structure of the healthcare unit in which the pharmacy is provided*
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 operation authorization of the healthcare unit accompanied by the annex in which the pharmacy 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 layout of the unit and data regarding the pharmacy premises and its location within the healthcare facility 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
The list of equipment with furniture, utensils, and apparatus*
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 provided by law*
Descarcă
Scanned document
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
Job descriptions of pharmacists, approved by the College of Pharmacists of Romania*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
FOR HEAD PHARMACIST - Employment contract or proof of practicing the profession in a liberal form, for a full-time position with a working time of 8 hours; CFR membership certificate; Current professional certificate issued by CFR*
Descarcă
Scanned document
In the case of the position not being filled through the competition, the provisions of art. 26 of OMS no. 869/2015 will be taken into account - they are to be uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The document from which the address of the healthcare unit and, respectively, of the pharmacy can be identified (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
Applicant type request*
Descarcă
Formular tipizat
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 (DSP). - The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of transmission to the College of Pharmacists of Romania, to 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 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
Issued documents

Denumire

Tip document

Descarcă


-
Decision of conformity of the space intended for 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:
30
Calendar days
Case filling duration:
15
Calendar days
Notification deadline:
5
Calendar days
Appeal routes

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

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
03 April 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.
Satu Mare 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.
Satu Mare Public Health Directorate*
Str. Avram Iancu nr. 16
Telefon: 0261-768101
Fax: 0261-768103
Email: office@dspjsm.ro
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