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Setting up a closed-circuit pharmacy (UF-DSP)*

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Procedure
Online
Companii
National

Details

The procedure addresses the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will submit on the platform the documents specified in Ord MS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the verification report and the conformity or non-conformity decision, and submission on the platform.

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Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
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 approval/endorsement document for the structure of the healthcare unit in which the pharmacy is provided*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an advanced electronic signature*
The sanitary operating authorization of the healthcare unit accompanied by the annex in which the pharmacy 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 unit plan and data regarding the pharmacy premises and its location within the healthcare facility in whose structure 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*
List of furniture, utensils, and equipment*
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 an extended electronic signature*
The job descriptions of pharmacists, endorsed by the College of Pharmacists of Romania*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
FOR CHIEF PHARMACIST - Employment contract or proof of practicing the profession in a liberal form, for a full-time position with a working time duration of 8 hours; CFR membership certificate; Current professional certificate issued by CFR*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
In the case of the position not being filled through a competition, the provisions of art. 26 from OMS no. 869/2015 are taken into account - they are uploaded to the platform, signed with an extended electronic signature*
The document showing the address of the healthcare unit and, respectively, the pharmacy (the tax registration certificate)*
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


-
Compliance decision for the space intended as 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

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 common law provisions are applicable.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
07 April 2020
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.
Valcea 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.
Str. Decebal 4A
Telefon: 0250747720
Fax: 0250746504
Email: ASPJ.VALCEA@ASPJVALCEA.RO
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