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Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*

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Procedure
Online
Companii
National

The procedure is addressed to drugstores for the establishment of chief drugstore-chief unit-pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicinal Policy and Medical Devices is also notified concurrently.

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Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Standard request*
Descarcă
Formular tipizat
According to Model no. 4 annex from the Norms regarding the establishment, organization and operation of pharmaceutical units approved by Order of the Minister of Health no. 444/2019. - Download the document, fill it out, and then upload it to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The articles of incorporation of the company*
Descarcă
Scanned document
- is uploaded on the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of registration of the company at the trade register office*
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 issued by the trade register office, certifying the registration as a working point of the space intended for the drugstore or, as appropriate, the registered office with activity, for which authorization is requested*
Descarcă
Scanned document
- is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Space sketch*
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
- uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List regarding furniture and equipment*
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
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 advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
DRUGSTORE LED BY CHIEF PHARMACIST - Employment contract or proof of practicing the profession in a freelance 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
The chief pharmacist who is also the administrator or sole associate of the community pharmacy/drugstore for which authorization is requested and does not have an employment contract because of this must submit: a declaration on their own responsibility stating that they have full-time employment with a working time of 8 hours in the unit for which authorization is requested; the CFR membership certificate and the current professional certificate issued by CFR; In the situation where the drugstore is run by a chief pharmacy assistant, only a declaration stating that there is no chief pharmacist in the unit will be uploaded – it will be uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
PHARMACY LED BY CHIEF PHARMACY MEDICAL ASSISTANT - Employment contract or proof of practicing the profession in a liberal form, for full-time with working hours of 8 hours; Practice license issued by OAMGMAMR*
Descarcă
Scanned document
The chief pharmacy medical assistant, who is also the administrator or sole associate of the drugstore for which authorization is requested and does not have an employment contract for this reason, must submit: a statement on their own responsibility that they have a full-time schedule with a working time of 8 hours; documents attesting the right to practice freely issued by OAMGMAMR; In the situation where the drugstore is managed by a chief pharmacist, only a statement reflecting this fact will be uploaded – it 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


-
Compliance decision for the space designated 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 case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.


*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
09 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.
Public Health Directorate Buzau*
*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.
Public Health Directorate Buzau*
Str. Grigore Bastan Nr. 3
Telefon: 0238725690/1
Fax: 0238721539
Email: medprev@dspbz.ro
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