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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

Details

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

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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 annex from 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.*
The company’s articles of incorporation*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration of the company at the trade registry office*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The certificate of attestation issued by the trade register office, certifying the registration as a place of business of the space intended for the drugstore, or, as the case may be, of the registered office with activity, for which authorization is requested*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
Space sketch*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with extended electronic signature*
Technical memorandum*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The list regarding furniture and equipment*
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 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 on the platform, signed with extended electronic signature*
DROGHERIE LED BY 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
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 for this reason, must submit: a declaration on their own responsibility that they have a full-time schedule with a working duration of 8 hours in the unit for which the authorization is requested; the CFR membership certificate and the current professional certificate issued by CFR; In the situation where the drugstore is managed by a chief pharmacy medical assistant, only a declaration must be uploaded stating that there is no chief pharmacist for the unit – this is uploaded to the platform, signed with an extended electronic signature*
DRUGSTORE RUN BY CHIEF PHARMACY MEDICAL ASSISTANT - Employment contract or proof of practicing the profession in a liberal form, for full-time with a working time duration of 8 hours; License to practice issued by OAMGMAMR*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
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 declaration on his own responsibility stating that he has a full-time schedule with a working duration 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 declaration confirming this fact will be uploaded – uploaded to the platform, signed with an extended electronic signature.*
Issued documents

Denumire

Tip document

Descarcă


-
Decision of compliance of 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 case of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.


*
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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