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Establishment of a 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 establishing a drugstore-chief unit-chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.

*
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 of the Rules regarding the establishment, organization and operation 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
The articles of incorporation of the company*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of company registration with the trade registry 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 of attestation issued by the trade register office, which certifies the registration as a place of business of the space intended for the drugstore or, as the case may be, the registered office with activity, for which authorization is requested*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended 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
The 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
List regarding the provision of furniture 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
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
DRUGSTORE RUN 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
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 sworn statement that they have a full-time schedule 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 the CFR; In the situation where the drugstore is managed by a chief pharmacy assistant, only a statement must be uploaded showing that there is no chief pharmacist of the unit - it is uploaded to the platform, signed with an advanced electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
DRUGSTORE MANAGED BY CHIEF PHARMACY NURSE - 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; Free practice authorization issued by OAMGMAMR*
Descarcă
Scanned document
The chief pharmacy nursing 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 their own responsibility stating 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 declaration confirming 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 common law provisions 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.
Valcea Public Health Directorate*
Str. Decebal 4A
Telefon: 0250747720
Fax: 0250746504
Email: ASPJ.VALCEA@ASPJVALCEA.RO
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