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Setting up 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 the establishment of a chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate of Medicine Policy and Medical Devices, is simultaneously notified.

*
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 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 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 registration of the company at the Trade Register Office*
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 certificate issued by the trade register office, certifying the registration as a work point of the space intended for the drugstore or, as applicable, the registered office with activity, for which authorization is requested*
Descarcă
Scanned document
- is uploaded to the platform, signed with 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
Technical memorandum*
Descarcă
Scanned document
- is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List regarding 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
PHARMACY LED BY CHIEF PHARMACIST - Employment contract or proof of practicing the profession in liberal form, for a full-time schedule 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 declaration on his own responsibility stating that he has a full-time position 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 managed by the chief pharmacy medical assistant, only a declaration must be uploaded showing that there is no chief pharmacist of the unit - it is 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 NURSE - Employment contract or proof of practicing the profession in a liberal form, for full-time with a working time duration of 8 hours; Free practice authorization issued by OAMGMAMR*
Descarcă
Scanned document
The chief pharmacy medical assistant, who is also the administrator or sole associate of the drugstore for which the 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 duration of 8 hours; documents attesting the right to free practice issued by OAMGMAMR; In the situation where the drugstore is managed by a chief pharmacist, only a declaration proving 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 of the space intended 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: 
24 April 2019
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.
Calarasi 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.
Calarasi Public Health Directorate*
Str. Prelungirea Bucuresti Nr. 24, BL M19
Telefon: 0242311462
Fax: 0242312680
Email: DSP_JUD_CLS@YAHOO.COM
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