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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 establishing drugstore-chief unit-pharmacist chief or chief pharmacy medical assistant. The Ministry of Health, the Directorate for Medicines 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 from the Norms regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, filled in, and then uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The company's articles of incorporation*
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 at 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 issued by the trade registry office, certifying the registration as a working point of the space intended for the drugstore or, as appropriate, the headquarters 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
Sketch space*
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 technical report*
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 equipment with furniture and appliances*
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 extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
DRUGSTORE LED BY CHIEF PHARMACIST - Employment contract or proof of professional practice in liberal form, for a full-time schedule with a working 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 their own responsibility stating that they have a full-time job with a working duration of 8 hours in the unit for which authorization is requested; the CFR member 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 stating that there is no chief pharmacist in the unit must be uploaded – 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 MEDICAL ASSISTANT - Employment contract or proof of practicing the profession in a liberal form, for full-time with a working time 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 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 duration of 8 hours; documents certifying the right to practice freely 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 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: 
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.
Ialomita 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.
Ialomita Public Health Directorate*
Str. AL. COSMINULUI, NR. 4
Telefon: 0243/230280
Fax: 0243/232384
Email: dsp.ialomita@dspialomita.ro
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