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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 a drugstore - unit chief - chief pharmacist or chief pharmacy technician. The Ministry of Health, the Directorate for 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 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 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 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 of findings issued by the trade registry office, attesting the registration as a place of business of the premises intended for the drugstore or, as the case may be, of 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
- is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List regarding the supply 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 extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
PHARMACY RUN BY A CHIEF PHARMACIST - The employment contract or proof of exercising the profession in a liberal form, for a full-time position with a working time of 8 hours; The CFR membership certificate; The 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 work full time, with a working duration 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 a chief pharmacy medical assistant, only a declaration shall be uploaded indicating that there is no chief pharmacist in the unit - this shall be uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
DRUGSTORE RUN BY HEAD 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 nurse, who is also the administrator or sole associate of the drugstore requesting authorization and does not have a work contract for this reason, must submit: a declaration on their own responsibility that they are employed full-time with a working schedule 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 stating this fact must be 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


-
Decision of compliance of 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.
Vrancea 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.
Vrancea Public Health Directorate*
Bdul Garii, nr. 14
Telefon: 0237225979
Fax: 0237225732
Email: dspvn@gmx.net
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