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Pharmacy/drugstore authorization - ONLINE SALE (Electronic commerce) (UF-DSP)*

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in the situation where the registration of the mention attesting the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific products for drugstores is requested.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Standard request*
Descarcă
Formular tipizat
According to Model no. 13 annex from the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is to be 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
Sketch of the space from which the existence of the area with special purpose dedicated to activities specific to the online pharmacy/drugstore will result*
Descarcă
Scanned document
The specially designated space must have a minimum of 10 sqm and can also be obtained by reorganizing the existing space, in addition to the areas provided for in the Rules regarding the establishment, organization and operation of pharmaceutical units - uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating authorization or duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
- it is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The decision to appoint the pharmacist responsible for the sale and dispensing via electronic commerce of medicines that are provided without a medical prescription*
Descarcă
Scanned document
Only in the case of drugstores, in the absence of a pharmacist, the decision to appoint the pharmacy assistant with responsibilities in carrying out e-commerce activities within the drugstore will be uploaded – it will be uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement of the pharmacy/drugstore operating hours program*
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
art. 42 - 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
Certificate of membership of the College of Pharmacists of Romania for the pharmacist responsible for sales and dispensing through electronic commerce*
Descarcă
Scanned document
Only in the case of drugstores, in the absence of a pharmacist, the OAMGMAMR membership certificate for the pharmacy medical assistant responsible for conducting electronic commerce activities within the drugstore 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
Proof of insurance for the transportation of medicines released and sold through online trading activity under the conditions provided by the Rules on the establishment, organization, and operation of pharmaceutical units*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Employment contract or proof of exercising the profession in a liberal form for the responsible pharmacist/pharmacy assistant*
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
Job description endorsed by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for selling and dispensing through electronic commerce*
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
Statement on own responsibility regarding compliance with the provisions of the Logo Agreement signed between Romania and the European Commission, published on the website of the Ministry of Health.*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Job description sheet endorsed by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for sales and dispensing via electronic commerce*
Descarcă
Scanned document
- 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


-
Certificate of compliance of the premises intended for use 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 apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
25 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.
The 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.
The Vrancea Public Health Directorate*
Bdul Garii, nr. 14
Telefon: 0237225979
Fax: 0237225732
Email: dspvn@gmx.net
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