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Authorization of pharmacies/drugstores - ONLINE SALES (E-commerce) (UF-DSP)*

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Procedure
Online
Companii
National

Details

The procedure is addressed to pharmaceutical units in situations where the registration of the statement is requested, which attests the authorization for sale and dispensing through the information society of medicines that are granted without a medical prescription/specific products of drugstores.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Request type*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
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 downloaded, filled in and then uploaded to the platform, signed with an extended electronic signature.*
The outline of the space from which the existence of the area with a special destination for activities specific to the online pharmacy/drugstore should emerge*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
The special designated space must have at least 10 sqm and can also be obtained by reorganizing the existing space, in addition to the areas provided for in the Norms regarding the establishment, organization, and operation of pharmaceutical units - uploaded to the platform, signed with an advanced electronic signature.*
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
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded on the platform, signed with advanced electronic signature*
The decision to appoint the pharmacist responsible for the sale and dispensing via e-commerce of medicines that are supplied without a medical prescription*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
Only in the case of drugstores, in the absence of a pharmacist, the appointment decision of the pharmacy medical assistant with responsibilities in carrying out electronic commerce activities within the drugstore will be uploaded – it will be uploaded to the platform, signed with an extended electronic signature.*
Declaration of pharmacy/drugstore operating hours*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
Proof of payment of the fee required by law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
art. 42 - Law no. 266/2008 - The Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Member certificate of the College of Pharmacists of Romania for the pharmacist responsible for the sale and release through electronic commerce*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
Only in the case of drugstores, in the absence of a pharmacist, the OAMGMAMR membership certificate for the pharmacy medical assistant with responsibilities in conducting electronic commerce activities within the drugstore will be uploaded - it is uploaded to the platform, signed with an extended electronic signature*
Proof of insurance for the transport of medicines dispensed and sold through online commerce activity under the conditions provided by the Regulations regarding the establishment, organization, and functioning of pharmaceutical units*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Employment contract or proof of exercising the profession in a liberal form for the pharmacist/pharmacy assistant responsible*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Job description endorsed by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for the sale and dispensing via electronic commerce*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
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
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Job description endorsed by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for sales and dispensing through electronic commerce*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Issued documents

Denumire

Tip document

Descarcă


-
Decision of compliance of the space with the destination of pharmaceutical unit*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Inspection report*
obligatoriu cu semnatură digitală disponibil și 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 event of a dispute between the beneficiary and the competent authority, the provisions of common law shall 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.
Str. Decebal 4A
Telefon: 0250747720
Fax: 0250746504
Email: ASPJ.VALCEA@ASPJVALCEA.RO
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