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Pharmacy/drugstore authorization - ONLINE SALES (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 certifying the authorization for sale and release through the information society of medicines that are granted without 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 downloaded, filled out, and then uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The layout of the space showing the existence of the area with a special destination for the specific activities of the online pharmacy/drugstore*
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 surfaces provided by the Norms regarding the establishment, organization, and operation of pharmaceutical units - it is 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 extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating permit or duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
Scanned document
- 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 granted without a medical prescription*
Descarcă
Scanned document
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 must be uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement of pharmacy/drugstore operating schedule*
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
Proof of payment of the fee stipulated by law*
Descarcă
Scanned document
art. 42 - 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
Certificate of membership of the College of Pharmacists of Romania for the pharmacist responsible for the sale and dispensing through electronic commerce*
Descarcă
Scanned document
Only in the case of drugstores, in the absence of a pharmacist, the Certificate of Membership of OAMGMAMR for the pharmacy medical assistant with responsibilities in carrying out the e-commerce activity within the drugstore will be uploaded - it is uploaded on the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of insurance for the transport of medicines dispensed and sold through online commerce activity under the conditions provided by the Norms regarding the establishment, organization, and functioning 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 pharmacist/pharmacy assistant responsible*
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 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
- 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
The job description approved by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for the sale and dispensing through 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
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 common law provisions are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
09 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.
Public Health Directorate Buzau*
*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.
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