Single digital gateway for public services
Authorization for pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
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Procedure
Online
Companii
National
The procedure is addressed to pharmaceutical units in situations where the entry certifying the authorization for sale and release through the information society of medicines that are granted without a medical prescription/specific drugstore products 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 Rules 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.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Sketch of the space demonstrating the existence of the area with special purpose dedicated to the specific activities of the online pharmacy/drugstore*
Descarcă
Scanned document
The specially designated space must have at least 10 sqm and can also be obtained by reorganizing the existing space, in addition to the surfaces provided in 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 submission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, 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
The operating authorization or the 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 an 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 appointment decision of the pharmacy medical assistant with responsibilities in carrying out e-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
Statement of 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 - 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 selling and dispensing through electronic commerce*
Descarcă
Scanned document
Only in the case of drugstores, in the absence of a pharmacist, the Membership Certificate of OAMGMAMR for the pharmacy medical assistant with responsibilities in conducting e-commerce activities within the drugstore will be uploaded - it is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of insurance for the transport of medicines released and sold through online commerce activity under the conditions provided by the Rules regarding the establishment, organization, and operation of pharmaceutical units*
Descarcă
Scanned document
- is uploaded to the platform, signed with 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
Job description form endorsed by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for the sale and dispensing through e-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
Job description sheet endorsed by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for the sale and dispensing via e-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
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:
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.
Hunedoara 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.
Hunedoara Public Health Directorate*
Str. 22 Decembrie, Nr.58
Telefon:
0254211848
Fax:
0254213758
Email:
deva@asphd.ro
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