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

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying authorization for sale and release through the information society of medicines dispensed without medical prescription/specific products of 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 functioning 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
Sketch of the space showing the existence of the surface with a special purpose for 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 areas 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 operates, of the notification according to model no. 9 from the appendix to the Norms*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an advanced 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
- 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 through 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 medical assistant with responsibilities in carrying out e-commerce activities 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
Pharmacy/Drugstore operating schedule statement*
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 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 member of the College of Pharmacists of Romania for the pharmacist responsible for the sale and release 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 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
Proof of insurance for the transport of medicines dispensed 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
- it 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 practicing the profession in a liberal form for the pharmacist/pharmacy assistant responsible*
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 sheet approved by the College of Pharmacists of Romania/OAMGMAMR for the position of pharmacist/pharmacy assistant responsible for sale and dispensing through electronic commerce*
Descarcă
Scanned document
- is uploaded to the platform, signed with 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
- 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 the sale 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
Standard request to DSP*
Descarcă
Formular tipizat
According to Model no. 2 from the annex to the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - Download the document, fill it in, and then upload it to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request Applicant type*
Descarcă
Formular tipizat
According to Model no. 3 from the annex to the Rules regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 444/2019. The request is addressed to the Ministry of Health and will be communicated to it by the DSP. 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
Issued documents

Denumire

Tip document

Descarcă


-
Compliance decision 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 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: 
27 March 2025
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.
Botosani 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.
Botosani Public Health Directorate*
Str. Col.Tomoroveanu Nr.1
Telefon: 0231513525
Fax: 0231515112
Email: djspbotosani@yahoo.com
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