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Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
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Procedure
Online
Companii
National
Details
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions on which the operating authorization was issued - relocation of headquarters/working point. Changes must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request type*
Descarcă
According to Model no. 10 from the annex to the Rules 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 advanced electronic signature.*
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Updated certificate of findings with the new address of the pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right to use the space designated as a pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Sketch of the space*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum regarding the new space of the pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate regarding the demographic criterion*
Descarcă
- According to art. 20 of Law no. 266/2008 - Pharmacy Law, republished - In the case where the address of the pharmaceutical unit is in the same locality, a declaration proving this must be uploaded. - it is uploaded to the platform, signed with an extended electronic signature*
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 annex to the Norms*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee provided by law*
Descarcă
art. 42 - Law no. 266/2008 - the Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Standard request to DSP*
Descarcă
According to Model no. 2 from the annex to the Regulations regarding the establishment, organization, and operation 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.*
Applicant Type Request*
Descarcă
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 MS and will be communicated to it by the DSP. The document is downloaded, filled out, and then uploaded to the platform, signed with an extended electronic signature.*
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:
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.
Str. Col.Tomoroveanu Nr.1
Telefon:
0231513525
Fax:
0231515112
Email:
djspbotosani@yahoo.com
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