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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
The procedure applies to pharmaceutical units in the event of changes to the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/working point. The modifications must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the modification.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Applicant-type request to DSP*
Descarcă
Formular tipizat
According to Model no. 2 from the annex to the Rules 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.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating authorization or duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Updated certificate of attestation with the new address of the pharmaceutical unit*
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 document certifying the right to use the space designated for a pharmaceutical unit*
Descarcă
Scanned document
- is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Sketch of the space*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical memorandum regarding the new premises of the pharmaceutical unit*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate regarding the demographic criterion*
Descarcă
Scanned document
- According to art. 20 of Law no. 266/2008 - the Pharmacy Law, republished - In the situation where the address of the pharmaceutical unit is in the same locality, a statement must be uploaded attesting to this fact. - 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. 7 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
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
Standard applicant request*
Descarcă
Formular tipizat
According to Model no. 3 from the annex to the Norms regarding the establishment, organization, and functioning 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 DSP. - 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
Issued documents
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 apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
21 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.
Arad 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.
Arad Public Health Directorate*
Str. Andrei Şaguna, Nr. 1-3
Telefon:
0257 254 438
Fax:
0257 230 010
Email:
secretariat@dsparad.ro
Table of contents
Competent entities
Compartiment Supraveghere Epidemiologica si Controlul Bolilor Transmisibile
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