Single digital gateway for public services
Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
favorite_border
Add favorite
Procedure
Online
Companii
National
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for the issuance of the operating authorization - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Product 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
-
Standard request*
Descarcă
Formular tipizat
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. - 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
Operating authorization or duplicate issued by the Ministry of Health in case of loss of authorization*
Descarcă
Scanned document
- is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Updated finding certificate 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 attesting the right of use over the space intended for the 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
Space sketch*
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 technical memorandum regarding the new premises of the pharmaceutical unit*
Descarcă
Scanned document
- is uploaded to the platform, signed with an advanced 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 declaration must be uploaded to prove 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 carries out its activity, of the notification according to model no. 9 from the annex to the Rules*
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 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 provisions of common law are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
24 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.
Giurgiu 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.
Giurgiu Public Health Directorate*
Str. Bucuresti bloc 114, scara A
Telefon:
0246/214176
Fax:
0246/217251
Email:
secretariat@dspgiurgiu.ro
Table of contents
Competent entities
Biroul pentru Avize si Autorizatii Sanitare
Share your opinion
Provide your opinion about the content of this page. You can leave acomment about what we can improve. You will not receive a response toyour comment. Use the contact form to clarify any questions regardingthe information and services available on this portal.
Did you find what you were looking for?
Help us improve