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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
ROEID
Details
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions on which the operating authorization was granted - relocation of headquarters/working point. Changes must be notified to the Ministry of Health - Directorate for Medicinal 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
-
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 extended electronic signature*
Certificate of findings updated with the new address of the pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use for the space designated as a pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with extended electronic signature*
Draft of the space*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum regarding the new premises of the pharmaceutical unit*
Descarcă
- 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 - the Pharmacy Law, republished - In the situation where the address of the pharmaceutical unit is in the same locality, a declaration proving this fact must be uploaded. - it must be 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*
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
- is uploaded to the platform, signed with an extended electronic signature*
Request template to DSP*
Descarcă
- The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature.*
Applicant type request*
Descarcă
- 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 are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
01 April 2026
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.
Tulcea 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. Viitorului, 50
Telefon:
Fax:
Email:
secretariat@dspjtulcea.ro
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