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Modification of initial authorization conditions - MOVE OF HEADQUARTERS/WORK 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 changes occur in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/working point. Changes must be notified to the Ministry of Health - Directorate for 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


-
Operating authorization or duplicate issued by the Ministry of Health in case of loss of authorization*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with extended electronic signature*
Certificate of findings updated with the new address of the pharmaceutical unit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- 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
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Space sketch*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with extended electronic signature*
The technical memorandum regarding the new space of the pharmaceutical unit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate regarding the demographic criterion*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- 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 is uploaded to the platform, signed with an advanced electronic signature*
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit carries out its activity of the notification according to model no. 9 from the annex to the Norms*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee required by law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
art. 42 - Law no. 266/2008 - The Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Request form to DSP*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 2 from the annex to the Regulations regarding the establishment, operation, and organization 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
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model No. 3 from the annex to the Rules regarding the establishment, operation, and organization 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 Public Health Directorate (DSP). -The document is downloaded, filled out, and then uploaded to the platform, signed with an extended electronic signature.*
Issued documents

Denumire

Tip document

Descarcă


-
Decision of compliance of the space intended as a pharmaceutical unit*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Inspection report*
obligatoriu cu semnatură digitală disponibil și 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 common law provisions shall apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
13 July 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.
Dambovita 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.
Localitatea Targoviste, str. Tudor Vladimirescu, nr. 15-17. cod postal 130100,
Telefon: 0245.613.604
Fax: 0245.611.067
Email: dspdambovita@dspdambovita.ro
Table of contents

Competent entities

Compartimentul farmaceutic
A.D.R.
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