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Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/working point (UF-DSP)*
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Procedure
Online
Companii
National
The procedure applies to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for relocating the headquarters/branch. The modifications must be notified to the Ministry of Health – Directorate for 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
-
The operating authorization or the 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
The document certifying the right to use the premises designated as a 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 sketch of the space before the changes made*
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 layout of the space after modifications have been made*
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*
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 prescribed by law*
Descarcă
Scanned document
art. 42 - Law no. 266/2008 - Pharmacy Law, republished - 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 Romanian College of Pharmacists, 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 Norms*
Descarcă
Scanned document
- uploaded to the platform, signed with advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Standard request to DSP*
Descarcă
Formular tipizat
According to Model no. 2 from the annex to the Norms 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.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request template applicant*
Descarcă
Formular tipizat
According to Model no. 3 from the annex to the Norms regarding the establishment, functioning, 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 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
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:
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.
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.
Dambovita Public Health Directorate*
Localitatea Targoviste, str. Tudor Vladimirescu, nr. 15-17. cod postal 130100,
Telefon:
0245.613.604
Fax:
0245.611.067
Email:
dspdambovita@dspdambovita.ro
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Competent entities
Compartiment de supraveghere si control boli transmisibile
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