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Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORK POINT (UF-DSP)*

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Procedure
Online
Companii
National

The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity takes place at a different address of the headquarters/working point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period. The applicant must upload on the platform the documents provided in Order MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and the conformity or non-conformity decision, and uploading them on the platform.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
Standard request to DSP*
Descarcă
Formular tipizat
According to Model no. 2 from the annex to the Norms regarding the establishment, organization and functioning 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
The operating license or the duplicate issued by the Ministry of Health in case of loss of the license*
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 findings with the new address of the place of business*
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 designated as 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
The outline 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 space of 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
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 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 an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Applicant’s template request*
Descarcă
Formular tipizat
According to Model no. 3 from the annex to the Rules regarding the establishment, organization and operation 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
Issued documents

Denumire

Tip document

Descarcă


-
Decision of compliance of the space with the purpose of pharmaceutical unit*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Inspection report*
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 common law provisions shall apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
26 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.
Caras Severin 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.
Caras Severin Public Health Directorate*
Str. Spitalului, nr.36
Telefon: 0255224691
Fax: 0255224691
Email: dspcs@asp-caras.ro
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