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  3. Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/working point (UF-DSP)*

Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/working point (UF-DSP)*

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Procedure
Online
Companii
National

The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for granting the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocating the headquarters/work point. Changes must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the change.

*
Details

The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for granting the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocating the headquarters/work point. Changes must be notified to the Ministry of Health - Directorate of 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
The document certifying the right of use for the space designated as a pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The sketch of the space before the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The layout of the space after the modifications have been made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Technical memorandum*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Proof of payment of the fee provided by law*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Proof of submission 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 Regulations*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Request type*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Decision of compliance of the space with the purpose of pharmaceutical unit*
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Inspection report*
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Fees

Title

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 apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
23 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.
Arges 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.
Arges Public Health Directorate*
Pitesti, Str.Execitiu, Nr.39 bis
Telefon:
Fax: 0248216484
Email: director@dsparges.ro
www.dsparges.ro
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