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

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

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Procedure
Online
Companii
Cetateni
National
ROEID

Details

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for the issuance of the operating authorization - any other modification made to the space 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 modification.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
The operating permit or the duplicate issued by the Ministry of Health in case of loss of the permit*
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 of use over 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 extended electronic signature*
The sketch of the space before the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
Sketch of the space after the modifications have been made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
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 stipulated 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 extended 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*
Request type*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 13 from the annex to the Rules regarding the establishment, organization, and operation 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.*
Issued documents

Denumire

Tip document

Descarcă

-
Compliance decision of the space designated 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 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: 
24 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.
Directia de Sanatate Publica Maramures
*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.
Directia de Sanatate Publica Maramures
Str. Victoriei nr. 132, Baia Mare, RO
Telefon: 0262/218386 0262/276501
Fax: 0262/276002
Email: depozitdsp@dspmm.ro
www.dspmm.ro
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