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

Change 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
National
ROEID

Details

The procedure addresses pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - any other change affecting the premises of the pharmaceutical unit, except for relocation of the headquarters/branch. 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 permit 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 an extended electronic signature*
The document certifying the right to use the space designated for a pharmaceutical unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The layout of the space before the changes made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
The layout of the space after modifications have been made*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
- 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 - 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 operates, 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
- is uploaded to the platform, signed with an extended electronic signature*
Standard request*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 13 from the annex to the Norms 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

-
Decision on the compliance 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 common law provisions apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
03 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.
Covasna 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.
Covasna Public Health Directorate*
str. Gödri Ferenc nr. 12
Telefon: 0267 351398
Fax: 0267 351459
Email: dsp@dspcovasna.ro
www.dspcovasna.ro
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