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Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
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Procedure
Online
Companii
Institutii
National
ROEID
The procedure applies to pharmaceutical units in situations where changes occur in the conditions underlying the issuance of the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocation of the headquarters/working 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
-
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
- it is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The document certifying the right to use the space designated as a pharmaceutical unit*
Descarcă
Scanned document
- it is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Sketch of the space prior to the changes made*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Sketch 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
- it is uploaded to the platform, signed with 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 - 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 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
- it is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request to DPSJ BN*
Descarcă
Formular tipizat
According to Model no. 2 annex from the Regulations regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 484/2025 - 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 to MS*
Descarcă
Formular tipizat
According to Model no. 3 annex from the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 484/2025 - 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 authorities, the provisions of common law shall apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
15 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.
Public Health Directorate of Bistrita-Nasaud County*
*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.
Public Health Directorate of Bistrita-Nasaud County*
Granicerilor nr. 5, Bistrita, RO
Telefon:
0263232601
Fax:
0263231137
Email:
dspj.bistrita_nasaud@dspbn.elcom.ro
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Competent entities
Compartiment de supraveghere epidemiologica si control boli transmisibile
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