Home
Home
Single digital gateway for public services
favorite_border

MODIFICATION OF INITIAL AUTHORIZATION CONDITIONS - ANY ALTERATION TO THE SPACE - DOES NOT INCLUDE THE MOVING OF THE HEADQUARTERS/WORK POINT (UF-DSP)*

favorite_border
Add favorite
Procedure
Online
Companii
Cetateni
National
ROEID

Details

The procedure applies to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocating the headquarters/working point. The changes must be notified to the Ministry of Health - Department 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 permit or 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 to use the premises designated as a pharmaceutical unit*
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 prior to the changes made*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The outline of the space after 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
- is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee provided 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 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
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


-
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

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: 
23 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.
Alba 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.
Bld Revolutiei 1989, Nr. 23
Telefon: 0258835243
Fax: 0258834600
Email: sanatate_publica@dspalba.ro
Table of contents

Competent entities

Compartiment de Supraveghere si Control Boli Transmisibile
A.D.R.
This site is managed by the Romanian Digitalisation Authority and is an official website of the Romanian Government
Public Institutions
Need assistance?
EU Institutions
Info
Your Europe
PNRR
PNRR. Finanțat de Uniunea Europeană
UrmătoareaGenerațieUE
© 2024 roepas.ro