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Modification of initial authorization conditions - change of authorization holder pharmaceutical unit manager - head of pharmaceutical unit*
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Procedure
Online
Companii
National
ROEID
Details
The procedure addresses pharmaceutical units when there are changes in the conditions underlying the issuance of the operating authorization - change of holder of the operating authorization by replacing the manager of the pharmaceutical unit.
The changes must be notified to the Ministry of Health - Directorate of Medicine and Medical Devices Policy within 5 working days from the date of the change.
IMPORTANT - All uploaded documents must be named as follows - pharmacy name_county name_** Ex: Ana farm_SM_request.pdf
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The communication from the former holder notifying that they no longer hold the position of unit manager, specifying the date from which they no longer occupy this position*
Descarcă
-it is uploaded to the platform, signed with an extended electronic signature*
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
-is uploaded to the platform, signed with an extended electronic signature*
The resolution/decision of the management of the commercial company/healthcare unit regarding this change, dated and registered, stating the date from which it produces its effects*
Descarcă
-is uploaded to the platform, signed with an extended electronic signature*
REVISAL extract or any other document showing the change of position for the former unit manager*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of membership of the College of Pharmacists of Romania for the new chief pharmacist (pharmacies/drugstores) or Certificate of membership issued by OAMGMAMR for the chief pharmacy nurse (exclusively in the case of drugstores)*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Current professional certificate issued by the College of Pharmacists of Romania for the new chief pharmacist*
Descarcă
In the situation where the request is made by drugstores for the replacement of the chief pharmacy medical assistant, a statement formulated by the administrator of the pharmaceutical unit must be uploaded, specifying that the unit is managed only by the chief pharmacy assistant and there is no chief pharmacist. - it is uploaded to the platform, signed with an extended electronic signature*
Employment contract or proof of practicing the profession in a liberal form for a full-time position for the head of the pharmaceutical unit*
Descarcă
In the case of closed-circuit pharmacies, the employment contract for a full-time position, on an indefinite period, is uploaded for the head pharmacist of the unit or, if the position is not filled by competition, the provisions of art. 26 of OMS no. 869/2015 are taken into consideration.
In the case of drugstores - the employment contract or proof of practicing the profession in a liberal form for a full-time position for the new manager of the pharmaceutical unit is uploaded to the platform, signed with an extended electronic signature.*
Statement on own responsibility from the person requesting the appointment to show that they no longer hold the position of manager in another pharmaceutical unit: warehouse, pharmacy or drugstore*
Descarcă
- it is uploaded to the platform, signed with an 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 operates, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee provided by law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with an extended electronic signature*
Standard request / application
Descarcă
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
30
Working days
Case filling duration:
15
Working days
Notification deadline:
Legislation
Appeal routes
The institution responsible for the document:
Public Health Directorate Satu Mare
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
20 August 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.
Satu Mare 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.
Str. Avram Iancu nr. 16
Telefon:
0261-768101
Fax:
0261-768103
Email:
office@dspjsm.ro
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Biroul Avize si Autorizatii
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