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Modification of initial authorization conditions - Change of PHARMACEUTICAL UNIT MANAGER (UF-MS)*
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Procedure
Online
Companii
National
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating license - change of the holder of the Operating License by the replacement of the head of the pharmaceutical unit. The changes must be notified to the Ministry of Health - Directorate of Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named obligatorily in the format "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Cerere.pdf
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request*
Descarcă
Formular tipizat
According to Model no. 4 appendix from 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.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating authorization or duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The resolution/decision of the management of the commercial company/medical unit to terminate the employment relationship of the head of the pharmaceutical unit, dated and registered, mentioning the date from which he/she no longer holds this position*
Descarcă
Scanned document
- it is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
REVISAL extract or any other document indicating the change in classification for the former unit manager*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
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
Scanned document
- is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Current professional certificate issued by the College of Pharmacists of Romania for the new chief pharmacist*
Descarcă
Scanned document
In the situation where the request is made by drugstores for the replacement of the chief pharmacy assistant - a statement will be uploaded, formulated by the administrator of the pharmaceutical unit, specifying that the unit is managed only by the chief pharmacy assistant and there is no chief pharmacist. - it will be uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Employment contract or proof of exercising the profession in a liberal form for a full-time position for the head of the pharmaceutical unit*
Descarcă
Scanned document
In the case of closed-circuit pharmacies, the employment contract for a full-time, indefinite period is uploaded for the chief pharmacist of the unit or, if the position is not filled through competition, the provisions of art. 35 from annex no. 1 of OMS no.166/2023 are considered. 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 head of the pharmaceutical unit is uploaded - it is uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on one's own responsibility from the person requesting the appointment stating that they no longer hold the position of manager in another pharmaceutical unit: warehouse, pharmacy or drugstore*
Descarcă
Scanned document
- it is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of transmission to the Romanian College of Pharmacists, the territorial branch corresponding to the county where the pharmaceutical unit operates of the notification.*
Descarcă
Scanned document
According to model no. 7 from the annex to the Norms - it is uploaded to the platform, signed with an 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
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The decision/resolution of the management of the company/healthcare unit appointing the new head of the pharmaceutical unit, dated and registered, indicating the date from which it produces effects*
Descarcă
Scanned document
- is 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 case of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
31 March 2025
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.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
*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.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
Intr. Cristian Popisteanu, nr. 1-3
Telefon:
0213072500
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartimentul Autorizare și Monitorizare Unități Farmaceutice
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