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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 cases where there are changes in the conditions that formed the basis for issuing 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 for Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named in the format "pharmacy name_county name_**." (** represents a brief description of the uploaded document) ex.: ANAFARM_BV_Cerere.pdf
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request type*
Descarcă
Formular tipizat
According to Model no. 4 annex from the Norms regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, filled in 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 authorization*
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
The decision/resolution of the management of the commercial company/healthcare unit to terminate the employment relationship of the manager of the pharmaceutical unit, dated and registered, indicating the date from which they no longer occupy this position*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
REVISAL extract or any other document showing the change of employment position 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 medical assistant (exclusively in the case of drugstores)*
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
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 must 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 is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The employment contract or proof of practicing the profession in a liberal form for a full-time position for the manager of the pharmaceutical unit*
Descarcă
Scanned document
In the case of closed-circuit pharmacies, the employment contract for a full-time position with an indefinite period is uploaded for the chief pharmacist of the unit or, if the position is not filled through a competition, the provisions of art. 35 from annex no. 1 of OMS no. 166/2023 are taken into account. 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 to the platform, signed with an advanced electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on 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
- 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 Romanian College of Pharmacists, the corresponding territorial branch of the county in which the pharmaceutical unit carries out its activity, 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 an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The decision/resolution of the management of the company/health unit to appoint the new head of the pharmaceutical unit, dated and registered, stating the date from which it takes effect*
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 event of a dispute between the beneficiary and the competent authority, the common law provisions 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 and Medical Devices 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 and Medical Devices Department*
Intr. Cristian Popisteanu, nr. 1-3, Sector 1, RO
Telefon:
0213141912
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartimentul Farmaceutic si Dispozitive Medicale
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