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Modification of initial authorization conditions - Change of PHARMACEUTICAL UNIT MANAGER (PU-MS)*
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Procedure
Online
Companii
Cetateni
National
ROEID
Details
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions based on which the operating license was issued - change of Holder of the Operating License by replacing the head of the pharmaceutical unit. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Department within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named as follows pharmacy name_county name_**. (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request*
Descarcă
According to Model no. 4 annex from the Rules regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 444/2019. - Download the document, fill it out, and then upload it to the platform, signed with an extended electronic signature.*
Operating authorization or duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The resolution/decision of the management of the commercial company/healthcare unit regarding the termination of the employment relationship of the head of the pharmaceutical unit, dated and registered, indicating the date from which they no longer occupy this position*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
REVISAL excerpt or any other document showing the change of classification for the former unit manager*
Descarcă
- is uploaded to the platform, signed with an advanced 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 medical assistant (exclusively in the case of drugstores)*
Descarcă
- 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 will 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*
The employment contract or proof of exercising the profession in a liberal form for a full-time position for the head of a pharmaceutical unit*
Descarcă
In the case of closed-circuit pharmacies, the employment contract for a full-time position, with an indefinite period, is uploaded for the head 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 is uploaded for a full-time position for the new head of the pharmaceutical unit - it is uploaded to the platform, signed with an extended electronic signature.*
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
- is uploaded to the platform, signed with an extended electronic signature*
Proof of transmission to the Romanian College of Pharmacists, the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity of the notification.*
Descarcă
According to model no. 7 from the annex to the Norms - it is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee required by law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - is uploaded to the platform, signed with an extended electronic signature*
The decision/resolution of the management of the company/health unit for the appointment of the new head of the pharmaceutical unit, dated and registered, specifying the date from which it takes effect*
Descarcă
- it is uploaded to the platform, signed with extended electronic signature*
Fees
Title
Payment method
Value
Currency
Taxă fixă
OP
50
RON
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
Calendar days
Appeal routes
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law apply.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
10 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.
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.
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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