Single digital gateway for public services
Modification of initial authorization conditions - change of authorization holder - HEAD OF THE PHARMACEUTICAL UNIT*
favorite_border
Add favorite
Procedure
Online
Companii
Cetateni
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 authorization - change of the Operating Authorization holder by replacing the manager of the pharmaceutical unit. The changes must be notified to the Ministry of Health - Directorate for Medicines Policy and Medical Devices within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be obligatorily named in the format "pharmacy name_county name_**." (** represents a brief 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
-
The communication of the former holder by which he announces that he no longer holds the position of unit manager, specifying the date from which he no longer occupies this position*
Descarcă
Scanned document
-is uploaded onto the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The operating permit or the duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
Scanned document
- 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 commercial company/healthcare unit regarding this change, dated and registered, stating the date from which it produces its effects*
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
REVISAL extract or any other document showing the change of position for the former head of the unit*
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
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 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 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 on the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
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, permanent position for the chief pharmacist of the unit is uploaded, or, if the position is not filled through competition, the provisions of art. 26 of OMS no. 869/2015 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 extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility from the person requesting the appointment, stating that he/she no longer holds the position of head 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 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
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 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
Standard request*
Descarcă
Formular tipizat
According to Model no. 12 annex from the Norms regarding the establishment, organization and functioning of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, completed and then uploaded on 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 common law provisions apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
24 March 2022
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.
Ialomita 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.
Ialomita Public Health Directorate*
Str. AL. COSMINULUI, NR. 4
Telefon:
0243/230280
Fax:
0243/232384
Email:
dsp.ialomita@dspialomita.ro
Table of contents
Competent entities
Compartiment avize/autorizari
Share your opinion
Provide your opinion about the content of this page. You can leave acomment about what we can improve. You will not receive a response toyour comment. Use the contact form to clarify any questions regardingthe information and services available on this portal.
Did you find what you were looking for?
Help us improve