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Modification of initial authorization conditions - Change of authorization holder - Legal entity BY MERGER - SAME ADDRESS (UF-MS)*
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Procedure
Online
Companii
National
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization by modifying the legal entity (through absorption) and maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the modification.
IMPORTANT!!! All uploaded documents must be obligatorily named in the form "pharmacy name_county name_**.pdf" (** 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
-
Operating permit or duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
Scanned document
- 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 of the administrator of the absorbed company regarding the existence or non-existence of any litigations involving the operating license concerning the absorbed company*
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 document attesting the right of use over the space intended for a pharmaceutical unit*
Descarcă
Scanned document
- 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 that no changes have occurred compared to the last mention on the annex to the operating 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
Proof of submission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, of the notification according to model no. 7 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
The employment contract or proof of exercising the profession in a liberal form, for a full-time position with a working time duration of 8 hours, for the chief pharmacist, registered in the name of the new authorization holder*
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 an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request type*
Descarcă
Formular tipizat
According to Model no. 4 from the annex to the Rules 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 advanced electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
AGA Resolution and Company Decision regarding the merger, Published in the Official Gazette, Part IV*
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 stating the exact address of the work point of the absorbing company, issued by ONRC;*
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 registration mentions regarding the registration of the headquarters and/or the work point of the absorbing company, issued by ONRC*
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 registration of mentions recording the merger by absorption between the absorbing company and the absorbed company*
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 registration mentions regarding the deletion of the absorbed work point*
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 publication of the merger by absorption project in the Official Gazette, Part IV*
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 provisions of common law 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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