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Modification of initial authorization conditions - Change of authorization holder - DURING THE SUSPENSION PERIOD (UF-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 that were the basis for issuing the operating authorization - change of holder of the Operating Authorization during the period in which the Authorization is suspended.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request type*
Descarcă
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 extended electronic signature.*
Operating authorization or duplicate issued by the Ministry of Health in case of loss of authorization + annexes*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Sale-purchase contract regarding the business assets, notarized; ONRC certificate of mention registration regarding the registration of the sale-purchase contract, for the seller and for the buyer; ONRC certificate regarding the deletion of the working point of the selling company or proof of deletion of the pharmacy activity*
Descarcă
They are submitted only for the situation provided in art. 7 point III of the Rules approved by OMS no. 444/2019. (sale - purchase) If the applicant does not fall within this situation and needs to submit the documentation for other types of change of authorization holder, a "blank sheet" signed electronically must be uploaded.*
Deed or Minutes of Award; ONRC Certificate of registration. mentions regarding the Deed or Minutes of Award for the seller, respectively for the buyer; Extended ONRC finding certificate of the selling company from which the deletion of the place of operation with the activity of the place of operation of the selling company should result or proof of deletion of the pharmacy activity*
Descarcă
They are submitted only for the situation provided in art. 7 point I of the Rules approved by OMS no. 444/2019. (adjudication - insolvency) If the applicant does not fall under this situation and must submit documentation for other types of changes of the holder of authorization, an "empty sheet" signed electronically is uploaded.*
Certificate of adjudication, Minutes of enforcement proceedings and completion, Handover deed of the asset; ONRC Certificate of registration mentions regarding the registration of the adjudication deed for the buyer/adjudicator; Extended ONRC certificate of the buyer/adjudicator; Extended ONRC certificate for the work point that was the subject of the sale within the enforcement proceedings*
Descarcă
They are submitted only for the situation provided in art. 7 point I^1 of the Regulations approved by OMS no. 444/2019 (award - forced execution). If the applicant does not fall under this situation and needs to submit the documentation for other types of change of authorization holder, a "blank sheet" signed electronically must be uploaded.*
AGA Resolution + Decision of merging companies: Proof of publication of the merger project in MOf, Part IV; The articles of incorporation of the company resulting from the merger; Declarations of companies ceasing through absorption or consolidation; ONRC Mention Certificate regarding the registration of the merger*
Descarcă
They are submitted only for the situation provided in art. 7 item II of the Rules approved by OMS no. 444/2019 (merger). If the applicant does not fall under this situation and needs to submit documentation for other types of changes of authorization holder, a "blank sheet", signed electronically, shall be uploaded.*
Proof of publication of the Division Project in the Official Gazette, Part IV or on the website of the divided company; ONRC certificate of mentions by which the division of the company is registered as a divided company and the newly created company*
Descarcă
They are submitted only for the situation provided for in art. 7 point IV of the Rules approved by OMS no. 444/2019 (division). If the applicant does not fall under this situation and needs to submit documentation for other types of changes of the authorization holder, a "blank sheet", electronically signed, is uploaded.*
Statement on own responsibility of the administrator of the selling company regarding the existence or non-existence of any disputes involving the operating authorization concerning the selling company*
Descarcă
- is uploaded to the platform, signed with an advanced electronic signature*
Statement on own responsibility that no changes have occurred compared to the last mention on the annex to the operating authorization*
Descarcă
- 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 with a working duration of 8 hours, for the chief pharmacist, registered in the name of the new authorization holder*
Descarcă
- 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*
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit carries out its activity, of the notification according to model no. 7 from the annex to the Norms*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility of the company administrator who holds the authorization, justifying the reason for not having the right to use the space mentioned in the Authorization*
Descarcă
- is uploaded to the platform, signed with an advanced electronic signature*
Fees
Title
Payment method
Value
Currency
Taxă fixă
OP
50
RON
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
15
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 administrative law are applicable.
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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