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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
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 during the period when the Authorization is suspended.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request*
Descarcă
Formular tipizat
According to Model no. 4 in the annex to the Norms 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.*
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 the authorization + annexes*
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
Sale-purchase contract regarding the commercial fund, authenticated; ONRC certificate of registration mentions regarding the CVC registration, for the seller and for the buyer; ONRC certificate regarding the deletion of the working point of the seller company or proof of pharmacy activity deletion*
Descarcă
Scanned document
They are submitted only for the situation provided in art. 7 point III of the Regulations approved by OMS no. 444/2019. (sale - purchase) If the applicant is not in this situation and must submit documentation for other types of change of authorization holder, an "empty sheet", electronically signed, is uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Act or Minutes of Award; ONRC Certificate of registration mentions regarding the Act or Minutes of Award for the seller, respectively for the buyer; Extended ONRC Certificate of findings of the selling company showing the cancellation of the working point with the activity of the working point of the selling company or proof of cancellation of pharmacy activity*
Descarcă
Scanned document
They are submitted only for the situation provided in art. 7 point I of the Rules approved by OMS no. 444/2019. (award - insolvency) If the applicant does not fall into this situation and needs to submit documentation for other types of change of authorization holder, a "blank sheet", signed electronically, is uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of adjudication, Minutes of conduct and completion of enforced execution, Delivery act of asset; ONRC Certificate of registration mentions regarding registration of adjudication act for buyer/adjudicatee; Extended ONRC Certificate of buyer/adjudicatee; Extended ONRC Certificate for the work point that was the object of the sale within the enforced execution*
Descarcă
Scanned document
They are submitted only for the situation provided in art. 7 item I^1 of the Regulations approved by OMS no. 444/2019 (adjudication - enforcement). 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" signed electronically must be uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
AGA resolution + Decision of the merging companies: Proof of publication of the merger project in the Official Gazette, Part IV; The articles of association of the company resulting from the merger; Declarations of the companies that cease through absorption or merger; ONRC certificate of mentions regarding the registration of the merger*
Descarcă
Scanned document
They are submitted only for the situation provided for in art. 7 point II of the Rules approved by OMS no. 444/2019 (merger). In case the applicant is not found in this situation and must submit documentation for other types of change of authorization holder, an "empty sheet", electronically signed, is uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of publication of the Division Project in the Official Gazette, Part IV or on the website of the divided company; ONRC certificate of entries by which the division of the company is registered as a divided company and the newly created company*
Descarcă
Scanned document
They are submitted only for the situation provided for in art. 7 point IV of the Norms approved by OMS no. 444/2019 (division). If the applicant does not fall within this situation and needs to submit documentation for other types of change of authorization holder, a "blank sheet" is uploaded, electronically signed.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Self-declaration by the administrator of the selling company regarding the existence or non-existence of disputes involving the operating license concerning the selling 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
Declaration on own responsibility that no changes have occurred compared to the last mention on the appendix to the operating permit*
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 employment contract or proof of practicing the profession in a liberal form, for a full-time position with a working time 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 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 carries out its activity 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
Declaration on own responsibility of the company administrator who holds the authorization, justifying the reason for not holding the right of use over the space from the 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
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
45
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
0
Calendar days
Legislation
None
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the provisions of administrative law 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 Units Authorization and Monitoring 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 Units Authorization and Monitoring Department*
Intr. Cristian Popisteanu, nr. 1-3
Telefon:
0213072500
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartimentul Autorizare și Monitorizare Unități Farmaceutice
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