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Change 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 changes occur in the conditions that formed the basis for issuing the operating authorization - change of the 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 from the annex to 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 to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Operating permit or duplicate issued by the Ministry of Health in case of loss of the permit + annexes*
Descarcă
Scanned document
- 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, respectively for the buyer; ONRC certificate regarding the deletion of the seller company's working point or proof of pharmacy activity deletion*
Descarcă
Scanned document
Are submitted only for the situation provided in art. 7 point III of the Norms approved by OMS no. 444/2019. (sale - purchase) In case the applicant does not fall under this situation and needs to submit documentation for other types of change of authorization holder, an "empty sheet", electronically signed, must be uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Deed or Minutes of Award; ONRC Certificate of registration with mentions regarding the Deed or Minutes of Award for the seller and for the buyer; Extended ONRC certificate of findings for the selling company showing the removal of the work point with the activity at the work point of the selling company or proof of removal 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. (adjudication - insolvency) If the applicant is not in this situation and needs to submit documentation for other types of change of authorization holder, an "empty sheet", electronically signed, must be uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of award, Minutes of the conduct and completion of enforcement, Asset handover document; ONRC certificate for registration of mentions regarding the registration of the award document 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
Scanned document
They are submitted only for the situation provided in art. 7 point I^1 of the Rules approved by OMS no. 444/2019 (adjudication - enforcement). In the event that the applicant does not fall under this situation and needs to submit documentation for other types of license holder change, an "empty sheet," electronically signed, should 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; Articles of incorporation of the company resulting from the merger; Declarations of the companies ceasing to exist by 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 Norms approved by OMS no. 444/2019 (merger). If the applicant does not fall under this situation and must submit documentation for other types of change of license holder, an "empty sheet" signed electronically 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 mentions registering the division of the company as the divided company and of 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). In case the applicant does not fall under this situation and must submit the documentation for other types of change of the authorization holder, a "blank sheet", electronically signed, is uploaded.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Statement on own responsibility of the administrator of the selling company regarding the existence or non-existence of any litigations involving the operating authorization related to 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 in the annex to the operating 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
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 required 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
Proof of submission to the Romanian College of Pharmacists, the territorial branch corresponding to the county in which 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
Statement on own responsibility of the company administrator who holds the authorization, justifying the reason for not holding the right of use over the space in the Authorization*
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
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 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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