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Modification of initial authorization conditions - Change of authorization holder - Legal entity THROUGH SALE PURCHASE - SAME ADDRESS (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 holder of the Operating Authorization by modifying the legal entity (through SALE-PURCHASE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the modification.
IMPORTANT!!! All uploaded documents must be obligatorily named in the format "pharmacy name_county name_**." (** represents the briefest possible 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 advanced 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 working point of the purchasing 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 attesting the exact address of the buyer company's place of business, issued by ONRC*
Descarcă
Scanned document
- is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility by the administrator of the selling company regarding the existence or non-existence of any litigation involving the operating license of 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
The document certifying the right of use for the premises designated as a pharmacy 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
Proof of submission to the Romanian College of Pharmacists, the territorial branch corresponding to the county where 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
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
Authenticated sale-purchase contract regarding the business assets*
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 mentions regarding the registration of the sale-purchase contract, issued by the ONRC 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
Certificate of registration mentions regarding the registration of the sale-purchase contract, issued by the ONRC to the purchasing company*
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 mentioning the removal of the seller company's place of business, issued by the Trade Register Office (ONRC) or proof of the termination of pharmacy activity*
Descarcă
Scanned document
- is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Standard request*
Descarcă
Formular tipizat
According to Model no. 4 from the annex to the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is to be downloaded, filled in, and then 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 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
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
5
Calendar days
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the common law provisions 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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