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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORK POINT - Legal entity THROUGH AWARDING (UF-DSP)*
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Procedure
Online
Companii
National
ROEID
Details
The procedure is addressed to pharmaceutical units in the situation where changes occur to the conditions that formed the basis for the issuance of the operating authorization - change of holder of the Operating Authorization by modifying the legal entity (through adjudication) and change of address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Standard request*
Descarcă
According to Model no. 10 annex from the Norms 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.*
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration, mentions regarding the registration of the buyer company's working point, issued by ONRC*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate attesting the exact address of the workplace of the purchasing company, issued by ONRC*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Awarding act or Awarding report concluded between the judicial administrator, the representative of the selling company and the purchaser*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration mentions regarding the registration of the deed of awarding or the awarding minutes by the selling company*
Descarcă
- is uploaded to the platform, signed with extended electronic signature*
Certificate of registration with mention regarding the registration of the deed of adjudication or the adjudication report by the purchasing company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Extended certificate of the selling company showing the removal of the operating unit that was subject to the sale*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Declaration on own responsibility of the administrator of the selling company regarding the existence or non-existence of any litigations involving the operating authorization of the selling company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right to use the space designated as a pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Space sketch*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
- it 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 schedule with a working time of 8 hours, for the chief pharmacist, registered in the name of the new authorization holder*
Descarcă
In the case of drugstores - the employment contract or proof of practicing the profession in a liberal form for a full-time position for the new manager of the pharmaceutical unit is uploaded - uploaded on the platform, signed with an extended electronic signature*
Proof of payment of the fee provided 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 where the pharmaceutical unit carries out its activity, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Proof of compliance with the provisions of Article 20 of the Pharmacy Law*
Descarcă
Law no. 266/2008 - the pharmacy law, republished - the document certifying the situation provided by law, signed with an extended electronic signature, is uploaded to the platform*
Fees
Title
Payment method
Value
Currency
Taxă variabilă
OP
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
02 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.
Giurgiu Public Health Directorate*
*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.
Str. Bucuresti bloc 114, scara A
Telefon:
0246/214176
Fax:
0246/217251
Email:
secretariat@dspgiurgiu.ro
Table of contents
Competent entities
Biroul pentru Avize si Autorizatii Sanitare
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