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Modification of initial authorization conditions - Change of authorization holder and RELOCATION OF HEADQUARTERS/WORKING POINT - Legal entity BY AWARD (UF-DSP)*
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Procedure
Online
Companii
National
ROEID
Details
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for granting the operating license - change of operating license holder by modifying the legal entity (through adjudication) and change of the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Drug 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
-
Request type*
Descarcă
According to Model no. 10 annex from the Regulations regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, filled out, 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 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 place of business, issued by ONRC*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of attestation with the exact address of the work point of the purchasing company, issued by ONRC*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Deed of adjudication or Adjudication report concluded between the judicial administrator, representative of the selling company and the adjudicator*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration mentions regarding the registration of the adjudication deed or the adjudication minutes by the selling company*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Certificate of registration mentions regarding the registration of the deed of adjudication or the minutes of adjudication by the purchasing company*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Extended certificate of ascertainment of the selling company indicating the cancellation of the operating branch that was the subject of the sale*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Statement on own responsibility of the administrator of the selling company regarding the existence or non-existence of any litigations involving the operating authorization concerning the selling company*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use over the space designated as a pharmaceutical unit*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Space sketch*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The employment contract or proof of practicing 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
In the case of drugstores - the employment contract or proof of practicing the profession independently for a full-time position for the new pharmaceutical unit manager is uploaded - it is uploaded to 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 in which the pharmaceutical unit operates, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
- it 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 attesting the situation provided by the law is uploaded to the platform, signed with an extended electronic signature*
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
5
Calendar days
Appeal routes
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
20 August 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.
Satu Mare 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. Avram Iancu nr. 16
Telefon:
0261-768101
Fax:
0261-768103
Email:
office@dspjsm.ro
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Competent entities
Biroul Avize si Autorizatii
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