Gorj Public Health Directorate*

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions underlying the issuance of the operating license - relocation of headquarters/branch. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the change.

The procedure is addressed to the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will submit on the platform the documents provided for in OMS 444/2019 – transmission of the documents to the DSP, preparation by the local DSP of the verification report and of the decision of compliance or non-compliance, and submission on the platform.

​SANITARY AUTHORIZATION BASED ON THE SELF-DECLARATION is the administrative procedure by which the competent authority registers the self-declaration regarding compliance with the legal regulations applicable to the field and is notified and required to verify conformity.

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CERTIFYING COMPLIANCE with hygiene and public health standards is the administrative procedure by which the conformity with legal regulations regarding public health is assessed for operational objectives that carry out activities with risks to the population's health.

The notification of compliance certification can be issued in emergency mode - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.

art. 1 The authorization for free practice is the official document, issued by the Ministry of Health through the county public health department or the Bucharest municipality, which must be obligatorily held by every person who provides public services connected to the medical act: dental technique; biology, biochemistry and chemistry; medical physics; physiotherapy; psychology; speech therapy; sociology; vocal therapy; optics-optometry; prosthetics-orthotics; hearing prosthetics; audiology; nutrition and dietetics. The authorization for free practice for public services connected to the medical act is endorsed annually. The documents required for issuing the authorization for free practice for public services connected to the medical act for each category are listed in the application form.

art.2 By way of exception from the provisions of art.1, legally constituted professional organizations, with authority to issue documents certifying professional training and the right to free practice for the organization’s members, shall issue authorization for free practice for their own members who perform public services connected to the medical act included in the organization’s statute and competences.

(Order 1992/2023 - for the approval of the Methodological Norms regarding the establishment, authorization, equipping, operation and registration of private practice offices for services connected to the medical act, as well as for establishing the documents required for issuing practice authorizations for personnel who carry out services connected to the medical act)

The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that were the basis for issuing the operating license - any other modification made to the space of the pharmaceutical unit, except for relocation of the headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Policy and Medical Devices within 5 working days from the date of the change.

The procedure is addressed to pharmaceutical units that wish to establish closed-circuit pharmacies at an address other than the hospital or at the hospital's address being coordinated by the pharmacy in the healthcare unit; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is stipulated.

The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate

The procedure is addressed to pharmaceutical units in cases where the registration of the mention certifying the authorization for sale and dispensing via the information society of medicines granted without a medical prescription/specific products for drugstores is requested.

The procedure is addressed to pharmaceutical units in situations where the addition of the resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity takes place at a different address of the headquarters/branch compared to the initial one. The documents are sent 60 working days before the expiration of the legal term for the suspension of activity.

The procedure is addressed to drugstores for establishing a drugstore - head of unit - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.

This procedure regulates the manner of access to public interest information according to Law no. 544/2001 and the Methodological Norms from February 7, 2002, for applying Law no. 544/2001 regarding free access to public interest information, with the subsequent amendments and completions, within the Gorj Public Health Directorate.

The person responsible for applying Law no. 544/2001 regarding free access to public interest information, with the subsequent amendments and completions, at the level of the Gorj Public Health Directorate is Pitian Elena, inspector within the Public Relations Department.

Public authorities and institutions have the obligation to respond in writing to requests for public interest information within 10 days, or, as the case may be, within a maximum of 30 days from the registration of the request, depending on the difficulty, complexity, volume of documentary work, and urgency of the request. If the time required to identify and disseminate the requested information exceeds 10 days, the response will be communicated to the applicant within a maximum of 30 days, provided that the applicant is notified in writing of this fact within 10 days.

The deadlines for communicating a response to applicants for information of interest are calculated from the date the request is registered, and the day on which the term begins to run and the day it expires are not included in the calculation of the deadlines. When the last day of a deadline falls on a non-working day, the deadline is extended to the first working day that follows.

As regards the personal data collected by the Gorj Public Health Directorate, these are processed in accordance with the provisions of Regulation (EU) no. 679/2016 on the Protection of Personal Data, the purpose of processing this data being established by the fulfillment of the duties and legal obligations instituted by Law no. 544/2001 regarding free access to information of public interest, with the subsequent amendments and completions.

More information regarding the policy of the Gorj Public Health Directorate in relation to the processing of personal data, as well as the data protection officer within the institution, can be found on the institution's website https://dsp-gorj.centruldecalcul.ro/ , in the section “https://dsp-gorj.centruldecalcul.ro/protectia-datelor-cu-caracter-personal-gdpr/”

Specialized public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about the way of fulfilling the requirements of the legal provisions in force regarding hygiene and public health when locating, arranging, constructing, and modifying for the operation of a unit that carries out an activity posing a risk to the population's health;

The notification of specialized assistance can be issued urgently - within 5 working days from the submission of the file, by paying an urgent fee of 150 lei.

In accordance with the provisions of Order of the Minister of Health no. 1059/20.11.2003 regarding the mandatory nominal declaration and record of doctors (published in Official Gazette no. 860/12.03.2003), the Public Health Directorate of Gorj County is authorized to grant stamp codes (based on a certificate) for doctors who have the right to free practice (certified by the membership certificate in the professional colleges) and carry out their professional activity in a healthcare unit in Gorj County.

THE REQUIRED DOCUMENTS will be submitted to DSP Gorj, RUNOS Department

Attention resident doctors:

According to the provisions of art. 17, para. (1) of Government Ordinance no. 12/2008, approved with amendments by Law no. 179/2008 "starting with the 2005 class of graduates licensed by the faculty of medicine, obtaining the right to free practice is done after passing the specialist doctor exam".

Also, the same normative act in art. 18, para. (2) provides for doctors in supervised/assisted practice that "The medical act performed by the doctor during the 3 years of practice is under the responsibility of a doctor with the right to free practice."

In view of the above, doctors in supervised/assisted practice cannot benefit from the granting of a stamp code.

Note: All requested documents will be checked against the original.