Gorj Public Health Directorate*

The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/work point. 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 addresses 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 upload on the platform the documents stipulated in OMS 444/2019 - transmission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the inspection report and the decision of compliance or non-compliance, and uploading them on the platform.

SANITARY AUTHORIZATION BASED ON 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 requested to verify compliance.

CERTIFICATION OF COMPLIANCE with hygiene and public health standards is the administrative procedure by which the conformity assessment with legal regulations regarding public health is carried out for operational objectives that carry out activities with risk to the health of the population.

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

art. 1 The license for free practice is the official document, issued by the Ministry of Health through the county public health department, respectively of the municipality of Bucharest, which must be obligatorily held by each person providing public services connected to medical acts: 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 license for free practice for public services connected to the medical act is endorsed annually. The documents necessary for issuing the license for free practice for public services connected to the medical act for each respective category are listed in the application form.

art.2 By exception from the provisions of art.1, legally established professional organizations, competent in issuing documents certifying professional training and the right to free practice for members of the organization, issue licenses for free practice for their own members who perform public services connected to the medical act included in the organization’s statutes and competences.

(Order 1992/2023 - for the approval of the Methodological Norms regarding the establishment, authorization, equipment, functioning, and registration of free practice offices for services connected to the medical act, as well as for establishing the documents necessary for issuing the licenses for free practice for personnel providing services connected to the medical act)

The procedure addresses pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for relocation of the headquarters/work point. The changes must be notified to the Ministry of Health - Policy Department for Medicinal Products 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 that of the hospital or at the hospital address, being coordinated by the pharmacy of the healthcare unit. The operating authorization of the healthcare unit, accompanied by the annex in which the pharmacy is specified, must be submitted obligatorily.

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 situations where the registration of the mention attesting the authorization for sale and release via the information society of medicines that are granted without a medical prescription/specific drugstore products is requested.

The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resuming the activity is requested during the suspension period or upon its expiration. The resumption of the activity takes place at a different address of the headquarters/working point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period.

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

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

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

Authorities and public institutions are obliged 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 about this fact within 10 days.

The deadlines for responding to applicants for public interest information are calculated from the date of registration of the request and the day from which the deadline starts to run, nor the day it is fulfilled, are not included in the calculation. When the last day of a deadline falls on a non-working day, the deadline is extended until the next working day.

Regarding personal data collected by the Gorj Public Health Directorate, it is processed in accordance with the provisions of Regulation (EU) no. 679/2016 on Personal Data Protection, the purpose of processing such data being that set by fulfilling the duties and legal obligations established by Law no. 544/2001 regarding free access to public interest information, with its subsequent amendments and completions.

More information regarding the policy of the Gorj Public Health Directorate in relation to personal data processing, 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/"

Public health specialty assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about the way in which the requirements of the legal provisions in force regarding hygiene and public health are fulfilled in the location, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population;

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

In accordance with the provisions of the Order of the Minister of Health no. 1059/20.11.2003 regarding the mandatory nominal declaration and the registration of doctors (published in MO no. 860/12.03.2003), the Public Health Directorate of Gorj County is authorized to grant signature codes (on the basis of a certificate) for doctors who have the right to practice independently (as evidenced by the membership certificate in professional colleges) and carry out their professional activity in a healthcare unit in Gorj County.

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

Attention to 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 medical school graduates, the acquisition of the right to practice independently is granted after passing the specialist doctor exam.”

Also, the same normative act in art. 18, para. (2) stipulates 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 practice independently.”

Considering the above, doctors in supervised / assisted practice cannot be granted a signature code.

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