Alba Public Health Directorate*

The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to the Public Health Directorate (DSP).

Specialized public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about how to comply with the current legal provisions regarding hygiene and public health in the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity posing a risk to the health of the population;

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.

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 related to the field and is notified and requested for conformity verification.

This document can be issued urgently - within 5 working days from the submission of the file, by paying an urgent fee of 150 lei.

The sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, prepares the evaluation report, and issues the sanitary authorization of operation or the notification of its rejection.

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

The sanitary authorization for operation based on the evaluation report is the administrative procedure through which the competent authority assesses the conformity of the objective, prepares the evaluation report, and issues the sanitary operation authorization or the notification of its rejection.

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

The procedure aims to establish the activities carried out within DSP Alba, for the purpose of issuing stamp codes to doctors (newly entering the system with the right to free practice) from Alba County, from the list of available codes received from the National Center for Statistics and Informatics in Public Health Bucharest, and registering them in the territorial Register of doctors from Alba County. The procedure applies to all doctors from Alba County employed in healthcare units under the subordination or coordination of the Ministry of Health, except for doctors employed in county blood transfusion centers and in healthcare units under the subordination of other ministries and other central institutions with their own healthcare network.

​The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/working 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.

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​The procedure is addressed to drugstores for the establishment of a drugstore - head of the unit - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified at the same time.

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​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's address, being coordinated by the pharmacy within 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.

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

According to the Order of the Minister of Health no. 50/2004 – regarding the methodology for referring certain categories of patients for treatment abroad, with subsequent amendments and completions, the initiation by the County Public Health Directorates of the procedure to obtain approval for treatment abroad is made only after the patient has gone through and exhausted all levels of medical care in the country and there is a recommendation from the specialist doctor at the last level that the patient needs a treatment that cannot be performed in Romania.

Referral for treatment abroad is made for patients registered on the list of a family doctor, who have gone through all levels of medical assistance, namely primary specialized medical assistance, and who have been hospitalized in medical units that provide high quality professional and technical medical services, but whose health has not been restored. Exceptions are infants aged 0-1 year for whom the file can be drawn up immediately after the condition is diagnosed in a medical unit within a university center, without the need to go through all these stages.

The person requesting referral for treatment abroad or his/her legal representative or caregiver (spouse, up to IVth degree relative) shall submit the patient’s medical documents (hospital discharge note, medical letter, results of medical investigations, the attending doctor’s recommendation for treatment abroad, etc.) together with an application from the patient to the public health directorate in whose territorial area the patient, legal representative, or caregiver resides, accompanied by copies of their identity documents.

art. 1 The license 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 providing public services connected to the medical act: medical physics; psychology; speech therapy; medical sociology; voice 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 approved annually. The documents required for issuing the license 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, competent in issuing documents certifying professional training and the right of free practice for the members of the organization, issue licenses for free practice for their own members who carry out public services connected to the medical act included in the organization’s statute and competencies.

(Order 1992/2023 - for the approval of the Methodological Norms on the establishment, authorization, equipping, functioning, and registration of free practice offices for services connected to the medical act, as well as for the determination of the documents required for issuing licenses of free practice for personnel carrying out services connected to the medical act)

CERTIFICATION OF COMPLIANCE with hygiene and public health regulations is the administrative procedure by which compliance with legal regulations regarding public health is assessed for operational facilities that carry out activities with risks to the health of the population.

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

The healthcare units provided in annex no. 1 of ORDER no. 1,159 of August 31, 2010 are authorized, upon their request, by the county public health directorates or of the municipality of Bucharest, as the case may be.

The healthcare units are authorized for the outpatient medical examination of candidates for obtaining a driving license and of drivers of motor vehicles or trams, with the exception of persons involved in road traffic safety, whose medical examination is ensured by specialized medical units, approved by the Ministry of Transport and Infrastructure, according to their own regulations.

The sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority assesses the compliance of the objective, prepares the evaluation report, and issues the sanitary authorization of operation or the notification of its rejection.

The sanitary authorization of operation can be issued under an emergency regime - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.

The procedure involves collaboration with the Epidemiology Department, specialists who are part of the inspection committee: an emergency medicine doctor, an intensive care specialist, and an engineer.
- The requests made available to applicants specify the documents required according to ORDER MS No. 1519 of December 2, 2009;
- The documents registered with an entry number are completed with the data provided in the aforesaid order;
- The file with the documents is analyzed within the department, and if it is complete, the meeting of the inspection committee is requested, for authorization. The committee must include an auto engineer from a public structure that operates ambulances and two doctors specializing in emergency medicine or intensive care anesthesiology who also work in a prehospital structure;
- The members of the inspection committee go to the applicant’s location and verify the authenticity of the documents in the file, according to each committee member’s expertise. The travel costs, accommodation of committee members, as well as the per diem will be covered by the private service providers/public service requesting the authorization and will be calculated according to Government Decision no. 1,860/2006 regarding the rights and obligations of the personnel of the authorities and public institutions during delegation and secondment in another locality, as well as in the case of travel, within the locality for work purposes, with subsequent amendments and additions.
- The authorization committee meeting will take place within 30 days from the applicant’s submission.
- The issuance of the authorization is done according to the authorization model issued by the health directorates, stipulated in MS Order no. 1519/2009. On the date of filing the authorization file, its expiration date must be no less than 60 days. The operating authorization for private providers of prehospital emergency medical assistance and assisted/non-assisted medical transport, as well as public services, shall be issued by the Alba Public Health Directorate based on the inspection report prepared by the inspection committee.
- The initial validity period of the authorization is 3 years. The committee appointed by the county public health directorate will prepare a new inspection report and will propose to the coordinating director:
a) extension of the operating authorization’s validity for 5 years, if the inspection report is favorable;
b) temporary suspension of activity according to art. 7;
c) extension of the operating authorization’s validity for 6 months to remedy identified deficiencies, if they are not life-threatening to patients;
d) cancellation of the operating authorization.
- The operating authorization is issued for one or more domains of activity, as follows:
a) emergency medical assistance and assisted medical transport;
b) emergency consultations and non-assisted medical transport.

The procedure is addressed to pharmaceutical units in the event that changes occur in the conditions that formed the basis for issuing the operating authorization - any other modification made to the pharmaceutical unit's premises, except for relocating the headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicine and Medical Devices Policy within 5 working days from the date of the modification.

The procedure is addressed to pharmaceutical units in cases where the registration of the statement attesting the authorization for sale and dispensing through 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 they request the registration of the mention of resumption of activity during the suspension period or upon its expiration. The resumption of 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.

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Specialist public health assistance is the administrative-professional procedure by which, upon request, natural or legal persons are informed about how to comply with 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 conducting an activity with health risk for the population;

The specialist assistance notification can be issued urgently - within 5 working days from the date of file submission, upon payment of an emergency fee of 150 lei.

The sanitary operating authorization based on the evaluation report is the administrative procedure through which the competent authority assesses the compliance of the objective, prepares the evaluation report, and issues the sanitary operating authorization or the notification of its rejection.

The sanitary operating authorization can be issued in an emergency regime—5 working days from the submission of the file—by paying an emergency fee of 150 lei.

Doctors who carry out their activity in contractual relationship with the county health insurance houses or of the municipality of Bucharest, directly or through medical service providers, can continue their activity, after reaching the age of 70, upon request, with an annual approval issued by the county public health directorate or of the municipality of Bucharest and by CMR, through the county medical colleges or that of the municipality of Bucharest, based on the health certificate.

The county public health departments and that of the municipality of Bucharest authorize home care providers, based on a declaration on their own responsibility, who meet the following criteria:

a) the express mention in the deed/document of establishment regarding the provision of home care as an object of activity;

b) the existence of specialized personnel according to the provisions of art. 6;

c) the existence of a job description for each employed person, specifying the level of professional training, competencies, and responsibilities;

d) the existence of a headquarters for the home care dispatch center;

e) the existence of equipment for storing and accessing medical and communication documents, specific to the field of activity.

Home care means any medical or medical-related activity provided by specialized personnel at the patient's home, which contributes to the improvement of their physical and psychological well-being. ACCORDING TO ORDER No. 2520/2022 of August 29, 2022

The authorization for outpatient examination of candidates for obtaining a driving license and drivers of motor vehicles or trams is valid throughout the period in which the authorization conditions are met, with annual endorsement.

The authorization is valid throughout the period of fulfillment of the authorization conditions, with annual endorsement.

The sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, prepares the evaluation report, and issues the sanitary authorization to operate or the notification of its rejection.

The sanitary authorization to operate may be issued in urgent mode - 5 working days from the submission of the file, by paying an urgent fee of 150 lei.

The medical practice is established at the request of the main physician or the associated physicians within the medical civil society.

The founding document of the medical practice or the medical civil society is the certificate of registration in the Unique Register of Medical Practices.

The sanitary operation authorization based on the evaluation report is the administrative procedure by which the competent authority evaluates the conformity of the objective, prepares the evaluation report, and issues the sanitary operation authorization or the notification of its rejection.

If the technical project and the drawn plans are not current/updated, the following must be specified in writing:

a. On the plan, it must be recorded that no changes have occurred compared to the designed situation, and if changes have occurred, they must be recorded graphically on the plan. In the first case, the beneficiary signs (name, surname, signature and stamp). In the second case, along with the beneficiary, in solidarity with them, the initial designer will record their acceptance or refusal of the changes made, with acceptance or refusal being signed and stamped by both the beneficiary and the designer (name, surname, signature, stamp);

b. Entries will be made on each plan (where applicable).

The sanitary operation authorization can be issued in an emergency regime—5 working days from file submission, by paying an emergency fee of 150 lei.

The annual visa represents written confirmation by the local public health authority regarding compliance with the sanitary authorization previously issued.

THE ENDORSEMENT of the sanitary operating authorization based on the evaluation report can be issued urgently - 5 working days from the submission of the file, by paying an urgent fee of 150 lei.

​The procedure addresses the establishment of closed circuit pharmacies serving medical units and/or outpatient clinics; the manager of the medical unit submits the application accompanied by the requested documentation. The applicant will upload to the platform the documents provided in OMS 444/2019 - transmission of documents to DSP, preparation by the local DSP of the verification report and the conformity or nonconformity decision, and uploading to the platform.

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​The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending documents to the DSP.

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

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