Public Health Directorate Alba*
Available procedures
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to DSP.
*Sanitary authorization for 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 for operation or the notification of its rejection.
The sanitary authorization for operation can be issued in an emergency regime - 5 working days from the submission of the file, upon payment of an emergency fee of 150 lei.
*CERTIFICATION OF COMPLIANCE with hygiene and public health standards is the administrative procedure by which the evaluation of compliance with legal regulations regarding public health is carried out for operational facilities conducting activities that pose a risk to public health.
The notification of certification of compliance can be issued in an expedited manner - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
*The sanitary operating authorization based on the evaluation report is the administrative procedure by which the competent authority assesses the conformity of the objective, prepares the evaluation report, and issues the sanitary operating authorization or the notification of its rejection.
If the technical project and the drawing plans are not current/updated, the following shall be specified in writing:
a. On the plan, it will be recorded that no changes have occurred compared to the designed situation, and if changes have occurred, these should be graphically recorded on the plan. In the first case, the beneficiary signs (name, surname, signature, and stamp). In the second case, along with the beneficiary, jointly with them, the original designer will record acceptance or refusal for the changes, the acceptance or refusal will be signed and stamped by both the beneficiary and the designer (name, surname, signature, stamp);
b. The notes will be made on each plan (where applicable).
The sanitary operating authorization can be issued in emergency mode - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
*The sanitary authorization for 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 for operation or the notification of its rejection.
The sanitary authorization for 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 authorization for the outpatient examination of candidates for obtaining a driving license and drivers of motor vehicles or trams is valid for the entire period during which the authorization conditions are met, with annual endorsement.
The authorization is valid for the entire period during which the authorization conditions are met, with annual endorsement.
*The county public health directorates and that of Bucharest municipality authorize home care providers based on a statutory declaration, which must meet the following criteria:
a) the founding act/document must explicitly mention the provision of home care as an object of activity;
b) existence of specialized staff in accordance with the provisions of Art. 6;
c) existence of a job description for each employed person, specifying the level of professional training, competencies, and responsibilities;
d) existence of a headquarters for the home care dispatch center;
e) existence of facilities for storing and accessing medical and communication documents specific to the field of activity.
Home care refers to any medical or medical-related care activity provided by specialized staff at the patient's home, which contributes to the improvement of the patient's physical and mental well-being. ACCORDING TO ORDER No. 2520/2022 of August 29, 2022
*The healthcare units provided in Annex no. 1 of ORDER no. 1.159 of August 31, 2010 shall be authorized, upon their request, by the county public health directorates or that of the Municipality of Bucharest, as applicable.
The healthcare units shall be authorized for outpatient medical examination of candidates for obtaining a driving license and of drivers of motor vehicles or trams, except for 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 procedure aims to establish the activities carried out within DSP Alba, for the issuance of stamp codes to doctors (newly entered into the system with the right to practice) from Alba county, from the list of available codes received from the National Center for Statistics and Health Informatics Bucharest and their registration in the territorial register of doctors from Alba county. The procedure applies to all doctors in Alba county employed in health units under the subordination or coordination of the Ministry of Health, except for doctors employed in county blood transfusion centers and in health units under the subordination of ministries and other central institutions with their own health network.
*The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying authorization for the sale and release through the information society of medicines granted without medical prescription/specific products for drugstores is requested.
art. 1 The free practice authorization is the official document, issued by the Ministry of Health through the county public health directorate, or the Bucharest municipality, which must be obligatorily held by every person who provides public services related to the medical act: medical physics; psychology; speech therapy; medical sociology; voice therapy; optics-optometry; prosthetics-orthotics; hearing prosthetics; audiology; nutrition and dietetics. The free practice authorization for public services related to the medical act is validated annually. The documents needed to issue the free practice authorization for public services related to the medical act for each category are listed in the application form.
art.2 By exception to the provisions of art.1, the legally constituted professional organizations, with competence in issuing documents attesting professional training and the right to free practice for their members, issue free practice authorizations for their own members who provide public services related 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 free practice offices for services related to the medical act, as well as for establishing the documents necessary for issuing free practice authorizations for personnel performing services related to the medical act)
The sanitary authorization for operation 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 authorization for operation or the notification of its rejection.
The sanitary authorization for operation can be issued urgently - within 5 working days from the submission of the file, by paying an urgent fee of 150 lei.
*The annual endorsement represents written confirmation by the local public health authority regarding compliance with the sanitary authorization previously issued.
ENDORSEMENT of the sanitary operating authorization based on the evaluation report can be issued on an emergency basis - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
*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 for the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population;
The specialized assistance notification can be issued in emergency regime - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
*HEALTH AUTHORIZATION BASED ON THE AFFIDAVIT is the administrative procedure by which the competent authority registers the affidavit regarding compliance with the applicable legal regulations in the field and is notified and requested to verify compliance.
This document can be issued under emergency procedure - 5 working days from the file submission, by paying an emergency fee of 150 lei.
*The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for the issuance of the operating license - moving headquarters/branch. The changes must be notified to the Ministry of Health - Directorate of Pharmaceuticals and Medical Devices within 5 working days from the date of the change.
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 Romania for the establishment of LOCAL DISTRIBUTION OFFICES - forwarding documents to DSP.
The procedure involves collaboration with the Epidemiology Department, specialists who are part of the inspection commission: emergency medicine physician, ICU specialist, and engineer.
- The requests made available to applicants specify the necessary documents according to MINISTRY ORDER No. 1519 of December 2, 2009;
- The documents registered with an entry number are filled out with the data stipulated by the aforementioned order;
- The file with the documents is analyzed within the department and, if complete, a request is made for the meeting of the inspection commission, for authorization. The commission must obligatorily include an automotive engineer from a public structure that has ambulances in its equipment, as well as 2 doctors specializing in emergency medicine or anesthesiology and intensive therapy, who also operate in a pre-hospital structure;
- The members of the inspection commission go to the applicant's location and assess the veracity of the documents in the file, according to the competences of each member of the inspection commission. Travel costs, accommodation for the commission members, as well as per diem will be covered by private providers of services/the public service requesting authorization and will be calculated according to Government Decision no. 1.860/2006 regarding the rights and obligations of the staff of authorities and public institutions during delegation and secondment to another locality, as well as in the case of travel, within the locality, in the interest of service, with subsequent amendments and additions.
- The meeting of the authorization commission will take place within 30 days from the date of submission of the applicant's request.
- The authorization is issued according to the model of authorization issued by health directorates, as provided in Ministry Order no. 1519/2009. On the date of submission of the file for authorization, the expiration term must not be less than 60 days. The operating authorization for private providers of pre-hospital emergency medical care and assisted medical transport and unassisted sanitary transport, as well as public services, is issued by the Alba Public Health Directorate based on the inspection report prepared by the inspection commission.
- The initial validity period of the authorization is 3 years. The commission appointed by the county public health directorate will prepare a new inspection report and propose to the coordinating director:
a) extension of the validity period of the operating authorization for a period of 5 years, if the inspection report is favorable;
b) temporary suspension of activity according to art. 7;
c) extension of the validity period of the operating authorization for a period of 6 months in order to remedy the identified deficiencies, if these are not of a nature to endanger the lives of patients;
d) withdrawal of the operating authorization.
- The operating authorization is issued for one or several fields of activity, as follows:
a) emergency medical care and assisted medical transport;
b) emergency consultations and unassisted sanitary transport.
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 in the healthcare unit, the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is provided must necessarily be submitted.
The procedure applies to pharmaceutical units in situations where there are changes to the conditions underlying the issuance of the operating authorization - any other modification concerning the premises of the pharmaceutical unit, except for the relocation of the headquarters/working point. Changes must be notified to the Ministry of Health - Directorate for Drug Policy and Medical Devices within 5 working days from the date of the change.
The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at a different address of the headquarters/work point than the initial one. The documents are sent 60 working days before the expiration of the legal suspension period.
The procedure is addressed to the establishment of closed circuit pharmacies that serve healthcare units and/or outpatient clinics; the healthcare unit manager submits the application accompanied by the required documentation. The applicant will submit on the platform the documents stipulated in OMS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the verification report and the conformity or nonconformity decision, and submission on the platform.
The procedure is addressed to drugstores for establishing a drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Drug Policy and Medical Devices, is also notified simultaneously.
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 for obtaining approval for treatment abroad is done only after the patient has gone through and exhausted all levels of medical care in the country and there is a recommendation from the highest-level specialist physician that the patient needs treatment that cannot be performed in Romania.
The referral for treatment abroad is made for patients registered with a family physician, who have gone through all levels of medical assistance, namely primary and specialized medical care, and who have been hospitalized in medical units providing high-quality professional and technical services, but whose health has not been restored. Exceptions are infants aged 0 – 1 year for whom the file can be prepared immediately after the diagnosis of the condition in a medical unit within a university center, without the need to go through all these stages.
The person requesting the referral for treatment abroad or their legal representative or relative (husband/wife, relative up to the fourth degree) will submit the patient’s medical documents (hospital discharge ticket, medical letter, investigation results, recommendation from the attending physician regarding treatment abroad, etc.) together with an application from the patient to the public health directorate in the territorial area where the patient, legal representative, or relative resides, accompanied by copies of their identity documents.
*Specialist public health 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 when siting, arranging, constructing, and modifying for the operation of a unit that conducts activities with risk to the health of the population;
The specialist assistance notification can be issued urgently - 5 working days from the submission of the file, upon payment of an urgent fee of 150 lei.
*Doctors who carry out their activity in a contractual relationship with the county health insurance houses or the Bucharest municipality, directly or through medical service providers, may continue their activity, after reaching the age of 70, upon request, with an annual approval issued by the county public health directorate or the Bucharest municipality and by CMR, through the county medical colleges or the Bucharest municipality, based on the health certificate.
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The sanitary authorization for operation 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 authorization for operation or the notification of its rejection.
The sanitary authorization for operation may be issued under emergency regime – 5 working days from the submission of the file, by paying an emergency 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 for operation or the notification of its rejection.
The sanitary authorization for operation can be issued under emergency regime - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
*The medical practice is established at the request of the principal physician or the associate 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 procedure is addressed to pharmaceutical units in cases where the registration of the mention of 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/working point than the initial one. The documents must be submitted 60 working days before the expiry of the legal suspension period.
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