Alba Public Health Directorate*

The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending 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 the manner 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 with risk to the health of the population;

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

THE SANITARY AUTHORIZATION BASED ON THE SELF-DECLARATION is the administrative procedure by which the competent authority registers the self-declaration regarding the compliance with the legal regulations relevant to the field and is notified and requested for conformity verification.

This document can be issued in an emergency regime - 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 evaluates 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 urgently – within 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 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 under the emergency regime - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.

The procedure aims to establish the activities carried out within DSP Alba, for the issuance of stamp codes for doctors (newly-entered into the system with the right to practice independently) from Alba County, from the available free codes list received from the National Center for Statistics and IT in Public Health 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 authority or coordination of the Ministry of Health, except for doctors employed in county blood transfusion centers and in health units under the authority of ministries and other central institutions with their own health network.

​The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions on which the operating authorization was granted - relocation of headquarters/working point. 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.

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

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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 address, being coordinated by the pharmacy from the healthcare unit; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is specified.

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The procedure is addressed to pharmaceutical units in situations where registration of the resumption of activity is requested during the suspension period or at its expiration. The resumption of activity is carried out at a different address of the headquarters/working point than the initial one. The documents are to 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 for obtaining approval for performing 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 last level specialist doctor that the patient needs treatment which cannot be performed in Romania.

Referral for treatment abroad is made for patients registered with a family doctor, who have gone through all levels of medical care, namely primary and specialized medical care, and who have been hospitalized in medical units offering high professional and technical quality medical services, but whose health has not been restored. An exception is made for infants aged 0 - 1 year for whom the dossier can be drawn up immediately after the diagnosis of the condition in a medical unit within a university center, without the need to go through all of these steps.

The person requesting referral for treatment abroad or his/her legal representative or next of kin (spouse, relative up to the fourth degree) shall submit the patient's medical documents (hospital discharge note, medical letter, medical investigation results, the attending physician's recommendation for treatment abroad, etc.) together with a request from the patient to the public health directorate in whose territorial area the patient, the legal representative or the next of kin resides, accompanied by copies of their identity documents.

art. 1 The practice license 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 every person providing public services related to the medical act: medical physics; psychology; speech therapy; medical sociology; vocal therapy; optics-optometry; prosthetics-orthotics; auditory prosthetics; audiology; nutrition and dietetics. The practice license for public services related to the medical act is validated annually. The documents necessary for issuing the practice license 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, legally constituted professional organizations, with competence in issuing documents certifying professional training and the right to practice for their members, issue practice licenses for their own members who carry out 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, functioning and registration of private practice offices for services related to the medical act, as well as for establishing the necessary documents for issuing practice licenses for personnel carrying out services related to the medical act)

CERTIFICATION OF COMPLIANCE with hygiene and public health regulations is the administrative procedure by which the compliance assessment with legal regulations regarding public health is carried out for operational objectives 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, at their request, by the county public health departments or that of the municipality of Bucharest, as applicable.

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

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.

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

The procedure involves collaboration with the Epidemiology Department, specialists who are part of the inspection commission: emergency medicine physician, ICU specialist, and engineer.
- Requests made available to applicants specify the documents required according to MS ORDER No. 1519 of December 2, 2009;
- Documents registered with an entry number are completed with the data provided by the above-mentioned order;
- The file with the documents is analyzed within the department, and if it is complete, the convening of the inspection commission is requested for authorization. The commission must include an auto engineer from a public structure that has ambulances in its inventory, as well as 2 physicians specialized in emergency medicine or intensive care anesthesia who also operate in a pre-hospital structure;
- The members of the inspection commission travel to the applicant's location and evaluate the authenticity of the documents included in the file, according to the competencies of each commission member. Travel costs, accommodation, as well as allowances will be borne by private service providers/public service requesting authorization and will be calculated according to Government Decision no. 1.860/2006 regarding the rights and obligations of personnel of public authorities and institutions during delegation and secondment to another locality, as well as in the case of travel within the locality for service purposes, with subsequent amendments and additions.
- The convening of the authorization commission will take place within 30 days from the submission of the applicant’s request.
- The issuance of the authorization is done according to the authorization model issued by the health directorates, provided in MS ORDER No. 1519/2009. On the date of submitting the file for authorization, the expiration period must not be less than 60 days. The operating authorization for private providers of emergency medical assistance services, pre-hospital medical transport, assisted medical transport, and non-assisted sanitary transport, as well as for 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 nominated by the county public health directorate will prepare a new inspection report and propose to the coordinating director:
a) extension of the operating authorization validity period 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 operating authorization validity period for a period of 6 months for remedying observed deficiencies, if they do not endanger the lives of patients;
d) withdrawal of the operating authorization.
- The operating authorization is issued for one or more areas of activity, as follows:
a) emergency medical assistance and assisted medical transport;
b) emergency consultations and non-assisted sanitary transport.

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

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​The procedure is addressed to pharmaceutical units in situations where the request is made for registration of the mention that certifies the authorization for sale and release through the information society of medicines that are granted without a medical prescription/specific products of drugstores.

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​The procedure is addressed to pharmaceutical units in situations where the request is made to register the resumption of activity during the suspension period or at its expiration. The resumption of activity is carried out at a different address of the headquarters/working point than the initial one. The documents are submitted 60 working days before the expiration of the legal suspension period.

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Specialized public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about the way to fulfill 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 with risk to the health of the population;

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

The sanitary operation 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 operation authorization or the notification of its rejection.

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

Doctors carrying out their activity under 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 department or the public health department of Bucharest municipality and by the CMR, through the county medical colleges or the Bucharest municipality medical college, based on a health certificate.

The county public health directorates and the Bucharest municipality public health directorate authorize home care providers, based on a self-declaration, who meet the following criteria:

a) the establishment act/document expressly mentions the provision of home care as an activity object;

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 location 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 is understood as any medical or related care activity performed by specialized personnel at the patient's home, which contributes to the improvement of their physical and mental well-being. ACCORDING TO ORDER No. 2520/2022 dated August 29, 2022

Authorization for the 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 approval.

Authorization is valid throughout the period during which the authorization conditions are met, with annual approval.

The sanitary operating authorization 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 operating authorization or the notice of its rejection.

The sanitary operating authorization may be issued urgently - within 5 working days from the submission of the file, by paying an emergency fee of 150 lei.

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

The establishment document of the medical office or the medical civil society is the registration certificate in the Unique Register of Medical Offices.

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.

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

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

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

The sanitary authorization for operation can be issued in urgent regime—5 working days from the file submission, by paying an urgent 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 permit based on the evaluation report 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 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 shall submit on the platform the documents stipulated in OMS 444/2019 - transmission of documents to the Public Health Directorate (DSP), drafting by the local DSP of the verification report and of the compliance or non-compliance decision, and submission on the platform.

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

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

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