Arad Public Health Directorate*
Available procedures
Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient facilities, the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents provided in Ord MS 444/2019 - sending the documents to the DSP, the drawing up by the local DSP of the verification report and the compliance or non-compliance decision and their submission on the platform.
*Modification of initial authorization conditions -ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating permit - any other change 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 Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Sanitary Authorization for Functioning based on the evaluation report - Medical Activities - Emergency regime*
“The sanitary operating authorization based on the evaluation report is the administrative procedure by which the competent authority assesses the compliance of the objective, draws up the evaluation report, and issues the sanitary operating authorization or the notification of its rejection.”
*Sanitary Operating Authorization based on the evaluation report - Funeral Services Activities - Emergency regime*
“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 authorization for operation or the notification of its rejection.”
*Sanitary Authorization for Operation based on the evaluation report - Medical Activities*
“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, draws up the evaluation report and issues the sanitary authorization for operation or the notification of its rejection.”
*Sanitary Operating Authorization based on the evaluation report - Units water distribution stations / water bottling*
“The sanitary authorization for operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, draws up the evaluation report, and issues the sanitary authorization for operation or the notification of its rejection.”
*Certification of conformity - urgent procedure*
“The certification of compliance with hygiene and public health standards applies, upon the request of the activity holder, for the purpose of assessing compliance with legal regulations regarding public health for operational objectives that carry out activities with a risk to the health of the population.”
Establishment of separate areas within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate areas for outpatient dispensing within the NHP, located at the same address or at a different address from that of the hospital (UF-DSP)*
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; the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is specified must be obligatorily submitted.
*Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific products for drugstores is requested.
*Establishment of local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to DSP.
*Notification of specialized assistance in public health*
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 at 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.
*Specialized public health assistance notification - emergency regime*
Specialized public health assistance is the administrative-professional procedure through 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.
*AFIR PROJECTS Specialized public health assistance notification OR Compliance certification - urgent procedure*
Specialist public health assistance is the administrative-professional procedure by which, upon request, physical or legal persons are informed about the way of fulfilling the requirements of the legal provisions in force regarding hygiene and public health in the placement, arrangement, construction and modification for the operation of a unit conducting an activity with risk for the health of the population.
*Certification of conformity*
”Certification of compliance with hygiene and public health standards applies, at the request of the activity holder, for the purpose of assessing compliance with legal regulations regarding public health for operational objectives that carry out activities with risk for the health status of the population”.
*Specialized Public Health Assistance Notification - Annex for obtaining the operating permit from the City Hall*
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 location, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population.”
*Registration in the single register of practices*
Registration in the unified register of offices.
*Sanitary Operating Authorization based on the evaluation report - medical, tattoo, piercing*
“Sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, draws up the evaluation report, and issues the sanitary authorization of operation or the notification of its rejection.”
*Sanitary Operation Authorization based on the evaluation report - Water distribution unit stations / water bottling units - In Emergency regime*
”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, draws up the evaluation report, and issues the sanitary authorization for operation or the notification of its rejection.”
*Sanitary Operating Authorization based on the evaluation report - Funeral Services Activities*
”The sanitary operating authorization based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, draws up the evaluation report, and issues the sanitary operating authorization or the notification of its rejection.”
*Notice of specialist assistance in public health - Annex for obtaining the operating authorization from the City Hall - Urgent procedure*
Specialized public health assistance is the administrative-professional procedure through which, upon request, individuals or legal entities are informed about how 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.”
*Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for setting up a drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate for Medicine Policy and Medical Devices is also notified at the same time.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure applies 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/working point. The modifications must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the modification.
*Resumption of activity during the suspension period of the operating authorization or upon expiration of the interval - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the registration of the mention of resuming 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/work point than the initial one. The documents are sent 60 working days before the expiration of the legal suspension period.
*The license to practice*
License to practice freely.
*The Sanitary Operating Authorization based on the declaration on one’s own responsibility*
“Sanitary authorization based on the declaration on own responsibility is the administrative procedure by which the competent authority registers the declaration on own responsibility regarding compliance with the legal regulations applicable to the field and is notified and requested to verify conformity.”
*AFIR PROJECTS Specialized public health assistance notification OR Certification of compliance*
Specialized public health assistance is the administrative-professional procedure by which, upon request, natural or legal persons 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.”
*Sanitary Operating Authorization based on the evaluation report - Units providing activities of nursing homes and homes for persons unable to care for themselves*
“The sanitary operating authorization based on the evaluation report is the administrative procedure through which the competent authority evaluates the conformity of the objective, draws up the evaluation report and issues the sanitary operating authorization or the notification of its rejection.”
*Sanitary Operating Authorization based on the evaluation report - Units providing activities of elderly homes and homes for people unable to care for themselves - Emergency procedure*
“The sanitary authorization for operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, draws up the evaluation report, and issues the sanitary authorization for operation or the notification of its rejection.”
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