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 request accompanied by the required documentation. The applicant will submit on the platform the documents provided for in Order MS 444/2019 - the transmission of documents to the DSP, preparation by the local DSP of the verification report and of the conformity or non-conformity decision, and their submission on the platform.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include moving the headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes 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 the relocation of the 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.
*Sanitary Operating Authorization based on the evaluation report - Medical Activities - Emergency regime*
”Sanitary authorization of 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 of operation or the notification of its rejection”.
*Sanitary Operating Authorization based on the evaluation report - Funeral Services Activities - Emergency regime*
”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.”
*Sanitary Authorization of Operation based on the evaluation report - Medical Activities*
”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 - Water distribution unit stations / water bottling*
”The sanitary authorization for operation 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 authorization for operation or the notification of its rejection”.
*Emergency conformity certification*
”Certification of compliance with hygiene and public health regulations is applied, 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 to the health of the population.”
Establishment of distinct spaces in the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct spaces for outpatient dispensing within the PNS, 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 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 specified.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration is requested for the mention attesting the authorization to sell and dispense, through the information society, medicines granted without a medical prescription/specific products of drugstores.
*Establishment of a 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 the DSP.
*Specialized public health assistance notification*
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, building, and modifying 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 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 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.”
*AFIR PROJECTS Notification of specialized public health assistance OR Certification of conformity -urgent procedure*
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 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."
*Certification of conformity*
“The 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 posing risks to the health of the population.”
*Specialized Public Health Assistance Notification - Annex for Obtaining the Operating Authorization 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 manner of fulfilling the requirements of the legal provisions in force regarding hygiene and public health when siting, arranging, constructing, and modifying for the operation of a unit that carries out an activity with risk to public health.
*Registration in the single register of offices*
Registration in the unified registry of practices.
*The Sanitary Operating Authorization based on the evaluation report - medical, tattoo, piercing*
”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.”
*Sanitary Operating Authorization based on the evaluation report - Water distribution station units / water bottling - In Emergency Regime*
"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."
*Sanitary Operating Authorization based on the evaluation report - Funeral Services Activities*
”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, draws up the evaluation report, and issues the sanitary authorization of operation or the notification of its rejection.”
*Specialized public health assistance notification - Appendix for obtaining the operating authorization from the City Hall - In Emergency mode*
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, building, and modifying for the operation of a unit conducting 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.
*Setting up a drugstore - unit manager - chief pharmacist or chief pharmacy assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate for Medicine Policy and Medical Devices, is also notified simultaneously.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes 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 - Department of Drug Policy and Medical Devices within 5 working days from the date of the change.
*Resumption of activity during the suspension period of the operating license or upon expiration of the interval - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
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 takes place at a different address of the headquarters/point of work than the initial one. The documents are submitted 60 working days before the expiration of the legal activity suspension period.
*The free practice authorization*
Free practice authorization.
*Sanitary Operating Authorization based on self-declaration*
"Sanitary authorization based on self-declaration is the administrative procedure by which the competent authority registers the self-declaration regarding compliance with legal regulations applicable to the field and is notified and requested for conformity verification."
*AFIR PROJECTS Notification of specialist assistance in public health OR Certification of conformity*
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 on hygiene and public health regarding 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.
*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 authorization for operation based on the evaluation report is the administrative procedure through 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 providing activities of nursing homes for the elderly and homes for people unable to care for themselves - In Emergency Regime*
"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, draws up the evaluation report and issues the sanitary authorization for operation or the notification of its rejection."
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