Sibiu Public Health Directorate*
Available procedures
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.
*Pharmacy/drugstore authorization - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where registration is requested for the mention certifying authorization for the sale and delivery, through the information society, of medicines granted without medical prescription/specific drugstore products.
*Specialized public health assistance, at the request of individuals and legal entities*
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 placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the population’s health;
Establishment of distinct areas within the closed-circuit pharmacy structure at an address different from that of the hospital and/or distinct areas 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's address being coordinated by the pharmacy within the healthcare unit; it is mandatory to submit the healthcare unit's operating authorization accompanied by the annex in which the pharmacy is specified.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
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 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 of Medicinal Product 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 period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the mention regarding the 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 expiration of the legal suspension period.
*Sanitary authorization of operation based on a declaration on own responsibility*
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
*Sanitary authorization for operation based on the evaluation report*
It 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 functioning or the notification of its rejection.
The sanitary authorization for functioning can be issued in emergency regime - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
Establishment of a pharmacy with closed circuit (UF-DSP)*
The procedure is addressed to 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 requested documentation. The applicant shall submit on the platform the documents provided for in Order MS 444/2019 – sending the documents to the Public Health Directorate (DSP), preparation by the local DSP of the inspection report and the conformity or non-conformity decision, and submission on the platform.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate for Medicinal Policy and Medical Devices, is also notified simultaneously.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
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 the Public Health Directorate (DSP).
Certification of compliance with hygiene and public health regulations*
CERTIFICATION OF COMPLIANCE with hygiene and public health standards is the administrative procedure by which compliance with legal regulations regarding public health is assessed for operational objectives that carry out activities posing 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.
Annual visa*
Represents the written confirmation from the local public health authority regarding compliance with the previously issued sanitary authorization.
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