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.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the entry certifying authorization for sale and dispensing through the information society of medicines granted without prescription/specific drugstore products is requested.
*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 fulfillment of 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 posing 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 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 in the healthcare unit. It is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is provided.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions that were the basis for issuing the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for relocating the headquarters/branch. The changes must be notified to the Ministry of Health - Directorate for Medicinal 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 at the expiration of the period - 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 at its expiration. The resumption of activity takes place at a different address of the headquarters/working point compared to the initial one. The documents are to 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 statutory declaration regarding compliance with the legal regulations relevant to the field and is notified and requested to verify compliance
*The sanitary authorization of operation based on the evaluation report*
It 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 in urgent mode - 5 working days from the submission of the file, by paying an urgent fee of 150 lei.
Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics, the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents stipulated in Ord MS 444/2019 - submission of documents to the DSP, preparation by the local DSP of the verification report and of the compliance or non-compliance decision and uploading on the platform.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing the head drugstore unit - 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 conditions of authorization - 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 conformity with hygiene and public health standards*
CERTIFICATION OF COMPLIANCE with hygiene and public health norms is the administrative procedure through which the compliance evaluation with legal regulations regarding public health is carried out for operational objectives that conduct activities with health risk for the population.
The compliance certification notification can be issued as an emergency - 5 working days from the submission of the file, by paying an emergency fee of 150 lei.
Annual visa*
It represents the written confirmation by the local public health authority regarding compliance with the sanitary authorization previously issued.
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