Suceava 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.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is intended for 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 requested documentation. The applicant will upload on the platform the documents provided in Order MS 444/2019 – transmission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and uploading it on the platform.
*Modification of initial conditions of authorization - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units when there are changes in the conditions that formed the basis for issuing the operating license - relocation of headquarters/branch. Changes must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Pharmacy/drugstore authorization - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific drugstore products is requested.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing drugstore-chief unit-chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the office/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions underlying the issuance of the operating authorization - any other modification made to the premises 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 change.
*Establishment of local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICINES - submission of documents to the Public Health Directorate (DSP).
Establishment of separate spaces within the closed-circuit pharmacy structure at an address different from that of the hospital and/or separate 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's address, coordinated by the pharmacy from the healthcare unit. It is mandatory to submit the operating license of the healthcare unit accompanied by the annex in which the pharmacy is specified.
*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 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 is carried out at a different address of the headquarters/working point than the initial one. The documents are sent 60 working days before the expiration of the legal suspension period.
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