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.
*Setting up a closed-circuit pharmacy (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 will upload on the platform the documents provided in Order MS 444/2019 – submission of documents to DSP, preparation by the local DSP of the inspection report and of the compliance or non-compliance decision, and their uploading on the platform.
*Modification of initial authorization conditions - CHANGE OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (PU-PHD)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/work 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.
*Pharmacies/drugstores authorization - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the registration of the mention certifying the authorization for sale and release through the information society of medicines granted without medical prescription/specific products of drugstores is requested.
*Establishment of drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore-chief 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 authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of the headquarters/point of work (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - any other change made to the space of the pharmaceutical unit, except for relocation of the headquarters/work 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 OFFICES - submission of documents to the Public Health Directorate (DSP).
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 dispensing from outpatient care within PNS, located at the same address or at another address than 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 from 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.
*Resumption of activity during the suspension period of the operating license or upon expiration of the interval - WITH CHANGE OF ADDRESS OF HEADQUARTERS/WORK POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases 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/working point than the initial one. The documents are to be submitted 60 working days before the expiration of the legal suspension period.
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