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 - sending documents to the Public Health Directorate.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to 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 shall upload to the platform the documents provided in Order MS 444/2019 - sending the documents to the DSP, drawing up the verification report and the compliance or non-compliance decision by the local DSP, and uploading them to the platform.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORK POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/branch. 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.
*Pharmacy/drogery authorization - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting the authorization for sale and dispensing through the information company of medicines that are 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 the establishment of a drugstore-chief unit-chief pharmacist or chief pharmacy assistant. The Ministry of Health, the Directorate for Medicines Policy and Medical Devices, is also notified at the same time.
*Change of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocating the headquarters/branch (UF-DSP)*
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 - any other modification made to the premises of the pharmaceutical unit, except for relocation of the headquarters/work point. The modifications must be notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the modification.
*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 within 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 NHP, 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 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/WORK POINT ADDRESS (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 is carried out at a different address of the headquarters/working point from the initial one. The documents are to be submitted 60 working days before the expiration of the legal suspension period.
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