Public Health Directorate of Bistrita-Nasaud County*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
Resumption of activity during the suspension period of the operating license or at the expiration of the interval - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the resumption mention is requested during the suspension period or upon its expiry. The resumption of activity takes place at a different address of the headquarters/work point than the initial one. The documents are sent 60 working days before the expiry of the legal suspension period.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies that serve medical units and/or outpatient clinics, the manager of the medical unit submits the application accompanied by the requested documentation. The applicant must upload on the platform the documents specified in Ord MS 444/2019 - transmission of documents to DSP, preparation by the local DSP of the verification report and the conformity or non-conformity decision, and submission on the platform.
*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).
*Authorization of pharmacies/drugstores - ONLINE SALES (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying authorization for sale and dispensing through the information society of medicines granted without medical prescription/specific products of drugstores is requested.
*Establishment of distinct areas within the closed-circuit pharmacy structure at an address different from that of the hospital and/or distinct areas for ambulatory dispensing within the PNS, located at the same address or at a different address from that of the hospital (UF-DSP)*
The procedure concerns the 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 PNS, located at the same address or at a different address from the hospital.
*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.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure applies to pharmaceutical units in situations where changes occur in the conditions underlying the issuance of the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocation of the headquarters/working point. 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.
*Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure applies to pharmaceutical units in situations where there are changes to the conditions underlying the issuance of the operating license-relocation of headquarters/work point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Product Policy and Medical Devices within 5 working days from the date of the change.
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