Bistrita-Nasaud Public Health Department*
Available procedures
Establishment of drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
Resumption of activity during the suspension period of the operating authorization or at the expiration of the interval - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the 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 compared to the initial one. The documents must be submitted 60 working days before the expiration of the legal term of activity suspension.
*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 request accompanied by the required documentation. The applicant shall upload on the platform the documents stipulated in Ord MS 444/2019 - the transmission of documents to DSP, the preparation by the local DSP of the verification report and the conformity or non-conformity decision, and the uploading 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 SALE (E-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 society of medicines granted without a medical prescription/specific drugstore products is requested.
*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 an address different from that of the hospital (UF-DSP)*
The procedure concerns the establishment of distinct areas within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct areas for outpatient dispensing within the NHP, located at the same address or at a different address from that of 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 MODIFICATION TO THE SPACE - Does not include relocation of headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where changes occur in the conditions that formed the basis for issuing the operating authorization - any other change affecting the pharmaceutical unit's premises, except for the relocation of the headquarters/working point. The 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 - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that formed the basis for issuing the operating authorization - relocation of 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.
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