Cluj-Napoca Public Health Directorate*
Available procedures
Establishment of distinct spaces within the structure of the closed-circuit pharmacy at a different address than that of the hospital and/or distinct spaces for outpatient dispensing within the PNS, located at the same address or at a different 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 within the healthcare unit; the operating authorization of the healthcare unit must be submitted, accompanied by the annex in which the pharmacy is specified.
*Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the inclusion 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.
*Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING LOCATION ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the recording 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/work point than the initial one. The documents are sent 60 working days before the expiration of the legal activity suspension period.
*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 addresses 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 submit on the platform the documents specified in Ord MS 444/2019 – sending the documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the conformity or non-conformity decision, and submission on the platform.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event of changes to 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 Pharmaceutical 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 - sending documents to the Public Health Directorate (DSP).
*Establishment of a drugstore - head of unit - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing a chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
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