Bistrita-Nasaud Public Health Directorate*

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating license-relocation of 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.

The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.

The procedure addresses the establishment of closed-circuit pharmacies serving healthcare units and/or ambulatory care. The manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents stipulated 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.

The procedure is addressed to pharmaceutical units in situations 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/branch compared to the original one. The documents must be submitted 60 working days before the expiration of the legal suspension period.

The procedure is addressed to pharmaceutical units in situations where the registration of the note certifying the authorization for sale and release through the information society of medicines granted without a medical prescription/specific products for drugstores is requested.

The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating permit - any other modification made to the space of the pharmaceutical unit, except for changing the headquarters/place of business. Modifications must be notified to the Ministry of Health - Policy Directorate for Medicines and Medical Devices within 5 working days from the date of the modification.

The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending documents to the Public Health Directorate (DSP).

The procedure targets the establishment of distinct spaces within the closed-circuit pharmacy structure 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.