Bacau Public Health Directorate*

The procedure is addressed to pharmaceutical units in situations where there are 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 of Medicine Policy and Medical Devices within 5 working days from the date of the change.

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating license - any other change made to the pharmaceutical unit's space, except for relocating the 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.

The procedure is addressed to pharmaceutical units in situations where the recording of the resumption of activity is requested during the suspension period or at its expiration. The resumption of activity takes place at a different address of the headquarters/working point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period.

The procedure is addressed to Pharmaceutical Units for the establishment of closed circuit pharmacies – the submission of documents to the Public Health Directorate.

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 compulsorily submitted, accompanied by the annex in which the pharmacy is specified.

The procedure is addressed to pharmaceutical units in cases where enrollment of the mention certifying authorization for sale and release through the information society is requested for medicines granted without prescription/specific products of drugstores.

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

The procedure is addressed to drugstores for the establishment of a drugstore-chief unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate for Drug Policy and Medical Devices, is also notified simultaneously.

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).