Caras Severin Public Health Directorate*

The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES. The applicant will submit on the platform the documents provided in Order MS 444/2019 – sending the documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the decision of conformity or non-conformity, and submission on the platform.

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for granting the operating authorization - relocation of headquarters/branch. The changes must be notified to the Ministry of Health - Directorate of Pharmaceutical Policy and Medical Devices within 5 working days from the date of the change. The applicant shall submit on the platform the documents stipulated in Order MS 444/2019 - sending the documents to the Public Health Directorate (DSP), preparation by the local DSP of the inspection report and the compliance or non-compliance decision, and submission on the platform.

The procedure is addressed to pharmaceutical units in the situation where the registration of the resumption of activity is requested during the suspension period or at its expiration. The resumption of activity is carried out 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 applicant will upload to the platform the documents provided for in MS Order 444/2019 – sending the documents to the Public Health Directorate (DSP), preparation of the verification report and the decision of compliance or non-compliance by the local DSP, and uploading them to the platform.

The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate. The applicant will submit on the platform the documents provided in Ord MS 444/2019 - submission 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 the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the request accompanied by the required documentation. The applicant will upload on the platform the documents specified in Ord MS 444/2019 - sending the documents to DSP, preparation by the local DSP of the inspection report and the compliance or non-compliance decision, and uploading them on the platform.

The procedure is addressed to pharmaceutical units that dispense without a prescription or medical script. The applicant shall submit on the platform the documents stipulated in Order MS 444/2019 - transmission of documents to the Public Health Department (DSP), preparation by the local DSP of the verification report and of the decision of compliance or non-compliance, and submission on the platform.

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’s address being coordinated by the pharmacy from the healthcare unit; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is specified.

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 made to the pharmaceutical unit's space, except for relocating the headquarters/work 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. The applicant must submit on the platform the documents provided in MS Order 444/2019 - transmission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the compliance or non-compliance decision, and submission on the platform.

The procedure is addressed to pharmaceutical units in cases where the entry is requested certifying the authorization for sale and dispensing through the information society of medicines that are granted without a medical prescription/specific products for drugstores. The applicant will upload on the platform the documents provided in Order MS 444/2019 - sending documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the compliance or non-compliance decision, and uploading these on the platform.