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 - submission of documents to the DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/work 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 applicant must submit the documents specified in Ord MS 444/2019 on the platform - sending the documents to 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 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/working point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period. The applicant must upload on the platform the documents provided in Order MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and the conformity or non-conformity decision, and uploading them on 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 Order MS 444/2019 - submission of documents to the PHD, preparation by the local PHD of the verification report and the conformity or non-conformity decision and uploading them to the platform.

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 application accompanied by the requested documentation. The applicant will upload on the platform the documents provided in Order MS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the verification 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 referral. The applicant shall submit on the platform the documents provided in Ord MS 444/2019 - submission of documents to the 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 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 obligatorily submitted, accompanied by the annex in which the pharmacy is specified.

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the 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 modification. The applicant shall submit on the platform the documents provided in Ord MS 444/2019 - sending the documents to DSP, preparation by the local DSP of the inspection report and the conformity or nonconformity decision, and submission on the platform.

The procedure is addressed to pharmaceutical units in situations where a request is made for registering the mention that attests the authorization for selling and dispensing, through the information society, medicines that are granted without medical prescription/specific products for drugstores. The applicant shall submit on the platform the documents stipulated in Order MS 444/2019 - transmission of documents to DSP, preparation by the local DSP of the inspection report and the conformity or nonconformity decision, and submission on the platform.