Arges Public Health Directorate*

The procedure is addressed to pharmaceutical units in situations where the registration 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/branch 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 in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to the Public Health Directorate.

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

The procedure applies to pharmaceutical units in situations where changes occur in the conditions that formed the basis for granting the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocating the headquarters/work point. 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 the request is made to register the mention certifying the authorization for sale and dispensing through the information society of medicines granted without medical prescription/specific products of drugstores.

The procedure addresses pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/working point. 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 - sending documents to the Public Health Directorate

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 submit on the platform the documents specified in Ord MS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the verification report and the decision of conformity or nonconformity, 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 within the healthcare unit. It is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is listed.