Brasov Public Health Directorate*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
Establishment of rural/seasonal community office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - transmission of documents to the Public Health Directorate.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - 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.
*Establishment of distinct spaces within the structure of the closed-circuit pharmacy 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 that of the hospital (UF-DSP)*
The procedure applies 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 submitted, accompanied by the annex in which the pharmacy is specified.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include moving the headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event that there are changes to the conditions that formed the basis for the issuance of the operating authorization - any other change made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/working point. Changes must be notified to the Ministry of Health - Directorate for Medicines Policy and Medical Devices within 5 working days from the date of the change.
*Pharmacy/drogery authorization - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the mention certifying the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific drugstore products is requested.
*Resumption of activity during the period of suspension of the operating authorization or upon expiry of the period - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
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 request accompanied by the required documentation. The applicant shall submit 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.
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