Buzau Public Health Directorate*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of drugstore-chief unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate for Medicine Policy and Medical Devices is also notified at the same time.
*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 to the conditions that formed the basis for the issuance of 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 calendar days from the date of the change.
*Establishment of a local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to the 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 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 another address than that of the hospital (UF-DSP)*
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 of 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.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for granting the operating authorization - any other modification made to the space of the pharmaceutical unit, except for changing the headquarters/working point. The modifications 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.
*Resumption of activity during the suspension period of the operating authorization or at the end of the period - WITH CHANGE OF REGISTERED OFFICE/WORKING POINT ADDRESS (UF-DSP)*
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 are to be submitted 60 calendar days before the expiration of the legal suspension period.
Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient care; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will submit on the platform the documents stipulated in Ord 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 submission on the platform.
*Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the mention attesting the authorization for sale and dispensing via the information society of medicines granted without a medical prescription/specific products for drugstores is requested.
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