Bucharest Public Health Directorate*
Available procedures
Authorization pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the statement attesting authorization for sale and dispensing through the information society of over-the-counter medicines/specific drugstore products is requested.
*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 situations where there are changes to the conditions that formed the basis for issuing the operating license - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/point of work. 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.
*Resumption of activity during the suspension period of the operating authorization or at the expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in case a request is made to register the mention of resumption of activity 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 sent 60 working days before the expiration of the legal suspension period.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore - unit chief - chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is simultaneously notified.
*Establishment of community pharmacy (UF-DSP)*
Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses 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 shall submit on the platform the documents provided in OMS 444/2019 – transmission of documents to the DSP, preparation by the local DSP of the verification report and the decision of conformity or non-conformity, and submission on the platform.
*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 ambulatory dispensing within the NHP, located at the same address or at a different address from 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 provided.
*Establishment of 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 Public Health Directorate (DSP).
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/branch. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the change.
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