Bucharest Public Health Directorate*
Available procedures
Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where registration of the statement certifying the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific drugstore products is requested.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE PREMISES - Does not include relocation of the headquarters/branch (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that formed the basis for the issuance of 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 change.
*Resumption of activity during the suspension period of the operating authorization or upon expiry of the period - WITH CHANGE OF THE HEADQUARTERS/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 is carried out at a different address of the headquarters/branch compared to the initial one. Documents must be submitted 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 setting up a drugstore - unit manager - 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.
*Establishment of community pharmacy (UF-DSP)*
Establishment of a closed-circuit pharmacy (UF-DSP)*
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 application accompanied by the requested documentation. The applicant will 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 outpatient dispensing within the PNS, 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 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 specified.
*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 Public Health Directorate.
*Modification of initial authorization conditions - MOVING 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/working point. The changes must be notified to the Ministry of Health - Directorate of Pharmaceuticals and Medical Devices within 5 working days from the date of the change.
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