Dambovita Public Health Directorate*
Available procedures
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 separate spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate 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 wishing 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 provided.
Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization to sell and dispense, through the information society, medicines that are granted without a medical prescription/specific products of drugstores is requested.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient care; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents provided 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 uploading them on the platform.
*Establishment of drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of chief drugstore-chief pharmacist unit or chief pharmacy medical assistant. The Ministry of Health, Directorate for Medicinal Policy and Medical Devices is also notified simultaneously.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for the issuance of 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.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/working point (UF-DSP)*
The procedure applies to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for relocating the headquarters/branch. 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.
*Resuming activity during the suspension period of the operating authorization or at the expiration of the interval - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the resumption mention is requested during the suspension period or upon its expiration. The resumption of activity is carried out at a different address of the headquarters/working point than the initial one. Documents must be sent 60 working days before the expiration of the legal suspension period.
*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 DSP.