Teleorman Public Health Directorate*
Available procedures
Establishment of a drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of the chief drugstore - chief pharmacist of the unit or chief pharmacy assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure addresses pharmaceutical units in cases where the entry certifying authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific products for drugstores is requested.
*Establishment of local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending documents to the Public Health Directorate (DSP).
Setting up a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient facilities, 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 Order MS 444/2019 - sending the documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the decision of conformity or nonconformity, 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 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 within the healthcare unit; the operating authorization of the healthcare unit must be submitted, accompanied by the annex in which the pharmacy is specified.
*Change of initial authorization conditions - ANY MODIFICATION TO THE PREMISES - Does not include relocation of the headquarters/working point (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur 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/working point. The changes must be notified to the Ministry of Health - Directorate for Drug Policy and Medical Devices within 5 working days from the date of the modification.
*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
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 on which the operating authorization was issued - relocation of headquarters/work 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.
*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 takes place at a different address of the headquarters/branch than the initial one. The documents must be submitted 60 working days before the legal suspension period expires.
*