Olt Public Health Directorate*
Available procedures
Establishment of a 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 - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases 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 - 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 license or upon expiration 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 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/working point than the initial one. The documents shall 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 the establishment of drugstore-chief unit-chief pharmacist or chief pharmacy medical 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 is addressed to pharmaceutical units in cases where the registration of the mention certifying the authorization for sale and release through the information society of medicines which are provided without a medical prescription/specific products for drugstores is requested.
*Establishment of a closed circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies serving healthcare facilities and/or outpatient clinics, the manager of the healthcare unit shall submit the application accompanied by the requested documentation. The applicant shall upload on the platform the documents provided for in Ord MS 444/2019 - transmission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the conformity or non-conformity decision, and their upload on the platform.
*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 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.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE PREMISES - Does not include relocation of headquarters/working point (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that were the basis for granting the operating authorization - any other change 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 of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*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 DSP.