Harghita Public Health Directorate*
Available procedures
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, and the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant must submit on the platform the documents stipulated in Ord MS 444/2019 – submission 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 drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing chief drugstore-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*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 in which the pharmacy is provided.
Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF ADDRESS OF HEADQUARTERS/WORKING POINT (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/work point than the initial one. The documents are submitted 60 working days before the expiration of the legal suspension period.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for the issuance of the operating permit - any other change made to the space of the pharmaceutical unit, except for relocating the headquarters/branch. 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.
*Pharmacy/drugstore authorization - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization for sale and release through the information company of medicines provided without medical prescription/specific products of 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 OFFICINES - submission of documents to the Public Health Directorate (DSP).
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 in the conditions which formed the basis for the issuance of 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.
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