Harghita Public Health Directorate*
Available procedures
Establishment of pharmacy with closed circuit (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant shall upload on the platform the documents provided in Ord MS 444/2019 - transmission of documents to the DSP, the local DSP’s preparation of the inspection report and the compliance or non-compliance decision, and their submission on the platform.
*Setting up a drugstore - unit manager - chief pharmacist or chief pharmacy nurse assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing chief drugstore-chief unit-pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate for Medicine Policy and Medical Devices, is simultaneously notified.
*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 of the healthcare unit; it is mandatory to submit the operating license of the healthcare unit accompanied by in which the pharmacy is provided.
Resumption of activity during the suspension period of the operating authorization or upon expiration 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 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/working point than the initial one. The documents are to be 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 the headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions on which the operating authorization was based - any other modification made to the pharmaceutical unit's premises, except for relocating the headquarters/working point. Modifications must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the modification.
*Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the statement attesting authorization for sale and dispensing through the information society of medicines granted without a 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 OFFICES - submission of documents to the Public Health Directorate (DSP).
Setting up 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 - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for granting 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.
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