Covasna Public Health Directorate*
Available procedures
Establishment of a closed-circuit pharmacy (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 requested documentation. The applicant will submit on the platform the documents provided in Ord MS 444/2019 - the transmission of documents to DSP, the preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
Pharmacy/Drugstore Authorization - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the mention certifying the authorization to sell and dispense, through the information society, over-the-counter medicines/specific products for drugstores is requested.
*Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure applies to pharmaceutical units in situations where the entry of the mention of activity resumption is requested during the suspension period or at its expiration. The resumption of activity takes place at a different address of the headquarters/operating point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
Establishment of local distribution office (UF-DSP)*
The procedure addresses pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - 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.
*Establishment of separate areas within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate areas 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 the hospital's or at the hospital's address being coordinated by the pharmacy in 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.
*Modification of initial authorization conditions - ANY CHANGE TO THE PREMISES - 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 issuing the operating authorization - any other modification 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 of Medicine Policy and Medical Devices within 5 working days from the date of the change.
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