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 required documentation. The applicant will submit on the platform the documents provided in Order MS 444/2019 - transmission of documents to the DSP, 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)*
Authorization of pharmacies/drugstores - ONLINE SALE (Electronic Commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the note certifying the authorization to sell and dispense through the information society of medicines granted without a medical prescription/specific drugstore products is requested.
*Resumption of activity during the suspension period of the operating license or at the end of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resuming activity is requested during the suspension period or at its expiration. The resumption of activity takes place at a different address of the headquarters/working 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 - CHANGE OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
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).
*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 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. The operation authorization of the healthcare unit accompanied by the annex in which the pharmacy is provided must obligatorily be submitted.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include the relocation of the headquarters/branch (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 license - any other modification made to the space of the pharmaceutical unit, except for relocation of the 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 modification.
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