Hunedoara Public Health Directorate*
Available procedures
Authorization for pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the entry certifying the authorization for sale and release through the information society of medicines that are granted without a medical prescription/specific drugstore products 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).
*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; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant must submit on the platform the documents provided in Ord MS 444/2019 - sending the documents to the DSP, the drafting by the local DSP of the verification report and the conformity or nonconformity decision, and their submission on the platform.
*Establishment of a drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for setting up chief drugstore-chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate of Drug Policy and Medical Devices is also notified concurrently.
*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 to the conditions that 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 for 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 permit or upon expiry of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure addresses pharmaceutical units in situations where the entry of the resumption of 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 are submitted 60 business days before the expiration of the legal suspension period.
*Establishment of community pharmacy (UF-DSP)*
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 that of the hospital or at the hospital’s address, being coordinated by the pharmacy within the medical unit; the operating authorization of the medical unit, accompanied by the annex in which the pharmacy is specified, shall be mandatorily submitted.
*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 cases where modifications occur to the conditions that formed the basis for granting the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/work point. The modifications must be notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the modification.
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