Maramures Public Health Directorate*
Available procedures
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 a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics. The manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents provided for in Order MS 444/2019 - submission of documents to the DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and uploading them on the platform.
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of head drugstore unit-head pharmacist or head pharmacy medical 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 case of changes in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/work point. Changes are notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Establishment of local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending documents to the Public Health Directorate (DSP).
*Pharmacy/drugstore authorization - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting the authorization to sell and release, via the information society, of over-the-counter medicines/products specific to drugstores is requested.
*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 authorization of the healthcare unit accompanied by the annex in which the pharmacy is provided.
*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 in the conditions that formed the basis for issuing the operating authorization - any other modification made to the pharmaceutical unit's premises, except for moving the headquarters/working point. 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 modification.
*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 is addressed to pharmaceutical units in situations where the registration of the mention of 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/branch compared to the initial one. Documents are sent 60 working days before the expiration of the legal suspension period.
*