Timis Public Health Directorate*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of drugstore-chief unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Drug Policy and Medical Devices Directorate is also notified simultaneously.
*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 NSP, 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; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the appendix in which the pharmacy is provided for.
*Establishment of 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 applies to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating license - relocation of headquarters/work point. The changes must be notified to the Ministry of Health - Directorate of Drug Policy and Medical Devices within 5 working days from the date of the change.
*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 for in Order MS 444/2019 - the transmission of documents to the Public Health Directorate (DSP), the preparation by the local DSP of the verification report and of the compliance or non-compliance decision, and their submission (upload) on the platform.
*Modification of initial authorization conditions -ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions that formed the basis for issuing the operating authorization - any other change affecting the space of the pharmaceutical unit, except for the relocation of the headquarters/working point. Changes must be notified to the Ministry of Health - Directorate for Drug Policy and Medical Devices within 5 working days from the date of the change.
*Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting the authorization for sale and dispensing through the information society of medicines that are granted without a medical prescription/specific drugstore products is requested.
*Resumption of activity during the suspension period of the operating license or upon expiration of the interval - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where 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 submitted 60 working days before the expiration of the legal suspension period.
*Establishment of local distribution office (UF-DSP)*
The procedure is addressed to pharmacy units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submitting documents to the DSP.