Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
Available procedures
Voluntary suspension of the operating license of the pharmaceutical unit for a period longer than 30 calendar days (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where the suspension of the operating authorization is requested for justified reasons or for objective reasons invoked by the authorization holder, for a period of time between 30 days and 180 days (calendar days). The suspension request must be notified to the Ministry of Health - Directorate for Medicine Policy, Devices and Medical Technologies within 5 working days before the interruption of activity.
IMPORTANT !!! All uploaded documents must obligatorily be named as follows: "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - SAME ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where the mention of resumption of activity is requested during the suspension period or at its expiration. The resumption of activity is carried out at the same address as the headquarters/point of work. The documents must be submitted 30 working days before the expiration of the legal suspension period.
IMPORTANT!!! All uploaded documents must be named as follows: "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
Modification of initial authorization conditions - Change of PHARMACEUTICAL UNIT MANAGER (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions on which the operating authorization was initially issued - change of holder of the Operating Authorization by replacing the head of the pharmaceutical unit. These changes must be notified to the Ministry of Health - Directorate for Drug Policy, Medical Devices, and Technologies within 5 working days from the date of the change.
IMPORTANT !!! All uploaded documents must be obligatorily named in the format "pharmacy name_county name_**." (** represents the briefest description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
Modification of initial authorization conditions - Change of authorization holder - Legal entity BY MERGER - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where modifications occur to the conditions that formed the basis for issuing the operating authorization – change of holder of the Operating Authorization by modifying the legal entity (through absorption) while maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health – Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the modification.
IMPORTANT!!! All uploaded documents must obligatorily be named in the format "pharmacy name_county name_**.pdf" (** stands for a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Establishment of a closed-circuit pharmacy (DSP-MS)*
The procedure is addressed to County Public Health Directorates, as well as the Bucharest municipality for the establishment of closed circuit pharmacies - sending documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The resolution deadline (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents will be named obligatorily as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (DSP-MS)*
The procedure is addressed to the County Public Health Directorates and the Bucharest Municipality Public Health Directorate, in situations where a request is made to register the mention attesting the authorization of sale and supply via the information society of over-the-counter medicines/specific products for drugstores - transmission of documents to the Ministry of Health - Directorate for Medicinal Policy, Medical Devices and Technologies.
The resolution period (3 calendar days) represents the deadline for transmitting all documents to the Ministry of Health
IMPORTANT!!! Uploaded documents must be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest Municipality, sector 1), MARIAFARM_BV.pdf
*Resumption of activity during the suspension period of the operating permit or upon expiration of the interval - WITH THE CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, respectively the Bucharest municipality in situations where the inscription of the mention for 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 - transmission of documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The resolution term (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be named obligatorily as follows: "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - Change of authorization holder - Legal entity THROUGH AWARD (WITHIN THE ENFORCEMENT PROCEDURE) - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in case there are changes in the conditions that were the basis for issuing the operating authorization - change of the holder of the Operating Authorization by modifying the legal entity through adjudication (WITHIN THE ENFORCEMENT PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Pharmaceuticals and Medical Devices within 5 working days from the date of the change.
IMPORTANT !!! All uploaded documents must be obligatorily named as follows: "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Cessation of activity pharmacy/drugstore - ONLINE SALE (E-commerce) (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where the inclusion of the mention (on the operating authorization) is requested for the cessation of sales and dispensing, through the information society, of medicines available without a medical prescription/specific drugstore products.
IMPORTANT!!! All uploaded documents must be named obligatorily in the following format: "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Voluntary suspension of the operating license of the pharmaceutical unit for a period of less than 30 calendar days (UF-MS)*
The procedure addresses pharmaceutical units in situations when suspension of the operating authorization is requested for justified reasons or for objective reasons invoked by the holder of the authorization, for a period of less than 30 calendar days. The request to suspend the authorization must be notified to the Ministry of Health - Directorate of Medicines Policy, Devices and Medical Technologies within 5 working days before the interruption of activity.
IMPORTANT!!! The uploaded document must be obligatorily named in the form "pharmacy name_county name."
Modification of initial authorization conditions - Change of authorization holder - Legal entity THROUGH SALE-PURCHASE - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in the situation where there are changes in the conditions that formed the basis for issuing the operating license - change of Operating License Holder by modifying the legal entity (through SALE-PURCHASE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate for Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must obligatorily be named as follows: "pharmacy name_county name_**." (** means a very brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Termination of distinct spaces in 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 another address than that of the hospital (UF-MS)*
Distinct spaces intended to ensure assistance with medicines for the wards or pavilions of healthcare units within whose structure they operate, located at different addresses from the healthcare unit, as well as distinct spaces intended for dispensing medicines for outpatient care within national health programs, located at the same address or at a different address, may cease activity by notifying the Ministry of Health for the purpose of registering the corresponding mention on the annex to the operating authorization of the coordinating pharmaceutical unit.
IMPORTANT!! All uploaded documents must be obligatorily named in the format "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Modification of initial authorization conditions - Change of authorization holder - Legal entity THROUGH ASSIGNMENT - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for issuing the operating authorization - change of holder of Operating Authorization by modifying the legal entity (through adjudication) and maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be obligatorily named as follows "pharmacy name_county name_**.pdf" (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Establishment of community pharmacy (DSP-MS)*
The procedure is intended for the County Public Health Directorates, as well as that of the municipality of Bucharest for the establishment of community pharmacies - forwarding documents to the Ministry of Health, Pharmaceutical and Medical Devices Directorate. The resolution term (3 calendar days) represents the term for transmitting all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must obligatorily be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality sector 1), MARIAFARM_BV.pdf
*Establishment of rural community office or seasonal office (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, and for the municipality of Bucharest, for the establishment of LOCAL OR SEASONAL DISTRIBUTION OFFICES - sending documents to the Ministry of Health, the Pharmaceutical Directorate and medical devices.
The resolution deadline (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be named compulsorily as follows: "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (DSP-MS)*
The procedure is addressed to County Public Health Departments, respectively the Bucharest municipality in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/branch - sending documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate.
The resolution period (3 calendar days) represents the period for sending all documents to the Ministry of Health
IMPORTANT!!! The uploaded documents must be named mandatorily in the form "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality district 1), MARIAFARM_BV.pdf
*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 (DSP-MS)*
The procedure is addressed to County Public Health Directorates, and respectively the municipality of Bucharest for the 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 NHP, located at the same address or at a different address from that of the hospital - submission of documents to the Ministry of Health - Directorate for Medicines Policy and Medical Devices. The resolution period (3 calendar days) represents the period for transmitting all documents to the Ministry of Health
IMPORTANT!!! Uploaded documents must mandatorily be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf
*Correction of material errors entered on the Operating Authorization or within the mentions in the Annex to the authorization (UF-MS)*
The procedure is addressed to pharmaceutical units and targets situations where there are errors in the Operating Authorization or in the annex (mentions) thereto, in relation to the documents submitted by the applicant.
The applicant will upload to the platform a request for correction of the erroneously entered data, the Operating Authorization or its annex, as applicable, as well as the document supporting the correction of the material error.
IMPORTANT!!! The uploaded request must be named in the following way: "pharmacy name_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
Modification of authorization conditions - CHANGES TO THE TRADE NAME, REGISTERED OFFICE ADDRESS, WORKING POINT ADDRESS ACCORDING TO THE STREET NOMENCLATURE (UF-MS)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions on which the operating authorization was issued in the following situations (not cumulative):
- change of the commercial name (brand) of one or more pharmacy points of sale
- change of registered office address without productive activity
- change of postal address name in the situation where the Local Council changes the street naming plan.
- change of registration number in the Trade Register
IMPORTANT!!! All uploaded documents must obligatorily be named as "pharmacy name_county name_**." (** represents the shortest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Authorization of community pharmacies for SEASONAL FLU VACCINATION ACTIVITY (UF-MS)*
The procedure is addressed to pharmaceutical units (authorized community pharmacies) that additionally request authorization to provide the vaccination service against seasonal flu by administering vaccines intended for the eligible population.
*Obtaining a duplicate of the operating authorization (UF-MS)*
The procedure refers to pharmaceutical units in case of loss of the operating authorization, for the purpose of obtaining a duplicate of it.
IMPORTANT!!! All uploaded documents must be named in the following mandatory format: "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*
Voluntary cancellation of the operating authorization (UF-MS)*
The procedure is addressed to pharmaceutical units in cases where CANCELLATION OF THE OPERATING LICENSE is requested if the pharmaceutical unit ceases its activity. The documents must be submitted within 30 working days from the cessation of activity.
IMPORTANT !!! All uploaded documents must mandatory be named in the format "pharmacy name_county name_**." (** stands for a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Abolition of rural community office in case a community pharmacy is established in the rural locality / Abolition of closed circuit office (UF-MS)*
The procedure is drawn up for situations in which local distribution offices are dismantled when a community pharmacy is established in a rural locality. At the time of issuing the operating authorization for the newly established community pharmacy, the Ministry of Health notifies the holder of the operating authorization for the community pharmacy in whose structure the office operates (art. 13, par. 5 of Law 266/2008, republished).
The procedure also applies to situations in which a closed circuit office is dismantled.
IMPORTANT!!! All uploaded documents must be named mandatorily in the format "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Modification of initial authorization conditions - Change of authorization holder - Legal Entity BY DIVISION - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for issuing the operating authorization -change of the holder of the Operating Authorization by modifying the legal entity (through division) and maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Pharmaceutical Directorate and Medical Devices within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must obligatorily be named in the form "pharmacy name_county name_**." (** represents the briefest description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
Establishment of drugstore (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, as well as the Bucharest Municipality, for the establishment of drugstores - sending documents to the Ministry of Health, Pharmaceutical and Medical Devices Directorate. The resolution deadline (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT!!! Uploaded documents must be named compulsorily in the format "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions -ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/working point (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, and the Bucharest Municipality Directorate in situations where there are changes to the conditions that formed the basis for the issuance of the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/branch - forwarding the documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The processing timeframe (3 calendar days) represents the deadline for forwarding all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest Municipality, Sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - CHANGE OF PHARMACEUTICAL UNIT MANAGER NAME (PU-MS)*
The procedure is addressed to pharmaceutical units in cases where changes occur in the name of the head of the pharmaceutical unit - chief pharmacist, as a result of their marriage or divorce.
IMPORTANT!!! All uploaded documents must obligatorily be named in the form "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Change of initial authorization conditions - Change of authorization holder - DURING THE SUSPENSION PERIOD (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for issuing the operating authorization - change of the holder of the Operating Authorization during the period in which the Authorization is suspended.