Ministry of Health Pharmaceutical and Medical Devices 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 holder of the authorization, for a period ranging from 30 days to 180 days (calendar days). The request for suspension of the authorization must be notified to the Ministry of Health - Directorate of Medicine Policy, Medical Devices and Technologies within 5 working days before the interruption of activity.
IMPORTANT!!! All uploaded documents must be obligatorily 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 license 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 registering the mention of resuming activity within the suspension period or upon its expiration is requested. The resumption of activity takes place at the same address of the headquarters/working point. The documents must be submitted 30 working days before the expiration of the legal suspension period.
IMPORTANT!!! All uploaded documents must be named in the following mandatory 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 PHARMACEUTICAL UNIT MANAGER (UF-MS)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that formed the basis for issuing the operating authorization - change of Holder of the Operating Authorization by replacing the manager of the pharmaceutical unit. 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 be named in the format "pharmacy name_county name_**." (** represents a brief description of the uploaded document) ex.: ANAFARM_BV_Cerere.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 there are changes in the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization by modifying the legal entity (through absorption) 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 modification.
IMPORTANT!!! All uploaded documents must be obligatorily named in the form "pharmacy name_county name_**.pdf" (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Setting up a closed-circuit pharmacy (DSP-MS)*
This procedure addresses County Public Health Directorates, and the municipality of Bucharest for the establishment of closed circuit pharmacies - sending documents to the Ministry of Health - Pharmaceutical Directorate and medical devices. The resolution deadline (3 calendar days) represents the period for sending all documents to the Ministry of Health.
IMPORTANT!!! Uploaded documents must be obligatorily named using the format “pharmacy name_DSP_county name” e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (DSP-MS)*
The procedure is addressed to County Public Health Directorates, as well as the Bucharest municipality, in situations where the registration of the mention certifying authorization for sale and release via the information society of over-the-counter medicines/products specific to drugstores is requested - transmission of documents to the Ministry of Health - Directorate for Medicines 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 strictly as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
*Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (DSP-MS)*
The procedure is addressed to County Public Health Directorates, and that of the municipality of Bucharest in situations where the registration of the mention of activity resumption is requested during the suspension period or upon its expiration. The resumption of activity takes place at another address of the headquarters/working point different from 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 transmitting all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be obligatorily named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = municipality of Bucharest, sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - Change of authorization holder - Legal entity BY AWARD (WITHIN THE ENFORCEMENT PROCEDURE) - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization by modification of the legal entity through adjudication (WITHIN THE ENFORCEMENT PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. 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 mandatorily be named as follows: "pharmacy name_county name_**." (** stands for the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Cessation of pharmacy/drugstore activity - ONLINE SALE (Electronic commerce) (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention (on the operating authorization) regarding the cessation of the activity of selling and dispensing, through the information society, medicines granted without a medical prescription/specific products for drugstores is requested.
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
*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 where the 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 for suspension of the authorization must be notified to the Ministry of Health - Directorate of Medicine Policy, Devices and Medical Technologies within 5 working days before the cessation of activity.
IMPORTANT!!! The uploaded document must obligatorily be 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 situations where changes occur in the conditions that formed the basis for issuing the operating authorization - change of holder of the Operating Authorization 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 of Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the modification.
IMPORTANT!!! All uploaded documents must be obligatorily named in the format "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 - Legal entity BY AWARD - SAME ADDRESS (UF-MS)*
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 - change of holder of the Operating Authorization by changing 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" (** stands for a brief description of the uploaded document) ex.: ANAFARM_BV_Request.pdf
*Establishment of community pharmacy (DSP-MS)*
The procedure is addressed to County Public Health Directorates, or the one of the city of Bucharest for the establishment of community pharmacies - sending documents to the Ministry of Health, Pharmaceutical and Medical Devices Directorate. The resolution period (3 calendar days) represents the period for transmitting all documents to the Ministry of Health.
IMPORTANT!!! Uploaded documents must be named in the following format: "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest city, District 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 to the municipality of Bucharest, for the establishment of LOCAL DISTRIBUTION or SEASONAL OFFICES - sending documents to the Ministry of Health, Pharmaceutical Directorate and medical devices.
The resolution period (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT !!! The uploaded documents must be named obligatorily in the form "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality district 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - MOVE OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (DSP-MS)*
The procedure is addressed to County Public Health Directorates, as well as that of Bucharest Municipality in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/work point - submission of documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate.
The resolution deadline (3 calendar days) represents the deadline for submitting all documents to the Ministry of Health
IMPORTANT !!! The uploaded documents must obligatorily be named as follows: "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest Municipality, district 1), MARIAFARM_BV.pdf
*Establishment of a closed-circuit office 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 the County Public Health Directorates, as well as that of the municipality of Bucharest for the establishment of separate spaces within the closed-circuit pharmacy structure at an address different from that of the hospital and/or separate spaces for outpatient dispensing within the PNS, located at the same address or at a different address from the hospital - transmission of documents to the Ministry of Health - Directorate of Medicinal Policy and Medical Devices. The resolution period (3 calendar days) represents the deadline for transmitting all documents to the Ministry of Health
IMPORTANT!!! The uploaded documents must be named obligatorily as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = municipality of Bucharest, sector 1), MARIAFARM_BV.pdf
*Correction of material errors entered on the Operating Authorization or within the mentions from the Annex to the authorization (UF-MS)*
The procedure is addressed to pharmaceutical units and targets situations where there are errors in the content of the Operating License or in its annex (mentions) in relation to the documents submitted by the applicant.
The applicant will upload to the platform a request to correct the erroneously entered data, the Operating License or its annex, as the case may be, as well as the document supporting the correction of the material error.
IMPORTANT!!! The uploaded request must be named in the following format: "pharmacy name_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest, district 1), MARIAFARM_BV.pdf
Change of authorization conditions - CHANGES IN THE TRADE NAME, REGISTERED OFFICE ADDRESS, WORK POINT ADDRESS ACCORDING TO THE STREET NOMENCLATURE (UF-MS)*
The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for the issuance of the operating authorization in the following situations (these are not cumulative):
- change of commercial name (brand) of one or more pharmacy points of sale
- change of registered office address without business activity
- modification of postal address name in the situation where the Local Council changes the street name plan.
- change of registration number in the Trade Register
IMPORTANT !!! All uploaded documents must be named obligatorily in the format "pharmacy name_county name_**." (** represents the briefest 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 influenza vaccination service 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 thereof.
IMPORTANT !!! All uploaded documents must be obligatorily named in the following format "pharmacy name_county name_**." (** represents a brief description of the uploaded document) ex.: ANAFARM_BV_Request.pdf
*
Voluntary cancellation of the operating authorization (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where CANCELLATION OF THE OPERATING AUTHORIZATION is requested if the pharmaceutical unit ceases activity. The documents are to be submitted within 30 working days from the cessation of activity.
IMPORTANT !!! All uploaded documents must be mandatorily named in the form "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Abolition of rural community dispensary in case a community pharmacy is established in the rural locality/ Abolition of closed circuit dispensary (UF-MS)*
The procedure is drawn up for situations in which local distribution offices are closed when a community pharmacy is opened 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 of the community pharmacy in whose structure the office is operating (art. 13, para. 5 of Law 266/2008, republished).
The procedure also applies to situations in which a closed circuit office is dissolved.
IMPORTANT !!! All uploaded documents must be named as "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 addresses pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating license - change of holder of Operating License 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 and Medical Devices Directorate 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 possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
Establishment of drugstore (DSP-MS)*
The procedure is addressed to County Public Health Directorates, as well as the Bucharest municipality, for the establishment of drugstores - the transmission of documents to the Ministry of Health, the Pharmaceutical and Medical Devices Directorate. The resolution period (3 calendar days) represents the deadline for transmitting all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents will be obligatorily named in the form "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/working point (DSP-MS)*
The procedure is addressed to County Public Health Directorates and that of the municipality of Bucharest in situations where there are changes in the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/working point - sending documents to the Ministry of Health - Pharmaceutical Directorate and medical devices. The resolution period (3 calendar days) represents the time frame for sending all documents to the Ministry of Health
IMPORTANT!!! Uploaded documents must obligatorily be named as follows "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf
Change of initial authorization conditions - CHANGE OF HEAD OF PHARMACEUTICAL UNIT NAME (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where changes occur to the name of the head of the pharmaceutical unit - chief pharmacist, as a result of their marriage or divorce.
IMPORTANT!!! All uploaded documents must be named as follows: "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 changes occur in the conditions that formed the basis for issuing the operating authorization - change of the holder of the Operating Authorization during the period when the Authorization is suspended.