Braila Public Health Directorate*
Available procedures
PUBLIC HEALTH SPECIALTY ASSISTANCE (APPROVAL – POPULATION HEALTH)*
The procedure is addressed to individuals and legal entities in Romania for obtaining the notification of specialized public health assistance (authorization/agreement - public health - according to the Urbanism Certificates issued by the administrative-territorial units at the level of Braila County) for projects involving the placement, arrangement, construction, and modification for the operation of a unit carrying out an activity that poses a risk to public health.
The sanitary operating authorization based on the evaluation report for funeral service providers*
Pharmacy/Drugstore Authorization-ONLINE SALE (Electronic Commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the entry certifying authorization for sale and dispensing through the information society of medicines granted without medical prescription/specific drugstore products is requested.
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 that serve healthcare facilities and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant must upload on the platform the documents specified in Order MS 444/2019 – sending the documents to the DSP, preparation by the local DSP of the verification report and the conformity or non-conformity decision, and uploading them on the platform.
*Change of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event of changes in the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Policy and Medical Devices within 5 working days from the date of the change.
*Establishment 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 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; the authorization to operate of the healthcare unit must be submitted, accompanied by the annex in which the pharmacy is specified.
*Resumption of activity during the suspension period of the operating authorization or at the expiration of the interval - WITH CHANGE OF ADDRESS OF HEADQUARTERS/WORK POINT (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 upon its expiration. The resumption of activity takes place at a different address of the headquarters/working point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period.
*Free Practice Authorization for Activities Related to the Medical Act*
Establishment of drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore-chief unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*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 changes occur in the conditions that formed the basis for issuing the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for relocating the headquarters/working 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.
*Establishment of local distribution office (UF-DSP)*
SANITARY AUTHORIZATION TO OPERATE BASED ON THE ASSESSMENT REPORT*
The procedure for sanitary authorization based on the evaluation report applies to activities/objectives, at the request of the activity holders, regardless of the form of legal organization.
The request and obtaining of the sanitary operating authorization through the evaluation procedure are mandatory for carrying out the following activities, regardless of the form of organization of the applicant:
a) treatment and distribution of drinking water;
b) production of mineral waters and other bottled waters;
c) manufacturing ice for human consumption from drinking water;
d) arrangement of natural bathing areas;
e) hospital medical care activities;
f) general medical care activities;
g) specialized medical care activities;
h) dental care activities;
i) activities of medical care centers;
j) activities of mental recovery and detoxification centers, excluding hospitals;
k) activities of nursing homes and homes for people unable to care for themselves;
l) other activities related to human health, according to the legal regulations in force;
m) piercing, artistic tattooing, cosmetic tattooing, dermal implantation activities.
n) activities regarding the provision of public services ancillary to the medical act
SANITARY OPERATING LICENSE BASED ON SELF-DECLARATION*
The procedure for sanitary authorization of operation based on a declaration of own responsibility applies to all individuals or legal entities carrying out one of the activities included in Annex no. 2 to OMS no. 1030/2009 with amendments and additions, and who are not subject to registration in the trade register.
For this procedure NO FEE IS CHARGED
ANNEX 2
LIST of activities authorized based on the declaration of own responsibility (CAEN codes)
1011 - Processing and preserving meat
1012 - Processing and preserving poultry meat
1013 - Manufacture of meat products (including poultry meat)
1020 - Processing and preserving fish
1031 - Processing and preserving potatoes (chips production)
1032 - Manufacture of fruit and vegetable juices
1039 - Processing and preserving fruits and vegetables n.e.c.
1041 - Manufacture of oils and fats
1042 - Manufacture of margarine and other similar edible products
1051 - Manufacture of dairy products and cheese
1052 - Manufacture of ice cream
1061 - Manufacture of milling products
1062 - Manufacture of starch and starch products
1071 - Manufacture of bread; manufacture of cakes and fresh pastry products
1072 - Manufacture of biscuits and rusks; manufacture of cakes and preserved pastry products
1082 - Manufacture of cocoa products, chocolate and confectionery products
1083 - Processing tea and coffee
1084 - Manufacture of condiments and ingredients
1085 - Manufacture of prepared meals
1086 - Manufacture of homogenized food preparations and dietary foods
1089 - Manufacture of other food products n.e.c.
1101 - Distilling, refining and mixing alcoholic beverages
1102 - Manufacture of wine from grapes
1104 - Manufacture of other non-distilled beverages, obtained by fermentation
1105 - Manufacture of beer
1106 - Manufacture of malt
1107 - Production of non-alcoholic soft drinks
2660 - Manufacture of equipment for radiology, electrodiagnosis and electrotherapy
3811 - Collection of non-hazardous waste
3812 - Collection of hazardous waste
3821 - Treatment and disposal of non-hazardous waste
3822 - Treatment and disposal of hazardous waste
4711 - Retail trade in non-specialized stores, predominantly selling food, beverages and tobacco
4721 - Retail sale of fresh fruits and vegetables, in specialized stores
4722 - Retail sale of meat and meat products, in specialized stores
4723 - Retail sale of fish, crustaceans and mollusks, in specialized stores
4724 - Retail sale of bread, pastry products and confectionery, in specialized stores
4729 - Retail sale of other food products, in specialized stores
4781 - Retail sale of food products, beverages and tobacco products through stalls, kiosks and markets
5510 - Hotels and other similar accommodation facilities
5520 - Accommodation facilities for holidays and short stays
5530 - Caravan parks, campsites and camps
5590 - Other accommodation services
5610 - Restaurants
5621 - Catering activities for events
5629 - Other catering services n.e.c.
5630 - Bars and other beverage serving activities
8510 - Preschool education
8520 - Primary education
8531 - General secondary education
8532 - Secondary technical or vocational education
8541 - Non-university higher education
8542 - University higher education
8551 - Education in sports and recreational area
8552 - Education in cultural area (foreign languages, music, theatre, dance, fine arts etc.)
8559 - Other forms of education n.e.c.
8560 - Support service activities for education
8790 - Other social assistance activities, with accommodation n.e.c.
8891 - Day care activities for children
8899 - Other social assistance activities, without accommodation n.e.c.
9311 - Activities of sports bases
9312 - Activities of sports clubs
9319 - Other sports activities
9329 - Other recreational and entertainment activities n.e.c.
9601 - Washing and (dry) cleaning of textile articles and fur products
CERTIFICATION OF COMPLIANCE WITH HYGIENE AND PUBLIC HEALTH STANDARDS*
a) activities involving the use of biocidal products for disinfection, pest control, and rodent control in spaces used by the population;
b) hairdressing activities and other beautification activities - starting January 1, 2021.
SANITARY AUTHORIZATION TO OPERATE BASED ON SELF-DECLARATION FOR PROJECTS UNDER REHABILITATION*
LIST of activities authorized based on the declaration on own responsibility (NACE codes)
1011 - Processing and preserving of meat
1012 - Processing and preserving of poultry meat
1013 - Manufacture of meat products (including poultry meat)
1020 - Processing and preserving of fish
1031 - Processing and preserving of potatoes (production of chips)
1032 - Manufacture of fruit and vegetable juices
1039 - Processing and preserving of fruit and vegetables n.e.c.
1041 - Manufacture of oils and fats
1042 - Manufacture of margarine and similar edible products
1051 - Manufacture of dairy products and cheeses
1052 - Manufacture of ice cream
1061 - Manufacture of milled grain products
1062 - Manufacture of starch and starch products
1071 - Manufacture of bread; manufacture of cakes and fresh pastry products
1072 - Manufacture of biscuits and rusks; manufacture of preserved cakes and pastry products
1082 - Manufacture of cocoa, chocolate and sugar confectionery products
1083 - Processing of tea and coffee
1084 - Manufacture of spices and ingredients
1085 - Manufacture of prepared meals
1086 - Manufacture of homogenized food preparations and dietetic food
1089 - Manufacture of other food products n.e.c.
1101 - Distilling, rectifying and blending of alcoholic beverages
1102 - Manufacture of wines from grapes
1104 - Manufacture of other non-distilled fermented beverages
1105 - Manufacture of beer
1106 - Manufacture of malt
1107 - Production of soft drinks
2660 - Manufacture of irradiation, electromedical and electrotherapeutic equipment
3811 - Collection of non-hazardous waste
3812 - Collection of hazardous waste
3821 - Treatment and disposal of non-hazardous waste
3822 - Treatment and disposal of hazardous waste
4711 - Retail sale in non-specialized stores with a predominant sale of food, beverages and tobacco
4721 - Retail sale of fresh fruit and vegetables in specialized stores
4722 - Retail sale of meat and meat products in specialized stores
4723 - Retail sale of fish, crustaceans and mollusks in specialized stores
4724 - Retail sale of bread, cakes, and confectionery in specialized stores
4729 - Retail sale of other food products in specialized stores
4781 - Retail sale of food, beverages and tobacco products via stalls, kiosks and markets
5510 - Hotels and similar accommodation facilities
5520 - Holiday and short-stay accommodation facilities
5530 - Caravan parks, campsites and camping grounds
5590 - Other accommodation services
5610 - Restaurants
5621 - Event catering activities
5629 - Other food service activities n.e.c.
5630 - Bars and other beverage serving activities
8510 - Pre-school education
8520 - Primary education
8531 - General secondary education
8532 - Secondary, technical or vocational education
8541 - Non-university higher education
8542 - University higher education
8551 - Sport and recreational education
8552 - Cultural education (foreign languages, music, theater, dance, fine arts, etc.)
8559 - Other forms of education n.e.c.
8560 - Educational support services activities
8790 - Other residential social assistance activities n.e.c.
8891 - Child day-care activities
8899 - Other social assistance activities, without accommodation n.e.c.
9311 - Activities of sports facilities
9312 - Activities of sports clubs
9319 - Other sports activities
9329 - Other recreation and amusement activities n.e.c.
9601 - Washing and (dry) cleaning of textile articles and fur products
Registration in the Unique Registry of Cabinets*