Braila Public Health Directorate*

The procedure is addressed to natural and legal persons in Romania for obtaining the notification of specialized public health assistance (approval/consent - population health - according to the Urban Certificates issued by the territorial administrative units at the level of Braila county) for projects involving the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risks to public health.

The procedure is addressed to pharmaceutical units in the situation where the registration of the mention attesting the authorization of sale and dispensing through the information society of medicines granted without medical prescription/specific drugstore products is requested.

The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.

The procedure addresses 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 requested documentation. The applicant shall upload on the platform the documents stipulated in Ord MS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the verification report and the conformity or nonconformity decision, and uploading them to the platform.

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating license - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the change.

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 address, being coordinated by the pharmacy in the healthcare unit. It is mandatory to submit the operating authorization of the healthcare unit accompanied by the appendix in which the pharmacy is specified.

The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resumption of activity is requested within the suspension period or at 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 expiry of the legal suspension period.

The procedure is addressed to drugstores for the establishment of the drugstore—unit chief—chief pharmacist or chief pharmacy assistant. The Ministry of Health, the Directorate for Medicine Policy and Medical Devices is also notified simultaneously.

The procedure addresses pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - any other modification affecting the pharmaceutical unit's premises, except relocation of the headquarters/branch. 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.

The procedure for sanitary authorization based on the evaluation report applies to activities/objectives, at the request of the activity holders, regardless of the legal form of organization.

Requesting and obtaining the sanitary operating authorization by following the evaluation procedure is mandatory for carrying out the following activities, regardless of the organizational form of the applicant:

a) treatment and distribution of drinking water;
b) production of mineral water and other bottled waters;
c) manufacturing of 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 connected to the medical act

The procedure for sanitary authorization of operation based on the declaration on one's own responsibility applies to all natural or legal persons who carry out one of the activities included in Annex no. 2 to OMS no. 1030/2009 with amendments and completions and who are not subject to registration with the trade register.

For this procedure NO FEE IS CHARGED

ANNEX 2

LIST of activities authorized based on declaration on one's own responsibility (NACE codes)

1011 - Processing and preservation of meat
1012 - Processing and preservation of poultry meat
1013 - Manufacture of meat products (including poultry meat products)
1020 - Processing and preservation of fish
1031 - Processing and preservation of potatoes (production of chips)
1032 - Manufacture of fruit and vegetable juices
1039 - Processing and preservation 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 cheese
1052 - Manufacture of ice cream
1061 - Manufacture of mill 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
1083 - Processing of 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 - Distillation, refining and mixing of alcoholic beverages
1102 - Manufacture of grape wine
1104 - Manufacture of other undistilled 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 sale in non-specialized stores, with predominance of food, beverages and tobacco products
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, pastry and confectionery in specialized stores
4729 - Retail sale of other food products in specialized stores
4781 - Retail sale of food, beverages and tobacco products from stalls, kiosks and markets
5510 - Hotels and similar accommodation facilities
5520 - Accommodation facilities for holidays and short stays
5530 - Caravan parks, campgrounds and camps
5590 - Other accommodation services
5610 - Restaurants
5621 - Catering activities for events
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 - Education in sport and recreation
8552 - Education in the cultural field (foreign languages, music, theatre, dance, visual arts, etc.)
8559 - Other forms of education n.e.c.
8560 - Support service activities for education
8790 - Other residential social assistance activities n.e.c.
8891 - Daily care activities for children
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 recreational and entertainment activities n.e.c.
9601 - Washing and (dry) cleaning of textiles and fur products