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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of July 12, 2012 No. 504

About approval of Sanitary regulations about equipping and operation of drugstores and pharmaceutical warehouses

According to article 6 of the Law No. 10-XVI of February 3, 2009 on the state supervision of public health (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183), parts (2) article 19 of the Law No. 1456-XII of May 25, 1993 on pharmaceutical activities (repeated publication: The official monitor of the Republic of Moldova, 2005, No. 59-61, of the Art. 200), with subsequent changes and amendments, and also for the purpose of ensuring higher level of protection of health of the population, DECIDES: the Government

1. Approve Sanitary regulations about equipping and operation of drugstores and pharmaceutical warehouses it (is applied).

2. To impose control over the implementation of this Resolution on the Ministry of Health.

3. Declare invalid the Resolution of the Chief state health officer of the Republic of Moldova No. 11 of September 29, 2005. "About approval and implementation of sanitary and epidemiologic rules and standard rates "About placement, equipping and operation of the pharmaceutical companies and organizations" (The official monitor of the Republic of Moldova, 2005, No. 154-156, of the Art. 528), with subsequent changes.

Prime Minister Vladimir FILAT

Countersigns:

Minister of Health Andrey Usaty

 

Approved by the Order of the Government No. 504 of July 12, 2012

Sanitary regulations about equipping and operation of drugstores and pharmaceutical warehouses

I. General provisions and scope

1. The sanitary regulations about equipping and operation of drugstores and pharmaceutical warehouses (in dalneyshemreglament) establish sanitary and hygienic requirements to designing, construction, reconstruction, operation and the organization of activities of all types of drugstores, pharmaceutical warehouses, and also their branches.

2. These Regulations are obligatory for execution by all organizations which activities are connected with this area, irrespective of type of property and form of business, the organization and conducting activities, types of the performed pharmaceutical activities and categories of patients and the population which are given pharmaceutical help.

3. Drugstores and their branches are placed in three types of rooms: separate buildings, extensions and first floor of apartment houses.

II. General requirements to rooms

4. Designing, construction and reconstruction of drugstores and pharmaceutical warehouses are performed according to the provisions NCM C.01.07-2012 "Public buildings and constructions", NCM C.01.08-2012 "Apartment residential buildings and constructions" the project and construction organizations (firms) licensed in the field.

5. Changes and approvals in standard projects on construction and reconstruction are performed according to the Law No. 163 of July 9, 2010 on permission of accomplishment of construction works and System of regulating documents in construction.

6. Acceptance in operation of again constructed/reconstructed drugstores and pharmaceutical warehouses is performed according to the Regulations on acceptance of construction works and equipment in place approved by the Order of the Government No. 285 of May 23, 1996.

7. In case of placement of drugstore (branch) in the building of other appointment or in the apartment house, its rooms shall be isolated from other rooms by main walls from fire-resistant materials with fire resistance limit according to the regulating document in construction of NCM E.03.02-2001 "Protection of Buildings, Structures and Installations against Fire Risk". Drugstores with production departments shall have separate entrances exits for visitors and for acceptance of medicines, with exit to the street or the adjacent territory. Drugstores and pharmaceutical warehouses are provided with the sidings equipped with ramps for wheelchairs according to regulations of construction of NCM C.01.062007 "Availability of Buildings and Constructions to Persons with Limited Opportunities".

8. Rooms of drugstores and warehouses shall be reported among themselves according to technological flow, and their isolation in the building or other spaces is not allowed. The drugstore, warehouse as necessary shall have special rooms with protection for storage of drugs.

9. The structure and the obligatory minimum areas of pharmaceutical rooms shall correspond to appendices No. 1-3 of these Regulations.

10. In the adjacent territory near drugstores and pharmaceutical warehouses located in separate buildings at distance of 20 meters from object and living space the square into which containers for collection of waste are placed is equipped.

11. The territory shall contain in proper sanitary condition constantly.

12. Cleaning of the territory, adjacent to drugstores, is performed by own forces.

13. Export of waste is performed centralized by services on sanitary cleaning on the authorized transport.

14. Production wastes and/or defective pharmaceutical medicines shall be neutralized (are destroyed) according to the Rules of the order medical waste No. 05-00 of December 14, 2001 approved by the Chief state health officer of the Republic of Moldova.

15. Waste containers shall be exposed to disinfection by the biodestructive products registered and approved in the Republic of Moldova according to instructions of the producer for use.

III. Hygienic requirements to rooms and the equipment

16. As finishing materials the materials registered for use in the Republic of Moldova can be applied.

17. Walls and ceiling of production rooms become covered with chemically resistant materials steady against damp processing and use of disinfectants.

18. In case of emergence on walls and ceiling of spots from dampness and pollution they are processed, bleached or painted, and in case of emergence on walls and ceiling of mold - they are processed by biodestructive medicines with fungicide action.

19. Floors in production rooms shall be water-proof, with smooth surface, without cracks, convenient for cleaning. Floors become covered by ceramic unglazed (terracotta) tile and linoleum with obligatory welding of seams.

20. The surface of the equipment shall be smooth, from the materials steady against impact of medicines, and in certain cases and to chemical reactants.

21. Furniture and the equipment are placed so that there were no unavailable places for cleaning and lighting sources were not encumbered.

22. It is not allowed to place the equipment not peculiar to pharmaceutical activities. It is not allowed to load amount of storage facility more than on 2/3.

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