ORDER OF THE MINISTRY OF HEALTH OF THE KYRGYZ REPUBLIC

of March 14, 2001 No. 76

About approval of the instruction for packaging, marking, transportation and storage of medicines

For the purpose of providing the population with high-quality medicines and streamlining of packaging, marking, transportation and storage of medicines in the territory of the republic,

Ministry of Health of the Kyrgyz Republic

ORDERS:

1. Approve:

- instruction for packaging, marking, transportation and storage of medicines.

2. To heads of pharmaceutical organizations and companies, irrespective of patterns of ownership, under production organization to be guided by requirements of the Instruction approved by this order.

3. To the director of the department of provision of medicines and medical equipment (to Mambetov M. A.) provide proper control of condition of production of medicines.

4. To impose control of execution of this order on the First deputy minister Aaliyev G. K.

Approved by the order MZ KR of March 14, 2001 No. 76

Instruction for packaging, marking, transportation and storage of medicines

This instruction extends to medicines, medicinal vegetable raw materials and immunobiological medicines for the person and establishes general requirements to packaging, marking, transportation and storage.

MEDICINES PACKAGING, MARKING, TRANSPORTATION AND STORAGE

1. PACKAGING

1.1. Packaging shall ensure safety of properties of medicines during fixed terms of the validity in case of their storage, application, transportation by different types of transport, taking into account possible overloads in transit and climatic conditions, and also convenience of use.

1.2. The consumer pack and corking means specified in tab. 1 shall be applied to packaging of medicines.

1.3. All types of consumer pack and corking means to it shall get out depending on properties, appointment and amount of medicine according to requirements of the State pharmacopeia of the USSR of the XI edition and (temporary) pharmacopoeian Articles to medicines.

1.4. The materials applied to production of container and corking means and also packaging materials shall not interact with medicines, cause changes of their properties and shall be allowed to application of the Kyrgyz Republic by the Ministry of Health.

1.5. Consumer pack from paper, cardboard, the polymeric and combined materials and corking means from polymeric materials shall not have smell. The slight smell only for products from rubber and polyethylene of low density is allowed.

1.6. Plastic bags with medicines shall be placed in tin or metal tins, or in the boxes made according to the corresponding regulating documentation. It is allowed to apply packets from parchment or from the waxed paper, the corresponding GOST, with the subsequent stacking in metal tins.

1.7. The medicines sensitive to light impact shall be packed into lightproof container according to the regulating documentation.

1.8. The medicines containing the flying, disappearing, hygroscopic or oxidized substances, shall be packed into the banks or bottles corked:

- the screw-on covers complete with traffic jams or laying with sealing elements;

- traffic jams with sealing elements;

- the rolled-up metal caps; complete with traffic jams or laying with sealing elements;

- the rolled-up metal covers.

1.9. The tableted medicines containing essential oils before packing in test tubes or cases shall be wrapped in the waxed paper or parchment of special brands.

1.10. When packing tablets, dragee or capsules the uplotniteli-shock-absorbers manufactured according to requirements of the regulating documentation shall invest in the container which does not have traffic jams with the shock-absorber.

It is allowed to apply medical hygroscopic cotton wool in accordance with GOST 5556-75.

1.11. Packaging shall be single for each series of the packed medicines.

1.12. Glass jars, test tubes, bottles, bottles, aerosol cans, metal tubas, and also planimetric container with medicines shall be packed into cardboard packs in coordination with Department of provision of medicines and medical equipment.

1.13. In coordination with Department of provision of medicines and medical equipment by delivery medical institutions are allowed to pack medicines into boxes without stacking in packs.

1.14. Ampoules and bottles with medicines for injections shall be packed:

- in cardboard boxes in accordance with GOST 12301-81;

- in cardboard packs in accordance with GOST 12303-80 or according to the regulating documentation;

- in planimetric container according to the specifications and technical documentation with the subsequent stacking in cardboard packs.

The syringe tubes with medicines for injections shall be packed into cardboard boxes in accordance with GOST 13501-68.

When packing ampoules it is allowed to apply as the shock-absorber medical artificial cotton of brand B in accordance with GOST 12923-82.

When packing ampoules with Aether chloratus it is allowed to apply medical artificial cotton of brand A in accordance with GOST 12923-82.

The device for opening of ampoules shall be enclosed in each packaging with ampoules. Depending on quantity and reservoir of consumer pack of box shall have partitions, lattices or nests.

1.15. It is allowed to pack medicines for injections complete with the solvent in the cases provided by the regulating documentation on specific types of medicines.

1.16. Bottles with blood substitutes shall be packed according to requirements of the regulating documentation.

1.17. Each medicine which is containing volatiles or having smell shall be packed separately from other medicines.

1.18. The consumer pack with medicines, except for packs with vegetable medicinal raw materials, shall be packed into group container: cardboard boxes or feet with the subsequent packing of foot in brown paper with strength indicators are not lower provided for paper of brand B weighing 1 sq.m. 50-70 g in accordance with GOST 8273-75 or in the thermoshrinkable film made according to the regulating documentation.

1.19. The group container with medicines (including with medicinal vegetable raw materials in the form of briquettes and wrappings in tubes) shall be pasted over or tied.

Requirements imposed to pasting shall correspond to the regulating documentation. It is allowed to apply to pasting of group container:

- tape with sticky layer of brands B and B in accordance with GOST 18251-87;

- polyethylene tape with sticky layer and the gummed glue tape according to the regulating documentation;

- brown paper of brand A weighing 1 sq.m. of 70 g in accordance with GOST 8273-75; bag paper of the M-70 brand in accordance with GOST 2228-81;

- cellulose film in accordance with GOST 7730-74 and other types of the varnished cellulose film which technical characteristics shall be not below provided in GOST 7730-74.

Materials according to the regulating documentation shall be applied to obvyazyvaniye of group container. When pasting group container or obvyazyvaniya its twine, threads or band their ends shall be stuck with the label providing opening control.

1.20. For export to the countries with tropical climate the group container (except container with ampoules) is placed in sack from polyethylene film thickness 0, - - - mm 0,12. in accordance with GOST 10354-82. The sack can be made of two layers of polyethylene film by 0,04 thickness - mm 0,08. The sack shall be made hermetically. Width of seam shall be at least 4 mm. It is allowed to pack no more than two folding boxes into one sack.

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