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Adopting Biorat in other countries

Procedures for the utilization of BIORAT in other countries are the same as for other biological products.




IMPORTING BIORAT

Sequence of procedures for importing Biorat is normally as follows:

• An accredited local organisation for the importation and registration of this type of product is identified and agreement is reached.

• The following documents are signed by Labiofam S.A. and the local organisation: Agency agreement. Non-disclosure agreement. Powers of attorney to represent Labiofam S.A. before the registration authorities.

• Labiofam S.A. provides the local organisation with the necessary documentation.

• Trademark registered and product included in health register. Although procedures may vary from one place to another, they generally depend on health and agriculture ministries, and the authorities responsible for receiving applications, examination and approval.

• Commercialisation of the product.

There have been occasions in which, because of urgent health requirements, the governments concerned have given temporary authorisation for the commercialisation of the product without having to go through steps 3, 4 and 5.

LOCAL PRODUCTION OF BIORAT

Another option is to produce the product locally in the country concerned, for which, once the above-mentioned steps have been completed, the creation of some form of economic partnership with a local organisation is needed. The next steps are as follows:

• A market study of the area where is commercialisation is planned is carried out to define technical requirements and the size of the production plant.

• An economic feasibility study is conducted to assess the viability of the project and the capital required for investment.

• Parties negotiate and agree on the contributions that each is to make towards the establishment of the partnership.

• Legal documents establishing the partnership are discussed and drawn up, as also the norms for administration, control and management.

• Competent authorities of the countries involved approve the investment and partnership projects. This procedure generally involves institutional organs responsible for foreign investment, science and technology, construction, industrial property, and the central bank.

• Investment is carried out.

• New enterprise comes into operation.

From the cultural, scientific and technical point of view, no special conditions are required for the utilisation of the product. As a rule, LABIOFAM includes in the package not only the product itself, but also technical assistance to support representatives in the registration process and for laboratory and field demonstrations. LABIOFAM also guarantees training of personnel in the application of the product and on-site supervision of application operations.

In cases where a partnership is to be set up with the aim of producing and commercialising the product in the applicant country, specialists and technical experts would be required in the fields of microbiology, biochemistry and physical analysis, as well as laboratory chemists, mechanical and electrical technicians and workers.

A factor to take into account in some countries is that rats can form part of religious certain beliefs and must be given due regard. Special treatment is necessary in such cases, in accordance with the customs of the area.

The Cuban organisation that is at present responsible for the production and commercialisation of BIORAT is the industrial group LABIOFAM through its trading company Labiofam S.A.

As mentioned above, LABIOFAM can provide all the necessary technical assistance required in the utilisation of the product, including registration procedures, personnel training and post sales services.