COUNTRY OF ORIGINBACTIVEC® Y GRISELESF®, Bio-larvicides for mosquito control
Adopting GRISELESF® and BACTIVEC® in other countries
The procedures for employing these bio-larvicides in other countries are similar to those for other biological products.
Importing GRISELESF® and BACTIVEC®
Importing these products to a specific country involves the following steps:
• A national accredited body for importing and registering this type of product is identified and an initial agreement is reached.
• LABIOFAM S.A. and the above mentioned body sign the following documents: Agency agreement; Non-disclosure agreement; Power of attorney to represent LABIOFAM S.A. before the registration authorities.
• LABIOFAM S.A. consigns the necessary documentation to this national body.
• The product is included in the health register and the trademark is deposited in the country concerned. Generally, those responsible for receiving, examining and approving applications are dependencies of the ministry of health, though this can vary from country to country.
• Product is commercialised.
There have been occasions when, because of emergency health needs, governments have granted temporary authorisations for the commercialisation of these products, without having to go through steps 3, 4 and 5.
Producing GRISELESF® and BACTIVEC® in other countries
Another possibility is to produce these products in the country itself. Once the above mentioned steps have been taken, some form of economic joint venture needs to be set up with a local organisation, after which the following steps are taken:
• A market study is conducted on the country in which the product is to be commercialised, including details on the size of the production factory and technical requirements.
• An economic feasibility study is conducted to assess viability and capital investment.
• The parties negotiate and agree on their respective contributions to the establishment of the joint venture.
• Legal documents setting up the joint venture are drafted and regulations governing administration, control and management are established.
• Joint venture and investment projects are approved by the competent authorities of the countries concerned, usually involving organisations responsible for foreign investment, science and technology, construction, industrial property and central banks.
• Investment.
• New enterprise begins operations.
