2. The details included in the technical file always depend on the nature of the product and on what is necessary, from the technical point of view, to demonstrate the conformity of the product either to the harmonized standards, if the manufacturer has followed them, or to the essential requirements of the relevant directive if the manufacturer has followed none or only some of the harmonized standards (Guide to the implementation of Community harmonization directives based on the new approach and the global approach. European Commission, 1994).
1. Within a period of six months from its receipt, the application for inclusion shall be completed by a technical dossier, established in one of the official Community languages and comprising all the information needed for the Commission to ensure that the conditions set out in Article 11 (2) of Regulation (EEC) No 2092/91 are met for products intended for export to the Community. In particular, it shall comprise the following detailed information.
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