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Product Authorisation Letter
"I need a Product Authorisation Letter to authorize our German distributor to sell our medical devices in Germany and Austria, with specific quality control requirements and quarterly reporting obligations, starting from March 2025."
1. Authorising Entity Details: Full legal name, address, and registration details of the authorising company
2. Authorised Party Details: Full legal name, address, and registration details of the party being authorised
3. Product Information: Specific details of products covered by the authorisation
4. Scope of Authorisation: Exact nature and extent of the authorisation being granted
5. Duration: Period for which the authorisation is valid
1. Territory Restrictions: Used when authorisation is limited to specific geographical areas
2. Quality Standards: Include when specific quality requirements must be maintained
3. Reporting Requirements: When regular reporting or monitoring is required
4. Sub-authorisation Rights: Whether the authorised party can extend rights to others
1. Product Specifications: Detailed technical specifications of authorised products
2. Brand Guidelines: If brand usage is part of the authorisation
3. Quality Standards Documentation: Specific quality requirements and testing procedures
4. Territory Maps: If geographical restrictions apply
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