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The Medicine Authorization Letter is a critical document in Malta's pharmaceutical regulatory framework, used when seeking approval for new medicines, variations to existing authorizations, or renewal of current authorizations. This document type is essential for pharmaceutical companies operating in Malta, which must comply with both national regulations (primarily the Medicines Act, Chapter 458) and EU pharmaceutical legislation. The letter serves as the formal communication channel between pharmaceutical companies and the Malta Medicines Authority, containing detailed information about medicinal products, their specifications, and compliance with regulatory requirements. It's particularly important given Malta's position as an EU member state, requiring alignment with both local and EU-wide pharmaceutical regulations. The document must include specific technical details, legal declarations, and supporting documentation as required by Maltese authorities.

1. Letter Header and Date: Official letterhead, date, and reference number

2. Addressee Details: Full details of the Medicines Authority and relevant department

3. Product Identification: Clear identification of the medicinal product including name, strength, pharmaceutical form, and MA number if existing

4. Authorization Scope: Specific details of what authorization is being requested or granted

5. Legal Basis: Reference to relevant legislation and regulatory framework under which the authorization is sought

6. Declaration of Compliance: Statement confirming compliance with relevant regulations and requirements

7. Contact Information: Details of the responsible person or entity for correspondence

8. Signature Block: Authorized signatory details and official signature