1. Legislation
• The Act of 20 July 2006 on the establishment and operation of the Federal Agency for Medicines and Health Products, Article 4/2, §§1 and 2;
• The Royal Decree of 12 May 2024 implementing scientific and technical advice on health products and advice on the status and classification of a product.
2. Guidance documents
Detailed guidance for national STA requests regarding the status and classification of a borderline product (This document is in preparation).