Regulatory Affairs – Makrolife Biotech Blog

EU Market Entry

Supplement or Medicinal Product? The EU Classification Mistake That Can Stop a Launch

A capsule can look like a food supplement and still raise medicinal-product questions. Learn how the EU assesses borderline products by presentation and function,…

September 10, 2026 14 min read Read more →

Food & Supplements

EU 2026/1427: New Egg Membrane Novel Food Rules

EU Regulation 2026/1427 authorises a new enzymatically produced egg membrane hydrolysate for adult food supplements at up to 500 mg/day. But protected data, supplier…

September 8, 2026 13 min read Read more →

Food & Supplements

Why a Supplier COA Is Not Enough for EU Compliance

A supplier Certificate of Analysis is valuable evidence, but it is not a complete EU compliance strategy. Learn the difference between specifications, batch COAs…

August 27, 2026 14 min read Read more →

Tag: Regulatory Affairs

Supplement or Medicinal Product? The EU Classification Mistake That Can Stop a Launch

EU 2026/1427: New Egg Membrane Novel Food Rules

Why a Supplier COA Is Not Enough for EU Compliance