Flashcards: Understanding French Medicine Regulations — 9 cartões

Legal status of medicines — definition?

Substances with therapeutic or diagnostic claims, regulated by law in France.

Legal status of medicines in France?

Defined by article L.5111-1 CSP.

Medicines vs dietary supplements — difference?

Medicines treat or prevent diseases; supplements support health without claims.

Distinction — medicines vs dietary supplements?

Medicines treat diseases; supplements support health.

AMM process — purpose?

To authorize pharmaceutical specialties for market.

Controlled substances — classification?

Based on risk; special prescription rules apply.

Special prescriptions — when needed?

For exceptional medicines with strict rules.

Generic medicines — bioequivalence?

Must show bioequivalence to original.

Biological medicines — examples?

Biotech drugs and biosimilars.