Regulatory catalogue

Legal force

L1Primary legislation

Act, directive or regulation adopted by the legislator. Legally binding (an EU directive binds through national transposition).

L2Implementing legislation

Delegated or implementing act, federal regulation (CFR), ministerial order or gazette notification. Legally binding.

G1Official guidance

Guideline or notification of a competent authority. Not law, but assessors expect it; deviations must be justified.

G2Templates and procedural guidance

Templates, Q&A, procedural and submission guidance of an authority. Practically required to pass the procedure.

SStandard

Technical or information standard (authority or standards body). Voluntary unless legislation refers to it.

PDraft or proposal

Legislative proposal, draft guidance or consultation. Not yet binding; monitor for artwork impact.

Relevance per packaging component

D Direct

Prescribes content, layout or codes printed on this component.

I Indirect

Affects the component through process, approval, coding infrastructure or design expectations.

C Context

Background: frames the requirements but contains none for this component itself.

Components (strip order)

1. Carton Outer packaging / folding carton
2. Label Immediate container label (bottle, tube, large vial, bag)
3. Blister / foil Blisters, strips, sachets, lidding foil
4. Small unit Small immediate packaging: ampoule, small vial, cartridge, pen
5. Leaflet Package leaflet / PIL, package insert, prescribing information, Medication Guide
6. Device Integral or co-packaged device and its instructions for use
7. Shipper / case Tertiary packaging: shipping case, homogeneous case, pallet
8. e-Labelling Electronic product information, QR / 2D-code linked content