Regulatory catalogue
Legislation and guidance that shape the labelling and packaging of human medicines, classified by issuer, legal force, markets and the packaging components they bear on. Each entry links to the publicly accessible source.
Coverage
Documents by region and legal force
Legal force says how strongly a document binds, from primary legislation (L1) to drafts (P). Select a number to filter.
| Region | L1Law | L2Rule | G1Guidance | G2Template / Q&A | SStandard | PDraft | All |
|---|---|---|---|---|---|---|---|
| EU institutionsEuropean Commission, Parliament and Council | 1 | 1 | · | · | · | · | 2 |
| EMA / HMA networkEuropean Medicines Agency, CMDh and the EU regulatory network | · | · | · | 2 | · | · | 2 |
| United StatesCongress, FDA, CPSC | · | 1 | 1 | · | · | · | 2 |
| ChinaNPC, NMPA, SAMR | · | 1 | · | · | 1 | · | 2 |
| JapanDiet, MHLW, PMDA | 1 | · | 1 | · | · | · | 2 |
| IndiaParliament, MoHFW, CDSCO, DGFT, NPPA | · | 2 | · | · | · | · | 2 |
What the classifications mean
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- Legislative proposal, draft guidance or consultation.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)
- Carton Outer packaging / folding carton
- Label Immediate container label (bottle, tube, large vial, bag)
- Blister / foil Blisters, strips, sachets, lidding foil
- Small unit Small immediate packaging: ampoule, small vial, cartridge, pen
- Leaflet Package leaflet / PIL, package insert, prescribing information, Medication Guide
- Device Integral or co-packaged device and its instructions for use
- Shipper / case Tertiary packaging: shipping case, homogeneous case, pallet
- e-Labelling Electronic product information, QR / 2D-code linked content
2 documents match
| Document | Legal force | Markets | Components | Effective | Source |
|---|---|---|---|---|---|
| RI-EU-001 Community code (Directive 2001/83/EC) European Parliament and Council · Directive 2001/83/EC, OJ L 311, 28.11.2001 | L1Law In force |
EU 27, EEA (IS, LI, NO) | Carton: DirectLabel: DirectBlister / foil: DirectSmall unit: DirectLeaflet: DirectDevice: ContextShipper / case: not relevante-Labelling: not relevantImpact: high | 18 Dec 2001 | Official text (opens in a new tab) |
| RI-EU-002 Safety features (Delegated Regulation 2016/161) European Commission · Delegated Regulation (EU) 2016/161, OJ L 32, 9.2.2016 | L2Rule In force |
EU 27, EEA (IS, LI, NO) | Carton: DirectLabel: DirectBlister / foil: ContextSmall unit: not relevantLeaflet: not relevantDevice: not relevantShipper / case: Contexte-Labelling: not relevantImpact: high | 9 Feb 2019 | Official text (opens in a new tab) |
Compiled from the issuers' public websites (status as of the date shown on each entry). Not legal advice and not a validated source: confirm requirements in the official text before regulatory use. Entries marked "verify" contain details not yet checked against the official text.