Short answer
A medicine normally needs marketing authorisation before Member State market placement. Authorisation rests on quality, safety, efficacy and benefit–risk evidence; it does not guarantee launch, supply, prescribing, reimbursement or affordable access.
For generics, 8+2+1 means dossier reliance after eight years, market entry normally after ten, and a possible further year for a qualifying new indication. This protection is separate from patents and supplementary protection certificates.
Supply law requires advance notification of market interruptions and places qualified continuity duties on authorisation holders and distributors. It does not promise that shortages will never occur. Off-label prescribing is not generally prohibited by EU pharmaceutical rules, but it remains subject to EU product rules and national medical, professional and reimbursement law. Named-patient and compassionate-use routes are narrower exceptions, not general access rights. Finally, Member States retain the main decisions on pricing, reimbursement and healthcare organisation, although EU transparency and health-technology-assessment rules shape those processes.
Marketing authorisation is the gate to the market
Directive 2001/83/EC states the basic rule for national authorisations, alongside the centralised procedure under Regulation (EC) No 726/2004:
No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State [...] or an authorisation has been granted in accordance with Regulation (EC) No 726/2004. —
The centralised route is mandatory for specified products, including products made using listed biotechnology processes, advanced-therapy medicinal products and orphan medicines. It is also available for certain innovative products or products of significant interest. The European Medicines Agency's scientific committee gives an opinion and the European Commission takes the authorisation decision. Other products proceed through national, decentralised or mutual-recognition routes under the Directive.
The authority examines quality, safety, efficacy and benefit–risk. Authorisation defines approved indications, dosage and warnings, not launch, prescribing or reimbursement.
Data protection delays reliance and market entry
Article 10 of Directive 2001/83/EC permits a generic applicant to avoid repeating the reference product's pre-clinical and clinical trials, but only after a protected period:
[T]he applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised [...] for not less than eight years [...]. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. —
The ten-year period can increase to a maximum of eleven years where, during the first eight years, the holder obtains an authorisation for a new therapeutic indication that brings significant clinical benefit compared with existing therapies. Article 14(11) of Regulation 726/2004 applies the corresponding protection to centrally authorised products.
The shorthand 8+2+1 therefore separates three concepts:
- after eight years, a generic applicant may rely on the reference dossier;
- after ten years, the authorised generic may normally be placed on the market; and
- an additional year may apply for the qualifying new indication.
This protection is separate from patents and supplementary protection certificates. In Astellas Pharma, C-557/16, the Court confirmed that expiry is a prerequisite for generic authorisation and that the reference-product holder can challenge the calculation's starting point.
In Laboratoires EuroGenerics, C-118/24, the Court confirmed that a biological medicine may serve as the reference for an abridged application concerning a chemically synthesised product if Article 10(2)(b)'s generic conditions are met. Member States may also allow their courts to review whether the authorised product truly qualifies as generic after a decentralised procedure. The judgment concerns pathway classification, not an automatic finding that data protection has expired.
Shortage duties allocate responsibility but do not guarantee supply
Under Article 23a of Directive 2001/83/EC, an authorisation holder that temporarily or permanently stops placing a product on a Member State market must generally notify the competent authority at least two months before the interruption, unless exceptional circumstances apply, and give reasons. Article 81 then distributes a continuity obligation across the supply chain:
The holder of a marketing authorisation [...] and the distributors [...] shall, within the limits of their responsibilities, ensure appropriate and continued supplies [...] so that the needs of patients in the Member State in question are covered. —
This responsibility-based duty is not an absolute supply warranty. National arrangements must be justified on public-health grounds, proportionate and compatible with Treaty rules.
Regulation (EU) 2022/123 adds Union coordination for critical medicines during public-health emergencies and major events. It establishes the European Shortages Monitoring Platform for data on supply, demand, availability and interruptions. Marketing authorisation holders and Member States must provide specified information for medicines on critical lists and support monitoring and mitigation. Those mechanisms complement, rather than erase, national reporting and Article 23a duties.
Off-label use is different from supplying an unauthorised product
An off-label use involves an authorised medicine used outside the authorised indication, patient group, dose or other product terms. It is not the same as importing or supplying a product with no relevant marketing authorisation.
In Novartis Farma, Case C-29/17, the Court drew the EU-level boundary clearly:
[T]he EU rules on pharmaceutical products prohibit neither the off-label prescription of a medicinal product nor its repackaging for such use but do require them to comply with the conditions laid down in those rules. —
That is not an EU right to demand off-label treatment. Prescribing standards, clinician responsibility and reimbursement remain substantially national, while EU rules concerning manufacture, repackaging, pharmacovigilance and product safety may still apply.
Article 5(1) of Directive 2001/83/EC separately allows a Member State, under its own law and to meet special needs, to exclude a product supplied for an individual patient in response to a genuine unsolicited order made to an authorised health professional's specifications and under that professional's direct responsibility. In Commission v Poland, Case C-185/10, the Court construed this exception strictly: “special needs” concern individual situations justified by medical considerations, and financial considerations alone are insufficient where an equivalent authorised product is available.
For certain serious conditions, Article 83 of Regulation 726/2004 also permits Member States to establish compassionate-use programmes for groups of patients using a product that is under a marketing-authorisation application or clinical trials. Both routes depend on detailed conditions and national action. Neither creates a general EU entitlement to an unapproved medicine.
Authorisation is not the same as affordable patient access
Article 168(7) TFEU preserves Member State responsibility for defining health policy, organising and delivering health services and medical care, and allocating resources. Directive 2001/83/EC and Regulation 726/2004 likewise preserve national powers over medicine prices and inclusion in health-insurance schemes.
EU law nevertheless structures parts of the access process:
- Directive 89/105/EEC requires pricing and reimbursement decisions to follow published procedures, deadlines, reasoned decisions and objective, verifiable criteria. It does not require a Member State to reimburse every authorised product.
- Regulation (EU) 2021/2282 has applied since 12 January 2025 and phases in joint clinical assessments, beginning with new cancer medicines and advanced-therapy medicinal products, extending to orphan medicines in 2028 and other relevant centrally authorised medicines in 2030.
- Joint clinical assessment reports must remain scientific and must not state an overall value judgment. National authorities must give them due consideration, but retain competence to decide the medicine's overall clinical added value in their healthcare system.
Access may depend separately on authorisation, exclusivity, intellectual property, supply, prescribing and reimbursement. Passing one gate does not open the others.
The pharmaceutical reform package is not yet current law
As reviewed on 31 July 2026, EUR-Lex records the proposed pharmaceutical directive (2023/0132/COD), proposed regulation (2023/0131/COD) and Critical Medicines Act (2025/0102/COD) as ongoing. Their proposed incentive, authorisation and shortage rules are not enacted law.
Until final acts are adopted, published and applicable, current rules remain the starting point. Each file should be rechecked for later adoption and its material date.
Conclusion
For a particular medicine, identify the authorisation and approved use, calculate regulatory and intellectual-property protection separately, map shortage notifications and supply roles, classify any exceptional treatment route, and apply the relevant national pricing and reimbursement law. EU authorisation controls market entry; exclusivity rewards supporting evidence; shortage rules distribute responsibilities; limited treatment routes preserve clinical flexibility; and Member States make the resource-allocation choices that turn permission into practical access.
Sources
This article provides general legal information, not advice for a specific matter. Laws, facts and procedural deadlines may change the result. Follow the linked primary sources and obtain local advice before acting.