Full, generic, hybrid, biosimilar, well-established use, fixed combination, informed consent: the legal basis of a marketing authorisation and what it tells you

Route and basis are two different questions

The four routes answer where a medicine is assessed: centrally, in a group of member states, by recognition, or nationally. The legal basis answers what the applicant had to prove, and it is chosen independently of the route. A generic can go through the centralised procedure; a new active substance can be authorised nationally. Every application states its basis, and the authorisation carries it for life.

For the commercial reader the basis matters for four reasons. It tells you which exclusivity clock the product ran against, and so when it could be filed and sold. It tells you whether the product can itself be the reference for later generics. It tells you whether the product is the same medicine as the brand (a copy of the brand’s own dossier) or an equivalent made to a different dossier. And it is where things go wrong: in 2026 the European Commission revoked the authorisation of Aumseqa (aumolertinib) because the application had leaned on data still under protection, the case note tells the story.

The seven bases

Basis	Directive 2001/83	Human Medicines Regulations 2012	What is filed	What it tells you
Full (including “mixed”)	Article 8(3)	Regulation 50	The applicant’s own pharmaceutical, pre-clinical and clinical results; a mixed application adds published literature	A new active substance, or a new use or form of an old one, with its own data; starts the exclusivity clocks; can be a reference product
Generic	Article 10(1)	Regulation 51B (51 for Northern Ireland)	No pre-clinical or clinical results; bioequivalence to the reference product	Same active substance, same pharmaceutical form, shown bioequivalent; filed after eight years, sold after ten (or eleven)
Hybrid	Article 10(3)	Regulation 52B (52)	Generic data plus the applicant’s own results where it departs from the reference: a different strength, form, route, salt or indication, or where bioequivalence cannot be shown by bioavailability studies	Same substance, not an exact copy; the same clocks as a generic, with its own data for the differences
Biosimilar	Article 10(4)	Regulation 53B (53)	Generic basis with supplementary comparative data, because a biological cannot meet the generic definition	A biological shown similar, not identical, to its reference; the generic clocks apply; cannot claim indications the reference does not have
Well-established use	Article 10a	Regulation 54	Published scientific literature in place of trials, for a substance in well-established use in the EU (or UK) for at least ten years with recognised efficacy and acceptable safety	A “bibliographic” application: no reference product, no reliance on anyone’s data; can itself be a reference product
Fixed combination	Article 10b	Regulation 55	New pre-clinical or clinical results for the combination, though not for each ingredient separately, where the ingredients are already authorised but not yet combined	A new product with its own clocks, even though every ingredient is old; a single pharmaceutical form, not a co-pack
Informed consent	Article 10c	Regulation 56	The pharmaceutical, pre-clinical and clinical documentation of an existing authorisation, used with its holder’s consent	The same medicine under another name or holder: identical composition and form, built on the same dossier

Two things that are not legal bases, though they are often spoken of as if they were. A new active substance is a description of what is being authorised, and is generally applied for under the full basis. A duplicate is a second authorisation for the same dossier under the same basis, with only the name changed; the UK requires it to be flagged as such.

The clocks the basis runs against

Under Article 10(1) a generic, hybrid or biosimilar application may be made once the reference product has been authorised in the EU for eight years, and the product may be marketed once ten years have passed, or eleven if the originator added a new indication of significant clinical benefit within the first eight. The UK has the same periods, counted from the UK authorisation. The three clocks together are explained in patent cover, data exclusivity and market protection; the EU’s pharmaceutical package, now in the legislative process, reshapes them.

The global marketing authorisation in Article 6(1) decides where the clock starts. Every additional strength, pharmaceutical form, route, presentation, variation and extension granted to the same holder for the same substance is part of the first authorisation, and runs on its date. A new salt or a new indication filed as an extension does not get a clock of its own; the Tecfidera litigation turned on exactly that.

Well-established-use and fixed-combination products rely on no reference product, so no eight-year wait applies to filing them; but each is a full product in its own right and can be the reference for the generics that follow, with the ordinary periods. An informed-consent product shares its parent’s dossier and its clocks. A new indication for a well-established substance earns the originator one further year during which generics may not cite the new studies.

Article 10(6) adds the Bolar provision: the studies and trials needed for a generic, hybrid or biosimilar application do not infringe the patent or SPC. That is why a generic can be fully developed and authorised before the patent expires, which is the premise of every launch-at-risk dispute on this site.

How to tell which basis a product has

An EMA public assessment report states the legal basis on its first pages (“generic application under Article 10(1)”, “hybrid application under Article 10(3)”, “full application under Article 8(3)”) and names the reference product. The MHRA’s public assessment reports do the same for UK products. National registers vary: some flag generics, few state the article. Where nothing is stated, the clues are the name (an INN plus a company name is almost always a generic or hybrid), the date (an application made in the ninth year after the reference product’s authorisation is on the generic clock), and the summary of product characteristics (a biosimilar’s refers to its reference product; an informed-consent product’s is a copy of its parent’s).

What it means if you are…

A parallel trader. The basis tells you what you are buying. An informed-consent product is physically the brand, which matters where a destination licence requires the import to be the same product as the one it cross-refers to. A generic or hybrid is a different product to a different dossier, and cannot be imported under a licence that cross-refers to the brand, however similar it is.

A generics or launch planner. Pick the basis to fit the data you have and the difference you want. A hybrid lets you carry a new strength or form without a full dossier, but the original data for the difference must be yours. A well-established-use application sidesteps the reference-product clocks entirely, but only for a substance with ten years of documented use and only on published evidence, with no original trials allowed.

A wholesaler or buyer. The basis is what makes substitution possible or not. A generic is bioequivalent and substitutable in most systems; a hybrid may differ in strength or form and need checking against the formulary; a biosimilar is similar, not identical, and its substitution rules are set country by country.

What to check

1. The legal basis stated in the assessment report, and for a generic, hybrid or biosimilar, the named reference product.
2. The reference product’s first authorisation date, which starts the eight- and ten-year clocks, and whether that product is part of an older global authorisation.
3. For a well-established-use or fixed-combination product, its own authorisation date, since it starts clocks of its own.
4. For an informed-consent product, which authorisation it is built on; the two share one dossier and one set of dates.

MPA Search records the first authorisation date in the EU and the UK for each product and the product licences country by country, which are the dates every one of these bases runs against.