Product licences
A product can only be sold where it is licensed, and the licence register shows who has been granted what. MPA holds the product licences granted by the national regulators, the UK register in full and the European national registers, so the licensed position for a medicine can be seen across markets in one search.
What it holds
- Product licences granted by the national regulators, with company, product, active ingredients, legal category and dates.
- The UK (MHRA) register in full, including the licence number on every record, so each licence can be checked at source.
- The national licences of other European countries, from their registers.
- The same product’s patents, SPCs and first EU authorisation alongside, if you subscribe to them.
- Markets
- The UK (MHRA) register and European national registers.
Who uses it, and why
- Generics and biosimilar companiesTo see who else is coming: which licences have already been granted for a molecule, and in which countries.
- Originators, brand and portfolio teamsTo see which generics and biosimilars have licences in hand, so competitor entry is visible early.
- Procurement and buyersTo find who holds the licences for an alternative, and whether a second supplier is available.
- Parallel traders and wholesalersTo check the product is licensed where it is going, and what is authorised in the source market.
- Patent attorneys and legal teamsWhich authorisations exist for a product and its generics, held by whom, and since when.
- Consultancies and advisersWho already holds licences in the markets in scope, for a market entry study or a portfolio review.
Questions it answers
Who holds a licence for this substance in the UK, and in each other market?
How many companies are already licensed, and is the field crowded?
Has a competitor been granted a licence, and when?
What is the legal category of the product in each market?
Is there a second supplier for a product we depend on?
Which licences does a company hold, across its range?
How it is searched
Assessing a product
- 1Search by substance, product, company or licence number.
- 2Read every licence for the product, with holder, active ingredients, legal category and dates.
- 3Compare the licensed position country by country.
- 4If you also subscribe to patents and SPCs, read the protection on the same product alongside.
Finding opportunities
- 1Work through a whole list of products in one go to see who is licensed for each.
- 2Count the licence holders to see where the field is already crowded and where it is still open.
- 3Search by company to see a competitor’s licensed range.
- 4Add the patent position, demand and prices from the other datasets to see whether an opening is worth taking.
Expert support, included
What a register entry or a licence actually means for your enquiry, and how the routes to authorisation relate one licence to another, is part of every subscription.
What to read first
All resources- ExplainersCentralised, decentralised, mutual recognition, nationalA medicine reaches the European market by one of four procedures. Each produces a different kind of authorisation, a different number format, and a different first-authorisation date. What the routes are, how to recognise them from a licence number, and why the route matters for SPC and exclusivity calculations.
- GlossaryCountry codes and the registers behind themThe two-letter codes on patent documents, licence numbers and price lists, for every country MPA covers: EU or not, which office grants patents and SPCs, which agency licenses medicines, which currency the prices are in, and the special codes (EP, WO, EU, XI) that are not countries at all.
- ExplainersThe generic development timeline in EuropeA generic cannot be filed until year eight of the reference product's data protection and cannot be sold until year ten, so development is timed backwards from a date. What each step takes for an oral solid, where the Bolar exemption covers it, what the application costs in time, why complex generics and biosimilars start years earlier, and what the programme means for the launch date everyone else is watching.
- ExplainersUnlicensed medicinesA medicine with no marketing authorisation in a country can still reach a patient there, by one of several routes that each have their own rules, suppliers and prices. What the EU's named-patient and compassionate-use provisions allow, how the UK's specials and import notifications work, how the large member states run early access, and what the routes mean for traders, planners and buyers.
- ExplainersSecond medical use patents and skinny labelsWhen the compound is free but one of its uses is still patented, a generic launches with that use cut out of its label. What a second-medical-use patent claims, how the carve-out works, why the UK pregabalin litigation turned on how a product is presented rather than what it is used for, how Germany and the Netherlands differ, and what it means for prescribing, dispensing and sourcing.
- GlossaryThe A to ZEvery term the resources on this site use, from added matter to the Windsor Framework, defined in a sentence or two for the commercial reader, with the piece that explains it in full. Patent types and the grounds patents fall on; SPC terms; the regulatory clocks; licences and parallel import; the trade-mark rules; the words on a price list.
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