July 1st 2012
Pharmaceutical products in the EU have market exclusivity for up to 11 years. Any generic company wanting to apply for a licence to market products after this exclusivity period has expired must be able to accurately determine the date of the first marketing authorisation and thereby know the date of its expiry.
It’s not as straightforward as it seems
A generic market authorisation is usually an abridged application procedure. This allows referral to the originators documentation provided this has been authorised in the EU not less than 8 years for data, 10 years for marketing plus a further year for additional presentation. That is why, irrespective of patent cover, it is vital for generic manufacturers to know the dates of the first EU authorisation in order to assess the right time to use a market authorisation obtained through an abridged application.
And that is where MPA’s invaluable database service comes in!
Knowledge of a product’s data exclusivity expiry is critical:
Accessing and assessing European marketing authorisations is complex, which is why MPA’s EU First Marketing Authorisations Review is essential. Produced by leading and experienced European patent and business intelligence specialists MPA Business Services, and available via Espicom, this constantly updated, interactive web-based subscription service will rapidly provide reliable access to the key marketing authorisation data you need. In addition, various levels of MPA’s market-leading consultancy service are included in all subscription packages.
To arrange a demonstration or find out more about price and distribution, please click on the link to contact firstname.lastname@example.org