The parallel import (PI) scheme allows medicinal products authorised in other European countries to be marketed in the UK in competition with the identical UK product supplied by the original manufacturer.
The granting of licences in the EU for such a purpose began in 1984. The MHRA liaises closely with the relevant competent authorities in the EU to obtain the necessary information to ensure that only those products which fully comply with the stringent criteria for parallel import are granted a licence.
Alternatively, Parallel Distribution is the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder. The EMA checks the compliance of products distributed in parallel with the conditions laid down in Community legislation on medicinal products and in the marketing authorisation of the product.
For a limited period after accession, some medicinal products on the market in the new Member States would not have the same level of IP protection found in the existing Member States. The Accession Treaties therefore introduced a transitional period to the full application of the principle of the free movement goods to prevent parallel trade in pharmaceutical products that lack equivalent IP right protection. The mechanism also introduces the requirement that parallel traders have to provide confirmation to the competent authority that they have informed the patent holder or beneficiary one month in advance of a notification for a parallel distribution. However, the legal responsibility for enforcing intellectual property rights will remain with the patent holder.
Ginova subscribes to an industry patent information database, and ensures that the requirements laid out for the Specific Mechanism are followed.