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Referrals in the EU

Referrals and arbitrations are regulatory procedures which can be invoked for a certain product if:
  • a risk to public health is deemed possible by a regulatory body or the EU Commission
  • opinions are different amongst Member States (divergent opinion)
  • the interest of the community is concerned (community interest)

In all these cases the EU commission, the CPMP, a regulatory authority of a Member State or the pharmaceutical entrepreneur can demand, that a referral be started. The consequence for a product is that it enters a procedure very similar to the centralised procedure (EC 2001/83) where the risks and benefits of the product are reviewed by the Committee for Proprietary Medicinal Products.

The consequences of such a procedure is either the harmonisation of the Summary of Product Characteristics (SPC) (usually it becomes more restrictive) or withdrawal of the product from the common (EU) market.

The procedure usually has massive consequences for a company concerned with such a procedure.

We have a high level of experience in supporting companies in all relevant and necessary steps of this procedure including:

  • planning the procedural timelines
  • defining the options for the product to keep it in the market place
  • facilitating authority meetings with rapporteur, co-rapporteur and other authorities
  • providing logistical input
  • assisting with the definition of fall back positions
  • assisting with running the procedure