EMA and European Commission Referrals 

Occasionally, for a variety of reasons, a product may be referred to EMA / CHMP for a decision on important aspects relating to the product, for example safety issues, non-fulfilment of a post-approval commitment, or divergent opinions by National Competent Authorities on a marketing authorisation or Type II variation. This can lead to changes in the product labelling (SmPC), a requirement to generate new data, or in rare occasions a recommendation to remove the product from the market. 

The referral can be made by National Competent Authorities, the European Commission, or the EMA, and may require a recommendation from PRAC. 

The decision to make a referral must refer to relevant legislation and includes:  

• Article 20 of Regulation 726/2004 (centrally authorised products) 
• Article 29(4) of Directive 2001/83/EC (“Mutual Recognition and Decentralised referral”) 
• Article 30 of Directive 2001/83/EC (“Harmonisation referral”) 

Kinesys Regulatory Advisory Board have supported a range of clients through such referrals, including from national agencies, CHMP, PRAC and from the Commission. These cover ophthalmic products, anti-inflammatory and immunology products, and metabolic agents. 

Our ex Agency Experts and the Kinesys Team are well versed in dealing with referrals, having sat on the various committees that deal with them, including CHMP. They are available to provide you with their knowledge and experience to address whatever type of issue you are facing – safety matters, post-approval commitments, or others.