Earlier this week, the Commission published a new Regulation amending Regulation 726/2004 that governs the centralised procedure and that sets out the rules for the EMA: Regulation 2019/5. Many of the changes move and consolidate the provisions set out in other Regulations into Regulation 726/2004 on the centralised procedure (known as the Regulation on the Centralised Procedure). We are preparing a more detailed advisory of the implications of the new Regulation, but some headline points are as follows:
- The rules on veterinary medicines have been removed from the Regulation on the Centralised Procedure, and the current Directive 2001/82/EC on veterinary products at national level has been repealed. The relevant provisions are now in a standalone regulation, Regulation 2019/6, which covers all the routes granting marketing authorisation for veterinary products in the Union – both at centralised and national level.
- The new Regulation consolidates and moves the “core elements” of the rules on conditional marketing authorisations, currently contained in Regulation 507/2006, into the Regulation on the Centralised Procedure.
- The new Regulation consolidates and moves the “core elements” on variations, currently in Regulation 1234/2008, into the Regulation on the Centralised Procedure, and Directive 2001/83/EC on the Community Code. The provisions of the Regulation on the Centralised Procedure and Directive 2001/83/EC are to remain aligned.
- The rules on financial penalties that may be imposed on marketing authorisation holders of centralised authorisations, who fail to comply with their obligations, are currently set out in Regulation 658/2007. Again, the “core elements” have been moved into the Regulation on the Centralised Procedure. In doing so, there are a number of changes to the rules. In particular, there is the ability to impose penalties on those within the same group of companies as the marketing authorisation holder where such entities “exert a decisive influence over the marketing authorisation holder” or “were involved in, or could have addressed, such failure to comply with the obligation by the marketing authorisation holder”. In addition, the scope of acts that may lead to penalties being imposed has been amended, and expanded in relation to the penalties for breach of the pharmacovigilance obligations.
- In a number of places, the new Regulation gives the Commission the power to adopt further delegated acts that complement the “core elements” now contained in the Regulation on the Centralised Procedure.
The new Regulation will apply from 28 January 2019. However, the current legislation that has been consolidated into the Regulation on the Centralised Procedure (other than in relation to veterinary products as noted above) will remain in force and continue to apply unless and until repealed.