Report on EMA Regulation Published

The EMA Regulation is arguably the single most important piece of legislation for the entire pharmaceutical industry as it sets out all the requirements by which their products are put on the market.

What is suspiciously not a major topic in the European Parliament at the moment, is the current revision of the Proposal for a Regulation on the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, aka; the EMA Regulation. 

The Proposal for a Regulation quietly published by the Commission and currently working its way through Parliament, is designed to separate human and veterinary medicine rather than having them contained in the same piece of legislation. 

While this is the purpose, this proposal still represents a reopening of the legislation and those in the know are already scrambling to suggest amendments. 

Drastic changes are unlikely however and it seems the Parliament is no more eager to have a drawn out debate over a proposal with hundreds of amendments than their colleagues in the European Commission.

On 14 April 2015 the Draft Report by the MEP responsible for this dossier in the Parliament’s Health Committee, Mr. Claudiu Ciprian Tănăsescu (S&D, Romania), was published. The Report stays clear of making any major changes and follows the same theme as the Commission. The legislation as it stands can be sumarised as follows.

Key Points:

  • The costs for the EMA for implementing and applying the new rules are entirely covered by fees charged to industry
  • The costs of the new centralized procedure will be recovered from those making medicinal products available on the market and from those seeking authorisation
  • This amendment establishes certain principles applicable to fees payable to the European Medicines Agency with consideration to the needs of SMEs
  • The increased work for the EMA and implementing centralized procedures needs to be balanced by fees, and MEPs showed concern over who would pay those fees and how much they would have to pay.
  • The Commission shall amend supplement fees by an implementing act which are under the control of the Member States

Relevant Dates:

  • Date for amendments: 15th June
  • Vote in ENVI Committee: 22nd September
  • Vote in Plenary: TBD

The full report is available here.

The VPH PAWG will be in attendance when this Report is presented by the Rapporteur during the week of 04 May 2015, and will provide a full update in next month’s edition of the VPH newsletter.


Date: 05/05/2015 | Tag: | News: 378 of 566
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