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New Medicines Legislation

In March 2004, a new EU Pharmaceutical Legislation was adopted.

The objective of the New Medicines Legislation (NML) is to harmonise the internal market for new medicinal products, laying down Community procedures for the authorization, supervision and pharmacovigilance of medicinal products for human (and veterinary) use.  These procedures are recognised as a great achievement to strengthen the competitiveness of the (bio)pharmaceutical industry.

The legislation created a compulsory centralized authorization procedure for high-technology medicinal products, particularly those resulting from biotechnological processes.  This in view of maintaining a high-level scientific evaluation and ensure patients safety.

The European Medicines Agency (EMEA) is implementing the New Medicines Legislation.  European Commission and Member States and EMEA are finalizing guidelines and procedures.

The EMEA has published a list of publication and consultation of guidance documents implementing the new pharmaceutical legislation.

EBE members extensively worked together to ensure proper implementation for the biopharmaceutical industry in a close cooperation with work led by EFPIA.

 

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  • Downloads

  • EMEA Guideline on Compassionate Use
    (56.1 KBkb) Download
  • Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use
    (48.158 KBkb) Download
  • EBE Comments to Draft Regulation on Conditional Marketing Authorisation
    (50.434 KBkb) Download
  • Guideline on the Procedure for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004
    (74.801 KBkb) Download
  • Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
    (259.598 KBkb) Download
  • Directive 2004/27/EC of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
    (186.083 KBkb) Download