Article 30 referrals

Divergent decision referral (Article 30 referrals)

This process is triggered when Member States (MS) have adopted different decisions over the years for some medicines e.g. different indications, contraindications or posology and there is a need to harmonise across the EU. This procedure can be initiated by the EC, a MS or the Marketing Authorisation Holder (MAH). The CMDh proposes each year products for harmonisation of SPs and forwards the assessment of product characteristics to the Committee for Medicinal Products for Human Use (CHMP) that is responsible for preparing opinions on questions concerning medicines for human use. By September 2013 the following antibiotics have been assessed and the Summary of Product Characteristics (SPC) harmonised in the EU. See Harmonisation of SPCs in the European Union

The following antibiotics are under review at CMDh (by September 2013)

  • Ceftriaxone
  • Amoxicillin

These antibiotics are proposed for priorisation of harmonisation (by September 2013)

  • Vancomycin
  • Ampicillin
  • Phenoxymethylpenicillin
  • Benzylpenicillin
  • Cefotaxime
  • Azithromycin
  • Clarithromycin
  • Erythromycin
  • Clindamycin
  • Rifampicin
  • Gentamicin
  • Tobramycin
  • Amikacin
  • Trimethoprim/Sulphamethoxazole
  • Metronidazole
  • Doxycycline

Harmonisation of SPCs in the European Union: indications, dosage


Leave a Reply

Your email address will not be published.