European Union
Proposal for a new EU Directive on medicinal products for human use: anticipated changes to antimicrobials
Changes to antimicrobials
April 30, 2024

One of the new measures that the EU Pharmaceutical Legislation Reform is expected to incorporate in the proposal for a new Directive relating to medicinal products for human use (the “Proposal”) concerns antimicrobials (see Post EU Pharmaceutical Legislation Reform).

Antimicrobial resistance is currently one of the major concerns of health authorities, and the World Health Organization (WHO) considers it one of the top global public health and development threats. To address the challenges posed by this threat, the current draft of the Proposal introduces provisions focused specifically on the approval, manufacturing and use of antimicrobials—classified as medicinal products “with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases,” where antibiotics, antivirals and antifungals are included.

We highlight the following anticipated changes:

  • Any antimicrobial products will be classified as prescription-only medicinal products, and Member States will be allowed to set additional conditions on their prescription to restrict the validity of medical prescriptions and limit the quantities prescribed.
  • Marketing authorization procedures for antimicrobials will also be subject to additional requirements such as submitting (i) an antimicrobial stewardship plan, (ii) a description of special information requirements (educational materials and a new “awareness card”), and (iii) an environmental risk assessment to address manufacturing, use and disposal risks. They will also be subject to further responsibilities on the pack size of the product.
  • National authorities will be allowed to impose additional conditions or obligations on marketing authorization holders of antimicrobials to ensure post-authorization assessment and monitoring of the risks of antimicrobial resistance.

Currently, the Proposal is still being reviewed by the Council, so the specific impact for the pharmaceutical industry is uncertain. However, the draft seems to leave the door open to the possibility of requiring that the pharmaceutical industry adapt the products already placed on the market to comply with these new rules.

April 30, 2024