AESGP committees

AESGP primarily operates via 6 technical committees. These committees are composed of AESGP members’ representatives; they meet regularly and develop AESGP positions in key areas.

Regulatory Affairs Committee

  • Leads the AESGP position and actions aiming to ensure that the pharmaceutical legislation and its implementation are proportionate to the specificities of non-prescription medicines 
  • Leads the AESGP position on the functioning of the European marketing authorisation procedures (centralised, decentralised/mutual recognition, and national) and develop suggestions for improvement 
  • Fosters a positive climate for the changed of legal status from prescription to non-prescription (so-called “switch”) and promotes best practices as model for more European harmonisation 
  • Makes sure that product information on non-prescription medicines is fit for purpose 
  • Provides high quality comments on draft guidance documents produced by authorities. The AESGP pools of experts on respectively Quality/Good Manufacturing Practices (GMP), Telematics, and Environment are particularly qualified to provide assistance on those specific topics. Experts in these groups are nominated by Regulatory Affairs Committee members. 
  • Fosters and coordinates the relationship with other stakeholders in healthcare

Herbal Medicinal Products Committee

  • Leads the AESGP position and actions directed towards a proper functioning of the legal and regulatory system for herbal and homeopathic medicines in Europe 
  • Supports the establishment of adequate herbal monographs and entries to the European Union ‘list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’ 
  • Avoids negative repercussions for herbal medicines through inappropriate regulatory measures in relation to quality and safety requirements 
  • Ensures good interaction between AESGP and all relevant stakeholders interested in herbal and homeopathic medicines 

Medical Devices Committee

  • Ensures that the category of self-care medical devices is recognised by all stakeholders 
  • Represents AESGP in various European Commission’s working groups which facilitate implementation of Medical devices Regulation 
  • Provides information on the category of self-care medical devices notably in relation to the extent of products concerned, the classification rules currently applying and, as far as possible, the market sale/data of this category

Food Supplements Committee

  • Provides clear industry input to ensure an appropriate implementation of the legal provisions impacting food supplements, including the health/nutrition claims regulation 
  • Interacts with the European Food Safety Authority (EFSA)
  • Prevents negative developments for food supplements, e.g. through inadequate restrictions of food additives or limits on contaminants 
  • Supports national activities to improve the recognition of food supplements, as appropriate 
  • Keeps the most comprehensive database of the sector up-to-date 

Pharmacovigilance Committee

  • Ensures that particularities of well-established actives are taken into account in any discussion related to the safety of medicines 
  • Contributes to well-functioning EU pharmacovigilance system 
  • Provides relevant and high-quality contributions to circulated draft guidance documents in relation to pharmacovigilance 

Economic/Public Relations Committee

  • Fosters the relationship with stakeholders in the healthcare sector
  • Leads debate on studies around the economic and public health value of self-care 
  • Leads the position of AESGP on key market access issues such as public advertising and branding of self-care products
  • Leads the AESGP position with regard to “new technologies” including eHealth, big data, digital strategies
  • Serves as a programme committee for the AESGP Annual Meetings and supports the organisation of these events