The political and regulatory environments for over-the-counter medicines, self care medical devices and food supplements are constantly evolving and a significant proportion of new regulation is laid down by the European Union.
By working closely with AESGP, the association of the European Self Medication Industry, PAGB is able to engage with EU institutions and seek to influence policy decisions. PAGB is a member of AESGP’s committees, covering regulatory affairs, herbal medicines, food supplements, medical devices, economic affairs and PR, and has a seat on the AESGP Board. We contribute information and expertise to a number of AESGP publications, such as the Economic and Legal Framework Study and the Ingredients Directory.
PAGB and AESGP worked together with other national associations and companies to lobby EU officials and parliamentarians to secure the continuation of the self care medical device classification, despite initial proposals to abolish it. Some devices will be up-classified when the regulation comes into effect, but AESGP is now working to secure adequate transitional arrangements for those products affected.
AESGP lobbying resulted in non-prescription medicines being exempted from the obligation to carry the new safety features which will be required on all prescription medicines from 2019.