What are the requirements for materials and activities initiated and developed by teams with global or regional headquarters in the UK which are not directed at UK health professionals?
Supplementary information to Clause 1.11 sets out the applicability of codes and requirements for such activities and materials. It states: Pharmaceutical companies must ensure that they comply with all applicable codes, laws and regulations to which they are subject.
This is particularly relevant when activities/materials involve more than one country or when a pharmaceutical company based in one country is involved in activities in another country.
Activities carried out and materials used by a pharmaceutical company located in a European country must comply with the national code of that European country as well as the national code of the country in which the activities take place or the materials are used.
Activities carried out and materials used in a European country by a pharmaceutical company located in a country other than a European country must comply with the European Federation of Pharmaceutical Industries and Associations Code as well as the national code of the country in which the activities are carried out and materials are used.
Examples: a company located in the UK carrying out an activity outside the UK but within Europe, such as in France, must comply with the UK Code and the French Code regardless of whether or not UK health professionals or other relevant decision makers are involved.
Conversely a company located in France carrying out an activity in the UK must comply with the ABP! Code regardless of whether or not UK health professionals or other relevant decision makers are involved.
Materials developed in the UK to be used outside the UK with non-UK health professionals etc are likely to be exempt from the ABPI Code.