Module 6

03/10/2024

Clause 1.17 Definition of Promotion

• Promotion means any activity undertaken by a

pharmaceutical company or with its authority which promotes the administration, consumption, purchase, prescription, recommendation, sale, supply or use of its medicines

• Clause 1.17 also lists materials/activities which are specifically included or excluded

• e.g. price lists (including unlicensed medicines), responses to unsolicited enquiries, risk minimisation materials

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Clause 1.24 Definition of Third Party

• A legal person/entity/individual that represents a company

• e.g. distributors, wholesalers, consultants, CROs, professional congress organisers, contracted sales forces, market research companies, advertising agencies, providers of services related to events etc • Companies are responsible for their third parties which come within the scope of the Code, even if they act contrary to the instructions which they have been given

The Organisation for Professionals in Regulatory Affairs

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