Compelling, Compliant Information to Successfully Promote Your Product
Any activity undertaken, organized, or sponsored by a company that is intended to promote the prescription, recommendation, supply, administration, or consumption of a pharmaceutical, biotechnology, or medical device product may be considered promotional material. Such marketing collateral can be available through various methods of communication, including ads and brochures, mailings, websites, congress materials, and presentations from spokespersons or medical representatives. This content must follow strict European Union (EU) and national guidelines relating to the promotion of medicines, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) code of practice.
During every step of the product lifecycle, your product’s messaging to healthcare professionals and patients must always be clear, compelling, and fully compliant. Whether you’re developing print materials, websites, digital sales aids, or patient support materials, ProPharma Group has the knowledge and experience to help ensure all of your marketing materials are balanced and aligned with all regulatory and ethical codes.
Fair Balance, Compliance, and Business Objectives
Promotional material has two equally important objectives: (1) it must achieve business goals, and (2) it must comply with regulatory constraints. Any promotional material must always accurately present both risks and benefits, and all claims need to be truthful, substantiated, and non-misleading.
At ProPharma Group, our experts can ensure that you adhere to applicable laws, regulations, and industry standards while maintaining the highest ethical standards for reporting of your sales, marketing, and promotional material in the EU/European Economic Area (EEA). We can help with all aspects of creating and publishing promotional material, including:
- Regulatory review of promotional and non-promotional materials and activities in accordance with the respective ethical codes in the local country
- Creation and update of Abbreviated Product Information (API) texts
- Support in setting up a routine for local review of promotional materials in the local country
- Advice on general questions regarding the local ethical codes