What Is a RIP?
Every Marketing Authorization Holder (MAH) operating in Belgium is legally required to appoint a RIP. Only one RIP is permitted per MAH, although one person can serve as a RIP for multiple companies simultaneously. The role exists to protect consumers by promoting the rational and safe use of medicines, based on complete and correct information.
The Responsibilities of a RIP
The RIP has a broad and impactful scope of responsibilities, including but not limited to:
- Ensuring compliance of product information: This includes verifying that the Summary of Product Characteristics and Patient Information Leaflets meet all regulatory requirements—and that these are correctly translated into Belgium’s official languages.
- Approval of promotional materials: The RIP must establish internal procedures for reviewing and approving all advertising and promotional content, such as brochures, digital media, and conference materials. Final approval of these materials falls under the RIP’s responsibility.
- Oversight of medical representative training: The RIP ensures that all company representatives who interact with healthcare professionals are properly trained and compliant with relevant legislation.
- Monitoring of medicine samples: The RIP ensures that the distribution of free samples adheres to Belgian regulations.
- Managing information requests: Whether questions come from patients or healthcare providers, the RIP ensures accurate and compliant responses.
- Compliance with rules on premiums and advantages: This includes overseeing activities such as hospitality, services, and compensation related to promotional events and professional interactions.
Becoming a RIP in Belgium
To act as a RIP, an individual must obtain an authorization number issued by the Federal Agency for Medicines and Health Products (FAMHP). This formal recognition confirms that the individual is qualified to safeguard public health through compliant communication.
By Sandra Hillaert
