The Role of the Responsible Person for Info & Publicity in Belgium

Given the direct impact pharmaceutical products have on human health, all information about them must be conveyed responsibly and accurately. 

In Belgium, as in the rest of the EU, the pharmaceutical industry is closely regulated, and pharmaceutical companies must adhere to strict guidelines regarding information and publicity. Each Marketing Authorization Holder (MAH) in Belgium must appoint a Responsible person for information and publicity (RIP) whose role is to ensure that the company complies with legal and ethical standards while communicating with healthcare professionals, patients, and the general public. The RIP plays a crucial role in preventing misleading, false, or harmful information from reaching healthcare providers or the public, thus safeguarding the integrity of the pharmaceutical industry and maintaining public trust.  

Legal Context and Obligation of the Marketing Authorization Holder (MAH) 

Under the legal framework established by the Directive 2001/83/EC of the European Parliament and of the Council (6 November 2001) on the Community Code relating to medicinal products for human use (Article 98), the law on Medicinal Products of 25 March 1964 (Article 9) and the Royal Decree concerning information and advertising for medicinal products for human use of 7 April 1995 (Articles 11, 13, 14, 15, 17 & 18), each MAH in Belgium must appoint one RIP. The RIP may be either a member of the company or an external consultant, and only one RIP is permitted per MAH. The MAH must notify the Federal Agency for Medicines and Health Products (FAMHP) of the RIP’s name and inform them of any subsequent changes. In the event of the RIP’s absence, his/her replacement must also be reported to the FAMHP. 

Responsibilities of the RIP 

The duties of the RIP include, but are not limited to: 

• Verifying the product information compliance (Summary of Product Characteristics and Package Leaflets) and their translations.  
• Overseeing and approving all advertising projects and promotional activities (e.g., brochures, online content, etc.) and establishing an appropriate internal procedure for these activities. 
• Ensuring compliance with regulations on ‘premiums or advantages’. 
• Overseeing the training of medicinal representatives interacting with healthcare professionals. 
• Ensuring compliance with regulations on medical samples 

Agreement Number and Qualifications 

To act as a RIP for a pharmaceutical company, an individual must obtain an agreement number issued by the FAMHP. To secure this number, the following conditions must be met: 

• Holder of a legal diploma in pharmacy, medicine, or veterinary medicine; 

(For EC nationals: equivalent diplomas with EU/EEA recognition may also be accepted) 

• Experience of at least one year in the field of pharmaceutical information demonstrated through a descriptive certificate of accomplished tasks.  

Once the agreement number is granted, the individual may serve as the RIP for an MAH. The agreement number is personal and is not tied to any specific company or MAH. Furthermore, a RIP can work for different companies concurrently. 

In conclusion, the Responsible Person for Information and Publicity (RIP) role is vital to ensuring that pharmaceutical companies in Belgium adhere to legal and ethical standards when communicating information about medicinal products. By overseeing advertising, training, and regulatory compliance, the RIP helps protect public health and maintain the integrity of the pharmaceutical industry. 

This article was written by: 

Karin Begtas 

Regulatory Affairs Specialist BeNeLux 

ProductLife Group