Publicity and Compliance
We support you in ensuring compliance of the promotional materials for your medicinal and healthcare products and of the promotional activities you sponsor or organize.
Publicity
As defined in Art 98 of Directive 2001/83 as amended, Marketing Authorisation Holders shall establish a scientific service for Medical Information.
In Belgium, this requirement is transposed in a Royal Decree that requires a Qualified Person Responsible for Information and Publicity (QP RIP) to be appointed and notified to the Health Authorities. IN2Pharma staff can act as QP RIP for your business in Belgium but also in the Netherlands and Luxembourg review and approve promotional material in compliance with applicable EU and local legislation.
IN2pharma offers support in all publicity for your medicinal and healthcare products in compliance with the applicable local legislation and regulatory requirements in Belgium, Luxembourg and the Netherlands. This includes (but is not limited to) the following tasks:
- Act as primary contact person for publicity to the local health authorities
- Review, suggest changes and/or approve local promotional material in compliance with local legislation on advertising
- Obtain approval from Authorities for advertising to the general public
- Establish or maintain local SOPs on Publicity, medical questions and Sample management to ensure these activities are compliant with local legislation and the Deontological Codes: Mdeon, Pharma.be, MedTech, CGR, … as applicable
- Facilitate the implementation and training of concerned staff in these SOPs
- Establish or maintain a control system for medical sample monitoring
- Control the distribution of medical samples to healthcare professionals and report to the Belgian Authorities as required
- Sign-off the declaration of conformity, certifying that any translations of the (scientific) leaflet of your medicinal products are conform to the respective current approved (scientific) leaflet
- Oversee the training of medical sales representatives to ensure an adequate medical education
Compliance & Transparency
Following several scandals on corruption in Big Pharma, healthcare compliance is a hot topic in most pharmaceutical and healthcare companies. According to recent local legislation, transfers of value from these companies to Healthcare Professionals (HCP) and Organizations (HCO) must be publicly disclosed on betransparent.be (B), Transparantieregister Zorg (NL) and via APL (Lux) every year.
IN2Pharma is well experienced in healthcare compliance and transparency requirements in Benelux. The support we offer includes (but is not limited to) the following tasks:
- Act as primary contact person for transparency to the local health authorities
- Provide training and advice on local healthcare compliance requirements
- Review and approve promotional activities and premiums & benefits: Compensation of services (speaker & consulting services by HCPs), Sponsorships and grants, Gifts and Hospitality in the context of scientific events
- Establish or maintain local SOPs on Promotional activities, Premiums & Benefits to HCP/Os to ensure these activities are compliant with local legislation and the Deontological Codes (Mdeon, Pharma.be, MedTech, CGR,…)
- Facilitate the implementation and training of concerned staff in these SOPs
- Review Mdeon visum applications in order to obtain the required visum in time
- Support in the establishment of contracts with HCPs and HCOs
- Upload or facilitate the preparation of the transparency file to be disclosed on national platforms
Phone
+32 16 891 600
Location
Hof Ter Loonst
Terloonststraat 22
1910 Kampenhout
Belgium
info@in2pharma.com