Art 98 of Directive 2001/83 as amended require Holders of Marketing Authorisation for Medicinal Products to appoint a Responsible Person for Medical Information.
Responsible Person for Medical Information Job Description
- during development, provide advice on legal requirements and other recommendations applicable to Medicines Promotion
- perform editorial checks of all written promotional materials; all elements must be scientifically correct, up-to-date, verifiable and non-misleading.
- ensure that information about medicines provided to healthcare professionals and to the general public is in line with the approved product information and the Summary of Product Characteristics.
- train marketing and sales representatives on the do's and dont's of medicines promotion.
- medical information procedures.
Audit of the Medical Information system consists of
- compliance of procedures with applicable regulatory requirements
- compliance of operating procedures with quality system requirements
- implementation of the quality system and documental instructions.
- processes for free sample distribution should meet all legal and procedural requirements
- documentation of free medical sample distribution
- staff qualifications, training records and documentation of experience
Want to know more / require a quote?
Send your request to mi [at] archemin.eu