After the grant of a Marketing Authorisation (MA) it is important that the entry of the product onto the market is successful. A successful launch depends on a number of factors that need to be considered before marketing the medicinal product. Depending on where the product is to be marketed, there are various local regulatory, legal as well as supply factors to be considered. Fulfilling these requirements for a launch presents some challenges as requirements can differ greatly within markets.
A review of the product packaging national requirements such as blue box requirements and inclusion of product national codes on the packaging materials needs to be carried out before launch. The packaging material should be reviewed for completeness, accuracy and conformance to the marketing authorisation. Some countries require the inclusion of national codes, mainly for reimbursement purposes to be included on the product packaging. Blue box requirements vary from market to market and according to the type of medicinal product and these should be verified prior to launch.
Depending on the active pharmaceutical ingredient or type of medicinal product, the provision of educational materials for healthcare professionals or patients may be required by health authorities as an additional risk minimisation measure. Educational materials can be brochures, patient alert cards or information on company websites to provide further information for users. Educational materials should be created in line with the agreed Risk Management Plan (RMP) for the medicinal product and with current regulatory requirements and must be submitted and authorised by the respective health authority before the launch. Local requirements, e.g. regarding style and communication plan, need to be taken into account.
Advertising and Promotion
Marketing and promotional activities are a crucial part of a new medicinal product launch. Ensuring compliance with national legislation for the advertising of medicinal products is essential. Some EU countries like Austria, Germany and Belgium require a named person to be responsible for scientific service and any promotional materials used for the medicinal product. The qualifications and experience mandatory for the responsible person differ within jurisdictions. Companies should ensure that the responsible person is appointed by the time the product is ready for launch.
Local Responsible Person for Pharmacovigilance
A legal requirement before product launch for some EU countries is a named responsible person for pharmacovigilance at the local national level. This named individual is required in addition to the company’s qualified person for pharmacovigilance (EU QPPV) and should also be registered according to the national requirements.
Further requirements for the launch of a medicinal product include contracts with local distributors. Health authorities may require informal or formal notification of local distributors; and in some cases approval is required for distribution activities. In line with the EU Directive on Falsified medicines, relevant medicinal products must be registered in the local electronic medicines verification system before the launch. This can be done by the pharmaceutical company or the authorised local distributor, depending on the specific constellation and local practice.
Further activities, that may be mandatory in the same countries and for some types of medicinal products, include pricing and reimbursement applications and registration in databases or compendia.