Promotion is a vital part of any medicinal product’s life cycle, but in order to avoid financial penalties, all interactions with physicians and patients must be both ethical and compliant with regulations.
By LINK Medical Regulatory Team
Communication has changed drastically over the last decade with the rise of mobile technology and social media. As a consequence, laws and regulations have sprung up governing the ways that pharmaceutical companies can use this technology to promote medicinal products. There is a range of quality systems in place to evaluate and assess promotional communication and activities, and compliance can present a significant challenge to companies striving to promote their medicinal product in the most effective way.
In Sweden, the promotion of medicines is governed by the pharmaceutical law and the Medical Products Agency’s (MPA) regulations for marketing pharmaceuticals, which are heavily influenced by European directives. In addition to the regulations laid out by the MPA, the Swedish Association of the Pharmaceutical Industry (LIF) has developed a set of ethical rules governing promotional activities.
Companies that fail to comply with rules and regulations in their promotional activities may face severe financial consequences. In Sweden, the Information Examiner Committee (IGN) has the power to hand out substantial fines of up to 500,000 SEK, which are payable to LIF. Similarly, in Denmark and Norway, violation of ethical regulations can result in fines of up to 300,000 DKK/NOK. In addition, violations recognised by the IGN are published publically, along with the amount of the fine. Thus, non-compliance not only leads to a financial setback, but also critical damage to brand integrity.
In order to ensure compliance when promoting a medicinal product, it can be beneficial to form a strategic partnership with external regulatory experts. LINK Medical’s highly competent regulatory team has over 25 years of experience covering both local and international regulatory guidelines. The team will hold a Communications Compliance Seminar in August; to get the invite and find out more about how to stay on the right side of regulations.
About LINK Medical
- LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe.
- LINK Medical has 180 employees providing expert guidance across every aspect of a project – all from ONE source.
- LINK Medical has regulatory specialists present in all Nordic countries.
- LINK Medical handles over 6500 regulatory projects per year, ranging from single tasks to larger projects for small and big companies in all of the Northern Europe.
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