Is your marketing material compliant?
Compliance and Medical Review Services provided by PhaMe in the Nordics and Baltics
Compliance and medical reviews are common tasks in the pharmaceutical industry when launching marketing material for a medicinal product or when inviting doctors to scientific conferences. Companies marketing medical devices, food supplements, and cosmetics have industry-specific requirements as well. In this article, we will be discussing how PhaMe can help you with compliance and medical reviews in the Nordic and Baltic countries.
It takes two to tango – compliance with regulations and ethics in the pharma industry
It is common knowledge that the pharmaceutical industry is heavily regulated. Thus, it is no surprise that the marketing material and marketing activities for medicinal products are also regulated. The PhaMe Compliance review ensures that all promotional and non-promotional activities related to medicines are in line with the European Union and national legislation.
The legal regulations for medicines are mandatory to follow for all pharmaceutical companies. In addition, companies may comply with ethical rules, codes of conduct, which are compiled by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and European Generics Medicines Association (EGMA).
The Code of EFPIA and Code of Conduct by EGMA outline ethical rules for the marketing of medicines to healthcare professionals and provide instructions on how to interact with healthcare professionals, healthcare organizations, and patient organizations. In summary, the codes of conduct ensure that the pharma industry performs promotional activities with professionalism and responsibility at the highest ethical level.
The PhaMe Compliance Review guarantees that the pharma industry’s ethical codes are considered during the entire life cycle of the marketing material and activities.
Be aware and check the local ethical codes!
The Code of EFPIA has been adopted to local ethical codes in all EFPIA member countries. The local ethical codes are also agreed with in the Nordic and Baltic countries and can be found on the website of e.g. PIF in Finland, LIF in Sweden, APME in Estonia, IPIA in Lithuania, and SIFFA in Latvia.
It is important to check the local ethical codes as they are slightly different in each country. For example, in Finland and Estonia, nurses are considered as consumers to whom prescription medicines cannot be marketed. In contrast, Sweden, Latvia, and Lithuania, consider nurses as healthcare professionals. Additionally, the pharma industry often invites healthcare professionals to attend conferences, which may take place overseas. In these cases, the local ethical code of the organizing country needs to be consulted before planning a doctor’s trip abroad.
PhaMe Compliance specialists are located in the Nordic and Baltic countries. Therefore, we can check the compliance of marketing according to the local ethical codes and in local languages.
Medical review – It’s not rocket science for PhaMe
Medical review of marketing material containing complex scientific and medical research results is literally rocket science for many – but not for PhaMe compliance specialists. Our specialists have a degree in pharmacy, medicine, or life sciences. Thus, the scientific content in marketing material for medicines can be easily reviewed.
Hang in there – what about non-medicinal products?
Non-medicinal products, such as medical devices, food supplements, and cosmetics, are also regulated by EU legislation, as well as by national authorities on medicine, food, product safety, chemicals, and environmental health. The classification of a product determines its number of requirements. Although there are less requirements to follow for non-medicinal products compared to medicines, the claims on their marketing materials and labeling need to be scientifically sound and truthful as well.
Hope for the best, prepare for the worst – with PhaMe’s help
It is a waste of time to hope that the marketing requirements for medicinal and non-medicinal products are of no concern. Thus, it is better to prepare the marketing material and activities according to the regulations and local ethic codes.
The variety of product classes equals to compliance with a variety of legal requirements and local ethical codes. To guide you through this jungle of requirements, PhaMe has Compliance specialists in the Nordic and Baltic countries. We offer local compliance and medical reviews for companies marketing medicinal products, medical devices, food supplements, or cosmetics.
Do your marketing materials and activities comply with the rules?
Do you need help with compliance review or medical review? Contact us!