Every day, millions of people rely on the quality and safety of our products.
All medicines have potential side effects as well as benefits. We
routinely monitor the safety and quality of all our products. This
includes review of safety data from clinical studies and review of
side effects and technical complaints received on marketed products.
By monitoring quality and safety information on our products we can
take due and appropriate actions to safeguard patient safety if needed.
We have in place a Quality Management System to ensure that we
adhere to international and local legislation and that safety
information is handled in the same way no matter in which country the
Our Global Safety team has a pharmacovigilance system in place
ensuring that the necessary means for collection and notification of
any safety data are in place.
Prior to any clinical investigation of a new pharmaceutical product
or medical device, a safety committee with members from all relevant
functional areas is established. This committee will exist throughout
the product or device’s life cycle. It is a multi-disciplinary team
providing assessments of safety data, for a pharmaceutical product or
medical device in development or on the market.
Further procedures ensure we can react promptly and adequately
if one of our products on the market, or used in clinical trials, is
suspected of being affected by a significant product defect, such as
recalling affected products.
We are committed to patient safety and want to make it easy for
patients to get in contact with us, if they have a complaint or want
to report a side effect. Therefore, we have established easily
accessible online complaint reporting directions with contact
information in local language.
Counterfeit products pose
significant and potentially life-threatening risks to the health of
patients. Such products may lack active ingredients so patients do not
receive the treatment they expect and need, or they may contain other
ingredients that could pose a safety risk.
To ensure patient safety, we have been implementing a comprehensive
anti-counterfeit programme. A cross functional Anti-Counterfeit
Working Group, chaired by the head of our Customer Complaint Centre,
ensures vigilant risk assessment and implementation of an
Anti-Counterfeit Product strategy.
We have an ongoing international collaboration with regulatory
bodies, scientific and trade organisations, law enforcement agencies
and other stakeholders to investigate counterfeit products and to
influence legislation regarding new anti-counterfeit measures.
Those found guilty of producing or/and distributing counterfeit Novo
Nordisk products are given fines and/or custodial sentences. China, as
a result of lobbying and official intervention, has increased the
length of sentences for counterfeiting.
We are a member of the Pharmaceutical Security Institute (PSI),
which on behalf of the approximately 30 largest pharmaceutical
companies, collects information and coordinates investigations into
counterfeit products worldwide.
We conduct regular reviews of risks through information exchange
with external collaborators. The investigation of suspected
counterfeit cases is reported via our affiliates or authorities.
Monthly internal counterfeit surveillance reports are reviewed by key
specialists and management.
Our Quality Management System identifies and investigates alleged
occurrences of counterfeited Novo Nordisk products. In China, we work
with local investigation firms to perform market searches to help
health authorities track down and seize counterfeit products. Outside
China, we conduct investigations of suspected counterfeit products
based on risk analysis and take legal action against those involved in
the counterfeiting of our products.
Recognising that low awareness and under-reporting are known issues
in many countries, we provide internal video training for our
In China, our proactive approach including collaboration with and
training of local authorities, and scouting for counterfeit products
and reporting these to local authorities has enabled us to keep
counterfeit products at a relatively lower level.
Currently, the main products being counterfeited
are NovoFine® in China and Norditropin® sold via
the internet or in fitness centres.
In 2022, Novo Nordisk had 3 product recalls.
In Belgium, the recall was due to distribution without approved
commercialisation. In Finland and Sweden, the recall was due to
temporary communication timeouts during dose log transfers. In
Algeria, the recall was due to a mix-up of information on the vignette
for one of Novo Nordisk's products.
In 2022, Novo Nordisk had not failed any inspections among those
that were resolved at year-end. During 2022, 150 inspections of Novo
Nordisk were conducted. The number of inspections is close to the
level it was at before COVID-19. At year-end, 113 inspections were
passed and 37 were unresolved, as final inspection reports had not
been received or the final authority's acceptance was pending, which
is normal. Follow-up on unresolved inspections will continue in 2023.