Registration and monitoring of side effects

Updated 19 April 2012

The Danish Medicines Agency registers side effects reported by doctors and patients

At the Danish Medicines Agency, we register and analyse the side effects (adverse reactions) of medicine that are reported to us by doctors and other healthcare professionals, pharmaceutical companies, patients and relatives.

The information that we receive about side effects helps us to continually assess the safety of medicines on the market.

Time frame for reporting

Doctors, dentists and veterinarians must report all serious adverse drug reactions to the Danish Medicines Agency no later than 15 days after they have come to their attention.

A list of medicines subject to stricter reporting requirements for doctors, dentists and veterinarians is available on the our website (the list is in Danish only). At www.medicin.dk (a Danish language website), it will also appear from the description of the medicine if the medicine is under intensive surveillance and therefore subject to a stricter reporting duty.

Healthcare professionals, patients, relatives and animal owners can also report side effects.

Daily review of serious side effects

Everyday, the Danish Medicines Agency reviews all serious adverse reactions reported the day before to evaluate if there is a need for follow-up measures.

If we receive reports of a particularly severe nature, we assess whether there is a causal relationship between the side effects experienced by the patients and the medicine they have taken. In this process, we also consider which follow-up measures are needed - e.g. measures targeting physicians.

The Danish Medicines Agency keeps the company informed of side effects

The Danish Medicines Agency informs the company responsible for the product about any suspected serious adverse reactions or non-serious adverse reactions seen in Denmark. When it concerns suspected serious adverse reactions, the Danish Medicines Agency notifies the company within 15 days from receipt of the information.

If the company responsible for the product requires further details about the report, it must send its questions to the Danish Medicines Agency, which then forwards them to the reporting doctor or other person.

The Danish Medicines Agency must keep the EU authorities informed of side effects

The Danish Medicines Agency must also notify the European Medicines Agency (EMA) and the authorities in other EU and EEA countries within 15 days from receipt of reports on suspected serious adverse reactions.

The Danish Medicines Agency and the regulatory authorities in other EU countries report side effects to a common European database of the European Medicines Agency. The database gives us access to side effects seen in other EU countries.

The company must inform the Danish Medicines Agency of side effects within 15 days

Further information on informing the Danish Medicines Agency and the time frames: Spontaneous adverse reactions

The company has the primary responsibility for the medicine

Even though the Danish Medicines Agency is obliged to register and monitor side effects, it is the individual pharmaceutical company (the marketing authorisation holder) which has the primary responsibility for the safety and efficacy of the medicine.

Among other things, the company must have a system that ensures that all information about suspected adverse reactions is collected and processed so that it is accessible in one place in the EU/EEA.

In addition, the company must keep a detailed record of all side effects, regardless of the country of origin. These records form part of the companies continuous monitoring activities and the drawing up of the so-called periodic safety update reports (PSURs).

The Danish Medicines Agency regularly receives reports on the safety of medicines

A company which is authorised to market a medicine must regularly submit a periodic safety update report (PSUR) to the Danish Medicines Agency. The PSUR documents the safety of the medicine.

Scientific evaluation of the benefit-risk balance

The periodic safety update report must list and review all reported suspected side effects and must also include a scientific evaluation of the benefits and risks associated with the medicine as well as provide an overall assessment of the medicine's safety (assessment of the risk profile).

At the Danish Medicines Agency, we subsequently assess whether we concur with the conclusions of the report, and we decide whether it is necessary to implement special safety measures. In addition, we subsequently check whether the company concerned follows up on identified safety problems related to the medicine

The Danish Medicines Agency may change, suspend or withdraw a marketing authorisation

The Danish Medicines Agency may change, suspend or withdraw a marketing authorisation for a medicine if we find that new information about the safety of the medicine calls for it. Obviously, we are obliged to ensure that the information is correct and valid before we can make a decision about e.g. the suspension of a marketing authorisation

What is most important - the benefits or the risks of the medicine?

The process of weighing the benefits and risks of a given medicine is central to our licensing and monitoring activities.

Not just any risk of side effect may warrant the removal of a product from the market. The best solution is often to inform doctors and patients of side effects, so that they can take them into account when choosing the appropriate treatment.

Literature articles

The Danish Medicines Agency does not require submission of literature articles regarding spontaneous reports transmitted to the Danish Medicines Agency.

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