3.02 Information about side effects is important
It is important that the individual user of a medicine is given comprehensive information about the side effects and risks that may be connected with using that particular medicinal product.
It is in the pharmaceutical industry’s interest to have as complete a picture as possible of the usage of individual products and to receive the most comprehensive information possible about the product, including its side effects, from authorities, doctors, patients and other health professionals.
It is also in the pharmaceutical industry’s interest that the information in package leaflets reflects the most recently updated knowledge about the use of the products which the companies have received concerning their products and consider relevant to pass on.
Therefore Lif fully endorses the augmented duty to report adverse events that has been introduced in respect of medicinal products during their first years on the market, and Lif also welcomes the fact that the user can now report adverse events directly to the authorities
Lif believes:
- that it is essential that patients who experience adverse reactions to a pharmaceutical product inform their doctor, the authorities or the company concerned. Only in this way can the authorities and the company concerned become aware of new adverse reactions,
- that, to ensure the quality of the individual adverse drug reaction reports, it is important that the company, if necessary, will have the opportunity to follow up on all types of reports submitted,
- that it is the responsibility of the company to gather and assess information about adverse reactions and together with the authorities to assess whether the product information needs to be changed,
- that it is essential that Danish industry complies with the EU requirements and that special national requirements are not imposed on the industry.
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