Annual report 2010 of the Danish Medicines Agency's laboratory control activities

22 July 2011

The drug regulatory authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2010 that describes the activities of the Agency to the OMCL network.

European laboratory cooperation in OMCL

The purpose of OMCL is to exchange knowledge and experience and to promote the elaboration of new common standards within the area of laboratory control of medicinal products. You can read more about the OMCL network in the box to the right.

Annual report 2010 of the Danish Medicines Agency's laboratory control activities

You can download the full report on our activities in the box to the right. Among the topics covered in the report are:

Testing of nationally authorised medicinal products

In 2010, the laboratory tested 545 nationally authorised medicinal products. Only two of these tests resulted in the withdrawal of products from the Danish market due to incorrect labelling, but a high share of the tests (73 %) caused us to discuss matters concerning labelling, SOPs as well as specifications and stability issues with the manufacturer.

Quality control of the labelling and packaging material of medicinal products

In 2010, the Danish Medicines Agency processed several cases concerning problems with the labelling and packaging material of medicinal products. A variety of problems were identified, including mix-ups between drug names and/or packaging design that look alike and poor legibility of package leaflets. In 2010, we continued to receive complaints regarding repackaging of parallel imported products.

Adverse incidents at hospitals

In 2010, the Danish Medicines Agency screened approx. 2,400 reports on adverse incidents that had been reported by hospitals to the Danish Patient Safety Database. 17 of these reports resulted in control cases regarding labelling and packaging material or the quality of the medicinal product.

Control of the availability of package leaflets on the portal at www.indlaegsseddel.dk

It should be easy for patients to have access to the latest version of a package leaflet of a medicine. To this end, the Danish Medicines Agency has developed a web-portal for package leaflets. It is mandatory for marketing authorisation holders to upload package leaflets (Danish: indlægsseddel) to the portal on www.indlaegsseddel.dk. In 2010, we have checked whether the companies have conformed with this requirement. We checked the leaflets of 233 products from 115 companies.

Illegal products and counterfeits

The Danish Medicines Agency maintained focus on illegal products and counterfeits in 2010. A new area of interest this year was electronic cigarettes (or e-cigarettes). In Denmark, e-cigarettes containing nicotine are considered a medicinal product. This means that they must be approved with a marketing authorisation before they may be sold legally on the Danish market. At present, there are no nicotine-containing e-cigarettes with a marketing authorisation in Denmark.

Illegal online sale of medicines and healthcare products may pose a serious risk to the health of consumers. The products may contain active pharmaceutical ingredients in varying quantities, quality and composition, with no guarantee of their safety and effect.

Development of test methods

We work with the detection of extraneous agents in veterinary vaccines by means of real-time PCR. And we also work with cell therapy products.

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