92000E3692

WRITTEN QUESTION P-3692/00

by John Cushnahan (PPE-DE) to the Commission

(23 November 2000)

Subject: The toxic nature of the Shu Gan Wan pill

Is the Commission aware of the toxic nature of the Shu Gan Wan (or Shu Kan Wan) pill, a traditional Chinese medicine? The pill is used to treat stomach or liver disorders and contains dangerous levels of mercury. What action does the Commission intend to take to protect consumers against this health risk?

Answer given by Mr Liikanen on behalf of the Commission

(19 December 2000)

No medicinal product may be marketed in the Community unless it has received a marketing authorisation and documentation has been submitted to enable its quality, safety and efficacy to be evaluated. Marketing authorisations are granted either through the centralised procedure for medicinal products

from biotechnology or for those which are particularly innovative, or through the national procedure. In the former case, the competent authority is the Commission, and in the latter, it is the authorities in the Member States.

Though traditional Chinese medicinal products such as Shu Gan Wan or Shu Kan Wan are presented as medicinal products with therapeutic benefits, they have no marketing authorisation under the centralised procedure. According to the data available, certain traditional Chinese medicinal products are contaminated by heavy metals such as mercury.

Since the Commission is not competent with regard to medicinal products which do not come under the centralised procedure, the national authorities are responsible for ensuring that only those medicinal products which have been properly authorised are marketed.