§ Mr. Matthew TaylorTo ask the Secretary of State for Health if he will list the standards relating to the permissible levels of testosterone in(a) edible and (b) medicinal products in the UK; and what procedures apply in circumstances where products are banned. [46802]
§ Ms JowellThe use of hormones as growth promoters in animal production has been banned in the European Union since 1988. Any confirmed residue of testosterone in food resulting from the use of a growth promoter is illegal.
There are no standards relating to permissible levels of testosterone in medicinal products for human use in the United Kingdom. Currently, there are 14 licensed human medicinal products (capsules, injections, implants and transdermal patches) which contain testosterone, one of several testosterone esters or methyltestosterone as the active ingredient at amounts of 20–250 milligrams. Recommended doses are based on information obtained from clinical trials. The products are indicated mainly for treatment of conditions in males where testosterone supplementation is required, and are obtainable only on prescription.
In cases where there are concerns relating to safety, quality or efficacy of any licensed medicinal product, the marketing authorisation (MA) may be withdrawn voluntarily by the MA holder. Alternatively, the licensing 42W authority may take steps to revoke or suspend the MA. Procedural provisions relating to the grant, renewal, variation, revocation or suspension of UK MAs are contained in the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994.
The sale, supply and importation of medicinal products, and of animal feeding stuffs incorporating such medicinal products, which are the subject of a prohibition order under Section 62 of the Medicines Act 1968 are illegal, and a criminal offence by virtue of Section 67(3) of this Act. The maximum penalty is 2 years' imprisonment and/or an unlimited fine on indictment to the Crown Court.