Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme. Approximately 19,000 reports of suspected ADRs are reported to the MHRA/CHM through this scheme each year by health professionals and patients.
The MHRA is committed to making information about the yellow scheme and the information it collects as accessible as possible on the MHRA website. Information on the Yellow Card Scheme website was most recently updated on 1 December 2006. Drug analysis prints were most recently updated on 18 November 2006 to include ADR data received by the MHRA up to and including 26 May 2006.
The MHRA is currently implementing a major upgrade of the drug safety monitoring database and data reporting systems. This upgrade includes a review of the presentation of aggregated drug safety information with a view to making the information easier to interpret. Subsequent to this redesign, the MHRA will update the adverse drug reaction data on a three-monthly cycle.
(2) what factors determine whether the medicines control agency removes from a retailer (a) the complete stock and (b) a sample of a product which they wish to test; and if she will make a statement;
(3) what guidance she issues to retailers on the categories of goods which are liable to seizure by the medicines control agency;
(4) what strategy the medicines control agency adopts in seizing products deemed unsafe from retailers in particular areas; what approach was used in relation to seizures from Hedonic of Portsmouth; and what the purpose of the seizures made was;
(5) what steps the medicines control agency has taken to seize health food products deemed unsafe from (a) wholesalers and (b) importers.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom regulatory authority with responsibility for the licensing and control of medicines on the UK market.
In the UK, medicinal products on the UK market are controlled under the Medicines Act 1968 and supporting regulations. The Act places controls on the sale, supply, distribution and manufacture of medicinal products in the UK. It also places a statutory duty on the Secretary of State for Health to enforce, or secure the enforcement of, the provisions of the Act. Section 8 contains rights of entry, powers to inspect products and equipment, to take samples and to seize products and documentation in order to ascertain whether or not there may have been a contravention of the legislative requirements. MHRA guidance on the legislative requirements is available in the “Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002” and on the MHRA website at www.mhra.gov.uk. No specific MHRA guidance is issued to retailers.
Medicinal products which do not meet the regulatory requirements cannot be guaranteed for their safety, quality or efficacy and may pose a significant risk to public health and their sale or supply may constitute a criminal offence. Products suspected of breaching these legislative requirements can be inspected, sampled and seized under powers available under section 8 of the Act. If it is not known whether or not a product offered for sale is falling outside licensing requirements, a sample can be taken and submitted for analysis.
Enforcement officers at MHRA carry out investigations into suspected illegal activity involving medicines on a UK-wide basis. If products in stock at a retail outlet are found to be illegally on sale, they can be seized and removed from the premises. The products seized from Hedonic in Southsea were in response to an adverse drug reaction report for a product on sale for humans and containing Benzyl Piperazine (BZP) a derivative of a veterinary product, Piperazine. MHRA investigations are continuing.