Chemistry Reference
In-Depth Information
such as the Commission on Human Medicines. These bodies consist of
independent members who are appointed by Ministers and are not staff of
MHRA. Not all applications for a Marketing Authorisation are successful;
the drug company may be asked to undertake further studies, or provide
additional data to support their application. Occasionally, an application
may fall due to serious issues relating to public health.
British Pharmacopoeia Commission
The British Pharmacopoeia Commission was established in 1970 under
Section 4 of the Medicines Act 1968. Members of the Commission (approx-
imately 20) are appointed by the Minister of Health and are responsible for
preparing new editions of the
British Pharmacopoeia
(BP) and the
British
Pharmacopoeia
(
Veterinary
). The Commission also provides members for
the UK delegation to meetings of the European Pharmacopoeia committees
in Strasbourg and is responsible, under Section 100 of the Medicines Act,
for selecting and advising on British Approved Names (BANs).
To help the Commission in its work, a number of Expert Advisory
Groups (EAGs) have been established. The EAGs function as committees of
the Commission and meet approximately four times a year; these are the
meetings where new monographs are planned and prepared and where the
'nitty gritty' of the Pharmacopoeia is discussed. There are EAGs covering
areas such as Medicinal Chemicals, Pharmacy, Herbal and Complementary
Medicines, Microbiology, Biological and Biotechnological Products, and
Veterinary Products. Each EAG is chaired by a member of the Commission
and is composed of experts in the relevant field.
The BP Commission can also call on expertise available in the British
Pharmacopoeia laboratories situated in the premises of the Laboratory of
the Government Chemist in West London. The BP laboratory carries out
and validates assay procedures for the Commission and in addition, is
responsible for the procurement, establishment, maintenance and sale of
British Pharmacopoeia Chemical Reference Substances (BPCRS). These
reference substances, as their name suggests, are authentic samples of a
drug or decomposition product which are used as standards in a drug assay.
The BP laboratory also fulfils an important forensic role in the control of
counterfeit medicines. With the advent of the internet, the public can easily
gain access to supplies of prescription-only medicines online. These
medicines are often adulterated, contaminated or simply counterfeit, and
comparison with authentic samples is necessary to ensure that the correct
preparation is supplied.
