Glossary of MHRA terms - B

B

---

BAN
British Approved Names. This is a list of officially recognised names of medicinal substances produced by the British Pharmacopoeia Commission. (See also rINN).

BAV
British Avenue, Blackpool (Centre for Assistive Technology).

BGMA
British Generic Manufacturers Association. This body represents the interests of UK based manufacturers and suppliers of generic medicines and promotes development of generic medicine industry.

BHMA
British Herbal Medicines Association. This body represents the interests of herbal medicine in the United Kingdom and ensures its continued statutory recognition.

Biological medicinal products and Biopharmaceutical products
A biological medicinal product contains an active biological substance. The following are considered as biological medicinal products: recombinant proteins, monoclonal antibodies, blood products and immunological products such as sera and vaccines, allergens and advanced technology products such as gene and cell therapy products.

Biologicals
Products which cannot be tested adequately by chemical means such as vaccines.

Biosimilar
The active substance of a biosimilar medicine is comparable to a biological reference medicine. Biosimilar and biological reference medicines are used at the same dose to treat the same disease. The name, appearance and packaging of a biosimilar medicine differs to that of a biological reference medicine.

Biotechnology
A biotechnology product is one manufactured by recombinant DNA technology, one where genetic manipulation of cells is required, or a monoclonal antibody. Applications for these products are required to be submitted through the European Centralised procedure.

BIR
British Institute of Radiology. The BIR is unique in the UK as a multidisciplinary radiological organisation which welcomes all radiological professionals into its membership. Equal medical/non-medical representation is maintained on its Council. Multidisciplinary collaboration and networking is fostered in particular through its scientific committees and scientific meetings.

BIRA
See: TOPRA [The Organisation for Professionals in Regulatory Affairs].

BMA
British Medical Association.

BNF
British National Formulary. This is a list of medicines used in the UK compiled by the British Medical Association and the Royal Pharmaceutical Society.

Borderline products
Products which are close to the boundary between medicines which need a licence, and products such as nutritional supplements, cosmetics etc. which do not. Classification depends either on the ingredient or the claim or both.

BP
British Pharmacopoeia. This is the only comprehensive collection of standards for UK medicinal substances. It is an essential reference for all individuals and organisations involved in pharmaceutical research, development, manufacture and testing.

BPC
British Pharmacopoeia Commission. The Commission is responsible for preparing new editions of the British Pharmacopoeia and for selecting and devising British Approved Names (BANs).

BROMI
Better Regulation of Over the Counter Medicines Initiative.

BPC
British Pharmacopoeia Commission.

BSE
Bovine Spongiform Encephalopathy.

BSI
British Standards Institution.