About the BP

Pharmacopoeias that have legal status within the UK are the British Pharmacopoeia (BP), including the BP (Veterinary), and the European Pharmacopoeia (Ph. Eur.). The BP provides the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products and:

  • is published every year in August
  • becomes effective on 1 January of the following year
  • incorporates all the monographs and texts of the Ph. Eur.

The BP is a vital reference tool for all individuals and organisations involved in pharmaceutical:

  • research
  • development
  • manufacture
  • quality control and analysis

What does the BP contain

  • general notices (providing general information applicable to all texts)
  • general monographs (apply to all dosage forms)
  • specific monographs providing mandatory standards for:
    • active pharmaceutical ingredients
    • excipients
    • formulated preparations (licensed and unlicensed products)
    • herbal drugs, herbal drug products and herbal medicinal products
    • materials for use in the manufacture of homoeopathic preparations
    • blood-related products
    • immunological products
    • radiopharmaceutical preparations
  • infrared reference spectra
  • appendices
  • supplementary chapters (providing additional guidance)
  • comprehensive index

British Pharmacopoeia (Veterinary)

The BP (Veterinary) is published as a companion volume to the British Pharmacopoeia. It contains standards for substances and products used solely in the practice of veterinary medicine in the UK.

The BP (Vet) also incorporates monographs and texts of the European Pharmacopoeia.

European Pharmacopoeia

The Ph. Eur. is published by the European Directorate for the Quality of Medicines & HealthCare.

The European Pharmacopoeia Commission is responsible for the publication of the Ph. Eur. The UK is a member of the EP Commission and is involved at all stages of Ph. Eur. monograph development.

Post UK EU transition information

Legal framework

The British Pharmacopoeia (BP) continues to be part of the Medicines and Healthcare products Regulatory Agency’s public health role.

The UK was a founding member of the Convention on the Elaboration of a European Pharmacopoeia and continues to be a member of the European Pharmacopoeia (Ph. Eur.). The UK continues to be a member of the Council of Europe (CoE) in its own right.

The British Pharmacopoeia (BP) continues to reproduce Ph. Eur. text for the convenience of our customers.

In the absence of European Pharmacopoeia standards, Directive 2001/83/EC allows the continued applicability of BP standards (as a third party pharmacopoeia) for medicines and their components. Where the BP is appropriately referenced in the regulations of an EU member state, it may be considered a national pharmacopoeia of that EU member state.

References to EU requirements

There are instances in BP text that refer to EU requirements and further information about these are provided below.

1. EU regulations that have been transposed into domestic UK law and their UK equivalent:

EU law

UK law

Veterinary Medicines Regulation 2001/82/EC

The Veterinary Medicines Regulations 2013 amended by an EU Exit SI 2019/775

Human Medicines Regulation 2001/83/EC

The Human Medicines Regulations 2012 amended by an EU Exit SI 2019/775

Quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells Directive 2004/23/EC

The Human Tissue (Quality and Safety for human application) Regulations 2007

Sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs (EU No. 589/2014) [NOTE: this was replaced by Regulation EU No. 2017/644]

The Contaminants in Food (Amendment) (EU Exit) Regulations 2019

Technical requirements for blood and blood components 2004/33/EC (implementing Directive 2002/98/EC)

The Blood Safety and Quality Regulations 2005 (SIs 2005/50, 2005/1098 and 2006/2013) (Amendment) (EU Exit) Regulations 2019 (SI 2019/4)

Quality of water intended for human consumption Directive 98/83/EC

A combination of The Water Supply (Water Quality) Regulations 2000 and The Water Supply (Water Quality) Regulations 2010

2. EU regulations that will be retained in UK law and fixed on 1 January 2021 with examples of where the text can be found in the BP (the monographs are not an exhaustive list):

EU regulation to be retained in the UK

Example monograph

Permitted daily exposure to pesticides (EC No. 396/2005)

Appendix XI L. Pesticide Residues

Prevention, control and eradication of certain transmissible spongiform encephalopathies (EC No. 999/2001)

Appendix XXII B. Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents Via Human and Veterinary Medicinal Products

Animal by-products and derived products not intended for human consumption and repealing Regulation (EC No. 1774/2002 (Animal by-products Regulation))

Appendix XXII B. Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents Via Human and Veterinary Medicinal Products

Commission Regulation (EC) No. 208/2005

(this was replaced by (EC) No 1881/2006)

Vegetable Fatty Oils

BPCRS customers in the EU

The BP values all our British Pharmacopoeia chemical reference substances (BPCRS) users. The BP continues to provide products and post-sale support of the highest standard to our users in the EU and across the world to help them demonstrate compliance with monographs of the BP. 

We would like to continue to provide advice to EU customers now the UK has left the EU: 

  • The key point from a commercial perspective is that the UK is now a “third country” in regards to its relationship with the EU.
  • This means that BPCRS imported from the UK into Europe may be subject to additional customs checks and/or subject to import duties.
  • BPCRS are made under Delivery at Place (DAP) incoterms. The BP is responsible for the goods during transport until delivery. Ownership is transferred to the buyer when the goods are available for unloading. The customer is responsible for import clearance and any applicable local taxes or import duties.
  • Any local taxes or import duties is required to be paid by the customer in order to clear the goods through customs. Our courier(s) will be in contact with customers to arrange customs clearance and ensure that this is completed as quickly as possible.
  • UK goods will be considered as “non originating” goods under the preferential rules of origin within the EU.

What EU customers should do to prepare:

  • All EU Customers can continue to place orders via the BP website as usual.
  • Ensure that your customer contact details are up to date on your website account.  We will provide these details to our couriers and they will use these to contact you and clear shipments through customs.
  • Make sure that you know how to contact your countries’ customs authorities and you understand the processes of payment of any taxes or duties that may be due, in order to clear your goods as smoothly as possible.
  • For any questions, please continue to contact our helpdesk at bpcrs@mhra.gov.uk.

Helpful Links

What is the BP?