Further information on BP operations from 1 January 2021
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 will continue 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 will be 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.