The British Pharmacopoeia M Vallender Acting Group Manager .

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Safeguarding public healthThe British PharmacopoeiaM VallenderActing Group Manager,BP & Laboratory Services

Safeguarding public healthOUTLINE IntroductionNational ActivityEuropean and International ActivityFutureBritish PharmacopoeiaM Vallender 29 February 2012Slide 2

Safeguarding public healthINTRODUCTION Medicines and Healthcare products Regulatory Agency(MHRA)- UK Government Agency for ensuring medicines and medical devices work and are acceptably safe BP and Laboratory Services Group-BP incorporated into the MHRA Trading Fund in 2003Part of Inspection, Enforcement and Standards Division of MHRA19 members (16.5 BP 1.5 Lab Services) 1 PAPublications & Reference Materials (BP; BP (Vet); British Approved Names; ElectronicUpdates)- Website- Management of Laboratories (BP and MHRA)Evaluation & development of BP monographs; BPCRS establishment-Forensic workSupport for Regulatory activityMarket surveillanceBritish PharmacopoeiaM Vallender 29 February 2012]] MHRA]Slide 3

Safeguarding public healthBP and Laboratory Services Group (continued) Websites-www.mhra.gov.uk/pharmacopoeia Information about the BP News BPCRS Orders Forum for BPC Experts and Advisors Feedback to BP Secretariat-www.pharmacopoeia.co.uk BP Online Sales of the BP Feedback to publisher and BP SecretariatBritish PharmacopoeiaM Vallender 29 February 2012Slide 4

British PharmacopoeiaM Vallender 29 February 2012Slide 5

Safeguarding public healthLEGISLATION Medicines Act 1968 (Section 99)EC Directives2001/83/EC (human medicines)2004/27/EC (amending Directive 2001/83/EC)2001/82/EC (veterinary medicines)2004/28/EC (amending Directive 2001/82/EC)2004/24/EC (traditional herbal medicinal products)2001/83/EC (homoeopathic medicines)British PharmacopoeiaM Vallender 29 February 2012Slide 6

Safeguarding public healthRegional Activity European Pharmacopoeia- National Pharmacopoeial Authority- Secretariat Support for the United Kingdom Delegation- UK Members of Groups of Experts and Working Parties European Medicines Agency- Names Review GroupInvented namesBritish PharmacopoeiaM Vallender 29 February 2012Slide 7

Safeguarding public healthInternational Activity MHRA Policy World Health Organisation- Group of Experts on Nomenclature- International Nonproprietary Names- Memorandum of Understanding- Monograph Development Collaboration International harmonisation- Feedback to European Pharmacopoeia Chinese Pharmacopoeia- Memorandum of Understanding (MHRA & SFDA)- Collaboration Agreement between Chinese Pharmacopoeia & British Pharmacopoeia- TCMs & Mutually Agreed ProjectsBritish PharmacopoeiaM Vallender 29 February 2012Slide 8

Safeguarding public healthTopics Covered in BPMedicinal substances (Human and Veterinary)Formulated PreparationsGeneral MonographsSpecific MonographsBiological and Biotechnological Products (Blood Products, Vaccines etc)RadiopharmaceuticalsSurgical MaterialsHerbal MedicinesHomoeopathic PreparationsUnlicensed MedicinesVeterinary MedicinesMethods of testSupplementary informationBritish PharmacopoeiaM Vallender 29 February 2012Slide 9

Safeguarding public healthPublished Monographs Revision Programme- Medicines Act section 102 (1)- Targeted- Consequential- ResponsiveBritish PharmacopoeiaM Vallender 29 February 2012Slide 10

Safeguarding public healthBP PublicationsBritish PharmacopoeiaM Vallender 29 February 2012Slide 11

Safeguarding public healthBritish PharmacopoeiaM Vallender 29 February 2012Slide 12

Safeguarding public healthBP & BP (Vet) 2012-Published August 2011Effective 1 January 201235 new BP monographsIntegrates Ph Eur monographs3 In-year Electronic UpdatesAvailable in Book and Electronic FormatsBritish PharmacopoeiaM Vallender 29 February 2012Slide 13

Safeguarding public healthLooking Ahead Annual BP and BP (Vet) Publication British Approved Names Supplements Increase in New Formulated Preparation Monographs (licensed and unlicensed) Supplementary Chapters for BP and BP (Vet) Red Tape Challenge European Pharmacopoeia (Expertise; Advice; Comments on drafts; Laboratory support; UKGovernment support) International Collaboration Stakeholder Co-operation (manufacturers; practitioners; pharmacies etc) Website www.mhra.gov.uk/pharmacopoeia Tailored Publications FeedbackBritish PharmacopoeiaM Vallender 29 February 2012Slide 14

Safeguarding public healthFuture Strategy for World PharmacopoeiasWorking together- Acknowledge roles of National Authority- Acknowledge regional roles- Acknowledge commercial activityBritish PharmacopoeiaM Vallender 29 February 2012Slide 15

Safeguarding public healthThank youAny Questions?British PharmacopoeiaM Vallender 29 February 2012Slide 16

The British Pharmacopoeia M Vallender Acting Group Manager, BP & Laboratory Services . Slide 2! British Pharmacopoeia M Vallender 29 February 2012 . British Approved Names Supplements

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