MHRA - Guidance List - Final

Guidance list for the Medicines and Healthcare products Regulatory Agency
Date last Next

published Target audience Type of review*
(MM- (Business Sector, guidance (select (MM-
Title* YYYY) Consumers etc) from drop-down) YYYY) Link Notes
MEDICINES REGULATIONS
MARKETING AUTHORISATIONS
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/ReviewofE
Review of EU medicines legislation (''2001 Review'') 10-2009 industry Regulatory 04-2010 Umedicineslegislation(2001Review)/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/ReviewofE
Sunset Clause 06-2009 industry Regulatory 01-2010 Umedicineslegislation(2001Review)/SunsetClause/index.htm
MHRA policy statement: Interpretation of Article 23a and Article 24 (4- Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
6) of Directive 2001/83EC - the so-called "Sunset Clause" 01-2007 industry Regulatory 01-2010 policy/documents/websiteresources/con2025697.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
Guidance Note 8: A guide to what is a medicinal product 06-2007 industry Regulatory See note ic/documents/publication/con007544.pdf Current - no review date
Guidance on requesting a review of a provisional determination Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
issued by the Borderline Section of the MCA 09-2001 industry Regulatory See note pol/documents/websiteresources/con009272.pdf To be read with Guidance Note 8
Guidance Note 14: The supply of unlicensed relevant medicinal Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
products for individual patients 01-2008 industry Regulatory See note ic/documents/publication/con007547.pdf Reviewed when there are changes to legislation
Guidance Note 23: Advertising and promotion of Medicines in the Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
UK - The Blue Guide 11-2005 industry Regulatory 10-2010 a/documents/publication/con2022589.pdf
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Marketing authorisations 07-2009 industry Regulatory 01-2010 medicines/Marketingauthorisations/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Marketingauthorisations/Abridgedproducts/index.ht
Abridged products (Marketing authorisations) 09-2005 industry Regulatory 06-2010 m
Pharmaceutical medicines/Marketingauthorisations/Biologicalandbiotechnology
Biological and biotechnology products (Marketing authorisations) 09-2005 industry Regulatory 06-2010 products/index.htm
Pharmaceutical medicines/Marketingauthorisations/Renewaloflicences/index.ht
Renewal of licences (Marketing authorisations) 05-2008 industry Regulatory 06-2010 m
Pharmaceutical medicines/Marketingauthorisations/Variationstolicences/index.
Variations to licences (Marketing authorisations) 07-2009 industry Regulatory 01-2010 htm
National Type II safety variations 'Request for Further Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Information'(RFI): Pilot project plan (Marketing authorisations) 07-2009 industry Regulatory 01-2010 a/documents/regulatorynews/con051864.pdf
Guidance on the appeal procedure for refused national Type II Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
variations 01-2005 industry Regulatory 01-2010 a/documents/websiteresources/con1004242.pdf
Pharmaceutical medicines/Marketingauthorisations/Changeofownershipapplica
Change of ownership applications (Marketing authorisations) 06-2009 industry Regulatory 01-2010 tions/index.htm
Parallel import licences 10-2009 industry Regulatory 04-2010 medicines/Parallelimportlicences/index.htm
Guidance note for PLPI companies on user testing of patient Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
information leaflets 02-2009 industry Regulatory 04-2010 plpi2/documents/websiteresources/con2031452.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Additional guidance on PIL user testing for PLPI products 09-2007 industry Regulatory 04-2010 plpi2/documents/websiteresources/con2033788.pdf
Questions and answers on PLPI PIL user testing 04-2008 industry Regulatory 04-2010 plpi2/documents/websiteresources/con014586.pdf
Bridging applications (PLPI) 06-2008 industry Regulatory 04-2010 plpi2/documents/websiteresources/con018049.pdf
Conditions for patient consultation by similarity to the UK leaflet 03-2009 industry Regulatory 04-2010 plpi1/documents/websiteresources/con041448.pdf
Pharmacovigilance for parallel imports products 09-2009 industry Regulatory 04-2010 plpi2/documents/websiteresources/con057402.pdf
Parallel import applications - Guidance concerning requests for Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
further information (RFIs) 01-2008 industry Regulatory 04-2010 plpi2/documents/websiteresources/con2033978.pdf
Application to leaflet variations (PLPI) 07-2009 industry Regulatory 04-2010 plpi2/documents/websiteresources/con054454.pdf
Legal status and reclassification 07-2009 industry Regulatory 06-2010 medicines/Legalstatusandreclassification/index.htm
Guidance note 11: Changing the legal classification in the United Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
Kingdom of a medicine for human use 04-2002 industry Regulatory See note ic/documents/publication/con007545.doc Under review
MHRA guidance on the application for exclusivity for change in legal Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
status of a medicine 06-2005 industry Regulatory 06-2010 a/documents/publication/con1004381.pdf
List A: Consolidated list of substances in prescription only medicines Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-

(POM), with exemptions for pharmacy sale or supply 11-2009 industry Information only 11-2010 a/documents/websiteresources/con009484.pdf
List B: Consolidated list of substances in authorised medicines for Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
general sale 07-2009 industry Information only 07-2010 a/documents/websiteresources/con009485.pdf
List C: Consolidated list of substances which are present in Pharmaceutical medicines/Legalstatusandreclassification/Listsofsubstances/C
authorised products which have been reclassified since 1 April 2002 11-2009 industry Information only 11-2010 ON2015073
Pharmaceutical medicines/Legalstatusandreclassification/Recentreclassificatio
Recent reclassifications 07-2009 industry Regulatory 01-2010 ns/index.htm
Pharmaceutical medicines/Informationforlicenceapplicants/Licenceapplicationf
Licence application forms 06-2009 industry Information only 01-2010 orms/index.htm Do we need to add individual forms?
Pharmaceutical medicines/Informationforlicenceapplicants/Fasttrackingofmark
Fast tracking of marketing authorisation applications 02-2008 industry Regulatory 02-2010 etingauthorisationapplications/index.htm
Changing the name of a company for authorisations held under Pharmaceutical medicines/Informationforlicenceapplicants/Changingthenameof
Medicines Regulations 08-2008 industry Regulatory 02-2010 acompany/index.htm
Reporting suspected adverse drug reactions (Info for licence Pharmaceutical medicines/Informationforlicenceapplicants/Reportingsuspected
holders) 09-2006 industry Regulatory 03-2010 adversedrugreactions/index.htm
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Mandatory electronic ICSR reporting 09-2006 industry Regulatory 03-2010 p/documents/websiteresources/con2018004.pdf
Pharmaceutical medicines/Informationforlicenceapplicants/PeriodicSafetyUpda
Periodic Safety Update Reports (Info for licence holders) 01-2009 industry Regulatory 01-2010 teReports/index.htm
Provisions to which the marketing authorisation is granted (Info for Pharmaceutical medicines/Informationforlicenceapplicants/Provisionstowhichth
licence holders) 01-2007 industry Regulatory 01-2010 emarketingauthorisationisgranted/index.htm
medicines/Informationforlicenceapplicants/Guidance/Bestpracti
Best practice guidance for national marketing authorisations (MA) Pharmaceutical ceguidanceforprocessingnationalmarketingauthorisationapplic
pilot initiative 08-2009 industry Best practice 02-2010 ations/index.htm
Guidance note 29: MHRA naming policy with respect to umbrella Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
segments of product names 12-2003 industry Regulatory See note ic/documents/publication/con007558.pdf Under review
Pharmaceutical medicines/Informationforlicenceapplicants/Guidance/Namingp
Changes to medicines names: BANs to rINNs 03-2008 industry Regulatory 06-2010 olicy/ChangestomedicinesnamesBANstorINNs/index.htm
Pharmaceutical medicines/Informationforlicenceapplicants/Guidance/Labelling
Labelling: Vitamin C 09-2006 industry Regulatory 06-2010 VitaminC/index.htm
Guidance on compliance with the Medicines (Child Safety) Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Regulations 2003 09-2003 industry Regulatory See note a/documents/websiteresources/con009529.pdf Reviewed when there are changes to legislation
Pharmaceutical medicines/Informationforlicenceapplicants/Guidance/Overdose
'Generic' overdose sections 01-2007 industry Regulatory 06-2010 sectionsofSPCs/Genericoverdosesections/index.htm
Minimum clinical particulars for pharmacy (P) and general sales list
(GSL) Ibuprofen for systemic administration - Guidance to marketing Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
authorisation (MA) holders 11-2007 industry Regulatory 06-2010 a/documents/websiteresources/con2033953.pdf
Minimum clinical particulars for non-selective prescription only
(POM) NSAIDs for systemic administration (excludes asprin/salicylic Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
acid derivatives) 11-2007 industry Regulatory 06-2010 a/documents/websiteresources/con2033954.pdf
Pharmaceutical medicines/Informationforlicenceapplicants/Otherusefulservices
Scientific advice for licence applicants 04-2009 industry Regulatory 02-2010 andinformation/Scientificadviceforlicenceapplicants/index.htm
medicines/Informationforlicenceapplicants/Otherusefulservices
Pharmaceutical andinformation/RequestsforMHRAtoactasReferenceMemberSt
Requests for MHRA to act as Reference Member State (RMS) 08-2007 industry Regulatory 06-2010 ate(RMS)/index.htm
Code of practice for pack design for over the counter medicines 10-2009 industry Regulatory 06-2010 a/documents/websiteresources/con031175.pdf
CLINICAL TRIALS
Pharmaceutical medicines/Clinicaltrials/Isaclinicaltrialauthorisationrequired/inde
Clinical trial authorisations: Is a clinical trial authorisation required? 07-2009 industry Regulatory 01-2010 x.htm
Is it a clinical trial of a medicinal product? 09-2005 industry Regulatory 01-2010 unit1/documents/websiteresources/con009394.pdf
Clinical trial authorisations: Applying for authorisation to conduct a Pharmaceutical medicines/Clinicaltrials/Applyingtoconductaclinicaltrial-
clinical trial - Initial application 07-2009 industry Regulatory 01-2010 Initialapplication/index.htm
medicines/Clinicaltrials/Applyingtoconductaclinicaltrial-
Clinical trial authorisations: Timescales and outcomes - Initial Pharmaceutical Initialapplication/Timescalesandoutcomes-
applications 03-2009 industry Information only 01-2010 Initialapplications/index.htm
Clinical trial authorisations: Maintaining a clinical trial authorisation - Pharmaceutical medicines/Clinicaltrials/Maintainingaclinicaltrialauthorisation(C
Amendments and trial conclusion 11-2009 industry Regulatory 01-2010 TA)-Amendmentsandtrialconclusion/index.htm
medicines/Clinicaltrials/Maintainingaclinicaltrialauthorisation(C
Clinical trial authorisations: Timescales and outcomes - Pharmaceutical TA)-Amendmentsandtrialconclusion/Timescalesandoutcomes-
Amendments 04-2008 industry Best practice 01-2010 Amendments/index.htm
Clinical trial authorisations: Making clinical trial submissions to the Pharmaceutical medicines/Clinicaltrials/MakingclinicaltrialsubmissionstotheMH
MHRA 07-2009 industry Best practice 01-2010 RA/index.htm
Fees for clinical trials 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Fees/index.htm
Pharmaceutical medicines/Clinicaltrials/Safetyreporting-
Clinical trial authorisations: Safety reporting - SUSARS and ASRs 03-2009 industry Information only 01-2010 SUSARSandASRs/index.htm
Clinical trials for medicines: Current issues 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Currentissues/index.htm
Clinical trials: Arrangements for trials which had an exemption or Pharmaceutical medicines/Clinicaltrials/Trialsapprovedbefore1May2004/index.
certificate on 1 May 2004 07-2009 industry Information only 01-2010 htm
Clinical trials: Frequently asked questions 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Questionsandanswers/index.htm
Pharmaceutical medicines/Clinicaltrials/UKclinicaltrialauthorisationassessment
UK clinical trial authorisation assessment performance 09-2009 industry Information only 01-2010 performance/index.htm
Clinical trials: Mock applications 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Mockapplications/index.htm
Pharmaceutical medicines/Clinicaltrials/Additionalinformationforapplicants/inde
Clinical trial authorisations: Additional information for applicants 07-2009 industry Information only 01-2010 x.htm
Pharmaceutical http://www.mhra.gov.uk/idcm2/groups/l-
Clarification of contraceptive wording in clinical trials 11-2007 industry Information only 01-2010 unit1/documents/websiteresources/con2033037.pdf
Regulatory requirement for QT interval assessment 11-2007 industry Information only 01-2010 unit1/documents/websiteresources/con2033038.pdf
Pharmaceutical medicines/Clinicaltrials/ImplementationoftheClinicalTrialsDirect
Implementation of the Clinical Trials Directive in the UK 07-2009 industry Regulatory 01-2010 iveintheUK/index.htm
Description of the Medicines for Human use (Clinical Trials) Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
regulations 2004 11-2005 industry Regulatory 01-2010 unit1/documents/websiteresources/con2022633.pdf
Medicines for Human Use (Clinical Trials) Regulations 2004 - Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Memorandum of understanting between MHRA, COREC and GTAC 10-2006 industry Regulatory 01-2010 unit1/documents/websiteresources/con2025075.pdf
Pharmaceutical medicines/Clinicaltrials/Legislationandguidancedocuments/ind
Clinical trial authorisations: Legislation and guidance documents 07-2009 industry Both 01-2010 ex.htm
INSPECTION, MANUFACTURING AND WHOLESALING
Guidance Note 6: Notes for applicants and holders of a wholesale Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
dealer's licence 08-2006 industry Regulatory See note ic/documents/publication/con007543.pdf Reviewed when there are changes to legislation
Interim guidance - minimising the risk of transmission of
Transmissible Spongiform Encephalopathies via unlicensed Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
medicinal products for human use 10-2003 industry Regulatory md/documents/websiteresources/con009281.pdf
Guidance Note 5: Notes for applicants and holders of a Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
manufacturer's licence 09-2005 industry Regulatory See note ic/documents/publication/con007542.pdf Reviewed when there are changes to legislation
Guidance Note 27: Guidance notes for industry on the preparation of Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
a Site Master File 07-2005 industry Regulatory See note ic/documents/publication/con007556.pdf Current - no review date
Guidance Note 28: Guidance notes for industry on the preparation of
a Site Master File for an overseas site subject to inspection by the Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
UK regulatory authority 07-2005 industry Regulatory See note ic/documents/publication/con007557.pdf Current - no review date
Pharmaceutical medicines/ManufacturersandWholesaleDealerslicences/index.
Manufacturer’s and Wholesale Dealer’s licences 11-2009 industry Regulatory 05-2010 htm
Guidance for UK Manufacturer's Licence and Manufacturer's Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Authorisation Holders on the use of stand alone contract laboratories Jan-08 industry Regulatory 05-2010 lic/documents/websiteresources/con2033764.pdf
Guidance note 30: Site Master File model: For manufacturing
'specials' licence holders or applicants for manufacturing
authorisations relating to small-scale activities, including Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
investigational medicinal products 03-2004 industry Regulatory See note ic/documents/publication/con007559.pdf Current - no review date
Guidance note 13: Manufacturer's Licences authorising a non-
orthodox practitioner to mix and assemble unlicensed medicinal Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
products 11-2004 industry Regulatory See note ic/documents/publication/con007546.pdf Reviewed when there are changes to legislation
Pharmaceutical medicines/Licensingtime-
Licensing time-based performance measures 11-2009 industry Information only 05-2010 basedperformancemeasures/index.htm
Time-based performance measures - Information Processing Unit 10-2009 industry Information only unit1/documents/websiteresources/con038831.pdf
Time-based performance measures - MHRA Licensing and VRMM Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
assessment teams 10-2009 industry Information only unit1/documents/websiteresources/con038832.pdf
Rules and Guidance for Pharmaceutical Manufacturers and Pharmaceutical http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi

Distributors 2007 - the 'Orange Guide' 02-2007 industry Regulatory See note cines/Othermedicinesregulatoryguidance/CON2030291 Current - no review date
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Good Manufacturing Practice: Frequently asked questions 07-2009 industry Regulatory 01-2010 ndstandards/GoodManufacturingPractice/FAQ/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Pharmaceutical ndstandards/GoodManufacturingPractice/Guidanceandlegislati
Good Manufacturing Practice: Qualified persons (QPs) 09-2009 industry Regulatory 03-2010 on/QualifiedPersonsQPs/index.htm
Good Manufacturing Practice: Compliance Report - Guidelines for Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
completion and submission 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041238.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Manufacturing Practice: Compliance Report - Interim update 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041239.pdf
Good Manufacturing Practice: Compliance Report - Example 1 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041240.pdf
Good Manufacturing Practice (GMP) risk-based inspections: Pharmaceutical ndstandards/GoodManufacturingPractice/Guidanceandlegislati
Questions and answers 07-2009 industry Regulatory 01-2010 on/Risk-basedinspections/Questionsandanswers/index.htm
Active Pharmaceutical Ingredient (API) focussed MHRA inspections Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
at dosage from manufacturers 10-2008 industry Regulatory 03-2010 insp/documents/websiteresources/con028396.pdf
Good Manufacturing Practice (GMP) expectations of Non Traditional Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Active Pharmaceutical Ingredients (APIs) 10-2008 industry Regulatory 03-2010 insp/documents/websiteresources/con028397.pdf
Inspected UK Contract GMP Quality Control Laboratories 07-2009 industry Information only 07-2010 insp/documents/publication/con2031300.pdf
Introduction of a risk based inspection programme for contract GMP Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
QC testing laboratories 08-2009 industry Regulatory 02-2010 insp/documents/publication/con054675.pdf
Guidance on completion of the contract GMP QC testing laboratory Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
change form 04-2009 industry Regulatory See note insp/documents/publication/con054674.pdf Current - no review date
Pharmaceutical ndstandards/GoodManufacturingPractice/Theinspectionproces
Good Manufacturing Practice: The inspection process 03-2009 industry Information only 02-2010 s/index.htm
Good Distribution Practice: Frequently asked questions 11-2009 industry Regulatory 05-2010 ndstandards/GoodDistributionPractice/FAQ/index.htm
Healthcare http://www.mhra.gov.uk/home/groups/is-
Refrigerated medicinal products: what pharmacists need to know 01-2009 professionals Regulatory 06-2010 insp/documents/websiteresources/con038595.pdf
Pharmaceutical http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi
Rules and Guidance for Pharmaceutical Distributors 2007 06-2007 industry Regulatory See note cines/Othermedicinesregulatoryguidance/CON2031492 Current - no review date
Good Distribution Practice: Compliance assessment report 03-2009 industry Regulatory 05-2010 insp/documents/websiteresources/con041279.doc Word document
Pharmaceutical ndstandards/GoodDistributionPractice/Theinspectionprocess/i
Good Distribution Practice: The inspection process 03-2009 industry Regulatory 02-2010 ndex.htm
Good Clinical Practice inpsections metrics report 06-2009 industry Regulatory 06-2010 insp/documents/websiteresources/con054563.pdf
GCP inspection findings classification 01-2008 industry Regulatory 06-2010 insp/documents/websiteresources/con2033551.pdf
Phase I Accreditation Scheme 11-2007 industry Regulatory 06-2010 insp/documents/websiteresources/con2033097.pdf
Guidance for formulating responses to GCP inspection findings 06-2007 industry Regulatory 06-2010 insp/documents/websiteresources/con2031399.pdf
GCP routine inspection process 08-2009 industry Regulatory 06-2010 insp/documents/websiteresources/con2024532.pdf
Guidance for the notification of serious breaches of GCP or the trial Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
protocol 02-2007 industry Regulatory 06-2010 insp/documents/websiteresources/con2030352.doc Word document
Pharmaceutical ndstandards/GoodClinicalPractice/Riskbasedinspections/index
Good Clinical Practice: Risk based inspections 06-2009 industry Regulatory 01-2010 .htm
Risk based GCP Inspections - Frequently asked questions 06-2009 industry Regulatory 06-2010 insp/documents/websiteresources/con049178.pdf
Pharmaceutical ndstandards/GoodClinicalPracticeforClinicalLaboratories/index
Good Clinical Practice for Clinical Laboratories 07-2009 industry Regulatory 01-2010 .htm
Guidance on the maintenance of regulatory compliance in
laboratories that perform the analysis or evaluation of clinical trial Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
samples 07-2009 industry Regulatory 01-2010 insp/documents/websiteresources/con051910.pdf
Good Laboratory Practice: Guidance on claiming compliance with Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona

the principles 10-2009 industry Regulatory 04-2010 ndstandards/GoodLaboratoryPractice/Guidance/index.htm
Guidance on the use of non-GLP compliant facilities for the conduct Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
of study phases 08-2008 industry Regulatory 04-2010 insp/documents/websiteresources/con2032323.pdf
Pesticide efficacy studies intended for submission to the United Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
States Environmental Protection Agency 08-2007 industry Regulatory 04-2010 insp/documents/websiteresources/con2031908.pdf
Registration, Evaluation, Authorisation and resitriction of Chemicals Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
(REACH) 08-2007 industry Regulatory 04-2010 insp/documents/websiteresources/con2031907.pdf
GLPMA expectiation for audit of the quality assurance programme 08-2007 industry Regulatory 04-2010 insp/documents/websiteresources/con2032324.pdf
GLPMA expectiations when using a contract quality assurance Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
service 06-2009 industry Regulatory 04-2010 insp/documents/websiteresources/con2025518.pdf
Guidance on the content of quality assurance statements 08-2007 industry Regulatory 04-2010 insp/documents/websiteresources/con2032325.pdf
Guide to UK GLP Regulations 1999 02-2000 industry Regulatory 12-2010 ic/documents/publication/con007566.pdf
Pharmaceutical ndstandards/GoodLaboratoryPractice/Riskbasedinspections/in
Good Laboratory Practice: Risk based inspections 07-2009 industry Regulatory 01-2010 dex.htm
Guidance on completion of the form used to notify the Good
Laboratory Practice Monitoring Authority (GLPMA) of changes within Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
the Good Laboratory Practice (GLP) test facility 04-2008 industry Regulatory 01-2010 insp/documents/websiteresources/con043966.pdf
Good Pharmacovigilance Practice 09-2009 industry Regulatory 03-2010 ndstandards/GoodPharmacovigilancePractice/index.htm
Guidance notes on the information requested for an MHRA statutory Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
pharmacovigilance inspection 09-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con057172.pdf
Pharmaceutical http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi
The Good Parmacovigilance Practice Guide 11-2008 industry Regulatory 06-2010 cines/Othermedicinesregulatoryguidance/CON028495
Pharmaceutical Pharmaceutical ndstandards/GoodPharmacovigilancePractice/Frequentlyaske
Frequently asked questions for Good Pharmacovigilance Practice 09-2009 industry industry 03-2010 dquestions/index.htm
Pharmaceutical ndstandards/GoodPharmacovigilancePractice/Riskbasedinspe
Good Pharmacovigilance Practice: Risk based inspections 07-2009 industry Regulatory 01-2010 ctions/index.htm
ndstandards/Risk-
Pharmaceutical basedInspectionProgrammeforgoodpracticeinspections/index.
Risk-Based Inspection Programme for good practice inspections 10-2009 industry Regulatory 04-2010 htm
Medicines testing 07-2007 industry Regulatory 06-2010 ndstandards/Medicinestesting/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Importinga
Pharmaceutical ndexportingmedicines/Importingunlicensedmedicines/index.ht
Importing unlicensed medicines 07-2009 industry Regulatory 01-2010 m
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Importinga
Exporting medicines 09-2005 industry Regulatory 06-2010 ndexportingmedicines/Exportingmedicines/index.htm
Certificate of pharmaceutical product (licensed products) - guidance Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
notes for completion of application form 04-2001 industry Regulatory 06-2010 ic/documents/licensing/con026403.pdf
Certificate of pharmaceutical product (unlicensed products) - Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
guidance notes for completion of application form 04-2001 industry Regulatory 06-2010 ic/documents/licensing/con026405.pdf
Certificate of manufacturing status - guidance notes for completion Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
of application form 04-2001 industry Regulatory 06-2010 ic/documents/licensing/con026407.pdf
Statement of licensing status of pharmaceutical products - guidance Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
notes for completion of application form 04-2001 industry Regulatory 06-2010 ic/documents/licensing/con026409.pdf
Guidance notes for the completion of application form for export Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
certification for the importaion of a pharmaceutical constituent 08-2003 industry Regulatory 06-2010 ic/documents/licensing/con026411.pdf
Policy document - TSE compliance requirements for exempt Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
imported products 04-2006 industry Regulatory 04-2010 md/documents/websiteresources/con1004134.pdf
Register of holders of Manufacturer's Authorisations for Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Investigational Medicinal Products (MIAIMP) 10-2009 industry Regulatory 10-2010 lic/documents/publication/con2025773.pdf
Department of Health and MHRA Register of Licensed Wholesale Pharmaceutical http://www.mhra.gov.uk/home/groups/is-

Dealer Sites (Human Veterinary and Combined Sites ) 2009 10-2009 industry Regulatory 10-2010 lic/documents/publication/con2025604.pdf
Department of Health and MHRA Register of Licensed Pharmaceutical http://www.mhra.gov.uk/home/groups/is-

Manufacturing Sites (Human Veterinay and Combined Sites) 2009 10-2009 industry Regulatory 10-2010 lic/documents/publication/con2030303.pdf
Use of test sites in Canada (GLP) 08-2009 industry Regulatory See note insp/documents/publication/con054680.pdf Current - no review date
Pharmaceutical http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi To be updated when new EU Pharmacogilance

Good Pharmacovigilance Practice Guide 11-2008 industry Regulatory See note cines/Othermedicinesregulatoryguidance/CON028495 legislation has been finalised
Recommendations on the control and monitoring of storage and Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
transportation temperatures of medicinal products 01-2001 industry Regulatory 10-2010 ic/documents/publication/con007569.pdf
BROMI
Better Regulation of Medicines Initiative (BROMI) 09-2009 industry Regulatory 03-2010 medicines/BetterRegulationofMedicines/index.htm
Better regulation of over-the-counter Medicines Initiative: First report Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
and recommendations 05-2006 industry Regulatory 03-2010 a/documents/websiteresources/con2023796.pdf
Better Regulation of over-the-counter Medicines Initiative: Second Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
report and recommendations 12-2006 industry Regulatory 03-2010 a/documents/websiteresources/con2025468.pdf
Better Regulation of over-the-counter Medicines Initiative: Third Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
report and recommendations 05-2008 industry Regulatory 03-2010 a/documents/websiteresources/con015089.pdf
Better Regulation of Medicines Initiative (BROMI): Fourth report on Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
progress 09-2009 industry Regulatory 03-2010 a/documents/websiteresources/con057264.pdf
BROMI Dossier Requirements for Type 1A and Type 1B UK National Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Notifications - Version 2.1 11-2007 industry Regulatory 03-2010 a/documents/websiteresources/con2033962.pdf
BROMI variations - frequently asked questions 05-2008 industry Regulatory 03-2010 a/documents/websiteresources/con017709.pdf
Letter to marketing authorisation holders: Better Regulation of Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Medicines Initiative (BROMI) - Variations Scheme 04-2008 industry Regulatory 03-2010 a/documents/websiteresources/con014920.pdf
Submission of BROMI notifications - Key points 04-2008 industry Regulatory 03-2010 a/documents/websiteresources/con014776.pdf
Improvements in Detailed Descriptions of Pharmacovigilance Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
System (DDPS) assessments 06-2009 industry Regulatory 03-2010 a/documents/regulatorynews/con049262.pdf
Better Regulation of Medicines: National informed consent (Article Pharmaceutical medicines/BetterRegulationofMedicines/Nationalinformedcons
10c, 'simple abridged') applications 04-2008 industry Regulatory 06-2010 ent(Article10csimpleabridged)applications/index.htm
National informed consent applications - BROMI checklist 02-2009 industry Regulatory 06-2010 unit1/documents/websiteresources/con2030171.doc Word document
BROMI Proprietary Association of Great Britain (PAGB) code of Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
practice audit report 10-2009 industry Regulatory 06-2010 a/documents/websiteresources/con059997.pdf
BROMI audit of braille notifications 10-2009 industry Regulatory 06-2010 a/documents/websiteresources/con059998.pdf
Special Mail 3 - New ways of working at MHRA 07-2005 industry Regulatory See note ic/documents/websiteresources/con2015643.pdf
Special Mail 5: frequently asked questions 06-2009 industry Regulatory See note ic/documents/websiteresources/con2025309.pdf Current - no review date
Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
BROMI fee reductions 04-2008 industry Regulatory 06-2010 cb/documents/websiteresources/con014479.pdf
LEAFLETS AND LABELLING
Guidance Note 25: Best Practice Guidance on the labelling and Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
packaging of medicines 06-2003 industry Regulatory See note ic/documents/publication/con007554.pdf Ongoing
Always read the leaflet - getting the best information with every Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
medicine 10-2005 industry Information only See note a/documents/publication/con2018041.pdf Ongoing
Always read the leaflet: additional 26 glossary terms 05-2007 industry Information only See note a/documents/publication/con2031244.pdf Ongoing
Guidance Note 25: Best Practice Guidance on labelling and Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
packaging of medicines 06-2003 industry Regulatory 12-2010 ic/documents/publication/con007554.pdf
Can you read the leaflet? A guideline on the usability of the patient Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
information leaflet for medicinal products for human use 06-2009 industry Information only See note a/documents/websiteresources/con049314.pdf No date
Guidance on the user testing of patient information leaflets 06-2005 industry Regulatory See note a/documents/publication/con1004417.pdf No date
Questions and answers to support the MHRA guidance on user Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
testing of patient information leaflets 06-2005 industry Regulatory See note a/documents/publication/con1004418.pdf No date
MHRA guidance on the development of artwork in relation to Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
medicines containing codeine and dihydrocodeine 10-2009 industry Regulatory See note a/documents/websiteresources/con059981.pdf No date
Guidance on communication of risk in patient information leaflets 06-2005 industry Regulatory See note a/documents/websiteresources/con049315.pdf Ongoing
Glossary of medical terms in lay language 05-2007 industry Regulatory See note a/documents/websiteresources/con049316.pdf Ongoing
Signposting from the patient information leaflet to additional sources Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
of information and other services 03-2009 industry Regulatory See note a/documents/websiteresources/con046601.pdf Ongoing
Guidance on information in the PIL to address areas of potential
misuse or abuse of over-the-counter (OTC) antihistamine sleep aid Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
and laxative medicines 04-2009 industry Regulatory See note a/documents/websiteresources/con049317.pdf Unknown
http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie
Labels, patient information leaflets and packaging of medicines: Pharmaceutical ntinformationleafletsandpackaging/Legislationandguidelines/in
Legislation and guidelines 05-2009 industry Regulatory 02-2010 dex.htm
Pharmaceutical ntinformationleafletsandpackaging/Applicationsforassessment/i
Labels and leaflets: Applications for assessment 06-2007 industry Regulatory See note ndex.htm Ongoing
Changes to labelling and patient information leaflets for all medicines http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie
subject to self certification by the applicant and formal notification to Pharmaceutical ntinformationleafletsandpackaging/Notificationscheme/index.ht
the MHRA 11-2009 industry Regulatory 05-2010 m
MHRA guidance on changes to labelling and patient information Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
leaflets for self certification document 11-2009 industry Regulatory See note a/documents/websiteresources/con2023799.pdf Ongoing
Changes to self certification - quality audit 05-2006 industry Regulatory 06-2010 a/documents/websiteresources/con2023801.pdf
Guidance on changes to labelling and patient information leaflets for
self certification - compliance with article 56(a) - inclusion of Braille Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
on the labelling 11-2009 industry Regulatory See note a/documents/websiteresources/con041517.pdf Unknown
Braille on labelling and in patient information leaflets: New provisions Pharmaceutical ntinformationleafletsandpackaging/Brailleonlabellingandinpatie
from 30 October 2005 03-2009 industry Regulatory 02-2010 ntinformationleaflets/index.htm
Questions and answers to address issues of national application of
the new provisions concerning Braille on labelling and in the patient Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
information leaflet of all medicines 10-2005 industry Regulatory See note a/documents/websiteresources/con2018141.pdf Unknown
Pharmaceutical ntinformationleafletsandpackaging/Usertestingofpatientinforma
User testing of patient information leaflets 01-2009 industry Regulatory 05-2010 tionleaflets/index.htm
Additional questions and answers on user testing of patient Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
information leaflets 06-2006 industry Regulatory See note p/documents/websiteresources/con2024001.pdf Current - no review date
Further guidance on designing patient information leaflets and how Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
to achieve success in user testing 03-2007 industry Regulatory See note a/documents/websiteresources/con2030572.pdf Ongoing
Guidance for the Pharmaceutical Industry on the use of bridging

studies to demonstrate compliance with article 59(3) of Council Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Directive 2001/83/EC (Consultation with Target Patient Groups) 12-2006 industry Regulatory See note p/documents/websiteresources/con2025471.pdf Current - no review date
Report of the findings of the survey of user test houses undertaken

on behalf of the Commission on Human Medicines Expert Advisory Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Group on Patient Information (CHMEAGPI) 03-2007 industry Regulatory See note a/documents/websiteresources/con2030408.pdf Current - no review date
Quality criteria for patient information leaflets 10-2007 industry Regulatory See note insp/documents/websiteresources/con2032836.pdf Ongoing
Pharmaceutical ntinformationleafletsandpackaging/Complaintsaboutlabellingan
Labelling and packaging of medicines: Complaints 02-2008 industry Regulatory 05-2010 dpackagingofmedicines/index.htm
Labels, patient information leaflets and packaging for medicines: Pharmaceutical ntinformationleafletsandpackaging/Frequentlyaskedquestions/i
Frequently asked questions 11-2009 industry Regulatory 05-2010 ndex.htm
MEDICINES FOR CHILDREN
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf
Medicines for children 09-2009 industry Regulatory 03-2010 orchildren/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf
Questions and Answers on UK strategy (Medicines for children) 09-2005 industry Regulatory 06-2010 orchildren/QAonUKstrategy/index.htm
Medicines for children: Questions and answers on the UK stategy Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
(pdf version) 08-2004 industry Regulatory 06-2010 p/documents/websiteresources/con009666.pdf
MHRA/Department of Health strategy on medicines for children 07-2004 industry Regulatory 06-2010 p/documents/websiteresources/con009667.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf
Requirements for submission of paediatric information required by Pharmaceutical orchildren/Requirementsforsubmissionofpaediatricinformationr
EU Paediatric Regulation 07-2009 industry Regulatory 01-2010 equiredbyEUPaediatricRegulation/index.htm
Guidance on the MHRA's handling of the requirement in the
Paediatric Regulation to undertake a 'complance check' during Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
validation 02-2009 industry Regulatory 06-2010 policy/documents/websiteresources/con020813.pdf
MHRA exercise to update SmPCs following EU paediatric work- Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf
sharing procedures 08-2009 industry Regulatory 02-2010 orchildren/Whatsnew/index.htm
Summary of Regulation on medicines for paediatric use 01-2007 industry Regulatory 02-2010 a/documents/websiteresources/con2025602.pdf
UK strategy document on medicines for children 07-2004 industry Regulatory 02-2010 p/documents/websiteresources/con009667.pdf
Questions and answers on the UK strategy on medicines for children 09-2005 industry Regulatory 02-2010 p/documents/websiteresources/con009666.pdf
MHRA policy on requesting paediatric data from companies 02-2007 industry Regulatory 02-2010 a/documents/websiteresources/con2030243.pdf
ADVERTISING OF MEDICINES
Advertising of medicines: Guidance for consumer website offering Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
medicinal treatment services 10-2008 industry Regulatory 10-2010 a/documents/websiteresources/con031140.pdf
Tips for vetting of promotional material 02-2008 industry Regulatory 02-2010 a/documents/websiteresources/con2032012.pdf
Guidance on the review of advertising by the Independent Review Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Panel 10-2009 industry Regulatory 10-2011 a/documents/websiteresources/con2022628.pdf
Memorandum of understanding between the Association of the
British Pharmaceutical Industry, the Prescription Medicines Code of
Practice Authority and the Medicines and Healthcare products Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Regulatory Agency 11-2005 industry Regulatory 11-2010 a/documents/websiteresources/con2022582.pdf
Guidance Note 24: Medicines which are promoted for use during Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
pregnancy: Guidance for the pharmaceutical industry 06-2003 industry Regulatory 11-2010 ic/documents/publication/con007553.pdf
Guidance Note 26: Disease awareness campaigns guidelines 06-2003 industry Regulatory 11-2010 ic/documents/publication/con007555.pdf
Blue Guide: Advertising and Promotion of Medicines in the UK 11-2005 industry Regulatory 11-2010 a/documents/websiteresources/con007552.pdf
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Enforcingth
Enforcing the law 09-2008 industry Regulatory 06-2010 elaw/index.htm
PATIENT GROUP DIRECTIONS
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
prescribingsellingandsupplyingofmedicines/ExemptionsfromMe
Pharmaceutical dicinesActrestrictions/PatientGroupDirectionsintheprivatesecto
Patient Group Directions in the private sector 09-2005 industry Regulatory 06-2010 r/index.htm
Healthcare dicinesActrestrictions/PatientGroupDirectionsintheNHS/index.h
Patient Group Directions in the NHS 09-2005 professionals Regulatory 06-2010 tm
Healthcare dicinesActrestrictions/Nurseandpharmacistindependentprescri
Nurse and pharmacist independent prescribing 09-2005 professionals Regulatory 06-2010 bing/index.htm
List of prescription only medicines prescribable by extended Healthcare http://www.mhra.gov.uk/home/groups/es-
formulary nurse prescribers 04-2005 professionals Regulatory 06-2010 foi/documents/websiteresources/con009691.pdf
Descriptions and classes of prescription only medicines in relation to
which appropriate district nurses and health visitors are appropriate Healthcare http://www.mhra.gov.uk/home/groups/es-
practitioners 04-2003 professionals Regulatory 06-2010 foi/documents/websiteresources/con009690.pdf
Healthcare prescribingsellingandsupplyingofmedicines/ExemptionsfromMe
Paramedics - exemptions from Medicines Act restrictions 10-2005 professionals Regulatory 06-2010 dicinesActrestrictions/Paramedics/index.htm
Chiropodists - exemptions from Medicines Act restrictions 10-2009 professionals Regulatory 04-2010 dicinesActrestrictions/Chiropodists/index.htm
Optometrists: exemptions from Medicines Act restrictions 11-2006 professionals Regulatory 06-2010 dicinesActrestrictions/Optometrists/index.htm
Midwives: exemptions from Medicines Act restrictions 09-2007 professionals Regulatory 06-2010 dicinesActrestrictions/Midwives/index.htm
Supplementary prescribing 11-2007 professionals Regulatory 06-2010 dicinesActrestrictions/Supplementaryprescribing/index.htm
prescribingsellingandsupplyingofmedicines/Frequentlyraisedis
Supply and administration of Botox, Vistabel, Dysport and other Healthcare sues/BotoxVistabelDysportandotherinjectablemedicinesincosm
injectable medicines in cosmetic procedures 10-2008 professionals Regulatory 06-2010 eticprocedures/index.htm
Market stalls and car boot sales (sale of medicines) 11-2007 Public Regulatory 06-2010 sues/Marketstallsandcarbootsales/index.htm
Vending machines (sale of medicines) 11-2006 Public Regulatory 06-2010 sues/Vendingmachines/index.htm
Non-medical prescribing and mixing medicines in palliative care and Healthcare prescribingsellingandsupplyingofmedicines/Frequentlyraisedis
other areas of clinical practice 09-2009 professionals Regulatory 03-2010 sues/Palliativecare/index.htm
Internet (supply of medicines) 11-2006 All sectors Information only 06-2010 sues/TheInternet/index.htm
Healthcare prescribingsellingandsupplyingofmedicines/Frequentlyraisedis
Advice on administering eye drops in retinal screening programmes 07-2007 professionals Best practice 06-2010 sues/Retinalscreening/index.htm
MINISTERIAL INDUSTRY STRATEGY GROUP
Ministerial Industry Strategy Group (MISG) New Technologies Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/MISGNewT
Advisory Panel 03-2009 industry Regulatory 02-2010 echnologiesAdvisoryPanel/index.htm
ADVANCED THERAPY MEDICINAL PRODUCTS
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Advancedtherapymedi
How we regulate advanced therapy medicinal products 07-2009 industry Regulatory 06-2010 cinalproducts/index.htm
Interim UK Regulatory Route Map for Stem Cell Research and Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
Manufacture 03-2009 industry Regulatory 06-2010 policy/documents/websiteresources/con041336.pdf
Tissue engineering - Questions and answers 08-2008 industry Regulatory 06-2010 herbal/documents/websiteresources/con2031532.pdf
NANOTECHNOLOGY
http://www.mhra.gov.uk/Howweregulate/Nanotechnology/index
How we regulate nanotechnology 02-2008 Devices industry Regulatory 06-2010 .htm
BLOOD
Pharmaceutical and
How we regulate blood 08-2009 devices industries Regulatory 06-2010 http://www.mhra.gov.uk/Howweregulate/Blood/index.htm
Explanatory memorandum to The Blood Safety and Quality Pharmaceutical and http://www.mhra.gov.uk/home/groups/is-
(Amendment) (No 2) Regulations 2005 No. 2898 10-2005 devices industries Regulatory 06-2010 insp/documents/websiteresources/con2022508.pdf
Guidance notes on the application form for a blood establishment Pharmaceutical and http://www.mhra.gov.uk/home/groups/is-
authorisation 09-2005 devices industries Regulatory 06-2010 insp/documents/websiteresources/con2015665.pdf
Pharmaceutical and http://www.mhra.gov.uk/home/groups/is-

Guidance on facilities and blood compliance reports for 2010 08-2009 devices industries Regulatory 06-2010 insp/documents/websiteresources/con054515.pdf
POLICY
http://www.mhra.gov.uk/Howweregulate/Howwedevelopolicy/in
Policy development and delivery 10-2008 All sectors Regulatory 06-2010 dex.htm
Pharmaceutical and http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti

Our negotiations in Europe 08-2009 devices industries Information only 02-2010 es/OurnegotiationsinEurope/index.htm
http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti
Mutual Recognition Agreements 08-2009 Devices industry Information only 02-2010 es/MutualRecognitionAgreements/index.htm
HERBAL AND HOMOEOPATHIC MEDICINES
http://www.mhra.gov.uk/home/groups/is-
Guidance sheet on herbal ingredients 03-2005 Herbal sector Regulatory 02-2011 pol/documents/websiteresources/con009276.pdf
Guidance for Retailers, Wholesalers, Importers and Manufacturers http://www.mhra.gov.uk/home/groups/pl-

on Registering Herbal Medicine under the THMR Scheme 03-2007 Herbal sector Information only 05-2010 p/documents/websiteresources/con2030651.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
Placing a herbal medicine on the UK market 08-2008 Herbal sector Regulatory 05-2010 cines/PlacingaherbalmedicineontheUKmarket/index.htm
Guidance note on the transitional arrangements set out in Directive http://www.mhra.gov.uk/home/groups/es-
2004/24/EC 04-2007 Herbal sector Regulatory 05-2010 herbal/documents/websiteresources/con009362.pdf
Guidance on arrangements for the transfer of certain herbal
products with a marketing authorisation to traditional herbal http://www.mhra.gov.uk/home/groups/es-
registration status 08-2008 Herbal sector Regulatory 05-2010 herbal/documents/websiteresources/con023222.pdf
cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
Traditional Herbal Medicines Registration Scheme 07-2009 Herbal sector Regulatory 02-2010 lMedicinesRegistrationScheme/index.htm
New guidance on consumer advertising for registered traditional http://www.mhra.gov.uk/home/groups/pl-
herbal medicines 04-2009 Herbal sector Regulatory 11-2011 p/documents/publication/con043820.xml
Guidance on arrangements for the transfer of certain herbal
products with a marketing authorisation to traditional herbal http://www.mhra.gov.uk/home/groups/es-
Guidance on use of HMPC monographs to demonstrate safety and http://www.mhra.gov.uk/home/groups/es-
traditional use 01-2008 Herbal sector Regulatory 11-2010 herbal/documents/websiteresources/con2033554.pdf
Briefing note: sources of evidence of traditional use under the http://www.mhra.gov.uk/home/groups/es-
proposed Directive on Traditional Herbal Medicinal Products 07-2005 Herbal sector Regulatory 11-2010 herbal/documents/websiteresources/con009364.pdf
Traditional Herbal Medicines Registration Scheme: How to obtain a lMedicinesRegistrationScheme/Howtoobtainamanufacturerslic
manufacturer's licence 02-2008 Herbal sector Regulatory 02-2010 ence/index.htm
Guidance Note: 'Traditional Herbal Medicinal Products Directive - http://www.mhra.gov.uk/home/groups/es-
Transitional Qualified Persons 02-2006 Herbal sector Regulatory 02-2011 herbal/documents/websiteresources/con2023100.pdf
lMedicinesRegistrationScheme/Howtoobtainawholesaledealers
THMRS: Responsible persons 02-2008 Herbal sector Regulatory 02-2011 licence/Responsiblepersons/index.htm
Traditional Herbal Medicines Registration Scheme: How to obtain a lMedicinesRegistrationScheme/Howtoobtainamanufacturersim
manufacturer's import licence (MIA) 02-2008 Herbal sector Regulatory 02-2010 portlicence/index.htm
Traditional Herbal Medicines Registration Scheme: Product cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
Information 09-2005 Herbal sector Regulatory 02-2010 lMedicinesRegistrationScheme/ProductInformation/index.htm
Permitted indications under the Directive on Traditional Herbal http://www.mhra.gov.uk/home/groups/es-
Medicinal Products 07-2005 Herbal sector Regulatory 02-2011 herbal/documents/websiteresources/con009363.pdf
Traditional Herbal Medicines Registration Scheme: cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
Pharmacovigilance 04-2008 Herbal sector Regulatory 02-2010 lMedicinesRegistrationScheme/Pharmacovigilance/index.htm
lMedicinesRegistrationScheme/Frequentlyaskedquestions/inde
THMRS: Frequently asked questions 08-2005 Herbal sector Information only 02-2010 x.htm
Traditional Herbal Medicines Registration Scheme: Guidance notes 09-2005 Herbal sector Regulatory 02-2010 lMedicinesRegistrationScheme/Guidancenotes/index.htm
Guidance note: provisions on the Directive on Traditional Herbal http://www.mhra.gov.uk/home/groups/es-

Medicinal Products that would determine dates of introduction 04-2007 Herbal sector Regulatory 02-2011 herbal/documents/websiteresources/con009362.pdf
Guidance on regulation of unlicensed herbal medicines made up by

a 3rd party for use by practitioner in a one to one consultation: http://www.mhra.gov.uk/home/groups/es-
arrangements pending possible reform of regulation 07-2006 Herbal sector Regulatory 05-2010 herbal/documents/websiteresources/con2024066.pdf
Traditional Herbal Medicinal Product Directive: Transitional Qualified http://www.mhra.gov.uk/home/groups/es-
Persons 09-2005 Herbal sector Regulatory 02-2011 herbal/documents/websiteresources/con009371.pdf
Guidance notes to companies on hearings before and written http://www.mhra.gov.uk/home/groups/l-cs-
representations to the Herbal Medicines Advisory Committee 08-2009 Herbal sector Regulatory See note el/documents/websiteresources/con023084.pdf Current - no review date
cines/PlacingaherbalmedicineontheUKmarket/Transferofherbal
The review and transfer of certain herbal product licences marketingauthorisationstotraditionalherbalregistrationstatus/ind
(marketing authorisation) to traditional herbal registration status 09-2009 Herbal sector Information only 05-2010 ex.htm
Outline impact Assessment on the review and transfer of some
herbal products with a marketing authorisation to traditional herbal http://www.mhra.gov.uk/home/groups/es-
Consolidated Guidance on Transitional arrangements for the
Directive on traditional herbal medicinal products (Directive http://www.mhra.gov.uk/home/groups/es-
2004/24/EC, amending Directive 2001/83/EC) 04-2007 Herbal sector Regulatory 11-2010 herbal/documents/websiteresources/con009362.pdf
List of herbal ingredients which are prohibited or restricted in http://www.mhra.gov.uk/home/groups/es-
medicines 04-2009 Herbal sector Regulatory 11-2010 herbal/documents/websiteresources/con009294.pdf
Advice to consumers: Safe use of herbal medicines 03-2009 Herbal sector Information only 05-2010 cines/Herbalsafetyadvice/Advicetoconsumers/index.htm
Advice to consumers - The Traditional Herbal Medicines cines/Herbalsafetyadvice/Advicetoconsumers-
Registration Scheme 11-2009 Herbal sector Information only 05-2010 TheTraditionalHerbalMedicinesRegistrationScheme/index.htm
Traditional ethnic medicine: public health and compliance with http://www.mhra.gov.uk/home/groups/es-
medicines law 11-2001 Herbal sector Regulatory 05-2010 herbal/documents/websiteresources/con2031846.pdf
Reporting problems with herbal medicines 02-2008 Herbal sector Information only 05-2010 cines/Reportingproblemswithherbalmedicines/index.htm
http://www.mhra.gov.uk/home/groups/es-
Public health risk with herbal medicines: An overview 07-2008 Herbal sector Best practice 11-2010 herbal/documents/websiteresources/con023163.pdf
Report on the 'Safety of herbal medicinal products' 07-2002 Herbal sector Regulatory 11-2010 herbal/documents/websiteresources/con009293.pdf
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform
ationandadvice/Adviceandinformationforconsumers/Usingherb
Using herbal medicines: Advice to consumers 03-2009 Public Information only 06-2010 almedicines/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Homoeopat
Homoeopathic medicines 09-2005 Herbal sector Regulatory 03-2010 hicmedicines/index.htm
Guidance note 17: The Homoeopathic Registration Scheme: http://www.mhra.gov.uk/home/groups/comms-
Guidance for manufacturers and suppliers 09-2003 Herbal sector Regulatory 03-2010 ic/documents/publication/con007550.pdf
http://www.mhra.gov.uk/home/groups/l-
The manufacture and control of dosage form for homoeopathics 07-2003 Herbal sector Regulatory 03-2010 plpi1/documents/publication/con007560.pdf
The control and quality of homoeopathic stocks 07-2003 Herbal sector Regulatory 03-2010 plpi1/documents/publication/con007561.pdf
Note on labelling requirements for homoeopathic products 10-2009 Herbal sector Regulatory 03-2010 plpi1/documents/websiteresources/con1004213.pdf
The Homoeopathic National Rules Scheme: Brief guidance for http://www.mhra.gov.uk/home/groups/l-
manufacturers and suppliers 09-2006 Herbal sector Regulatory 03-2010 unit1/documents/websiteresources/con2024923.pdf
FEES
Pharmaceutical and medicines/Informationforlicenceapplicants/Feesformedicinesbl
Fees for medicines, blood establishments and blood banks 11-2009 devices industries Regulatory 05-2010 oodestablishmentsandbloodbanks/index.htm
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/Appealtopersonsappointed/i
Fees for appeals to Persons Appointed (PA) 05-2009 industry Regulatory 04-2010 ndex.htm
Pharmaceutical and oodestablishmentsandbloodbanks/Drug-
Fees for drug - device combination products 03-2009 devices industries Regulatory 04-2010 devicecombinationproducts/index.htm
Pharmaceutical oodestablishmentsandbloodbanks/Scientificadvicemeetings/in
Fees for scientific advice meetings 03-2009 industry Regulatory 04-2010 dex.htm
Fees for licence renewals, reclassifications and assessment of Pharmaceutical oodestablishmentsandbloodbanks/Licencerenewalapplications
labels and leaflets 03-2009 industry Regulatory 04-2010 reclassificationsandassessmentsoflabelsandleaflets/index.htm
Pharmaceutical oodestablishmentsandbloodbanks/Licencevariationsapplicatio
Fees for licence variations applications 07-2009 industry Regulatory 01-2010 ns/index.htm
Pharmaceutical medicines/Informationforlicenceapplicants/Feesformedicinesbl
Fees for inspection 03-2009 industry Regulatory 04-2010 oodestablishmentsandbloodbanks/Inspectionfees/index.htm
Pharmaceutical oodestablishmentsandbloodbanks/OtherfeesforTraditionalHerb
Fees for Traditional Herbal Medicinal Products (THMP) 03-2009 industry Regulatory 04-2010 alMedicinalProducts(THMP)/index.htm
Pharmaceutical oodestablishmentsandbloodbanks/HomoeopathicNationalRule
Fees for Homoeopathic National Rules Scheme 03-2009 industry Regulatory 04-2010 sScheme/index.htm
Pharmaceutical medicines/Informationforlicenceapplicants/Feesformedicinesbl
Periodic fees 03-2009 industry Regulatory 04-2010 oodestablishmentsandbloodbanks/Periodicfees/index.htm
Pharmaceutical oodestablishmentsandbloodbanks/Feesforsafetyandqualityvetti
Fees for safety and quality vetting of unlicensed imported medicines 03-2009 industry Regulatory 04-2010 ngofunlicensedimportedmedicines/index.htm
Pharmaceutical and oodestablishmentsandbloodbanks/Feesforbloodbanksandothe
Fees for blood banks and other blood establishments 08-2009 devices industries Regulatory 02-2010 rbloodestablishments/index.htm
oodestablishmentsandbloodbanks/Bankaccountdetails/index.ht
Bank account details 03-2009 All sectors Information only 04-2010 m
MHRA fees definitions 04-2009 industry Regulatory 04-2010 cb/documents/websiteresources/con2023790.pdf
Clarification of terminology relating to periodic fees 04-2009 industry Regulatory 04-2010 cb/documents/websiteresources/con2023791.pdf
Payment easements for small companies 04-2009 industry Information only 04-2010 cb/documents/websiteresources/con2025630.pdf
SAFETY AND PHARMACOVIGILANCE
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalert
Selective Serotonin Reuptake Inhibitors (SSRIs): use in children and Healthcare sandrecalls/Safetywarningsandmessagesformedicines/CON01
adolescents with major depressive disorder 12-2003 professionals Best practice 06-2010 9494
Healthcare ationandadvice/Product-
MMR (measles, mumps and rubella) vaccine 03-2008 professionals Best practice 06-2010 specificinformationandadvice/MMRvaccine/index.htm
Healthcare http://www.mhra.gov.uk/home/groups/comms-
Aspirin and Reye's syndrome 04-2003 professionals Best practice 06-2010 ic/documents/websiteresources/con007619.pdf
http://www.mhra.gov.uk/home/groups/comms-
My medicines: pdf version of complete section 09-2008 Public Information only See note ic/documents/websiteresources/con025912.pdf Current - no review date
http://www.mhra.gov.uk/home/groups/pl-
Taking mediicnes - some questions and answers about side effects 12-2005 Public Information only See note a/documents/websiteresources/con2022719.pdf Current - no review date
ationandadvice/Adviceandinformationforconsumers/Counterfei
Counterfeit medicines and devices 10-2009 Public Information only 04-2010 tmedicinesanddevices/index.htm
ationandadvice/Adviceandinformationforconsumers/Usingherb
Using herbal medicines: Advice to consumers 03-2009 Public Information only 06-2010 almedicines/index.htm
ationandadvice/Adviceandinformationforconsumers/Buyingme
Risks of buying medicines over the internet 11-2009 Public Information only 05-2010 dicinesovertheInternet/index.htm
ationandadvice/Adviceandinformationforconsumers/Buyingme
Buying medical devices 06-2009 Public Information only 01-2010 dicaldevices/index.htm
Pharmacy leaflet - with your help we can make medical equipment http://www.mhra.gov.uk/Publications/Postersandleaflets/CON0
safe! 09-2004 Public Information only 06-2010 08390
http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesa
Pharmacovigilance - how we monitor the safety of medicines 10-2009 All sectors Information only 04-2010 fetyofproducts/Medicines/Pharmacovigilance/index.htm
Healthcare http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesa
New drugs and vaccines under intensive surveillance 11-2009 professionals Information only 05-2010 fetyofproducts/Medicines/BlackTriangleproducts/index.htm
http://www.mhra.gov.uk/home/groups/is-
Guide to Defective Medicinal Products 11-2004 All sectors Information only See note md/documents/publication/con007572.pdf New edition scheduled for January 2010
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
Healthcare professional reporting of suspected adverse drug Healthcare lems/Medicines/Reportingsuspectedadversedrugreactions/Hea
reactions 11-2009 professionals Information only 05-2010 lthcareprofessionalreporting/index.htm
lems/Medicines/Reportingsuspectedadversedrugreactions/Pati
Patient reporting of suspected adverse drug reactions 04-2008 Public Information only 06-2010 entreporting/index.htm
lems/Medicines/Reportingsuspectedadversedrugreactions/Dru
Drug Analysis Prints (DAPs) 03-2009 All sectors Information only 02-2010 ganalysisprints/index.htm
Reporting suspected adverse drug reactions: Information for the Pharmaceutical lems/Medicines/Reportingsuspectedadversedrugreactions/Info
Pharmaceutical Industry 11-2006 industry Information only 06-2010 rmationforthePharmaceuticalIndustry/index.htm
lems/Medicines/Reportingsuspectedadversedrugreactions/Info
Pharmaceutical rmationforthePharmaceuticalIndustry/E2BreportingwiththeMHR
E2B reporting with the MHRA: Updated information - January 2008 12-2007 industry Regulatory 06-2010 A/index.htm
Pharmaceutical rmationforthePharmaceuticalIndustry/E2BreportingwiththeMHR
E2B reporting - Questions and answers 04-2007 industry Regulatory 06-2010 A/QuestionsandanswersonE2Breporting/index.htm
Adverse drug reaction (ADR) reports received by the MHRA from Pharmaceutical rmationforthePharmaceuticalIndustry/AdversedrugreactionAD
literature articles 08-2009 industry Information only 02-2010 Rliteraturereportslist/index.htm
Healthcare http://www.mhra.gov.uk/Safetyinformation/Healthcareproviders
Targeted healthcare professional groups 10-2009 professionals Information only 04-2010 /index.htm
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafe
Drug Safety Update 11-2009 professionals Best practice 05-2010 tyUpdate/index.htm
http://www.mhra.gov.uk/Publications/Postersandleaflets/CON2
Information for women considering breast implants 11-2005 Public Information only 11-2010 022635
http://www.mhra.gov.uk/home/groups/pl-
Medicines use review: Understand your medicines 12-2005 Public Information only 12-2010 a/documents/websiteresources/con2023072.pdf
MEDICAL DEVICE REGULATION
Directives Bulletin 2 - The CE Marking 09-2007 Devices industry Regulatory 12-2010 era/documents/publication/con007490.pdf
Directives Bulletin 8 - Information about the EC Medical Devices http://www.mhra.gov.uk/home/groups/es-
Directives 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007494.pdf
Guidance note 7 - Guidance for manufacturers of Class I medical http://www.mhra.gov.uk/home/groups/es-
devices 06-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007511.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic
Borderline with medicines 09-2009 Devices industry Regulatory 12-2010 esDirective/Borderlinewithmedicines/index.htm
Directives Bulletin 17 - Medical devices and medicinal products 08-2009 Devices industry Regulatory 12-2010 era/documents/publication/con007498.pdf
Guidance note 20 - Borderlines with medical devices 08-2009 Devices industry Regulatory 12-2010 ic/documents/websiteresources/con057309.pdf
Medical Devices Classification 03-2009 Devices industry Regulatory 12-2010 esDirective/Classification/index.htm
Guidance on the Commission Directive on the reclassification of http://www.mhra.gov.uk/home/groups/es-

total hip, knee and shoulder joint replacement 07-2007 Devices industry Regulatory 12-2010 era/documents/websiteresources/con2031594.pdf
Directives Bulletin 4 - Conformity assessment procedures (medical http://www.mhra.gov.uk/home/groups/es-
device regulations) 03-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007492.pdf
Guidance note 9 - Guidance notes from manufacturers of custom- http://www.mhra.gov.uk/home/groups/es-
made devices 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007515.pdf
Guidance note 10 - Guidance notes for manufacturers of dental http://www.mhra.gov.uk/home/groups/es-
appliances (custom made devices) 03-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007516.pdf
Guidance note 18 - Guidance for notified bodies - Devices http://www.mhra.gov.uk/home/groups/comms-
incorporating a medicinal substance - consulting the MHRA 06-2003 Both industries Regulatory See note ic/documents/publication/con007551.pdf Under review
Guidance note 16 - Guidance notes for manufacturers of prosthetic http://www.mhra.gov.uk/home/groups/es-
and orthotic appliances 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007517.pdf
Ophthalmic products (Medical Devices Directive) 02-2008 Devices industry Regulatory 12-2010 esDirective/Ophthalmicproducts/index.htm
esDirective/DevicesusingmaterialsfromTSEsusceptibleanimals
Devices using materials from TSE susceptible animals 02-2006 Devices industry Regulatory 12-2010 /index.htm
Directives Bulletin 12 - Sale and supply of in vitro diagnostic medical http://www.mhra.gov.uk/home/groups/es-
devices (IVDs) 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007496.pdf
Guidance note 19 - Guidance notes on in vitro diagnostic medical http://www.mhra.gov.uk/home/groups/es-
devices directive 98/79/EC 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007521.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/InVitroDiagno
Borderlines (In vitro diagnostic medical devcies directive) 03-2009 Devices industry Regulatory 12-2010 sticMedicalDevicesDirective/Borderlines/index.htm
Directives Bulletin 20 - Conformity assessment procedures under http://www.mhra.gov.uk/home/groups/es-

the in vitro diagnostic medical devices directive 98/79/EC 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007501.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/i
Clinical trials for medical devices 09-2009 Devices industry Regulatory 12-2010 ndex.htm
Guidance note 1 - Guidance notes for manufacturers on clinical http://www.mhra.gov.uk/home/groups/es-
investigations to be carried out in the UK 09-2009 Devices industry Regulatory 12-2010 era/documents/publication/con007504.pdf
Guidance note 3 - Information for clinical investigators 07-2009 Devices industry Regulatory 12-2010 era/documents/publication/con007507.pdf
Guidance note 5 - Guidance on biocompatibility assessment 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007509.pdf
Guidance note 17 - Guidance notes for manufacturers on statistical http://www.mhra.gov.uk/home/groups/es-

considerations for clinical investigations of medical devices 10-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007518.pdf
Directives Bulletin 18 - The medical devices regulations: Implications http://www.mhra.gov.uk/home/groups/es-
on healthcare and other related establishments 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007499.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodie
Notified Bodies 05-2009 Devices industry Regulatory 12-2010 s/index.htm
Directives Bulletin 6 - The Notified Body 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007493.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodie
s/UKNotifiedBodiesundertheMedicalDevicesDirectives/index.ht
UK Notified Bodies under the Medical Devices Directives 05-2009 Devices industry Regulatory 12-2010 m
http://www.mhra.gov.uk/Howweregulate/Devices/Registrationo
Registration of medical devices 11-2009 Devices industry Regulatory 12-2010 fmedicaldevices/index.htm
Guidance note 8 - Guidance notes for the registration of persons http://www.mhra.gov.uk/home/groups/es-
responsible for placing devices on the market 12-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007512.pdf
Guidance note 8 - Guidance notes for the registration of persons http://www.mhra.gov.uk/home/groups/es-

responsible for placing devices on the market - Appendix A and B 01-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007513.pdf
Guidance note 18 - Guidance notes for the registration of persons
responsible for placing in vitro diagnostic medical devices on the http://www.mhra.gov.uk/home/groups/es-
market 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007519.pdf
Group codes for IVD registration 07-2006 Devices industry Regulatory 12-2010 era/documents/publication/con2031502.pdf
Directives bulletin 3 - Guidance on the operation of the EU vigilance http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
system in the UK 09-2008 Devices industry Regulatory 08-2013 ces/DirectivesBulletins/CON2033888
MEDDEV guidance Rev 5 review: Making medical device vigilance http://www.mhra.gov.uk/home/groups/dts-
more effective 11-2007 Devices industry Regulatory 11-2012 aic/documents/websiteresources/con2033158.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/Inhousemanu
In house manufacture (medical devices) 09-2005 Devices industry Regulatory 12-2010 facture/index.htm
Directives Bulletin 19 - Own brand labelling and rented products 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007500.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/Parallelimport
Parallel imports (medical devices) 01-2007 Devices industry Regulatory 12-2010 s/index.htm
Directives Bulletin 21 - Application for the exceptional use of non- http://www.mhra.gov.uk/home/groups/es-
complying devices 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007502.pdf
Enforcement policy - Compliance inspection and action - Your rights http://www.mhra.gov.uk/Howweregulate/Devices/Enforcement
(medical devices) 09-2008 Devices industry Regulatory 12-2010 policy-Complianceinspectionandaction-Yourrights/index.htm
http://www.mhra.gov.uk/Howweregulate/Devices/Medicaldevic
Medical device appeals 01-2007 Devices industry Regulatory 12-2010 eappeals/index.htm
Medical Device Technology Forum 07-2008 Devices industry Regulatory 06-2010 esTechnologyForum/index.htm
http://www.mhra.gov.uk/Howweregulate/Devices/Regulatoryne
Devices regulatory news 09-2009 Devices industry Regulatory 12-2010 ws/index.htm
http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti
Global Harmonization Task Force (GHTF) 09-2006 Devices industry Information only 06-2010 es/GlobalHarmonizationTaskForce/index.htm
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
DB 2008(04) In vitro diagnostic medical devices used in combination 09-2008 professionals Best practice 09-2012 lletins/CON025728
DB 2008(03) Guidance on the safe use of lasers, IPL systems and Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
LEDs 04-2008 professionals Best practice 04-2012 lletins/CON014775
DB 2007(03) Safety Guidelines for Magnetic Resonance Imaging Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
Equipment in Clinical Use 12-2007 professionals Best practice 12-2011 lletins/CON2033018
DB 2006(06) Safe Use of Bed Rails 12-2006 professionals Best practice 12-2010 lletins/CON2025348
DB 2006(05) Managing Medical Devices 11-2006 professionals Best practice 11-2010 lletins/CON2025142
DB 2006(04) Single-use Medical Devices: Implications and Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
Consequences of Reuse 10-2006 professionals Best practice 10-2010 lletins/CON2024995
DB 2006(03) Blood Pressure Measurement Devices 07-2006 professionals Best practice 07-2010 lletins/CON2024245
DB 2005(03) Guidance on the Safe and Effective Use of Batteries Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
and Chargers for Medical Devices 10-2005 professionals Best practice 10-2010 lletins/CON2022469
DB 2004(02) Guidance on the Stability of Wheelchairs 05-2004 professionals Best practice 05-2014 lletins/CON007306
DB 2003(04) The Safe Use of Ambulance Stretcher Trolleys 03-2003 professionals Best practice 03-2011 lletins/CON007317
DB 2003(03) Guidance on the Safe Use of Wheelchairs and Vehicle- Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
mounted Passenger Lifts 03-2003 professionals Best practice 03-2011 lletins/CON007319
DB 2003(02) Infusion Systems 03-2003 professionals Best practice 03-2011 lletins/CON007321
DB 2002(06) Benchtop Steam Sterilizers - Guidance on Purchase, Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu

Operation and Maintenance 10-2002 professionals Best practice 10-2010 lletins/CON007326
DB 2002(05) Decontamination of Endoscopes 07-2002 professionals Best practice 07-2010 lletins/CON007329
DB 2002(03) Management and Use of IVD Point of Care Test Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
Devices 03-2002 professionals Best practice 03-2010 lletins/CON007333
DB 2002(02) Management of In Vitro Diagnostic Medical Devices 03-2002 professionals Best practice 03-2010 lletins/CON007335
DB 2001(03) Guidance on the Safe Transportation of Wheelchairs 06-2001 professionals Best practice 06-2010 lletins/CON007342
DB 1999(02) Emergency service radios and mobile data terminals: Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
compatibility problems with medical devices 05-1999 professionals Best practice 05-2013 lletins/CON007355
DB 9804 The Validation and Periodic Testing of Benchtop Vacuum Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
Steam Sterilizers 06-1998 professionals Best practice 06-2012 lletins/CON007359
DB 9702 Electromagnetic Compatibility of Medical Devices with Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
Mobile Communications 03-1997 professionals Best practice 03-2011 lletins/CON007365
DB 9601 Latex Sensitisation in the Health Care Setting (Use of Latex Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
Gloves) 04-1996 professionals Best practice 04-2010 lletins/CON007367
Healthcare http://cmsupgradepd/Publications/Safetyguidance/DeviceBullet
DB 9504 The Management of Infusion Systems - A Report by t 11-1995 professionals Best practice 11-2010 ins/CON007369
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/Otherdevi
Devices in Practice - a guide for health and social care professionals 08-2008 professionals Best practice 08-2013 cesafetyguidance/CON007423
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/Otherdevi
Guidelines on Wheelchair Stability 08-2005 professionals Best practice 08-2010 cesafetyguidance/CON2018055
A Code of Practice for the Production of Human-derived Therapeutic Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/Otherdevi
Products 04-2005 professionals Best practice 04-2010 cesafetyguidance/CON007431
Sterilization, Disinfection and Cleaning of Medical Equipment:
Guidance on Decontamination from the Microbiology Advisory Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/Otherdevi
Committee to Department of Health 04-2005 professionals Best practice 04-2010 cesafetyguidance/CON007438
Equipped to Care - The safe use of medical devices in the 21st Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/Otherdevi
Century 10-2000 professionals Best practice 10-2010 cesafetyguidance/CON007425
Report of the Expert Working Group on Alarms on Clinical Monitors -
in response to Recommendation 11 of Sir Cecil Clothier's report of Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/Otherdevi
the Allitt Inquiry 02-1995 professionals Best practice 02-2010 cesafetyguidance/CON007433
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
Breast implants - guidance on the vigilance system (VG03) 10-2009 Devices industry Regulatory 10-2014 ces/Vigilanceguidanceforspecificdevices/CON2024564
Directives Bulletin 13 - Standards 03-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007497.pdf
Directives Bulletin 10 - The Classification Rules 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007495.pdf
Guidance note 6 - Requirements for UK Notified Bodies 06-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007510.pdf
Guidance note 4 - Pre-clinical assessment: Guidance for assessors 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007508.pdf
Neurostimulators - draft guidance on the vigilance system for CE- http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi

marked medical devices 07-2009 Devices industry Regulatory 07-2014 ces/Vigilanceguidanceforspecificdevices/CON052089
Intraocular lenses - guidance on the vigilance system (VG07) 06-2009 Devices industry Regulatory 06-2014 ces/Vigilanceguidanceforspecificdevices/CON035993
Coronary stents - guidance on the vigilance system (VG04) 03-2009 Devices industry Regulatory 03-2014 ces/Vigilanceguidanceforspecificdevices/CON033533
Inferior vena cava (IVC) filters - guidance on the vigilance system http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
(VG06) 03-2009 Devices industry Regulatory 03-2014 ces/Vigilanceguidanceforspecificdevices/CON041266
Artificial heart valves - guidance on the vigilance system (VG02) 11-2008 Devices industry Regulatory 11-2013 ces/Vigilanceguidanceforspecificdevices/CON020786
IVD blood glucose meters in POCT or home use - guidance on the http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
vigilance system (VG05) 11-2008 Devices industry Regulatory 11-2013 ces/Vigilanceguidanceforspecificdevices/CON020785
Joint replacement implants - guidance on the vigilance system http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi

(VG01) 06-2008 Devices industry Regulatory 06-2013 ces/Vigilanceguidanceforspecificdevices/CON020584
Optical Flyer - The application of the EC Medical Devices Directive
to ophthalmic medical practitioners, optometrists, dispensing http://www.mhra.gov.uk/home/groups/es-
opticians and manufacturing opticians 10-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007530.pdf
Medical device appeals 09-2005 Devices industry Regulatory 12-2010 ces/Otherdevicesregulatoryguidance/CON2022932
Post-market surveillance of CE marked joint replacement implants http://www.mhra.gov.uk/home/groups/dts-

including guidance to manufacturers on post-market clinical studies 09-2000 Devices industry Regulatory 09-2010 bi/documents/publication/con007529.pdf
The In Vitro Diagnostic Medical Devices Directive - Background http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
Note 05-2003 Devices industry Regulatory 12-2010 ces/Otherdevicesregulatoryguidance/CON007531
Enforcement Policy - Compliance Inspection and Action - Your http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
Rights 12-2002 Devices industry Regulatory 12-2010 ces/Otherdevicesregulatoryguidance/CON007523
MEDICINES AND MEDICAL DEVICES REGULATION
Medicines & Medical Devices Regulation: What you need to know 04-2008 All sectors Regulatory 04-2010 ic/documents/websiteresources/con2031677.pdf
Making Regulatory Decisions about Medicines and Medical Devices 09-2007 All sectors Information only 12-2010 sp/documents/websiteresources/con2030689.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Doesmypro
Pharmaceutical ductneedalicence/Borderlineproducts/Medicaldevicesandmedi
Medical devices and medicinal products borderline 09-2009 industry Information only 03-2010 cinalproductsborderline/index.htm
Pharmaceutical and http://www.mhra.gov.uk/home/groups/es-

Directives Bulletin 17: Medical devices and medicinal products 08-2009 devices industries Regulatory 12-2010 era/documents/publication/con007498.pdf

MHRA - Guidance List - Final

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Guidance list for the Medicines and Healthcare products Regulatory Agency

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List A: Consolidated list of substances in prescription only medicines Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-

Rules and Guidance for Pharmaceutical Manufacturers and Pharmaceutical http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi

Good Laboratory Practice: Guidance on claiming compliance with Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona

Department of Health and MHRA Register of Licensed Wholesale Pharmaceutical http://www.mhra.gov.uk/home/groups/is-

Department of Health and MHRA Register of Licensed Pharmaceutical http://www.mhra.gov.uk/home/groups/is-

Pharmaceutical http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi To be updated when new EU Pharmacogilance

Guidance for the Pharmaceutical Industry on the use of bridging

Report of the findings of the survey of user test houses undertaken

Pharmaceutical and http://www.mhra.gov.uk/home/groups/is-

Pharmaceutical and http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti

Guidance for Retailers, Wholesalers, Importers and Manufacturers http://www.mhra.gov.uk/home/groups/pl-

Guidance note: provisions on the Directive on Traditional Herbal http://www.mhra.gov.uk/home/groups/es-

Guidance on regulation of unlicensed herbal medicines made up by

Guidance on the Commission Directive on the reclassification of http://www.mhra.gov.uk/home/groups/es-

Directives Bulletin 20 - Conformity assessment procedures under http://www.mhra.gov.uk/home/groups/es-

Guidance note 17 - Guidance notes for manufacturers on statistical http://www.mhra.gov.uk/home/groups/es-

Guidance note 8 - Guidance notes for the registration of persons http://www.mhra.gov.uk/home/groups/es-

DB 2002(06) Benchtop Steam Sterilizers - Guidance on Purchase, Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu

Neurostimulators - draft guidance on the vigilance system for CE- http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi

Joint replacement implants - guidance on the vigilance system http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi

Post-market surveillance of CE marked joint replacement implants http://www.mhra.gov.uk/home/groups/dts-

Pharmaceutical and http://www.mhra.gov.uk/home/groups/es-

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