Académique Documents
Professionnel Documents
Culture Documents
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Marketingauthorisations/Biologicalandbiotechnology
Biological and biotechnology products (Marketing authorisations) 09-2005 industry Regulatory 06-2010 products/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Marketingauthorisations/Renewaloflicences/index.ht
Renewal of licences (Marketing authorisations) 05-2008 industry Regulatory 06-2010 m
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Marketingauthorisations/Changeofownershipapplica
Change of ownership applications (Marketing authorisations) 06-2009 industry Regulatory 01-2010 tions/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Questions and answers on PLPI PIL user testing 04-2008 industry Regulatory 04-2010 plpi2/documents/websiteresources/con014586.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Bridging applications (PLPI) 06-2008 industry Regulatory 04-2010 plpi2/documents/websiteresources/con018049.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Conditions for patient consultation by similarity to the UK leaflet 03-2009 industry Regulatory 04-2010 plpi1/documents/websiteresources/con041448.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Application to leaflet variations (PLPI) 07-2009 industry Regulatory 04-2010 plpi2/documents/websiteresources/con054454.pdf
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Informationforlicenceapplicants/Otherusefulservices
Scientific advice for licence applicants 04-2009 industry Regulatory 02-2010 andinformation/Scientificadviceforlicenceapplicants/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Code of practice for pack design for over the counter medicines 10-2009 industry Regulatory 06-2010 a/documents/websiteresources/con031175.pdf
CLINICAL TRIALS
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Clinicaltrials/Isaclinicaltrialauthorisationrequired/inde
Clinical trial authorisations: Is a clinical trial authorisation required? 07-2009 industry Regulatory 01-2010 x.htm
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Is it a clinical trial of a medicinal product? 09-2005 industry Regulatory 01-2010 unit1/documents/websiteresources/con009394.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Clinicaltrials/Applyingtoconductaclinicaltrial-
Clinical trial authorisations: Timescales and outcomes - Initial Pharmaceutical Initialapplication/Timescalesandoutcomes-
applications 03-2009 industry Information only 01-2010 Initialapplications/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Clinical trial authorisations: Making clinical trial submissions to the Pharmaceutical medicines/Clinicaltrials/MakingclinicaltrialsubmissionstotheMH
MHRA 07-2009 industry Best practice 01-2010 RA/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Fees for clinical trials 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Fees/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Clinicaltrials/Safetyreporting-
Clinical trial authorisations: Safety reporting - SUSARS and ASRs 03-2009 industry Information only 01-2010 SUSARSandASRs/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Clinical trials for medicines: Current issues 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Currentissues/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Clinical trials: Frequently asked questions 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Questionsandanswers/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Clinicaltrials/UKclinicaltrialauthorisationassessment
UK clinical trial authorisation assessment performance 09-2009 industry Information only 01-2010 performance/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Clinical trials: Mock applications 07-2009 industry Information only 01-2010 medicines/Clinicaltrials/Mockapplications/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
Regulatory requirement for QT interval assessment 11-2007 industry Information only 01-2010 unit1/documents/websiteresources/con2033038.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Licensingtime-
Licensing time-based performance measures 11-2009 industry Information only 05-2010 basedperformancemeasures/index.htm
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
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
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Manufacturing Practice: Compliance Report - Example 1 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041240.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Manufacturing Practice: Compliance Report - Example 2 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041241.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Manufacturing Practice: Compliance Report - Example 3 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041242.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Manufacturing Practice: Compliance Report - Example 4 03-2009 industry Regulatory 03-2010 insp/documents/websiteresources/con041243.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Pharmaceutical ndstandards/GoodManufacturingPractice/Theinspectionproces
Good Manufacturing Practice: The inspection process 03-2009 industry Information only 02-2010 s/index.htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Distribution Practice: Compliance assessment report 03-2009 industry Regulatory 05-2010 insp/documents/websiteresources/con041279.doc Word document
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Pharmaceutical ndstandards/GoodDistributionPractice/Theinspectionprocess/i
Good Distribution Practice: The inspection process 03-2009 industry Regulatory 02-2010 ndex.htm
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Good Clinical Practice inpsections metrics report 06-2009 industry Regulatory 06-2010 insp/documents/websiteresources/con054563.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
GCP inspection findings classification 01-2008 industry Regulatory 06-2010 insp/documents/websiteresources/con2033551.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Phase I Accreditation Scheme 11-2007 industry Regulatory 06-2010 insp/documents/websiteresources/con2033097.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Guidance for formulating responses to GCP inspection findings 06-2007 industry Regulatory 06-2010 insp/documents/websiteresources/con2031399.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Pharmaceutical ndstandards/GoodClinicalPractice/Riskbasedinspections/index
Good Clinical Practice: Risk based inspections 06-2009 industry Regulatory 01-2010 .htm
Pharmaceutical http://www.mhra.gov.uk/home/groups/is-
Risk based GCP Inspections - Frequently asked questions 06-2009 industry Regulatory 06-2010 insp/documents/websiteresources/con049178.pdf
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
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
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Pharmaceutical Pharmaceutical ndstandards/GoodPharmacovigilancePractice/Frequentlyaske
Frequently asked questions for Good Pharmacovigilance Practice 09-2009 industry industry 03-2010 dquestions/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
Pharmaceutical ndstandards/GoodPharmacovigilancePractice/Riskbasedinspe
Good Pharmacovigilance Practice: Risk based inspections 07-2009 industry Regulatory 01-2010 ctions/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
ndstandards/Risk-
Pharmaceutical basedInspectionProgrammeforgoodpracticeinspections/index.
Risk-Based Inspection Programme for good practice inspections 10-2009 industry Regulatory 04-2010 htm
Pharmaceutical http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/l-
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
BROMI audit of braille notifications 10-2009 industry Regulatory 06-2010 a/documents/websiteresources/con059998.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
Special Mail 3 - New ways of working at MHRA 07-2005 industry Regulatory See note ic/documents/websiteresources/con2015643.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/comms-
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
Guidance on communication of risk in patient information leaflets 06-2005 industry Regulatory See note a/documents/websiteresources/con049315.pdf Ongoing
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/pl-
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
Healthcare prescribingsellingandsupplyingofmedicines/ExemptionsfromMe
Chiropodists - exemptions from Medicines Act restrictions 10-2009 professionals Regulatory 04-2010 dicinesActrestrictions/Chiropodists/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
Healthcare prescribingsellingandsupplyingofmedicines/ExemptionsfromMe
Optometrists: exemptions from Medicines Act restrictions 11-2006 professionals Regulatory 06-2010 dicinesActrestrictions/Optometrists/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
Healthcare prescribingsellingandsupplyingofmedicines/ExemptionsfromMe
Midwives: exemptions from Medicines Act restrictions 09-2007 professionals Regulatory 06-2010 dicinesActrestrictions/Midwives/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
Healthcare prescribingsellingandsupplyingofmedicines/ExemptionsfromMe
Supplementary prescribing 11-2007 professionals Regulatory 06-2010 dicinesActrestrictions/Supplementaryprescribing/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
prescribingsellingandsupplyingofmedicines/Frequentlyraisedis
Market stalls and car boot sales (sale of medicines) 11-2007 Public Regulatory 06-2010 sues/Marketstallsandcarbootsales/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
prescribingsellingandsupplyingofmedicines/Frequentlyraisedis
Vending machines (sale of medicines) 11-2006 Public Regulatory 06-2010 sues/Vendingmachines/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
prescribingsellingandsupplyingofmedicines/Frequentlyraisedis
Internet (supply of medicines) 11-2006 All sectors Information only 06-2010 sues/TheInternet/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
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
Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
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
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
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-
registration status 01-2009 Herbal sector Regulatory 05-2010 herbal/documents/websiteresources/con038614.pdf
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
lMedicinesRegistrationScheme/Howtoobtainawholesaledealers
THMRS: Responsible persons 02-2008 Herbal sector Regulatory 02-2011 licence/Responsiblepersons/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
Traditional Herbal Medicines Registration Scheme: cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
Pharmacovigilance 04-2008 Herbal sector Regulatory 02-2010 lMedicinesRegistrationScheme/Pharmacovigilance/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
lMedicinesRegistrationScheme/Frequentlyaskedquestions/inde
THMRS: Frequently asked questions 08-2005 Herbal sector Information only 02-2010 x.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba
Traditional Herbal Medicines Registration Scheme: Guidance notes 09-2005 Herbal sector Regulatory 02-2010 lMedicinesRegistrationScheme/Guidancenotes/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
Advice to consumers: Safe use of herbal medicines 03-2009 Herbal sector Information only 05-2010 cines/Herbalsafetyadvice/Advicetoconsumers/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi
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
http://www.mhra.gov.uk/home/groups/es-
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
http://www.mhra.gov.uk/home/groups/l-
The control and quality of homoeopathic stocks 07-2003 Herbal sector Regulatory 03-2010 plpi1/documents/publication/con007561.pdf
http://www.mhra.gov.uk/home/groups/l-
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
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical and medicines/Informationforlicenceapplicants/Feesformedicinesbl
Fees for medicines, blood establishments and blood banks 11-2009 devices industries Regulatory 05-2010 oodestablishmentsandbloodbanks/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/Appealtopersonsappointed/i
Fees for appeals to Persons Appointed (PA) 05-2009 industry Regulatory 04-2010 ndex.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical and oodestablishmentsandbloodbanks/Drug-
Fees for drug - device combination products 03-2009 devices industries Regulatory 04-2010 devicecombinationproducts/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/Scientificadvicemeetings/in
Fees for scientific advice meetings 03-2009 industry Regulatory 04-2010 dex.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Fees for licence renewals, reclassifications and assessment of Pharmaceutical oodestablishmentsandbloodbanks/Licencerenewalapplications
labels and leaflets 03-2009 industry Regulatory 04-2010 reclassificationsandassessmentsoflabelsandleaflets/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/Licencevariationsapplicatio
Fees for licence variations applications 07-2009 industry Regulatory 01-2010 ns/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Informationforlicenceapplicants/Feesformedicinesbl
Fees for inspection 03-2009 industry Regulatory 04-2010 oodestablishmentsandbloodbanks/Inspectionfees/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/OtherfeesforTraditionalHerb
Fees for Traditional Herbal Medicinal Products (THMP) 03-2009 industry Regulatory 04-2010 alMedicinalProducts(THMP)/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/HomoeopathicNationalRule
Fees for Homoeopathic National Rules Scheme 03-2009 industry Regulatory 04-2010 sScheme/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
Pharmaceutical medicines/Informationforlicenceapplicants/Feesformedicinesbl
Periodic fees 03-2009 industry Regulatory 04-2010 oodestablishmentsandbloodbanks/Periodicfees/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical oodestablishmentsandbloodbanks/Feesforsafetyandqualityvetti
Fees for safety and quality vetting of unlicensed imported medicines 03-2009 industry Regulatory 04-2010 ngofunlicensedimportedmedicines/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
Pharmaceutical and oodestablishmentsandbloodbanks/Feesforbloodbanksandothe
Fees for blood banks and other blood establishments 08-2009 devices industries Regulatory 02-2010 rbloodestablishments/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof
medicines/Informationforlicenceapplicants/Feesformedicinesbl
oodestablishmentsandbloodbanks/Bankaccountdetails/index.ht
Bank account details 03-2009 All sectors Information only 04-2010 m
Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
MHRA fees definitions 04-2009 industry Regulatory 04-2010 cb/documents/websiteresources/con2023790.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
Clarification of terminology relating to periodic fees 04-2009 industry Regulatory 04-2010 cb/documents/websiteresources/con2023791.pdf
Pharmaceutical http://www.mhra.gov.uk/home/groups/es-
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
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform
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
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform
ationandadvice/Adviceandinformationforconsumers/Counterfei
Counterfeit medicines and devices 10-2009 Public Information only 04-2010 tmedicinesanddevices/index.htm
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/Safetyinformation/Generalsafetyinform
ationandadvice/Adviceandinformationforconsumers/Buyingme
Risks of buying medicines over the internet 11-2009 Public Information only 05-2010 dicinesovertheInternet/index.htm
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform
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
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
lems/Medicines/Reportingsuspectedadversedrugreactions/Pati
Patient reporting of suspected adverse drug reactions 04-2008 Public Information only 06-2010 entreporting/index.htm
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
lems/Medicines/Reportingsuspectedadversedrugreactions/Dru
Drug Analysis Prints (DAPs) 03-2009 All sectors Information only 02-2010 ganalysisprints/index.htm
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
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
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
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
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
lems/Medicines/Reportingsuspectedadversedrugreactions/Info
Pharmaceutical rmationforthePharmaceuticalIndustry/E2BreportingwiththeMHR
E2B reporting - Questions and answers 04-2007 industry Regulatory 06-2010 A/QuestionsandanswersonE2Breporting/index.htm
http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob
lems/Medicines/Reportingsuspectedadversedrugreactions/Info
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
http://www.mhra.gov.uk/home/groups/es-
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
http://www.mhra.gov.uk/home/groups/es-
Directives Bulletin 17 - Medical devices and medicinal products 08-2009 Devices industry Regulatory 12-2010 era/documents/publication/con007498.pdf
http://www.mhra.gov.uk/home/groups/comms-
Guidance note 20 - Borderlines with medical devices 08-2009 Devices industry Regulatory 12-2010 ic/documents/websiteresources/con057309.pdf
http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic
Medical Devices Classification 03-2009 Devices industry Regulatory 12-2010 esDirective/Classification/index.htm
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
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
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
DB 2003(02) Infusion Systems 03-2003 professionals Best practice 03-2011 lletins/CON007321
Healthcare http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu
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
http://www.mhra.gov.uk/home/groups/es-
Directives Bulletin 13 - Standards 03-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007497.pdf
http://www.mhra.gov.uk/home/groups/es-
Directives Bulletin 10 - The Classification Rules 02-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007495.pdf
http://www.mhra.gov.uk/home/groups/es-
Guidance note 6 - Requirements for UK Notified Bodies 06-2008 Devices industry Regulatory 12-2010 era/documents/publication/con007510.pdf
http://www.mhra.gov.uk/home/groups/es-
Guidance note 4 - Pre-clinical assessment: Guidance for assessors 01-2006 Devices industry Regulatory 12-2010 era/documents/publication/con007508.pdf
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
Intraocular lenses - guidance on the vigilance system (VG07) 06-2009 Devices industry Regulatory 06-2014 ces/Vigilanceguidanceforspecificdevices/CON035993
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
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
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
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
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi
Medical device appeals 09-2005 Devices industry Regulatory 12-2010 ces/Otherdevicesregulatoryguidance/CON2022932