mhra_guidance list - final

Guidance list for the Medicines and Healthcare products Regulatory AgencyDate last published Target audience (MM(Business Sector, YYYY) Consumers etc) Next review* Type of guidance (select (MMfrom drop-down) YYYY)

Title*

Link

Notes

MEDICINES REGULATIONS MARKETING AUTHORISATIONSReview of EU medicines legislation (''2001 Review'') Pharmaceutical 10-2009 industry Pharmaceutical 06-2009 industry Pharmaceutical 01-2007 industry Pharmaceutical 06-2007 industry Pharmaceutical 09-2001 industry Pharmaceutical 01-2008 industry Pharmaceutical 11-2005 industry Pharmaceutical 07-2009 industry Pharmaceutical 09-2005 industry Pharmaceutical 09-2005 industry Pharmaceutical 05-2008 industry Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 01-2005 industry Pharmaceutical 06-2009 industry Pharmaceutical 10-2009 industry Pharmaceutical 02-2009 industry Pharmaceutical 09-2007 industry Pharmaceutical 04-2008 industry Regulatory http://www.mhra.gov.uk/Howweregulate/Medicines/ReviewofE 04-2010 Umedicineslegislation(2001Review)/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/ReviewofE 01-2010 Umedicineslegislation(2001Review)/SunsetClause/index.htm http://www.mhra.gov.uk/home/groups/es01-2010 policy/documents/websiteresources/con2025697.pdf http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007544.pdf http://www.mhra.gov.uk/home/groups/isSee note pol/documents/websiteresources/con009272.pdf http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007547.pdf 10-2010 01-2010 http://www.mhra.gov.uk/home/groups/pla/documents/publication/con2022589.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Marketingauthorisations/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Marketingauthorisations/Abridgedproducts/index.ht m http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Marketingauthorisations/Biologicalandbiotechnology products/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Marketingauthorisations/Renewaloflicences/index.ht m http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Marketingauthorisations/Variationstolicences/index. htm http://www.mhra.gov.uk/home/groups/pla/documents/regulatorynews/con051864.pdf http://www.mhra.gov.uk/home/groups/pla/documents/websiteresources/con1004242.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Marketingauthorisations/Changeofownershipapplica tions/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Parallelimportlicences/index.htm http://www.mhra.gov.uk/home/groups/lplpi2/documents/websiteresources/con2031452.pdf http://www.mhra.gov.uk/home/groups/lplpi2/documents/websiteresources/con2033788.pdf http://www.mhra.gov.uk/home/groups/lplpi2/documents/websiteresources/con014586.pdf

Sunset Clause MHRA policy statement: Interpretation of Article 23a and Article 24 (46) of Directive 2001/83EC - the so-called "Sunset Clause" Guidance Note 8: A guide to what is a medicinal product Guidance on requesting a review of a provisional determination issued by the Borderline Section of the MCA Guidance Note 14: The supply of unlicensed relevant medicinal products for individual patients Guidance Note 23: Advertising and promotion of Medicines in the UK - The Blue Guide Marketing authorisations

Regulatory

Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory

Current - no review date To be read with Guidance Note 8 Reviewed when there are changes to legislation

Abridged products (Marketing authorisations)

Regulatory

06-2010

Biological and biotechnology products (Marketing authorisations)

Regulatory

06-2010

Renewal of licences (Marketing authorisations)

Regulatory

06-2010

Variations to licences (Marketing authorisations) National Type II safety variations 'Request for Further Information'(RFI): Pilot project plan (Marketing authorisations) Guidance on the appeal procedure for refused national Type II variations

Regulatory Regulatory Regulatory

01-2010 01-2010 01-2010

Change of ownership applications (Marketing authorisations) Parallel import licences Guidance note for PLPI companies on user testing of patient information leaflets Additional guidance on PIL user testing for PLPI products Questions and answers on PLPI PIL user testing

Regulatory Regulatory Regulatory Regulatory Regulatory

01-2010 04-2010 04-2010 04-2010 04-2010

Bridging applications (PLPI) Conditions for patient consultation by similarity to the UK leaflet Pharmacovigilance for parallel imports products Parallel import applications - Guidance concerning requests for further information (RFIs) Application to leaflet variations (PLPI)

Pharmaceutical 06-2008 industry Pharmaceutical 03-2009 industry Pharmaceutical 09-2009 industry Pharmaceutical 01-2008 industry Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 04-2002 industry Pharmaceutical 06-2005 industry Pharmaceutical 11-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 11-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 06-2009 industry Pharmaceutical 02-2008 industry Pharmaceutical 08-2008 industry Pharmaceutical 09-2006 industry Pharmaceutical 09-2006 industry Pharmaceutical 01-2009 industry Pharmaceutical 01-2007 industry


http://www.mhra.gov.uk/home/groups/l04-2010 plpi2/documents/websiteresources/con018049.pdf http://www.mhra.gov.uk/home/groups/l04-2010 plpi1/documents/websiteresources/con041448.pdf http://www.mhra.gov.uk/home/groups/l04-2010 plpi2/documents/websiteresources/con057402.pdf http://www.mhra.gov.uk/home/groups/l04-2010 plpi2/documents/websiteresources/con2033978.pdf http://www.mhra.gov.uk/home/groups/l04-2010 plpi2/documents/websiteresources/con054454.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof 06-2010 medicines/Legalstatusandreclassification/index.htm http://www.mhra.gov.uk/home/groups/commsUnder review See note ic/documents/publication/con007545.doc http://www.mhra.gov.uk/home/groups/pl06-2010 a/documents/publication/con1004381.pdf http://www.mhra.gov.uk/home/groups/pl11-2010 a/documents/websiteresources/con009484.pdf http://www.mhra.gov.uk/home/groups/pl07-2010 a/documents/websiteresources/con009485.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Legalstatusandreclassification/Listsofsubstances/C 11-2010 ON2015073 http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Legalstatusandreclassification/Recentreclassificatio 01-2010 ns/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Licenceapplicationf Do we need to add individual forms? 01-2010 orms/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Fasttrackingofmark etingauthorisationapplications/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Changingthenameof acompany/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Reportingsuspected adversedrugreactions/index.htm http://www.mhra.gov.uk/home/groups/plp/documents/websiteresources/con2018004.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/PeriodicSafetyUpda teReports/index.htm

Legal status and reclassification Guidance note 11: Changing the legal classification in the United Kingdom of a medicine for human use MHRA guidance on the application for exclusivity for change in legal status of a medicine List A: Consolidated list of substances in prescription only medicines (POM), with exemptions for pharmacy sale or supply List B: Consolidated list of substances in authorised medicines for general sale List C: Consolidated list of substances which are present in authorised products which have been reclassified since 1 April 2002


Information only Information only

Information only

Recent reclassifications

Regulatory

Licence application forms

Information only

Fast tracking of marketing authorisation applications Changing the name of a company for authorisations held under Medicines Regulations Reporting suspected adverse drug reactions (Info for licence holders) Mandatory electronic ICSR reporting

Regulatory

02-2010

Regulatory

02-2010

Regulatory Regulatory

03-2010 03-2010

Periodic Safety Update Reports (Info for licence holders) Provisions to which the marketing authorisation is granted (Info for licence holders)

Regulatory

01-2010

Regulatory

Best practice guidance for national marketing authorisations (MA) pilot initiative Guidance note 29: MHRA naming policy with respect to umbrella segments of product names

Pharmaceutical 08-2009 industry Pharmaceutical 12-2003 industry

Best practice Regulatory

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Provisionstowhichth 01-2010 emarketingauthorisationisgranted/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Guidance/Bestpracti ceguidanceforprocessingnationalmarketingauthorisationapplic 02-2010 ations/index.htm http://www.mhra.gov.uk/home/groups/commsUnder review See note ic/documents/publication/con007558.pdf

Changes to medicines names: BANs to rINNs

Pharmaceutical 03-2008 industry Pharmaceutical 09-2006 industry Pharmaceutical 09-2003 industry

Regulatory

Labelling: Vitamin C Guidance on compliance with the Medicines (Child Safety) Regulations 2003


http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Guidance/Namingp 06-2010 olicy/ChangestomedicinesnamesBANstorINNs/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Guidance/Labelling 06-2010 VitaminC/index.htm http://www.mhra.gov.uk/home/groups/plReviewed when there are changes to legislation See note a/documents/websiteresources/con009529.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Guidance/Overdose 06-2010 sectionsofSPCs/Genericoverdosesections/index.htm http://www.mhra.gov.uk/home/groups/pl06-2010 a/documents/websiteresources/con2033953.pdf http://www.mhra.gov.uk/home/groups/pl06-2010 a/documents/websiteresources/con2033954.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Otherusefulservices 02-2010 andinformation/Scientificadviceforlicenceapplicants/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Otherusefulservices andinformation/RequestsforMHRAtoactasReferenceMemberSt 06-2010 ate(RMS)/index.htm

'Generic' overdose sections Minimum clinical particulars for pharmacy (P) and general sales list (GSL) Ibuprofen for systemic administration - Guidance to marketing authorisation (MA) holders Minimum clinical particulars for non-selective prescription only (POM) NSAIDs for systemic administration (excludes asprin/salicylic acid derivatives)


Regulatory

Regulatory

Regulatory

Scientific advice for licence applicants

Pharmaceutical 04-2009 industry

Regulatory

Requests for MHRA to act as Reference Member State (RMS)


Regulatory

Code of practice for pack design for over the counter medicines


Regulatory

http://www.mhra.gov.uk/home/groups/pl06-2010 a/documents/websiteresources/con031175.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Isaclinicaltrialauthorisationrequired/inde x.htm http://www.mhra.gov.uk/home/groups/lunit1/documents/websiteresources/con009394.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/ApplyingtoconductaclinicaltrialInitialapplication/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/ApplyingtoconductaclinicaltrialInitialapplication/TimescalesandoutcomesInitialapplications/index.htm

CLINICAL TRIALSPharmaceutical 07-2009 industry Pharmaceutical 09-2005 industry Pharmaceutical 07-2009 industry

Clinical trial authorisations: Is a clinical trial authorisation required? Is it a clinical trial of a medicinal product? Clinical trial authorisations: Applying for authorisation to conduct a clinical trial - Initial application


01-2010 01-2010

Regulatory

01-2010

Clinical trial authorisations: Timescales and outcomes - Initial applications Clinical trial authorisations: Maintaining a clinical trial authorisation Amendments and trial conclusion

Pharmaceutical 03-2009 industry Pharmaceutical 11-2009 industry

Information only

01-2010

Regulatory

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Maintainingaclinicaltrialauthorisation(C 01-2010 TA)-Amendmentsandtrialconclusion/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Maintainingaclinicaltrialauthorisation(C TA)-Amendmentsandtrialconclusion/Timescalesandoutcomes01-2010 Amendments/index.htm

Clinical trial authorisations: Timescales and outcomes Amendments


Best practice

Clinical trial authorisations: Making clinical trial submissions to the MHRA Fees for clinical trials

Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 09-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 11-2007 industry Pharmaceutical 11-2007 industry Pharmaceutical 07-2009 industry Pharmaceutical 11-2005 industry Pharmaceutical 10-2006 industry Pharmaceutical 07-2009 industry Pharmaceutical 08-2006 industry Pharmaceutical 10-2003 industry Pharmaceutical 09-2005 industry Pharmaceutical 07-2005 industry Pharmaceutical 07-2005 industry Pharmaceutical 11-2009 industry

Best practice Information only

01-2010 01-2010

Clinical trial authorisations: Safety reporting - SUSARS and ASRs Clinical trials for medicines: Current issues Clinical trials: Arrangements for trials which had an exemption or certificate on 1 May 2004


01-2010 01-2010

Information only

01-2010

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/MakingclinicaltrialsubmissionstotheMH RA/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Fees/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/SafetyreportingSUSARSandASRs/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Currentissues/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Trialsapprovedbefore1May2004/index. htm

Clinical trials: Frequently asked questions

Information only

UK clinical trial authorisation assessment performance Clinical trials: Mock applications


http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof 01-2010 medicines/Clinicaltrials/Questionsandanswers/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/UKclinicaltrialauthorisationassessment 01-2010 performance/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof 01-2010 medicines/Clinicaltrials/Mockapplications/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Additionalinformationforapplicants/inde 01-2010 x.htm http://www.mhra.gov.uk/idcm2/groups/l01-2010 unit1/documents/websiteresources/con2033037.pdf http://www.mhra.gov.uk/home/groups/l01-2010 unit1/documents/websiteresources/con2033038.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/ImplementationoftheClinicalTrialsDirect 01-2010 iveintheUK/index.htm http://www.mhra.gov.uk/home/groups/l01-2010 unit1/documents/websiteresources/con2022633.pdf http://www.mhra.gov.uk/home/groups/l01-2010 unit1/documents/websiteresources/con2025075.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Clinicaltrials/Legislationandguidancedocuments/ind 01-2010 ex.htm http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007543.pdf http://www.mhra.gov.uk/home/groups/ismd/documents/websiteresources/con009281.pdf http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007542.pdf http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007556.pdf

Clinical trial authorisations: Additional information for applicants Clarification of contraceptive wording in clinical trials Regulatory requirement for QT interval assessment

Information only Information only Information only

Implementation of the Clinical Trials Directive in the UK Description of the Medicines for Human use (Clinical Trials) regulations 2004 Medicines for Human Use (Clinical Trials) Regulations 2004 Memorandum of understanting between MHRA, COREC and GTAC


Regulatory

Clinical trial authorisations: Legislation and guidance documents

Both

INSPECTION, MANUFACTURING AND WHOLESALINGGuidance Note 6: Notes for applicants and holders of a wholesale dealer's licence Interim guidance - minimising the risk of transmission of Transmissible Spongiform Encephalopathies via unlicensed medicinal products for human use Guidance Note 5: Notes for applicants and holders of a manufacturer's licence Guidance Note 27: Guidance notes for industry on the preparation of a Site Master File Guidance Note 28: Guidance notes for industry on the preparation of a Site Master File for an overseas site subject to inspection by the UK regulatory authority Regulatory Reviewed when there are changes to legislation


Reviewed when there are changes to legislation Current - no review date

Regulatory

Manufacturers and Wholesale Dealers licences

Regulatory

http://www.mhra.gov.uk/home/groups/commsCurrent - no review date See note ic/documents/publication/con007557.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/ManufacturersandWholesaleDealerslicences/index. 05-2010 htm

Guidance for UK Manufacturer's Licence and Manufacturer's Authorisation Holders on the use of stand alone contract laboratories Guidance note 30: Site Master File model: For manufacturing 'specials' licence holders or applicants for manufacturing authorisations relating to small-scale activities, including investigational medicinal products Guidance note 13: Manufacturer's Licences authorising a nonorthodox practitioner to mix and assemble unlicensed medicinal products

Pharmaceutical Jan-08 industry

Regulatory

http://www.mhra.gov.uk/home/groups/is05-2010 lic/documents/websiteresources/con2033764.pdf

Pharmaceutical 03-2004 industry Pharmaceutical 11-2004 industry Pharmaceutical 11-2009 industry Pharmaceutical 10-2009 industry Pharmaceutical 10-2009 industry Pharmaceutical 02-2007 industry Pharmaceutical 07-2009 industry Pharmaceutical 09-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 03-2009 industry

Regulatory

http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007559.pdf

Current - no review date

Regulatory

Licensing time-based performance measures Time-based performance measures - Information Processing Unit Time-based performance measures - MHRA Licensing and VRMM assessment teams Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 - the 'Orange Guide'

Information only Information only Information only

http://www.mhra.gov.uk/home/groups/commsReviewed when there are changes to legislation See note ic/documents/publication/con007546.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Licensingtime05-2010 basedperformancemeasures/index.htm http://www.mhra.gov.uk/home/groups/lunit1/documents/websiteresources/con038831.pdf http://www.mhra.gov.uk/home/groups/lunit1/documents/websiteresources/con038832.pdf http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi Current - no review date See note cines/Othermedicinesregulatoryguidance/CON2030291 http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona 01-2010 ndstandards/GoodManufacturingPractice/FAQ/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodManufacturingPractice/Guidanceandlegislati 03-2010 on/QualifiedPersonsQPs/index.htm http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con041238.pdf http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con041239.pdf http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con041240.pdf http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con041241.pdf http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con041242.pdf http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con041243.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodManufacturingPractice/Guidanceandlegislati on/Risk-basedinspections/Questionsandanswers/index.htm http://www.mhra.gov.uk/home/groups/isinsp/documents/websiteresources/con028396.pdf http://www.mhra.gov.uk/home/groups/isinsp/documents/websiteresources/con028397.pdf http://www.mhra.gov.uk/home/groups/isinsp/documents/publication/con2031300.pdf http://www.mhra.gov.uk/home/groups/isinsp/documents/publication/con054675.pdf http://www.mhra.gov.uk/home/groups/isinsp/documents/publication/con054674.pdf Current - no review date http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodManufacturingPractice/Theinspectionproces s/index.htm

Regulatory

Good Manufacturing Practice: Frequently asked questions

Regulatory

Good Manufacturing Practice: Qualified persons (QPs) Good Manufacturing Practice: Compliance Report - Guidelines for completion and submission Good Manufacturing Practice: Compliance Report - Interim update Good Manufacturing Practice: Compliance Report - Example 1 Good Manufacturing Practice: Compliance Report - Example 2 Good Manufacturing Practice: Compliance Report - Example 3 Good Manufacturing Practice: Compliance Report - Example 4

Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory

Good Manufacturing Practice (GMP) risk-based inspections: Questions and answers Active Pharmaceutical Ingredient (API) focussed MHRA inspections at dosage from manufacturers Good Manufacturing Practice (GMP) expectations of Non Traditional Active Pharmaceutical Ingredients (APIs) Inspected UK Contract GMP Quality Control Laboratories Introduction of a risk based inspection programme for contract GMP QC testing laboratories Guidance on completion of the contract GMP QC testing laboratory change form

07-2009 10-2008 10-2008 07-2009 08-2009 04-2009

Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry

Regulatory Regulatory Regulatory Information only Regulatory Regulatory

01-2010 03-2010 03-2010 07-2010 02-2010 See note

Good Manufacturing Practice: The inspection process


Information only

02-2010

Good Distribution Practice: Frequently asked questions Refrigerated medicinal products: what pharmacists need to know

Pharmaceutical 11-2009 industry Healthcare 01-2009 professionals Pharmaceutical 06-2007 industry Pharmaceutical 03-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 06-2009 industry Pharmaceutical 01-2008 industry Pharmaceutical 11-2007 industry Pharmaceutical 06-2007 industry Pharmaceutical 08-2009 industry Pharmaceutical 02-2007 industry Pharmaceutical 06-2009 industry Pharmaceutical 06-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 07-2009 industry Pharmaceutical 10-2009 industry Pharmaceutical 08-2008 industry Pharmaceutical 08-2007 industry Pharmaceutical 08-2007 industry Pharmaceutical 08-2007 industry Pharmaceutical 06-2009 industry Pharmaceutical 08-2007 industry Pharmaceutical 02-2000 industry Pharmaceutical 07-2009 industry


http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona 05-2010 ndstandards/GoodDistributionPractice/FAQ/index.htm http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con038595.pdf http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi Current - no review date See note cines/Othermedicinesregulatoryguidance/CON2031492 http://www.mhra.gov.uk/home/groups/isWord document 05-2010 insp/documents/websiteresources/con041279.doc http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodDistributionPractice/Theinspectionprocess/i 02-2010 ndex.htm http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con054563.pdf http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con2033551.pdf http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con2033097.pdf http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con2031399.pdf http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con2024532.pdf http://www.mhra.gov.uk/home/groups/isWord document 06-2010 insp/documents/websiteresources/con2030352.doc http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodClinicalPractice/Riskbasedinspections/index 01-2010 .htm http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con049178.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodClinicalPracticeforClinicalLaboratories/index 01-2010 .htm http://www.mhra.gov.uk/home/groups/is01-2010 insp/documents/websiteresources/con051910.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona 04-2010 ndstandards/GoodLaboratoryPractice/Guidance/index.htm http://www.mhra.gov.uk/home/groups/is04-2010 insp/documents/websiteresources/con2032323.pdf http://www.mhra.gov.uk/home/groups/is04-2010 insp/documents/websiteresources/con2031908.pdf http://www.mhra.gov.uk/home/groups/is04-2010 insp/documents/websiteresources/con2031907.pdf http://www.mhra.gov.uk/home/groups/is04-2010 insp/documents/websiteresources/con2032324.pdf http://www.mhra.gov.uk/home/groups/is04-2010 insp/documents/websiteresources/con2025518.pdf http://www.mhra.gov.uk/home/groups/is04-2010 insp/documents/websiteresources/con2032325.pdf http://www.mhra.gov.uk/home/groups/comms12-2010 ic/documents/publication/con007566.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodLaboratoryPractice/Riskbasedinspections/in 01-2010 dex.htm

Rules and Guidance for Pharmaceutical Distributors 2007 Good Distribution Practice: Compliance assessment report


Good Distribution Practice: The inspection process Good Clinical Practice inpsections metrics report GCP inspection findings classification Phase I Accreditation Scheme Guidance for formulating responses to GCP inspection findings GCP routine inspection process Guidance for the notification of serious breaches of GCP or the trial protocol


Good Clinical Practice: Risk based inspections Risk based GCP Inspections - Frequently asked questions


Good Clinical Practice for Clinical Laboratories Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples Good Laboratory Practice: Guidance on claiming compliance with the principles Guidance on the use of non-GLP compliant facilities for the conduct of study phases Pesticide efficacy studies intended for submission to the United States Environmental Protection Agency Registration, Evaluation, Authorisation and resitriction of Chemicals (REACH) GLPMA expectiation for audit of the quality assurance programme GLPMA expectiations when using a contract quality assurance service Guidance on the content of quality assurance statements Guide to UK GLP Regulations 1999

Regulatory

Regulatory

Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory

Good Laboratory Practice: Risk based inspections

Regulatory

Guidance on completion of the form used to notify the Good Laboratory Practice Monitoring Authority (GLPMA) of changes within the Good Laboratory Practice (GLP) test facility

Pharmaceutical 04-2008 industry Pharmaceutical 09-2009 industry Pharmaceutical 09-2009 industry Pharmaceutical 11-2008 industry Pharmaceutical 09-2009 industry Pharmaceutical 07-2009 industry

Regulatory

http://www.mhra.gov.uk/home/groups/is01-2010 insp/documents/websiteresources/con043966.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona 03-2010 ndstandards/GoodPharmacovigilancePractice/index.htm http://www.mhra.gov.uk/home/groups/is03-2010 insp/documents/websiteresources/con057172.pdf http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi 06-2010 cines/Othermedicinesregulatoryguidance/CON028495 http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodPharmacovigilancePractice/Frequentlyaske 03-2010 dquestions/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/GoodPharmacovigilancePractice/Riskbasedinspe 01-2010 ctions/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona ndstandards/RiskbasedInspectionProgrammeforgoodpracticeinspections/index. 04-2010 htm http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectiona 06-2010 ndstandards/Medicinestesting/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Importinga ndexportingmedicines/Importingunlicensedmedicines/index.ht 01-2010 m http://www.mhra.gov.uk/Howweregulate/Medicines/Importinga 06-2010 ndexportingmedicines/Exportingmedicines/index.htm http://www.mhra.gov.uk/home/groups/comms06-2010 ic/documents/licensing/con026403.pdf http://www.mhra.gov.uk/home/groups/comms06-2010 ic/documents/licensing/con026405.pdf http://www.mhra.gov.uk/home/groups/comms06-2010 ic/documents/licensing/con026407.pdf http://www.mhra.gov.uk/home/groups/comms06-2010 ic/documents/licensing/con026409.pdf http://www.mhra.gov.uk/home/groups/comms06-2010 ic/documents/licensing/con026411.pdf http://www.mhra.gov.uk/home/groups/is04-2010 md/documents/websiteresources/con1004134.pdf http://www.mhra.gov.uk/home/groups/is10-2010 lic/documents/publication/con2025773.pdf http://www.mhra.gov.uk/home/groups/is10-2010 lic/documents/publication/con2025604.pdf http://www.mhra.gov.uk/home/groups/is10-2010 lic/documents/publication/con2030303.pdf http://www.mhra.gov.uk/home/groups/isSee note insp/documents/publication/con054680.pdf

Good Pharmacovigilance Practice Guidance notes on the information requested for an MHRA statutory pharmacovigilance inspection


The Good Parmacovigilance Practice Guide

Regulatory Pharmaceutical industry

Frequently asked questions for Good Pharmacovigilance Practice

Good Pharmacovigilance Practice: Risk based inspections

Regulatory

Risk-Based Inspection Programme for good practice inspections Medicines testing

Pharmaceutical 10-2009 industry Pharmaceutical 07-2007 industry Pharmaceutical 07-2009 industry Pharmaceutical 09-2005 industry Pharmaceutical 04-2001 industry Pharmaceutical 04-2001 industry Pharmaceutical 04-2001 industry Pharmaceutical 04-2001 industry Pharmaceutical 08-2003 industry Pharmaceutical 04-2006 industry Pharmaceutical 10-2009 industry Pharmaceutical 10-2009 industry Pharmaceutical 10-2009 industry Pharmaceutical 08-2009 industry Pharmaceutical 11-2008 industry


Importing unlicensed medicines

Regulatory

Exporting medicines Certificate of pharmaceutical product (licensed products) - guidance notes for completion of application form Certificate of pharmaceutical product (unlicensed products) guidance notes for completion of application form Certificate of manufacturing status - guidance notes for completion of application form Statement of licensing status of pharmaceutical products - guidance notes for completion of application form Guidance notes for the completion of application form for export certification for the importaion of a pharmaceutical constituent Policy document - TSE compliance requirements for exempt imported products Register of holders of Manufacturer's Authorisations for Investigational Medicinal Products (MIAIMP) Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites ) 2009 Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinay and Combined Sites) 2009 Use of test sites in Canada (GLP)



Regulatory



Good Pharmacovigilance Practice Guide

Regulatory

http://www.mhra.gov.uk/Publications/Regulatoryguidance/Medi To be updated when new EU Pharmacogilance legislation has been finalised See note cines/Othermedicinesregulatoryguidance/CON028495

Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products

Pharmaceutical 01-2001 industry Pharmaceutical 09-2009 industry Pharmaceutical 05-2006 industry Pharmaceutical 12-2006 industry Pharmaceutical 05-2008 industry Pharmaceutical 09-2009 industry Pharmaceutical 11-2007 industry Pharmaceutical 05-2008 industry Pharmaceutical 04-2008 industry Pharmaceutical 04-2008 industry Pharmaceutical 06-2009 industry

Regulatory

http://www.mhra.gov.uk/home/groups/comms10-2010 ic/documents/publication/con007569.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof 03-2010 medicines/BetterRegulationofMedicines/index.htm http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con2023796.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con2025468.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con015089.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con057264.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con2033962.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con017709.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con014920.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/websiteresources/con014776.pdf http://www.mhra.gov.uk/home/groups/pl03-2010 a/documents/regulatorynews/con049262.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/BetterRegulationofMedicines/Nationalinformedcons ent(Article10csimpleabridged)applications/index.htm http://www.mhra.gov.uk/home/groups/lunit1/documents/websiteresources/con2030171.doc Word document http://www.mhra.gov.uk/home/groups/pla/documents/websiteresources/con059997.pdf http://www.mhra.gov.uk/home/groups/pla/documents/websiteresources/con059998.pdf http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con2015643.pdf http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con2025309.pdf Current - no review date http://www.mhra.gov.uk/home/groups/escb/documents/websiteresources/con014479.pdf

BROMIBetter Regulation of Medicines Initiative (BROMI) Better regulation of over-the-counter Medicines Initiative: First report and recommendations Better Regulation of over-the-counter Medicines Initiative: Second report and recommendations Better Regulation of over-the-counter Medicines Initiative: Third report and recommendations Better Regulation of Medicines Initiative (BROMI): Fourth report on progress BROMI Dossier Requirements for Type 1A and Type 1B UK National Notifications - Version 2.1 BROMI variations - frequently asked questions Letter to marketing authorisation holders: Better Regulation of Medicines Initiative (BROMI) - Variations Scheme Submission of BROMI notifications - Key points Improvements in Detailed Descriptions of Pharmacovigilance System (DDPS) assessments Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory

Better Regulation of Medicines: National informed consent (Article 10c, 'simple abridged') applications National informed consent applications - BROMI checklist BROMI Proprietary Association of Great Britain (PAGB) code of practice audit report BROMI audit of braille notifications Special Mail 3 - New ways of working at MHRA Special Mail 5: frequently asked questions BROMI fee reductions

04-2008 02-2009 10-2009 10-2009 07-2005 06-2009 04-2008

Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry Pharmaceutical industry


06-2010 06-2010 06-2010 06-2010 See note See note 06-2010

LEAFLETS AND LABELLINGGuidance Note 25: Best Practice Guidance on the labelling and packaging of medicines Always read the leaflet - getting the best information with every medicine Always read the leaflet: additional 26 glossary terms Guidance Note 25: Best Practice Guidance on labelling and packaging of medicines Can you read the leaflet? A guideline on the usability of the patient information leaflet for medicinal products for human use Guidance on the user testing of patient information leaflets Questions and answers to support the MHRA guidance on user testing of patient information leaflets Pharmaceutical 06-2003 industry Pharmaceutical 10-2005 industry Pharmaceutical 05-2007 industry Pharmaceutical 06-2003 industry Pharmaceutical 06-2009 industry Pharmaceutical 06-2005 industry Pharmaceutical 06-2005 industry Regulatory Information only Information only Regulatory http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/publication/con007554.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/publication/con2018041.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/publication/con2031244.pdf http://www.mhra.gov.uk/home/groups/comms12-2010 ic/documents/publication/con007554.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con049314.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/publication/con1004417.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/publication/con1004418.pdf Ongoing Ongoing Ongoing

Information only Regulatory Regulatory

No date No date No date

MHRA guidance on the development of artwork in relation to medicines containing codeine and dihydrocodeine Guidance on communication of risk in patient information leaflets Glossary of medical terms in lay language Signposting from the patient information leaflet to additional sources of information and other services Guidance on information in the PIL to address areas of potential misuse or abuse of over-the-counter (OTC) antihistamine sleep aid and laxative medicines Labels, patient information leaflets and packaging of medicines: Legislation and guidelines

Pharmaceutical 10-2009 industry Pharmaceutical 06-2005 industry Pharmaceutical 05-2007 industry Pharmaceutical 03-2009 industry Pharmaceutical 04-2009 industry Pharmaceutical 05-2009 industry Pharmaceutical 06-2007 industry Pharmaceutical 11-2009 industry Pharmaceutical 11-2009 industry Pharmaceutical 05-2006 industry Pharmaceutical 11-2009 industry Pharmaceutical 03-2009 industry Pharmaceutical 10-2005 industry Pharmaceutical 01-2009 industry Pharmaceutical 06-2006 industry Pharmaceutical 03-2007 industry

Regulatory Regulatory Regulatory Regulatory

http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con059981.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con049315.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con049316.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con046601.pdf

No date Ongoing Ongoing Ongoing

Regulatory

Regulatory

Labels and leaflets: Applications for assessment Changes to labelling and patient information leaflets for all medicines subject to self certification by the applicant and formal notification to the MHRA MHRA guidance on changes to labelling and patient information leaflets for self certification document Changes to self certification - quality audit Guidance on changes to labelling and patient information leaflets for self certification - compliance with article 56(a) - inclusion of Braille on the labelling Braille on labelling and in patient information leaflets: New provisions from 30 October 2005 Questions and answers to address issues of national application of the new provisions concerning Braille on labelling and in the patient information leaflet of all medicines

Regulatory


http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con049317.pdf Unknown http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Legislationandguidelines/in 02-2010 dex.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Applicationsforassessment/i Ongoing See note ndex.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Notificationscheme/index.ht 05-2010 m http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con2023799.pdf Ongoing http://www.mhra.gov.uk/home/groups/pl06-2010 a/documents/websiteresources/con2023801.pdf http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con041517.pdf Unknown http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Brailleonlabellingandinpatie 02-2010 ntinformationleaflets/index.htm http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con2018141.pdf Unknown http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Usertestingofpatientinforma 05-2010 tionleaflets/index.htm http://www.mhra.gov.uk/home/groups/plSee note p/documents/websiteresources/con2024001.pdf Current - no review date http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con2030572.pdf Ongoing

Regulatory

Regulatory

Regulatory

User testing of patient information leaflets Additional questions and answers on user testing of patient information leaflets Further guidance on designing patient information leaflets and how to achieve success in user testing Guidance for the Pharmaceutical Industry on the use of bridging studies to demonstrate compliance with article 59(3) of Council Directive 2001/83/EC (Consultation with Target Patient Groups) Report of the findings of the survey of user test houses undertaken on behalf of the Commission on Human Medicines Expert Advisory Group on Patient Information (CHMEAGPI) Quality criteria for patient information leaflets



Regulatory

http://www.mhra.gov.uk/home/groups/plSee note p/documents/websiteresources/con2025471.pdf




Labelling and packaging of medicines: Complaints

Regulatory

http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con2030408.pdf Current - no review date http://www.mhra.gov.uk/home/groups/isSee note insp/documents/websiteresources/con2032836.pdf Ongoing http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Complaintsaboutlabellingan 05-2010 dpackagingofmedicines/index.htm

Labels, patient information leaflets and packaging for medicines: Frequently asked questions MEDICINES FOR CHILDREN Medicines for children Questions and Answers on UK strategy (Medicines for children) Medicines for children: Questions and answers on the UK stategy (pdf version) MHRA/Department of Health strategy on medicines for children Requirements for submission of paediatric information required by EU Paediatric Regulation Guidance on the MHRA's handling of the requirement in the Paediatric Regulation to undertake a 'complance check' during validation MHRA exercise to update SmPCs following EU paediatric worksharing procedures Summary of Regulation on medicines for paediatric use UK strategy document on medicines for children Questions and answers on the UK strategy on medicines for children MHRA policy on requesting paediatric data from companies ADVERTISING OF MEDICINES Advertising of medicines: Guidance for consumer website offering medicinal treatment services Tips for vetting of promotional material Guidance on the review of advertising by the Independent Review Panel Memorandum of understanding between the Association of the British Pharmaceutical Industry, the Prescription Medicines Code of Practice Authority and the Medicines and Healthcare products Regulatory Agency Guidance Note 24: Medicines which are promoted for use during pregnancy: Guidance for the pharmaceutical industry Guidance Note 26: Disease awareness campaigns guidelines Blue Guide: Advertising and Promotion of Medicines in the UK Enforcing the law PATIENT GROUP DIRECTIONS

Pharmaceutical 11-2009 industry Pharmaceutical 09-2009 industry Pharmaceutical 09-2005 industry Pharmaceutical 08-2004 industry Pharmaceutical 07-2004 industry Pharmaceutical 07-2009 industry Pharmaceutical 02-2009 industry Pharmaceutical 08-2009 industry Pharmaceutical 01-2007 industry Pharmaceutical 07-2004 industry Pharmaceutical 09-2005 industry Pharmaceutical 02-2007 industry Pharmaceutical 10-2008 industry Pharmaceutical 02-2008 industry Pharmaceutical 10-2009 industry

Regulatory

http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatie ntinformationleafletsandpackaging/Frequentlyaskedquestions/i 05-2010 ndex.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf 03-2010 orchildren/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf 06-2010 orchildren/QAonUKstrategy/index.htm http://www.mhra.gov.uk/home/groups/pl06-2010 p/documents/websiteresources/con009666.pdf http://www.mhra.gov.uk/home/groups/pl06-2010 p/documents/websiteresources/con009667.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf orchildren/Requirementsforsubmissionofpaediatricinformationr 01-2010 equiredbyEUPaediatricRegulation/index.htm http://www.mhra.gov.uk/home/groups/es06-2010 policy/documents/websiteresources/con020813.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesf 02-2010 orchildren/Whatsnew/index.htm http://www.mhra.gov.uk/home/groups/pl02-2010 a/documents/websiteresources/con2025602.pdf http://www.mhra.gov.uk/home/groups/pl02-2010 p/documents/websiteresources/con009667.pdf http://www.mhra.gov.uk/home/groups/pl02-2010 p/documents/websiteresources/con009666.pdf http://www.mhra.gov.uk/home/groups/pl02-2010 a/documents/websiteresources/con2030243.pdf http://www.mhra.gov.uk/home/groups/pl10-2010 a/documents/websiteresources/con031140.pdf http://www.mhra.gov.uk/home/groups/pl02-2010 a/documents/websiteresources/con2032012.pdf http://www.mhra.gov.uk/home/groups/pl10-2011 a/documents/websiteresources/con2022628.pdf


Regulatory

Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory


Pharmaceutical 11-2005 industry Pharmaceutical 06-2003 industry Pharmaceutical 06-2003 industry Pharmaceutical 11-2005 industry Pharmaceutical 09-2008 industry


http://www.mhra.gov.uk/home/groups/pl11-2010 a/documents/websiteresources/con2022582.pdf http://www.mhra.gov.uk/home/groups/comms11-2010 ic/documents/publication/con007553.pdf http://www.mhra.gov.uk/home/groups/comms11-2010 ic/documents/publication/con007555.pdf http://www.mhra.gov.uk/home/groups/pl11-2010 a/documents/websiteresources/con007552.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Enforcingth 06-2010 elaw/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe dicinesActrestrictions/PatientGroupDirectionsintheprivatesecto 06-2010 r/index.htm

Patient Group Directions in the private sector


Regulatory

Patient Group Directions in the NHS

Healthcare 09-2005 professionals

Regulatory

Nurse and pharmacist independent prescribing List of prescription only medicines prescribable by extended formulary nurse prescribers Descriptions and classes of prescription only medicines in relation to which appropriate district nurses and health visitors are appropriate practitioners

Healthcare 09-2005 professionals Healthcare 04-2005 professionals Healthcare 04-2003 professionals Healthcare 10-2005 professionals


http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe dicinesActrestrictions/PatientGroupDirectionsintheNHS/index.h 06-2010 tm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe dicinesActrestrictions/Nurseandpharmacistindependentprescri 06-2010 bing/index.htm http://www.mhra.gov.uk/home/groups/es06-2010 foi/documents/websiteresources/con009691.pdf http://www.mhra.gov.uk/home/groups/es06-2010 foi/documents/websiteresources/con009690.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe 06-2010 dicinesActrestrictions/Paramedics/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe 04-2010 dicinesActrestrictions/Chiropodists/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe 06-2010 dicinesActrestrictions/Optometrists/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe 06-2010 dicinesActrestrictions/Midwives/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/ExemptionsfromMe dicinesActrestrictions/Supplementaryprescribing/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/Frequentlyraisedis sues/BotoxVistabelDysportandotherinjectablemedicinesincosm eticprocedures/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/Frequentlyraisedis sues/Marketstallsandcarbootsales/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/Frequentlyraisedis sues/Vendingmachines/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/Frequentlyraisedis sues/Palliativecare/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/Frequentlyraisedis sues/TheInternet/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Availability prescribingsellingandsupplyingofmedicines/Frequentlyraisedis sues/Retinalscreening/index.htm

Regulatory

Paramedics - exemptions from Medicines Act restrictions

Regulatory

Chiropodists - exemptions from Medicines Act restrictions


Regulatory

Optometrists: exemptions from Medicines Act restrictions

Healthcare 11-2006 professionals Healthcare 09-2007 professionals

Regulatory

Midwives: exemptions from Medicines Act restrictions

Regulatory

Supplementary prescribing


Regulatory

06-2010

Supply and administration of Botox, Vistabel, Dysport and other injectable medicines in cosmetic procedures


Regulatory

06-2010

Market stalls and car boot sales (sale of medicines)

11-2007 Public

Regulatory

06-2010

Vending machines (sale of medicines) Non-medical prescribing and mixing medicines in palliative care and other areas of clinical practice

11-2006 Public Healthcare 09-2009 professionals

Regulatory

06-2010

Regulatory

03-2010

Internet (supply of medicines)

11-2006 All sectors Healthcare 07-2007 professionals Pharmaceutical 03-2009 industry

Information only

06-2010

Advice on administering eye drops in retinal screening programmes

Best practice

06-2010

MINISTERIAL INDUSTRY STRATEGY GROUPMinisterial Industry Strategy Group (MISG) New Technologies Advisory Panel Regulatory http://www.mhra.gov.uk/Howweregulate/Medicines/MISGNewT 02-2010 echnologiesAdvisoryPanel/index.htm

ADVANCED THERAPY MEDICINAL PRODUCTS

How we regulate advanced therapy medicinal products Interim UK Regulatory Route Map for Stem Cell Research and Manufacture Tissue engineering - Questions and answers



http://www.mhra.gov.uk/Howweregulate/Advancedtherapymedi 06-2010 cinalproducts/index.htm http://www.mhra.gov.uk/home/groups/es06-2010 policy/documents/websiteresources/con041336.pdf http://www.mhra.gov.uk/home/groups/es06-2010 herbal/documents/websiteresources/con2031532.pdf http://www.mhra.gov.uk/Howweregulate/Nanotechnology/index 06-2010 .htm

NANOTECHNOLOGYHow we regulate nanotechnology 02-2008 Devices industry Regulatory

BLOODPharmaceutical and 08-2009 devices industries Pharmaceutical and 10-2005 devices industries Pharmaceutical and 09-2005 devices industries Pharmaceutical and 08-2009 devices industries

How we regulate blood Explanatory memorandum to The Blood Safety and Quality (Amendment) (No 2) Regulations 2005 No. 2898 Guidance notes on the application form for a blood establishment authorisation

Regulatory

06-2010 http://www.mhra.gov.uk/Howweregulate/Blood/index.htm http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con2022508.pdf http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con2015665.pdf http://www.mhra.gov.uk/home/groups/is06-2010 insp/documents/websiteresources/con054515.pdf http://www.mhra.gov.uk/Howweregulate/Howwedevelopolicy/in 06-2010 dex.htm http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti 02-2010 es/OurnegotiationsinEurope/index.htm http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti 02-2010 es/MutualRecognitionAgreements/index.htm http://www.mhra.gov.uk/home/groups/is02-2011 pol/documents/websiteresources/con009276.pdf http://www.mhra.gov.uk/home/groups/pl05-2010 p/documents/websiteresources/con2030651.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi 05-2010 cines/PlacingaherbalmedicineontheUKmarket/index.htm http://www.mhra.gov.uk/home/groups/es05-2010 herbal/documents/websiteresources/con009362.pdf http://www.mhra.gov.uk/home/groups/es05-2010 herbal/documents/websiteresources/con023222.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba 02-2010 lMedicinesRegistrationScheme/index.htm http://www.mhra.gov.uk/home/groups/pl11-2011 p/documents/publication/con043820.xml http://www.mhra.gov.uk/home/groups/es05-2010 herbal/documents/websiteresources/con038614.pdf http://www.mhra.gov.uk/home/groups/es11-2010 herbal/documents/websiteresources/con2033554.pdf

Regulatory

Regulatory

Guidance on facilities and blood compliance reports for 2010

Regulatory

POLICYPolicy development and delivery 10-2008 All sectors Pharmaceutical and 08-2009 devices industries 08-2009 Devices industry Regulatory

Our negotiations in Europe Mutual Recognition Agreements


HERBAL AND HOMOEOPATHIC MEDICINESGuidance sheet on herbal ingredients Guidance for Retailers, Wholesalers, Importers and Manufacturers on Registering Herbal Medicine under the THMR Scheme 03-2005 Herbal sector Regulatory

03-2007 Herbal sector

Information only

Placing a herbal medicine on the UK market Guidance note on the transitional arrangements set out in Directive 2004/24/EC Guidance on arrangements for the transfer of certain herbal products with a marketing authorisation to traditional herbal registration status

08-2008 Herbal sector 04-2007 Herbal sector



Regulatory

Traditional Herbal Medicines Registration Scheme New guidance on consumer advertising for registered traditional herbal medicines Guidance on arrangements for the transfer of certain herbal products with a marketing authorisation to traditional herbal registration status Guidance on use of HMPC monographs to demonstrate safety and traditional use





Briefing note: sources of evidence of traditional use under the proposed Directive on Traditional Herbal Medicinal Products


Regulatory

Traditional Herbal Medicines Registration Scheme: How to obtain a manufacturer's licence Guidance Note: 'Traditional Herbal Medicinal Products Directive Transitional Qualified Persons



http://www.mhra.gov.uk/home/groups/es11-2010 herbal/documents/websiteresources/con009364.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba lMedicinesRegistrationScheme/Howtoobtainamanufacturerslic 02-2010 ence/index.htm http://www.mhra.gov.uk/home/groups/es02-2011 herbal/documents/websiteresources/con2023100.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba lMedicinesRegistrationScheme/Howtoobtainawholesaledealers 02-2011 licence/Responsiblepersons/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba lMedicinesRegistrationScheme/Howtoobtainamanufacturersim 02-2010 portlicence/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba 02-2010 lMedicinesRegistrationScheme/ProductInformation/index.htm http://www.mhra.gov.uk/home/groups/es02-2011 herbal/documents/websiteresources/con009363.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba 02-2010 lMedicinesRegistrationScheme/Pharmacovigilance/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba lMedicinesRegistrationScheme/Frequentlyaskedquestions/inde 02-2010 x.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/TraditionalHerba 02-2010 lMedicinesRegistrationScheme/Guidancenotes/index.htm http://www.mhra.gov.uk/home/groups/es02-2011 herbal/documents/websiteresources/con009362.pdf

THMRS: Responsible persons


Regulatory

Traditional Herbal Medicines Registration Scheme: How to obtain a manufacturer's import licence (MIA)


Regulatory

Traditional Herbal Medicines Registration Scheme: Product Information Permitted indications under the Directive on Traditional Herbal Medicinal Products



Traditional Herbal Medicines Registration Scheme: Pharmacovigilance


Regulatory

THMRS: Frequently asked questions


Information only

Traditional Herbal Medicines Registration Scheme: Guidance notes Guidance note: provisions on the Directive on Traditional Herbal Medicinal Products that would determine dates of introduction Guidance on regulation of unlicensed herbal medicines made up by a 3rd party for use by practitioner in a one to one consultation: arrangements pending possible reform of regulation Traditional Herbal Medicinal Product Directive: Transitional Qualified Persons Guidance notes to companies on hearings before and written representations to the Herbal Medicines Advisory Committee


Regulatory


Regulatory

07-2006 Herbal sector 09-2005 Herbal sector 08-2009 Herbal sector


The review and transfer of certain herbal product licences (marketing authorisation) to traditional herbal registration status Outline impact Assessment on the review and transfer of some herbal products with a marketing authorisation to traditional herbal registration status


Information only

http://www.mhra.gov.uk/home/groups/es05-2010 herbal/documents/websiteresources/con2024066.pdf http://www.mhra.gov.uk/home/groups/es02-2011 herbal/documents/websiteresources/con009371.pdf http://www.mhra.gov.uk/home/groups/l-csCurrent - no review date See note el/documents/websiteresources/con023084.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/PlacingaherbalmedicineontheUKmarket/Transferofherbal marketingauthorisationstotraditionalherbalregistrationstatus/ind 05-2010 ex.htm http://www.mhra.gov.uk/home/groups/es05-2010 herbal/documents/websiteresources/con038615.pdf


Regulatory

Consolidated Guidance on Transitional arrangements for the Directive on traditional herbal medicinal products (Directive 2004/24/EC, amending Directive 2001/83/EC) List of herbal ingredients which are prohibited or restricted in medicines



http://www.mhra.gov.uk/home/groups/es11-2010 herbal/documents/websiteresources/con009362.pdf http://www.mhra.gov.uk/home/groups/es11-2010 herbal/documents/websiteresources/con009294.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi 05-2010 cines/Herbalsafetyadvice/Advicetoconsumers/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi cines/Herbalsafetyadvice/Advicetoconsumers05-2010 TheTraditionalHerbalMedicinesRegistrationScheme/index.htm http://www.mhra.gov.uk/home/groups/es05-2010 herbal/documents/websiteresources/con2031846.pdf http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedi 05-2010 cines/Reportingproblemswithherbalmedicines/index.htm http://www.mhra.gov.uk/home/groups/es11-2010 herbal/documents/websiteresources/con023163.pdf http://www.mhra.gov.uk/home/groups/es11-2010 herbal/documents/websiteresources/con009293.pdf http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform ationandadvice/Adviceandinformationforconsumers/Usingherb 06-2010 almedicines/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Homoeopat 03-2010 hicmedicines/index.htm http://www.mhra.gov.uk/home/groups/comms03-2010 ic/documents/publication/con007550.pdf http://www.mhra.gov.uk/home/groups/l03-2010 plpi1/documents/publication/con007560.pdf http://www.mhra.gov.uk/home/groups/l03-2010 plpi1/documents/publication/con007561.pdf http://www.mhra.gov.uk/home/groups/l03-2010 plpi1/documents/websiteresources/con1004213.pdf http://www.mhra.gov.uk/home/groups/l03-2010 unit1/documents/websiteresources/con2024923.pdf

Advice to consumers: Safe use of herbal medicines


Information only

Advice to consumers - The Traditional Herbal Medicines Registration Scheme Traditional ethnic medicine: public health and compliance with medicines law


Information only Regulatory

Reporting problems with herbal medicines Public health risk with herbal medicines: An overview Report on the 'Safety of herbal medicinal products'

02-2008 Herbal sector 07-2008 Herbal sector 07-2002 Herbal sector

Information only Best practice Regulatory

Using herbal medicines: Advice to consumers Homoeopathic medicines Guidance note 17: The Homoeopathic Registration Scheme: Guidance for manufacturers and suppliers The manufacture and control of dosage form for homoeopathics The control and quality of homoeopathic stocks Note on labelling requirements for homoeopathic products The Homoeopathic National Rules Scheme: Brief guidance for manufacturers and suppliers

03-2009 Public 09-2005 Herbal sector 09-2003 Herbal sector 07-2003 Herbal sector 07-2003 Herbal sector 10-2009 Herbal sector 09-2006 Herbal sector

Information only Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory

FEEShttp://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Appealtopersonsappointed/i ndex.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Drugdevicecombinationproducts/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Scientificadvicemeetings/in dex.htm

Fees for medicines, blood establishments and blood banks

Pharmaceutical and 11-2009 devices industries

Regulatory

05-2010

Fees for appeals to Persons Appointed (PA)


Regulatory

04-2010

Fees for drug - device combination products


Regulatory

04-2010

Fees for scientific advice meetings


Regulatory

04-2010

Fees for licence renewals, reclassifications and assessment of labels and leaflets


Regulatory

Fees for licence variations applications


Regulatory

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Licencerenewalapplications 04-2010 reclassificationsandassessmentsoflabelsandleaflets/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Licencevariationsapplicatio 01-2010 ns/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl 04-2010 oodestablishmentsandbloodbanks/Inspectionfees/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/OtherfeesforTraditionalHerb 04-2010 alMedicinalProducts(THMP)/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/HomoeopathicNationalRule 04-2010 sScheme/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl 04-2010 oodestablishmentsandbloodbanks/Periodicfees/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Feesforsafetyandqualityvetti ngofunlicensedimportedmedicines/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Feesforbloodbanksandothe rbloodestablishments/index.htm http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingof medicines/Informationforlicenceapplicants/Feesformedicinesbl oodestablishmentsandbloodbanks/Bankaccountdetails/index.ht m http://www.mhra.gov.uk/home/groups/escb/documents/websiteresources/con2023790.pdf http://www.mhra.gov.uk/home/groups/escb/documents/websiteresources/con2023791.pdf http://www.mhra.gov.uk/home/groups/escb/documents/websiteresources/con2025630.pdf

Fees for inspection


Regulatory

Fees for Traditional Herbal Medicinal Products (THMP)


Regulatory

Fees for Homoeopathic National Rules Scheme


Regulatory

Periodic fees


Regulatory

Fees for safety and quality vetting of unlicensed imported medicines


Regulatory

04-2010

Fees for blood banks and other blood establishments


Regulatory

02-2010

Bank account details MHRA fees definitions Clarification of terminology relating to periodic fees Payment easements for small companies

03-2009 All sectors Pharmaceutical 04-2009 industry Pharmaceutical 04-2009 industry Pharmaceutical 04-2009 industry

Information only Regulatory Regulatory Information only

04-2010 04-2010 04-2010 04-2010

SAFETY AND PHARMACOVIGILANCESelective Serotonin Reuptake Inhibitors (SSRIs): use in children and adolescents with major depressive disorder Healthcare 12-2003 professionals Healthcare 03-2008 professionals Healthcare 04-2003 professionals http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalert sandrecalls/Safetywarningsandmessagesformedicines/CON01 06-2010 9494 http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform ationandadvice/Product06-2010 specificinformationandadvice/MMRvaccine/index.htm http://www.mhra.gov.uk/home/groups/comms06-2010 ic/documents/websiteresources/con007619.pdf

Best practice

MMR (measles, mumps and rubella) vaccine Aspirin and Reye's syndrome

Best practice Best practice

My medicines: pdf version of complete section Taking mediicnes - some questions and answers about side effects

09-2008 Public 12-2005 Public


Counterfeit medicines and devices

10-2009 Public

Information only

Using herbal medicines: Advice to consumers

03-2009 Public

Information only

Risks of buying medicines over the internet

11-2009 Public

Information only

Buying medical devices Pharmacy leaflet - with your help we can make medical equipment safe!

06-2009 Public 09-2004 Public


http://www.mhra.gov.uk/home/groups/commsSee note ic/documents/websiteresources/con025912.pdf Current - no review date http://www.mhra.gov.uk/home/groups/plSee note a/documents/websiteresources/con2022719.pdf Current - no review date http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform ationandadvice/Adviceandinformationforconsumers/Counterfei 04-2010 tmedicinesanddevices/index.htm http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform ationandadvice/Adviceandinformationforconsumers/Usingherb 06-2010 almedicines/index.htm http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform ationandadvice/Adviceandinformationforconsumers/Buyingme 05-2010 dicinesovertheInternet/index.htm http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinform ationandadvice/Adviceandinformationforconsumers/Buyingme 01-2010 dicaldevices/index.htm http://www.mhra.gov.uk/Publications/Postersandleaflets/CON0 06-2010 08390 http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesa 04-2010 fetyofproducts/Medicines/Pharmacovigilance/index.htm http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesa 05-2010 fetyofproducts/Medicines/BlackTriangleproducts/index.htm http://www.mhra.gov.uk/home/groups/isSee note md/documents/publication/con007572.pdf New edition scheduled for January 2010 http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Hea 05-2010 lthcareprofessionalreporting/index.htm http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Pati 06-2010 entreporting/index.htm http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Dru 02-2010 ganalysisprints/index.htm http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Info 06-2010 rmationforthePharmaceuticalIndustry/index.htm http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Info rmationforthePharmaceuticalIndustry/E2BreportingwiththeMHR 06-2010 A/index.htm http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Info rmationforthePharmaceuticalIndustry/E2BreportingwiththeMHR 06-2010 A/QuestionsandanswersonE2Breporting/index.htm http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyprob lems/Medicines/Reportingsuspectedadversedrugreactions/Info rmationforthePharmaceuticalIndustry/AdversedrugreactionAD 02-2010 Rliteraturereportslist/index.htm http://www.mhra.gov.uk/Safetyinformation/Healthcareproviders 04-2010 /index.htm

Pharmacovigilance - how we monitor the safety of medicines

10-2009 All sectors Healthcare 11-2009 professionals 11-2004 All sectors Healthcare 11-2009 professionals

Information only

New drugs and vaccines under intensive surveillance Guide to Defective Medicinal Products Healthcare professional reporting of suspected adverse drug reactions


Information only

Patient reporting of suspected adverse drug reactions

04-2008 Public

Information only

Drug Analysis Prints (DAPs)

03-2009 All sectors

Information only

Reporting suspected adverse drug reactions: Information for the Pharmaceutical Industry


Information only

E2B reporting with the MHRA: Updated information - January 2008


Regulatory

E2B reporting - Questions and answers


Regulatory

Adverse drug reaction (ADR) reports received by the MHRA from literature articles Targeted healthcare professional groups

Pharmaceutical 08-2009 industry Healthcare 10-2009 professionals


Drug Safety Update Information for women considering breast implants Medicines use review: Understand your medicines

Healthcare 11-2009 professionals 11-2005 Public 12-2005 Public

Best practice Information only Information only

http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafe 05-2010 tyUpdate/index.htm http://www.mhra.gov.uk/Publications/Postersandleaflets/CON2 11-2010 022635 http://www.mhra.gov.uk/home/groups/pl12-2010 a/documents/websiteresources/con2023072.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007490.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007494.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007511.pdf http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic 12-2010 esDirective/Borderlinewithmedicines/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007498.pdf http://www.mhra.gov.uk/home/groups/comms12-2010 ic/documents/websiteresources/con057309.pdf http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic 12-2010 esDirective/Classification/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/websiteresources/con2031594.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007492.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007515.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007516.pdf http://www.mhra.gov.uk/home/groups/commsUnder review See note ic/documents/publication/con007551.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007517.pdf http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic 12-2010 esDirective/Ophthalmicproducts/index.htm http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic esDirective/DevicesusingmaterialsfromTSEsusceptibleanimals 12-2010 /index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007496.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007521.pdf http://www.mhra.gov.uk/Howweregulate/Devices/InVitroDiagno 12-2010 sticMedicalDevicesDirective/Borderlines/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007501.pdf http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/i 12-2010 ndex.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007504.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007507.pdf

MEDICAL DEVICE REGULATIONDirectives Bulletin 2 - The CE Marking Directives Bulletin 8 - Information about the EC Medical Devices Directives Guidance note 7 - Guidance for manufacturers of Class I medical devices Borderline with medicines Directives Bulletin 17 - Medical devices and medicinal products Guidance note 20 - Borderlines with medical devices Medical Devices Classification Guidance on the Commission Directive on the reclassification of total hip, knee and shoulder joint replacement Directives Bulletin 4 - Conformity assessment procedures (medical device regulations) Guidance note 9 - Guidance notes from manufacturers of custommade devices Guidance note 10 - Guidance notes for manufacturers of dental appliances (custom made devices) Guidance note 18 - Guidance for notified bodies - Devices incorporating a medicinal substance - consulting the MHRA Guidance note 16 - Guidance notes for manufacturers of prosthetic and orthotic appliances Ophthalmic products (Medical Devices Directive) 09-2007 Devices industry 01-2006 Devices industry 06-2006 Devices industry 09-2009 Devices industry 08-2009 Devices industry 08-2009 Devices industry 03-2009 Devices industry Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory

07-2007 Devices industry 03-2008 Devices industry 01-2006 Devices industry 03-2008 Devices industry 06-2003 Both industries 02-2006 Devices industry 02-2008 Devices industry


Devices using materials from TSE susceptible animals Directives Bulletin 12 - Sale and supply of in vitro diagnostic medical devices (IVDs) Guidance note 19 - Guidance notes on in vitro diagnostic medical devices directive 98/79/EC Borderlines (In vitro diagnostic medical devcies directive) Directives Bulletin 20 - Conformity assessment procedures under the in vitro diagnostic medical devices directive 98/79/EC Clinical trials for medical devices Guidance note 1 - Guidance notes for manufacturers on clinical investigations to be carried out in the UK Guidance note 3 - Information for clinical investigators

02-2006 Devices industry 02-2006 Devices industry 02-2006 Devices industry 03-2009 Devices industry




Guidance note 5 - Guidance on biocompatibility assessment Guidance note 17 - Guidance notes for manufacturers on statistical considerations for clinical investigations of medical devices Directives Bulletin 18 - The medical devices regulations: Implications on healthcare and other related establishments Notified Bodies Directives Bulletin 6 - The Notified Body

01-2006 Devices industry

Regulatory

http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007509.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007518.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007499.pdf http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodie 12-2010 s/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007493.pdf http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodie s/UKNotifiedBodiesundertheMedicalDevicesDirectives/index.ht 12-2010 m http://www.mhra.gov.uk/Howweregulate/Devices/Registrationo 12-2010 fmedicaldevices/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007512.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007513.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007519.pdf http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con2031502.pdf http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devi 08-2013 ces/DirectivesBulletins/CON2033888 http://www.mhra.gov.uk/home/groups/dts11-2012 aic/documents/websiteresources/con2033158.pdf http://www.mhra.gov.uk/Howweregulate/Devices/Inhousemanu 12-2010 facture/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007500.pdf http://www.mhra.gov.uk/Howweregulate/Devices/Parallelimport 12-2010 s/index.htm http://www.mhra.gov.uk/home/groups/es12-2010 era/documents/publication/con007502.pdf http://www.mhra.gov.uk/Howweregulate/Devices/Enforcement 12-2010 policy-Complianceinspectionandaction-Yourrights/index.htm http://www.mhra.gov.uk/Howweregulate/Devices/Medicaldevic 12-2010 eappeals/index.htm http://www.mhra.gov.uk/Howweregulate/Devices/MedicalDevic 06-2010 esTechnologyForum/index.htm http://www.mhra.gov.uk/Howweregulate/Devices/Regulatoryne 12-2010 ws/index.htm http://www.mhra.gov.uk/Howweregulate/Ourinternationalactiviti 06-2010 es/GlobalHarmonizationTaskForce/index.htm http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 09-2012 lletins/CON025728 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 04-2012 lletins/CON014775 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 12-2011 lletins/CON2033018



UK Notified Bodies under the Medical Devices Directives Registration of medical devices Guidance note 8 - Guidance notes for the registration of persons responsible for placing devices on the market Guidance note 8 - Guidance notes for the registration of persons responsible for placing devices on the market - Appendix A and B Guidance note 18 - Guidance notes for the registration of persons responsible for placing in vitro diagnostic medical devices on the market Group codes for IVD registration Directives bulletin 3 - Guidance on the operation of the EU vigilance system in the UK MEDDEV guidance Rev 5 review: Making medical device vigilance more effective In house manufacture (medical devices) Directives Bulletin 19 - Own brand labelling and rented products Parallel imports (medical devices) Directives Bulletin 21 - Application for the exceptional use of noncomplying devices Enforcement policy - Compliance inspection and action - Your rights (medical devices) Medical device appeals Medical Device Technology Forum Devices regulatory news Global Harmonization Task Force (GHTF) DB 2008(04) In vitro diagnostic medical devices used in combination DB 2008(03) Guidance on the safe use of lasers, IPL systems and LEDs DB 2007(03) Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use

05-2009 Devices industry 11-2009 Devices industry 12-2008 Devices industry


01-2008 Devices industry

Regulatory

02-2006 Devices industry 07-2006 Devices industry 09-2008 Devices industry 11-2007 Devices industry 09-2005 Devices industry 01-2006 Devices industry 01-2007 Devices industry 02-2006 Devices industry 09-2008 Devices industry 01-2007 Devices industry 07-2008 Devices industry 09-2009 Devices industry 09-2006 Devices industry Healthcare 09-2008 professionals Healthcare 04-2008 professionals Healthcare 12-2007 professionals

Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Regulatory Information only Best practice Best practice Best practice

DB 2006(06) Safe Use of Bed Rails DB 2006(05) Managing Medical Devices DB 2006(04) Single-use Medical Devices: Implications and Consequences of Reuse DB 2006(03) Blood Pressure Measurement Devices DB 2005(03) Guidance on the Safe and Effective Use of Batteries and Chargers for Medical Devices DB 2004(02) Guidance on the Stability of Wheelchairs

Healthcare 12-2006 professionals Healthcare 11-2006 professionals Healthcare 10-2006 professionals Healthcare 07-2006 professionals Healthcare 10-2005 professionals Healthcare 05-2004 professionals Healthcare 03-2003 professionals

Best practice Best practice Best practice Best practice Best practice Best practice

http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 12-2010 lletins/CON2025348 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 11-2010 lletins/CON2025142 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 10-2010 lletins/CON2024995 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 07-2010 lletins/CON2024245 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 10-2010 lletins/CON2022469 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 05-2014 lletins/CON007306 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 03-2011 lletins/CON007317

DB 2003(04) The Safe Use of Ambulance Stretcher Trolleys

Best practice

DB 2003(03) Guidance on the Safe Use of Wheelchairs and Vehiclemounted Passenger Lifts


Best practice

http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 03-2011 lletins/CON007319

DB 2003(02) Infusion Systems


Best practice

http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 03-2011 lletins/CON007321

DB 2002(06) Benchtop Steam Sterilizers - Guidance on Purchase, Operation and Maintenance DB 2002(05) Decontamination of Endoscopes DB 2002(03) Management and Use of IVD Point of Care Test Devices DB 2002(02) Management of In Vitro Diagnostic Medical Devices

Healthcare 10-2002 professionals Healthcare 07-2002 professionals Healthcare 03-2002 professionals Healthcare 03-2002 professionals

Best practice Best practice Best practice Best practice

http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 10-2010 lletins/CON007326 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 07-2010 lletins/CON007329 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 03-2010 lletins/CON007333 http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBu 03-2010 lletins/CON007335

DB 2001(03) Guidance on the Safe Transportation of Wheelchairs DB 1999(02) Emergency service radios and mobile data terminals: compatibility problems with medical devices DB 9804 The Validation and Periodic Testing of Benchtop Vacuum Steam Sterilizers DB 9702 Electromagnetic Compatibility of Medical Devices with Mobile Communications DB 9601 Latex Sensitisation in the Health Care Setting (Use of Latex Gloves)

DB 9504 The Management of Infusion Systems - A Report by tDevices in Practice - a guide for health and social care professionals Guidelines on Wheelchair Stability A Code of Practice for the Production of Human-derived Therapeutic Products

Healthcare 06-2001 profession

mhra_guidance list - final

Documents