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the blue guide advertising and promotion of medicines in the uk medicines and healthcare products regulatory agency third edition third revision november 2020 the blue guide advertising and promotion of ...

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     The Blue Guide 
      Advertising and Promotion 
        of Medicines in the UK 
         Medicines and Healthcare products  
               Regulatory Agency 
               Third Edition 
          Third revision - November 2020 
                    
         THE BLUE GUIDE 
                   
                   
        ADVERTISING AND 
          PROMOTION OF 
       MEDICINES IN THE UK 
                   
                   
                   
      Medicines and Healthcare products
             Regulatory Agency 
                   
              Third Edition 
         Third revision - November 2020 
                   
                   
                  MHRA Contact Points for Advice on  
                  Advertising and Promotion of Medicines 
                   
                   
                    
                             
                                Advertising Standards and Outreach Unit 
                                Medicines and Healthcare products Regulatory Agency 
                                10 South Colonnade 
                                LONDON  E14 4PU 
                   
                     
                     
                  General  advice  and  information  on  advertising  and  promotion  of  medicines, 
                  including  a  copy  of  this  guidance,  is  available  on  the  MHRA  website  at 
                  www.mhra.gov.uk. 
                   
                   
                            
                  For general enquiries about advertising  Email: advertising@mhra.gov.uk   
                  of licensed medicines and legislation      Tel:  020 3080 6523/6452 
                                                              
                  For enquiries about advertising policy     Email: advertising@mhra.gov.uk   
                                                             Tel:  020 3080 6765/7771/6039 
                   
                  For general enquiries about the MHRA: 
                   
                  Customer Services    E-mail: info@mhra.gov.uk  
                                                            Tel: 020 3080 6000 
                                                                    
                                                                 
                                                         2
                     Record of changes - Third edition 
                      
                     The Third Edition of the Blue Guide was published in August 2012.  It has been 
                     made available as an online resource rather than a printed publication with the 
                     expectation that it would be a dynamic document updated at regular intervals as 
                     required.   
                      
                     The following three specific updates have been made since 2012: 
                      
                     September 2014: 
                      
                     1.      Changes  to  reflect  the  Human  Medicines  (Amendment  No.  2) 
                             Regulations 2014 to simplify the information requirements for advertising 
                             to  healthcare professionals and other suppliers of medicines (primarily 
                             sections 6.4 and 6.5 and annexes 1, 4 and 5). 
                     2.      Additional advice on prohibited gifts and benefits (section 6.14) 
                     3.      Updated  guidance  for  providers  offering  medicinal  treatment  services 
                             (section 7.3 and appendix 6). 
                     4.      Updated information about adverse drug reaction reporting (section 7.6). 
                     5.      Additional  clarification  concerning  advertising  of  medicines for use in 
                             pregnancy (Appendix 3). 
                     6.      Updates to contact details for MHRA staff and information about NICE, 
                             ABPI and PMCPA.  
                      
                     July 2019: 
                      
                     1.      Addition of information about General Pharmaceutical Council 
                             guidance and the Distance Selling Logo to the guidance for providers 
                             offering medicinal treatment services (appendix 6). 
                     2.      Removal or updating of references to the Office of Fair Trading (sections 
                             3.4 and 10.2) and updated information about Radiocentre (section 10.3).  
                     3.      Update to MHRA contact details.  
                              
                     November 2020: 
                      
                     1.      Changes to permit limited advertising in certain types of public health 
                             emergency, reflecting the Human Medicines (Coronavirus and Influenza) 
                             (Amendment) Regulations 2020 (section 5.2). 
                     2.      Changes to include new licence categories for Great Britain and Northern 
                             Ireland and reflect the Human Medicines (Amendment etc.) (EU Exit) 
                             Regulations 2019 as amended by the Human Medicines (Amendment 
                             etc.) (EU Exit) Regulations 2020 (primarily sections 4.2, 5.5, 6.4 and 
                             Annex 3) and removal of references to European law. 
                     3.      Additional advice on samples (section 6.12) and ‘clinically proven’ claims 
                             and free offers (Appendix 6) and updated information on the Medicines 
                             and Devices Advertising Liaison Group (section 10.5).  
                                                                   3
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