This standard operating procedure applies to stop smoking services provided by North 51.

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1 Authr Name/Title Melanie McIlvar, Bid Develpment Manager Authr Signature Date: 4 th September 2017 Apprver Name/Title Jasn Shelley, Grup Directr f QA/RA Apprver Signature Date: 4 th September 2017 Issue Date 4 th September 2017 Effective Date 18 th September 2017 Review Date 4 th September 2019 Page Number Page 1 f 6 1. Purpse This plicy describes the prtcl fr the dispsal, including instances f prduct recall, f Nictine Replacement Therapy (NRT) as part f Nrth 51 s Stp Smking Services. This SOP is t ensure that a prduct recall is cnducted prmptly, cmpletely and in accrdance with any gvernmental health agencies regulatins and requirements f distributed prduct that is suspected r knwn t be defective, and/r pse ptential health risk t patients. 2. Scpe This standard perating prcedure applies t stp smking services prvided by Nrth Affected Staff All staff members f Binical Limited and Nrth 51 Limited, wrking within the fllwing divisins: Public Health and Lifestyle Services Refer t the training plan fr the members f staff affected by this prcedure. 4. Related and Reference Dcuments NUR-SOP-SSS-001 NUR-SOP-SSS-003 Prtcl fr the Direct Supply f Nictine Replacement Therapy Prtcl fr the Delivery f Stp Smking Medicatins 5. Abbreviatins Used Within This Prcedure DOC EMA Cntrlled Dcument Eurpean Medicines Agency

2 Page Number Page 2 f 6 MAH MHRA NRT QM SOP SPA Marketing Authrisatin Hlder Medicines and Healthcare Prducts Regulatry Agency Nictine Replacement Therapy QuitManager Standard Operating Prcedure Single Pint f Access 6. Definitins Used Within This Prcedure Waste NRT Is defined as fllws: NRT which is past its expiry date NRT that is damaged/defective NRT which is returned by a client NRT which is subject t a manufacturer s recall Recall Remval f ne r mre batches f prduct, thught r knwn t be in vilatin f ne r mre laws r rules in a cuntry, when the prduct is already in use and/r n sale and ut f the cntrl f site, and is retrieved frm the market place with the full knwledge f ne r mre Cmpetent Authrities. 7. Prcedure 7.1. General Nrth 51 is nt the Marketing Authrisatin Hlder (MAH) f any prducts and s des nt initiate any prduct r batch recalls Recalls are actins taken by the MAH f a prduct t remve a prduct (r batch) frm the market. Recalls may be initiated by the MAH r by request f a Regulatry agency e.g. the Medicines and Healthcare Prducts Regulatry Agency (MHRA), Eurpean Medicines Agency (EMA), etc The MHRA classifies recalls as fllws: Class I recall: Defects which are ptentially life-threatening r culd cause serius risk t health Class II recall: Defects which culd cause illness r mistreatment but are nt Class Class III recall: Defects which may nt pse a significant hazard t health but where a recall has been initiated fr ther reasns, (perhaps nt required by the regulatry authrity) but are nt class 1 r Class IV (Cautin in Use): Defect is f a minr nature that is f n threat t patient s safety, nr is it likely t impair prduct use r efficacy. It is desirable that

3 Page Number Page 3 f Dispsal f NRT defect is crrected and the crrectin may be carried ut at the pint f issue r use, but where failure t carry ut this remedial actin wuld nt present a significant, hazard t a patient All waste NRT must be returned t the central SPA including a NRT Dispsal Frm (Appendix A) Waste NRT must nt be issued t clients r kept by practitiners fr use as demnstratr prducts Returned waste NRT will be clearly marked fr dispsal, securely lcked away - separately t new NRT stck - and returned t the whlesaler fr safe dispsal The fllwing infrmatin must be centrally recrded n the designated spreadsheet in respect f waste NRT: Service returned frm Brand Type Batch number Reasn fr dispsal Value Date sent fr dispsal Cnfirmatin shuld be btained frm the whlesaler that the prduct has been received and destryed NRT Recall Nrth 51 will be ntified by manufacturers (r whlesalers) directly where the recall f NRT is required Recalls shuld be immediately ntified t the Grup Directr f Quality Assurance and Regulatry Affairs Any prduct remaining in stck shuld be placed in Quarantine physically, and shuld nt be assigned t any rders The Nrth 51 Business Intelligence Team will prvide a reprt f affected clients using batch number recrds If the prduct has nt been handled, the recall alert will be marked with the date and time received, date and time the system was checked and the date and time the recall was clsed The central SPA will place a message n QuitManager (QM) t infrm all users f the recall, including the prduct type and batch number The central SPA will cntact all affected clients, sending ut replacement NRT (where required) with a pre-paid envelpe fr the return f the recalled prduct A minimum f three attempts t cntact the client by phne (at different times f the day)

4 Page Number Page 4 f 6 will be made befre a letter, text and (dependent upn cntact infrmatin supplied) is sent t the client Details f actin taken, including where cntact attempts have been unsuccessful, and replacement prducts supplied must be recrded n QM fr each client Where the SPA has been unable t cntact a client, but the client attends a supprt sessin, the lcal stp smking practitiner must infrm the client f the recall, prvide replacement NRT (where required) and advise the client t hand any unused recalled NRT int their lcal pharmacy fr dispsal, dcumenting this advice in the sessin ntes The central SPA will request and review packaging/delivery ntes frm the whlesaler relating t deliveries made t lcal ffices Identified Lcal Leads will cllate recalled lcal ffice stck and return t the SPA Recalled medicinal prducts shuld be identified and stred separately in a dedicated recall area whilst awaiting a decisin n their dispsitin. All prduct returned and held in stck will be labelled Recalled Prduct and a cpy f the recall alert will be attached t each bx Recalled NRT will be returned by the central SPA t the whlesaler Credit ntes will be prvided by the whlesaler and sent t the Finance Department The fllwing infrmatin must be recrded (in a reprt frmat) in respect f recalled NRT: Date f recall Brand Type Affected client IDs (ID numbers nly) Ttal number and ID f clients successfully cntacted Ttal number and ID f clients nt successfully cntacted Number f prducts successfully recalled and returned t the whlesaler 8. Strage and Retentin f Recrds 8.1 Where nt recrded in QM, template spreadsheets must be used t cllate NRT dispsal and NRT recall recrds and these shuld be stred in SharePint. Recrds shuld be retained fr a minimum f five (5) years

5 Page Number Page 5 f 6 9. Versin Histry Versin Change Request Reasn fr Change Date f Issue Reference 01 N/A New Prcedure 4 th September 2017

6 Page Number Page 6 f Appendices 10.1 Appendix 1 NRT Dispsal Frm NRT Dispsal Please cmplete the table belw and return this frm, alng with the waste NRT, t the central SPA s that stck can be apprpriately dispsed f. Date f return: Brand Prduct (Inc. strength) Batch n. Quantity Reasn fr return Signature f persn respnsible fr the return: Print name:

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