Summary Of Notifications For Importation Of Unlicensed .

Jan 2015Unlicensed ImportsSummary Report for Importation of UnlicensedMedicines01 Jul 2014 – 30 Sep 2014Date:AuthorG. P. Matthews25-Feb-2015Date:ApprovedB. Sinclair-Jenkins25-Feb-2015

Jan 2015Unlicensed ImportsTable of ContentsTable of Contents . 21Introduction and Summary . 32Notifications for importation . 332.1Countries of export of products . 42.2Most frequently notified products . 52.3Vaccines . 72.4Shortages . 7Administrative matters . 93.1Process timings – Clinical Emergencies . 93.2Process timings – Routine notifications . 103.3 Process timings - Time to issue letters after receipt of further informationrequest responses . 113.4Process timings – Objection letters . 113.4.1Summary of reasons for objections to import . 114Inspection liaison . 125Conclusions . 122

Jan 2015Unlicensed Imports1 Introduction and SummaryThe current report covers the period 01-July-2014 to 30-September-2014 and showsthe import notification system to be operating substantially within the requirements ofSI 2012/19162 Notifications for importationGraph 1Monthly notifications for unlicensed importsNote: Excludes invalid and cancelled notifications3

Jan 2015Unlicensed ImportsGraph 2Breakdown of notifications by status, 01 Jul – 30 Sep 201418,779 notifications were received from 81 importers for the period 01-Jul-2014 to 30-Sep20142.1 Countries of export of productsTable 1Breakdown of valid notifications by country, 01 Jul – 30 Sep 2014PercentageShareRankExporting Country1Germany30.91%2United States of 10Switzerland1.38%11Portugal1.30%12The lic of Ireland0.68%16Slovakia0.65%17Japan0.54%18Czech Republic0.51%4

Jan 2015Unlicensed ImportsPercentageShareRankExporting Country19Sweden0.49%20United .23%24India0.18%25Cyprus0.14%26Lithuania0.09%27New EA33.89%* Not valid country of export!2.2 Most frequently notified productsTable 2 lists the 50 most frequently notified products during Q3/2014 in rank order.The data are for valid notifications only and do not include cancellations orincomplete notifications. The listing includes notifications which may not be intendedfor placing on the UK market. It includes both acceptable products and those to whichobjections to import have been raised. It is therefore not an indicator of productacceptability.Table 2. Top 50 Products by rank order of number of notificationsreceivedNote: These rankings were obtained manually and although believed to be representative may contain errorsRankNumber ofNotifications1074Product Name1Ibrutinib 140 mg Capsules2Midodrine Tablets all strengths3Homoeopathics & Herbals7424Thyroid Oral Preps5955Vitamins - Oral Preps5116Co-Trimoxazole Injections/Infusions4837Etoposide Injections4498Allergy Tests4059Fosfomycin Oral Preps39110Ketamine Injections34911Idebenone Tablets27910265

Jan 2015Unlicensed ImportsRankNumber ofNotifications268Product Name12Acetylcysteine Oral Preps13Sucralfate Tabs & Suspensions25714Bisacodyl Enemas 10 mg25115Betadine 5% Ophthalmic Soln23216Demeclocycline Hydrochloride 150 & 300 mg Tabs & Caps22217Benzathine Benzylpenicillin Injections22018Nortriptyline Tablets22019Carbimazole Tablets all Strengths21420Melatonin Oral Preps21321Potassium Chloride 600 mg Tablets & Caps21022Clindamycin 75 mg/5 ml Oral Suspensions20923BCG Instillations20724Erythromycin Injections/Infusions20125Tretinoin/Vitamin A & Hydroquinone Topicals (Creams Oints., GelsEtc.)20126Fumaric Acid Ester Tablets all Strengths17327Metolazone Tablets 2.5 mg15528Progesterone Injections 100 mg/ml15029Rifaximin 200 mg Tablets14630Flunarizine 5 & 10 mg Tablets and Capsules13931Phentolamine Injections13932Diphenoxylate Hydrochloride/Atropine Sulfate Tablets 2.5 mg/25mcg13633Pentosan Polysulphate Sodium 50 & 100mg Capsules13534Iloprost Injections & Infusions1341770335[Lutetium]-DOTA -Tyr -Octreotate Parenteral36Triamcinolone Topical Preps (Dental & Otic), incl with Neomycin,Gramicidin12737Colchicine 0.5 mg Tablets12038Patent Blue V 2.5% Solution11739Sodium Nitroprusside 50mg Pow/Soln for Injection11540Betamethasone Injections10941Pristinamycin 500 mg Tablets10342Carfilzomib 60 mg Lyophilized Injection10143Mexiletine Capsules10144Gadoteric Acid 279.32 mg/ ml Injections10045Melphalan Hydrochloride 50 mg Pow/Sol for Injection9946Lidocaine 2% Urethral Gel986130

Jan 2015Unlicensed Imports47Procaine Benzylpenicillin InjectionsNumber ofNotifications9348Diazoxide Suspensions & Capsules9249Streptozocin 1g Injections9150Potassium Citrate Tablets90RankProduct Name2.3 VaccinesIt should be noted that for vaccines, where any second administration is more than 3months after the first, the maximum quantity permitted per notification is 25 unitdoses.Table 3 gives a summary of vaccine notifications for Q3/2014. As with the listings forother products, the data are for valid notifications only and do not includecancellations or incomplete notifications. The listing includes notifications which maynot be intended for placing on the UK market. It includes both acceptable productsand those to which objections to import have been raised. It is therefore not anindicator of product acceptability.Table 3Vaccines/Immunoglobulinsnumber of notificationsRanknotifiedbyrankorderofNumber ofNotifications207Product Name1BCG Instillations2Yellow Fever Live Attenuated Vaccine383Lymphocyte Immune Globulin Anti Thymocyte Globulin (Equine)304Diphtheria Tetanus Pertussis Poliomyelitis HaemophilusInfluenza Vaccines255Tuberculin PPD216Rabies Immune Globulin Human127Meningitis C Vaccine68Diphtheria Tetanus Pertussis Vaccines49Varicella Zoster Immunoglobulin 500 IU/20 ml Infusion410Anti Human-T-Lymphocyte Immunoglobulin 20 mg/ml211Inactivated Polio Vaccine212Typhoid Vaccine (VI Capsular Polysaccharide) 25 mcg/0.5 ml Injection12.4 ShortagesTable 4. Products notified claiming UK product shortages, 01 Jul – 30Sep 2014Number ofNotifications480321Product NameCo-Trimoxazole InjectionsKetamine Injections7

Jan 2015Unlicensed ImportsProduct NameSucralfate Suspension & TabletsDemeclocycline Tablets 150 mgPotassium Chloride SR Tablets & CapsulesBCG InstillationsGadoteric Acid 279.32 mg/mlVasopressin 20 USP Units/ml InjectionsProgesterone Injection 100 mg/mlCytarabine 2 g/20 ml InjectionPhentolamine 0.4 mg/1.7 ml Sol For InjEtoposide 100 mg/5 ml InjectionsAmsacrine InjectionsTuberculin PPDTrifluoperazine 1 mg TabletsLevothyroxine Sodium TabletsAmantadine 10 mg/ml SyrupDexamethasone Injections 4 mg/mlDTaP/IPV/HIB VaccinesBetamethasone 4mg/1ml InjectionDiphenoxylate Hydrochloride Atropine Sulfate 2.5 mg 25 mcg TabletsHyoscine Transdermal PatchesDisulfram TabsDiclofenac Injection 75mg/2mlCholestyramine Sachets 4gOxytocin 10 IU/ml InjectionsMeningitis C VaccineLiothyronine Tablets 20 mcgChorionic Gonadotrophin 5,000 IU/1 ml VialsAcetazolamide 250 mg TabletsChlordiazepoxide Capsules 10 mgPyrazinamide 500 mg TabletsVecuronium Injections 10 mgRabies Immunoglobulin 1000-2000 IU Injection SolnHaloperidol 5 mg TabletsPerphenazine Tablets 4 mgPotassium Chloride 20 mmol in 50 mlTestosterone InjectionsTetracosactide 250 mcg/ml InjectionNumber 1616131313119886543333211111NOTE: This listing is indicative only and not exhaustive. It is based upon textcomments in the imports database.8

Jan 2015Unlicensed Imports3 Administrative matters3.1 Process timings – Clinical EmergenciesNormally, Clinical Emergency notifications can be processed within one working day.This can be up to four calendar days if the notification is received on a Fridayafternoon. Some notifications can take longer if there are queries, if a large numberhave been submitter, or if a medical assessment is required. A number of notificationsoriginally submitted as non-emergencies have been processed as emergenciesresulting from changes in circumstances. These show as extended processing timesTable 5Summary of Timings for Issuing Clinical EmergencyLetters, 01 Jul – 30 Sep 2014Numberof % NotificationsNotifications% 4 days179396.4% 1 day164288.28Total Clinical Emergencies processed18609

Jan 2015Unlicensed Imports3.2 Process timings – Routine notificationsGraph 3 shows statistics for 11162 notifications for Q3/2014 where both received andacknowledgement letter issue dates are available and provides an estimate of the timetaken to enter data onto the database after the received date of the notifications.Graph 3 Time taken to issue Acknowledgement Letters after receipt, 01Jul – 30 Sep 2014Significant delays can be experienced due to the necessity to obtain additionalinformation from some importers to enable completion of data entry. Wherespreadsheets have been submitted containing very large numbers of notifications theremay also be delays due to the time taken to enter the data before acknowledgementletters can be issued.10

Jan 2015Unlicensed Imports3.3 Process timings - Time to issue letters after receipt offurther information request responsesGraph 4Sep 2014Response times to further information provided, 01 Jul – 3040.00%35.00%30.00%% 2030Time (days)Importers responded to 249 requests for further information from the MHRA inQ3/2014 and letters permitting import were subsequently issued. Approximately 84%of these final letters were issued within 18 days of receiving the importer’s response.See Graph 4.3.4 Process timings – Objection lettersA total of 45 Objections with Reason letters were issued in Q3/2014. Of these, 34were issued where acknowledgements had previously been issued. All of these wereissued within 28 days of the acknowledgement.3.4.1 Summary of reasons for objections to importThe most common reason for objections to import in Q3/2014 was submission ofnotifications by importers with incorrect licences, in particular notifications for importfrom outside the EEA by holders of Wholesale Distribution Authorisations (theappropriate licence is a Manufacturer’s “Specials” Licence enabled for this activity).There were also a number of notifications where the proprietary names of productswere given when generic names or INNs were required.Finally, a number of notifications were received where an equivalent licensed productwas available in the UK.Table 6 provides a summary of the 45 objections raised in Q3/2014.1140

Jan 2015Unlicensed ImportsTable 6Reasons for objection to importSummaryInvalid LicenceInvalid Licence and missing dataMissing data (all repeats of same notification)UK Licensed product availableNumber ofnotifications543064 Inspection liaisonInformation in the form of listings of unlicensed products notified for import togetherwith background information including any significant issues is routinely provided tosupport site inspections of MS and WDA(H) holders. Eleven inspections weresupported in Q3/2014 and a number of Inspectorate general queries answered.5 ConclusionsThe Import Notification System is operating substantially within the requirements ofSI 2012/1916.Delays in printing urgent letters have been highlighted in staff training updates.12

Sucralfate Suspension & Tablets 238 Demeclocycline Tablets 150 mg 219 Potassium Chloride SR Tablets & Capsules 213 BCG Instillations 207 Gadoteric Acid 279.32 mg/ml 100 Vasopressin 20 USP Units/ml Injections 86 Progesterone Injection 100 mg/ml 73 Cytarabine 2 g/20 ml Injection 72 Phentolamine 0.4 mg/1.7 ml Sol For Inj 50