[insert title of report]

Summary Report for Importation of
Unlicensed Medicines
01 Oct 2015 – 31 Dec 2015

G. P. Matthews
Date: 12-Apr-2016 Date: 12-Apr-2016 Contents
Introduction and summary
News and current issues
Centrally Authorised products Notifications for importation
Countries of export of products Most frequently notified products Vaccines and immunoglobulins Administrative matters
Process timings – Clinical Emergencies Process timings – Routine notifications Process timings - Further information request responses Process timings – Objection letters Inspection liaison
Conclusions
Page 2 of 16
1 Introduction and summary
This report1 covers the period 01-October-2015 to 31-December-2015 and shows the import notification system to be operating substantially within the requirements of SI 2012/1916. 1 The data for this report were compiled on 23-March-2016 and reflect the Import Notification System at this date. Page 3 of 16
2 News and current issues
2.1 Centrally Authorised products
Occasionally shortages of Centrally Authorised products arise. At the time of writing, in Quarter 1, 2016, there is a shortage of Bexsero meningitis vaccine. This is a Centrally Authorised product with a Marketing Authorisation valid in all Member States. Some importers have enquired about notification of European Economic Area (EEA) sourced Bexsero for import as an unlicensed medicine. Products with Centrally Authorised marketing authorisations originating within the EEA are not unlicensed and may only be distributed by the Marketing Authorisation Holder or by way of Parallel Distribution following the European Medicines Agency (EMA) procedure. They cannot be notified for import as unlicensed medicines. Objection is likely to be raised to import of unlicensed equivalents from outside the EEA unless the shortage is Europe wide, in which case the MHRA is happy to consider notifications for import of non-EEA unlicensed products, as is currently the case with Bexsero. Page 4 of 16
3 Notifications for importation
Monthly notifications for unlicensed imports
Note: Excludes invalid and cancelled notifications Breakdown of valid notifications by status, 01 Oct – 31 Dec 2015
Page 5 of 16
3.1 Importers
A total of 19609 notifications were received from 90 importers for the period 01 Oct 2015 to 31 Dec
2015. Of these, 6 importers accounted for approximately 75%.
Table 1
Valid notifications by importer 01 Oct 2015 to 31 Dec 2015
Importer Details
Number of
Percentage Share
Of which 6 importers 3.2 Countries of export of products
Countries of export 01 Oct 2015 to 31 Dec 2015
Number of
Rank Exporting Country
United States of America Republic of Ireland Page 6 of 16
Number of
Rank Exporting Country
Page 7 of 16
3.3 Most frequently notified products
Top 50 frequently notified products 01 Oct 2015 to 31 Dec 2015
Product Name
Haloperidol Injections 5mg/ml Co-Proxamol 32.5mg/325mg Tablets Thyroid Oral Preps Melatonin Tablets and Capsules, All Strengths Co-Trimoxazole Inj/Inf 480mg/5ml Vitamins - Oral Preps Benzathine Penicillin Injections All Strengths Bisacodyl Enema 10mg/30ml Sodium Chloride Ophthalmic Preps (Ointments & Eyedrops) Cyclosporin Ophthalmic Ointments & Eyedrops Sucralfate Tablets and Oral Suspensions Tretinoin/Vitamin A with and without Hydroquinone Topicals (Creams Oints., Gels Etc.) Carfilzomib 60 mg Lyophilized Inj Pristinamycin 500mg Tablets Evofosfamide 100mg/ml Con. For Sol For Infus Talc For Pleurodesis Lu-Dota, Tyr Ocfreotate, Lutetium-177 (177 Lu) Labelled Adrenaline Injection,1:10,000 Syringe1mg/10ml Flunarizine Tablets & Capsules, All Strengths Pirenzepine 50mg Tablets Progesterone100mg/1ml Injections Cyclizine Injections 50mg/ml Idebenone 45mg Tablets & Capsules Povidone-Iodine 50 mg/ml Soln For Inj Fumaric Acid Esters 30 &120mg Tablets Mexiletine Capsules All Strengths Ketamine Injections L-Ornithine L-Aspartate Sachets/3000mg Betamethasone Injections All Strengths & Salts Bacillus Calmette-Guerin (BCG) Vaccines & Instillations Lacosamide 50 mg Tabs Acetylcysteine Oral Preparations (Tablets, Granules Etc.) Thioridazine Tablets All Strengths Triamcinolone Acetonide, Neomycin Sulfate, Nystatin, Gramicidin Ear Aspirin 300mg Suppositories Sultiame Tablets All Strengths Diazoxide 50mg/ml Oral Suspension Emtricitabine/Tenofovir Tablets, Various Dose Combinations Page 8 of 16
Product Name
Isoprenaline 0.2 mg/ml Injections Allergy Treatments (SCIT & SLIT) Pentosan Polysulfate 50 & 100mg Capsules Insulin, Human Injections All Strengths Dimethyl Sulfoxide 50% Intravesical Instln Solutions Doxycycline 100mg/5ml Sol For Inj Indigo Carmine 4mg/ml Inj Ranitidine 25 mg/ml Injection Chlorothiazide Tablets & Suspensions Vitamins, Parenteral 3.4 Vaccines and immunoglobulins
Table 4 Vaccines & immunoglobulins 01 Oct 2015 to 31 Dec 2015

Product Name
Number of
Notifications
Bacillus Calmette-Guerin (BCG) Vaccines & Instillations Typhoid Vaccine (VI Capsular Polysaccharide) 25 mcg/0.5 ml Injection Soln Antithymocyte Immunoglobulin (Horse) 50mg/ml Zn-DTPA Sol For Infusion Anti Human-T-Lymphocyte Immunoglobulin 20mg/ml CMV Immunoglobulin 5% Infn Soln 100iu/ml Diphtheria Antitoxin 500U/ml IgM Enriched Normal Human Immunoglobulin Solution For Infusion 5% Measles Vaccine (Live) Pow/Solv For Inj Polio Vaccine Inactivated Refined Equine Anti-Echis carinatus /ocellatus Venom Immunoglobulins (Echis carinatus Antivenom) 3.5 Shortages
Products notified claiming UK product shortages, 01 Oct 2015 to 31 Dec 2015
NOTE: This listing is indicative only and not exhaustive. It is based upon text comments in the imports database. Number of
Product Name
Haloperidol Injections 5mg/ml Co-Trimoxazole Inj/Inf 480mg/5ml Sucralfate Tablets and Oral Suspensions Adrenaline Injection,1:10,000 Syringe1mg/10ml Cyclizine Injection 50mg/ml BCG Instillations and Vaccines Page 9 of 16
Number of
Product Name
Ketamine 100mg/ml Injections Betamethasone 4mg/1ml Injections Levothyroxine Tablets All Strengths Potassium Chloride 600 mg SR Tabs& Caps Iobitriodol 300mg Iodine Per ml Vials Co-Phenotrope 2.5 mg/25 mcg Tablets Liothyronine 20& 25 mcg Tablets Melphalan 50mg Injections Vecuronium Injections 10mg Testosterone Ampoules/100mg In 2ml Disulfiram 500 mg Tablets Demeclocycline Tabs 150mg Primaquine 7.5 mg Tablets Lidocaine HCl Inj, 2%, Syringe, 100mg/5ml Sodium Bicarbonate Inj 8.4% Syringe 50mEq/50ml Metoclopramide Hcl 5mg/ml Sol For Inj/Inf Promethazine 50mg/2ml Injection Solution Suxamethonium 2% Injection Soln Tuberculin PPD 5iu/0.1ml Injection Soln Potassium Canrenoate 250mg/10ml Injection Ribavirin 6g/Vial Powder For Inhalation Sol Aspirin Suppositories 300mg DTAP/IPV vaccine DTAP/IPV/HIB vaccine Hyoscine 0.3 mg Chewable Tablets Megestrol 160mg Tabs Nefopam 30mg Tablets Clonidine Hydrochloride 150 mcg/ml Sol For Inj/Infus Trifluoperazine 1 mg Tablets Etoposide 100mg/5ml Conc For Infn Soln Hydrocortisone Sodium Succinate 100mg Vials Sulfinpyrazone Tablets 200mg Fomepizole Injections/Infusions Sulfinpyrazone 250 mg Tablets Amino Acid Solution (Infant) For Infusion Aspirin Powder & Solv For Soln For Inj 1g Vials Chloramphenicol Sodium Succinate 1 G Powder For Inj Cidofovir 375 mg/5ml Infusion Soln Dibotermin Alfa 12 mg Kit For Implant Edrophonium Chloride 10mg/ml Injection Gentamicin Sulphate (Septopal Chain) Labetalol100mg/20ml Sln For Inj/Inf Triamcinalone Acetonide 10mg/ml Inj Susp Vasopressin 20units/ml Inj Soln Page 10 of 16
4 Administrative matters
4.1 Process timings – Clinical Emergencies
Normally, Clinical Emergency notifications can be processed within one working day. This can be up to four calendar days or longer if the notification is received on a Friday afternoon or before a public holiday. Some notifications can take longer if there are queries, if a large number have been submitted, or if a medical assessment is required. Notifications originally submitted as non-emergencies may be processed urgently resulting from changes in circumstances. These will show as extended processing times. Graph 3 and Table 6 provide further information on timings. Time to Issue Clinical Emergencies, 01 Oct 2015 to 31 Dec 2015
ationci
tif
o
N 20.00%
Time to issue letter from receipt of notification (days)
Clinical Emergency Letter Timings, 01 Oct 2015 to 31 Dec 2015
Time to Process from Receipt
Number of
Comments
68.50% issued within 1 day 85.45% issued with 3 days 4.2 Process timings – Routine notifications
Graph 4 shows statistics for 838 notifications for Q4/2015 where both received and acknowledgement letter issue dates are available and provides an estimate of the time taken to enter data onto the database after the received date of the notifications. Page 11 of 16
Significant delays can be experienced due to the necessity to obtain additional information from some importers to enable completion of data entry. Where spreadsheets have been submitted containing very large numbers of notifications there may also be delays due to the time taken to enter the data before acknowledgement letters can be issued. Approximately 95% of acknowledgements were issued within 24 days of receipt of notifications. Time to issue Acknowledgements, 01 Oct 2015 to 31 Dec 2015
4.3 Process timings - Further information request responses
Importers responded to 219 requests for further information from the MHRA in Q4/2015 where letters permitting import were subsequently issued. Approximately 79% of these final letters were issued within 14 days of receiving the importer's response. See Graph 5. Page 12 of 16
Response times to further information provided, 01 Oct 2015 to 31 Dec 2015
cifi
ot
N
% 10.00%
Time from Importer's Response to Letter Issue (days)
4.4 Process timings – Objection letters
A total of 31 Objections with Reasons were issued in Q4/2015. Of these, 3 were issued where acknowledgements had previously been issued. Each of these Objection with Reason letters was issued within 28 days of acknowledgement. 4.4.1 Summary of reasons for objections to import
Reasons for objection to import
Number of
No special need: importer actually stated that they were aware of an available UK licensed product. Also countries of manufacture were not provided. Centrally Authorised product available Importer's licence not valid for activity Lactose free product requested, but UK licensed product was in fact lactose free Shortage of UK product claimed, but there was no shortage Equivalent UK licensed product available Unlicensed medicines must not be supplied if there is an equivalent licensed product available that can meet the patient's clinical needs. This may be a UK licensed product available within the UK or a Centrally Authorised product available within the EEA. Importers are reminded that importation of unlicensed medicines requires a Wholesale Dealer's Authorisation (WDA(H)) for import from within the EEA and a Manufacturer's "Specials" Licence (MS) for import from outside the EEA. In each case the licence must be enabled to permit this Page 13 of 16
activity by specifically selecting the appropriate options when applying for the licence, or by requesting a variation to add these options. Importers are also reminded that where the supplier is not the manufacturer, they must inform the MHRA of the supplier's details when notifying. Page 14 of 16
5 Inspection liaison
Information in the form of listings of unlicensed products notified for import together with background information including any significant issues is routinely provided to support site inspections of MS and WDA(H) holders and to assist Enforcement investigations. Five inspections were supported in Q4/2015 and a number of Inspectorate and Enforcement general queries answered. The Pharmaceutical Assessor for imported unlicensed medicines was pleased to attend two inspections in person to provide advice and support. Page 15 of 16
6 Conclusions
The import notification system has operated substantially within the requirements of the regulations during Quarter 4, 2015. Page 16 of 16

Source: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/517567/INS_2015_Q4_public.pdf

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