pharmaceutical and medical device proposal form · cisapride polychlorinated biphenyls (pcb's)...

Pharmaceuticaland MedicalDeviceProposal Form

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PHARMACEUTICAL AND MEDICAL DEVICE

BUSINESS QUESTIONNAIRE

❖ PLEASE READ THE IMPORTANT NOTES PRIOR TO COMPLETING THIS PROPOSAL FORM❖ PLEASE ATTACH PRODUCT BROCHURES AND ADDITIONAL COMPANY INFORMATION AS

APPROPRIATE

Name:

Address:

Postcode:

Registered/Trading Address:

Postcode:

Telephone no(s): Subsidiaries:

Website: Trade description:

Is your company involved in Clinical Trials?

If ‘YES' then please contact us for specific information required Yes No

1. PUBLIC AND PRODUCTS LIABILITY

Estimated annual turnover split between:

i) Own Manufacture (where you hold the Product Licence)

£

ii) Where you hold the Product Licence but manufacture is contracted to third party

£

iii) Where you Contract Manufacture for third parties

£

iv) Wholesale (unaltered from manufacturers)

£

v) Parallel Import / Repackaged or relabelled Wholesale Products

£

vi) Other*

£

* Please provide full details of how income is generated (if appropriate please provide specimen contracts):

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Please list your ten largest selling products / are they Own Manufacture / date first supplied :

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

2. EXPORTS

Please state estimated annual turnover to:

i) OwnManufacture

ii) ProductLicenceHolder

iii) ContractManufacture

iv) Wholesale vi) Other

i) USA

£ £ £ £ £

ii) Canada

£ £ £ £ £

iii) OECD Countries

£ £ £ £ £

iv) Rest of World

£ £ £ £ £

Are any exports sent direct to customer from manufacturers outside the UK? Yes No

If ‘YES’ please advise territory sent from:

Is there a formal contract in place regarding Quality Control?

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3. USA/CANADA

Please answer this question ONLY if you export to the USA/Canada.

(a) A full list of all products exported and turnover derived from each

(b) Are you required to Indemnify any Vendors and/or Distributors inUSA/Canada? Yes No

If 'YES' please provide names and addresses If 'NO' do they maintain their own insurance for Completed Operations/Products? State limit if known

4. IMPORTS

If you import products please state from which countries obtained and approximately percentage of total turnover against each.

5. PRODUCTS

Do products comply with all relevant:-

(a) British Standard, Industry and Trade Standards or Government SafetyLicensing Regulations or equivalent local legislation? Yes No

(b) Official Standard or Government Regulations laid down in countries towhich Products are exported? Yes No

Are any new products likely to be marketed during the next 12 months? Yes No

If ‘YES' please advise product name and product type:

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6. QUALITY CONTROL

(a) Do you have a written policy relating to Quality Control? Yes No

If ‘YES’, how often is it reviewed?

(b) Do you have a specific Quality Control Team? Yes No

If ‘YES’: (i) Who has overall responsibility?

(ii) Can control be overridden by Design, Production or Marketing Personnel?

(c) Does Quality Control involve the testing of a sample percentage ofproduct? Yes No

If ‘YES’, please state: (i) Percentage of products checked

(ii) Failure rate.

(d) Are sampling inspections made on incoming raw materials? Yes No

(e) What is the procedure for dealing with customers complaints?

(f) Are records of complaints retained? Yes No

If ‘YES’ for how long?

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7. RECALL

(a) Is it possible to trace the ultimate customer of individual products or batches in order to recall the products?

(b) Is there an formal procedure for emergency product recall?

(c) Has recall every been necessary or been considered? Yes No

If ‘YES’, please give details

(d) Please give details of Product lines discontinued because of incidence or injury or damage, or wherepotential hazards have been identified - stating when manufacture or supply ceased

8. MARKETING

(a) Are products labelled and supplied with clear instructions in the languageof the country to which they are supplied? Yes No

(b) Are products hazard warnings clearly shown on Products, Packagingand/or Instruction Manuals? Yes No

(c) Do your Legal and/or Design Departments have sight of all advertisingmaterial, sales brochures operating manuals etc. To check for misleadingstatements?

Yes No

(d) Are your Representatives warned against overstating usage oreffectiveness of Products? Yes No

9. RECORDS

Do you maintain an adequate system of records which would enable identification of:- (please indicate period records are kept for)

(a) Source of Product/raw materials/component parts purchased? Yes No

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(b) Source of design of Products manufactured? Yes No

(c) Quality control and testing procedures effective at the time of design and/ormanufacture? Yes No

(d) Research undertaken to minimise risk to health and safety? Yes No

10. SPECIFIED PRODUCTS

PLEASE CONFIRM WHETHER YOU ARE INVOLVED WITH ANY OF THE FOLLOWING PRODUCTS (OR ANY DERIVATIVES THEREOF). PLEASE NOTE THAT SOME OF THESE SPECIFIC PRODUCTS MAY BE EXCLUDED WITHIN THE POLICY. THESE EXCLUSIONS MAY BE PARTIALLY DELETED SUBJECT TO APPROPRIATE AND SATISFACTORY INFORMATION.

2,3,7,8 - Tetrachlorodibenzo-p-dioxin (TCDD) Lincomycin

2,4 - Dichlorophenoxyacetic acid (2,4-D) and 2,4,5 - Trichlorophenoxyacetic acid (2,4,5-T)

Lindane

5-Hydroxytryptophan (5-HTP) LYMErix (Lyme Disease Vaccine Recombinant OspA)

8 Hydroxy Quinolines Megestrol Acetate

Alosetron Meloxicam

Amiodarone Metformin

Antipsycotics Methyl Tertiary Butyl Ether (MTBE)

Any Product that does not have Regulatory Approval

Methylphenidate (MPH)

Apomorphine Metronidazole

Aprotinin (Bovine Pancreatic Trypsin Inhibitor) Mibefradil

Astemizole Minoxidil

Atomexetine Monoclonal Antibodies (mAb)

Benfluorex Nabilone

Benoxaprofen Naproxen

Benzbromarone Nefazodone

Blood Borne Pathogens Nicotine

Bromfenac Orlistat

Bromocriptine Oxandrolone

Budesonide Oxcarbazepine

Buproprion Oxycodone

Butorphanol Pemoline

Canthaxanthin Pergolide

Cerivastatin and/or any other Statins and/or Fibrates

Pertussis Vaccine

Chromated Copper Arsenate (CCA) Phenylpropanolamine (PPA)

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Chromium Picolinate Pimecrolimus

Cisapride Polychlorinated Biphenyls (PCB's)

Clindamycin Practolol

Clioquinol Pramipexole

Contraceptives (including birth control pills) fertility drugs and products specifically designed and marketed for use during and in connection with pregnancy Pramlintide

Cox-2 Inhibitors Primodos/Amenorone Forte

Danthron / Dorbanex Rapacuronium Bromide

Debendox Remoxipride

Dexfenfluramine, Fenfluramine, Phentermine, or any weight control product Rimonabant

Dicyclomine RotaShield Vaccine

Diethylstilbestrol (DES) Salbutamol or Albuterol

Dimeticone Selective Serotonin Reuptake Inhibitors (SSRI's)

Dioxins Serotonin Norepinephrine Reuptake Inhibitors (SNRI's)

Doxazosin Sertindole

Drugs used in Erectile Dysfunction Silicone

Ephedrine / Pseudoephedrine Skin whitening or lightening agents

Ephedrine Ma Huang Pseudoephedrin Chinese Ephedra Mahuang Extract Ephedra Ephedra Sinica Ephedra Extract Ephedra Herb Powder Epitonin or any derivative thereof Somatropin

Erythropoietin (EPO) Stavudine

Ethylenediaminetetraacetic Acid (EDTA) Sumatriptan

Etretinate Swine-Flu Vaccine

Exenatide Swiss-Flu Vaccine

Ezetimibe Tacrolimus

Fentanyl Tegaserod

Fialuridine Temafloxacin

Filgrastim Terbinafine

Finasteride Terbutaline

Flosequinan Terfenadine

Formoterol Thalidomide

Gabapentin Theophylline

Gamma-Hydroxybutyric Acid (GHB) Thiazolidinediones (Glitazones)

Genetically Modified Organisms (GMO's) and/or Genetically Engineered Organisms (GEO's)

Thimerosal or Thiomersal

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Germanium Tiagabine

Grepafloxacin TNF Blockers

Halons Tobacco or any Tobacco products

Hormone Replacement Therapies (HRT's) Tocrolimus

Hydromorphone Hydrochloride Tolcapone

Hydroquinone Tretinoin (retinoic acid or its salts)

Indoprofen Trovafloxacin or Alatrofloxacin

Itraconazole Tryptophan

Kava Kava (Piper Methysticum) Urea Formaldehyde or any products containing Formaldehyde

Ketorolac Valproic Acid

Latex and/or latex protein and/or latex derivatives and/or latex substances Varenicline

Lead Vigabatrin

Leflunomide Xi-melagatran

Leuomethadyl

Levomethadyl

Levonorgestrel

If you have answered YES to any of the products above please provide full details as follows:

Are products supplied on a Named Patient Basis only or in held accordance with Specials Licence granted? Yes No

If ‘YES’ please provide details of licence

11. PREMISES

(a) Have all Manufacturing location been inspected by MHRAIFDA or otherregulatory body? Yes No

If ‘YES’ what was date of lost inspection?

(b) Have you ever had a manufacturing licence withdrawn? Yes No

If ‘YES’ please give details including remedies

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12. GENERAL

(a) Has any Insurer ever:-

(i) Declined your proposal for Public and/or Products Liability insurance? Yes No

(ii) Refused your renewal for Public and/or Products Liability insurance? Yes No

(iii) Terminated your insurance for Public and/or Products Liabilityinsurance? Yes No

If ‘YES’ please give full details

(b) Have any incidents occurred during the last five years resulting, oralleged to have resulted in death, injury or disease to third parties or damage to

their property?


Yes No

Date Brief Details of Incident whether or not an insurance claim has been made

Paid Amount Insurers Outstanding

Reserve

If possible please supply confirmed claims experience from previous / current Insurers

(c) Are you aware of any circumstances that might give rise to a claim? Yes No


(d) Please state if your existing cover for Products Liability is on a "Claims made" basis or a "Lossesoccurring" basis.

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If on a "Claim made" basis please state retroactive date currently applied to your policy

(e) Who are your current Insurer(s)? If currently uninsured please state.

(f) What is the renewal date of your current Insurance policy covering Public and Products Liability?

Please state Limit(s) of Indemnity for which a quotation is required or local currency equivalent £

DECLARATION

I/we declare that to the best of my/our knowledge and belief the answers given on this proposal whether by me/us or on my/our behalf, are complete and true and that I/we have not withheld any material information.

If this proposal has been completed on my/our behalf, I/we agree the person is deemed to be my/our agent and not an agent for QBE Insurance (Europe) Limited and that I/we have read the information provided before signing the form.

I/We confirm that I/we have read and understood the above declaration and the important notes overleaf.

Proposer’s Signature _________________________________________ Date ________________________

If in company name, state position held ___________________________________________________________

The proposal must be signed by a principal, director or partner of the proposed insured.

IMPORTANT NOTES

Company information

QBE Insurance (Europe) Limited (company number 1761561) is authorised and regulated by the Financial Services Authority (registration number 202842).

QBE Underwriting Limited is the managing agent of QBE Casualty Syndicate 386 at Lloyd’s; QBE Syndicate 1886 at Lloyd’s and QBE Property Syndicate 200 at Lloyd’s.

QBE Underwriting Services (UK) Limited (company number 02262145) is an Appointed Representative of QBE Underwriting Limited (company number 01035198) and is authorised and regulated by the Financial Services Authority (registration number 204858).

The registered address for all the above is: Plantation Place, 30 Fenchurch Street, London EC3M 3BD.

Statement on completion

You must answer all questions correctly and provide all material information. Failure to do so may prejudice you under the policy or the premium that you are requested to pay. Answers such as ‘see presentation’ or ‘see your records’ should not be used. If there is insufficient space to answer questions, please use an additional sheet and attach to this form.

If you are unclear as to what is required in response to any question please contact your intermediary.

If there be any material change in, or material addition to, the information given in this proposal form you must notify us writing as soon as practical after you become aware of any such change or addition.

Full details of the policy cover, terms and condition are available on our website at www.qbeeurope.com. Alternatively please ask you intermediary for a full copy of the policy.

Choice of contract law

Your policy will be governed by and interpreted in accordance with the laws and jurisdiction stated in the schedule of the policy wording. Both you and us agree to submit to the jurisdiction of any court of competent jurisdiction within the country, state or territory stated as being applicable to comply with all requirements necessary to give such court jurisdiction.

Data Protection

Your information may be disclosed to agents and service providers appointed by us, such as claims handling agents and investigative agents. Your information may also be transferred to any country including countries outside the European Union, for the purpose of administration. Your information may be shared with other members of QBE Insurance Group. We are committed to ensuring that our customers’ personal information is protected. All personal information is treated in compliance with the Data Protection Act 1998 and we are registered on the Data Protection Register.

If at any time you wish to contact us with any enquiry relating to our practices governing the use of your personal information or for a copy of our data protection policy, you can do so by writing to:

The Compliance Officer, QBE Insurance (Europe) Limited, Plantation Place, 30 Fenchurch Street, London EC3M 3BD.

Complaints

If You have a question or complaint about this application for insurance or the conduct of its intermediary You should contact that intermediary in the first instance. If You wish to contact the us directly you should write to the address above. Please quote the quote reference or policy number as appropriate in any correspondence.

In the event that you remain dissatisfied and where the insurer is or includes a Lloyd’s syndicate it may be possible in certain circumstances to refer the matter to the Policyholder and Market Assistance Department at Lloyd’s, One Lime Street, London EC3M 7HA; Tel: 020 7327 5693.

If, after making a complaint you feel that the matter has not been resolved to your satisfaction then if you are an eligible complainant you may contact: The Financial Ombudsman Service, South Quay Plaza 2, 183 Marsh Wall, Docklands, London E14 9SR.

A summary of our complaint handling procedure is available on request and will also be provided to you when acknowledging a complaint.

http://www.qbeeurope.com/

Name: Address Postcode: RegisteredTrading Address Postcode: Telephone nos: Subsidiaries: Website: Trade description: 1 PUBLIC AND PRODUCTS LIABILITY: Estimated annual turnover split between: i Own Manufacture where you hold the Product Licence: fill_15: ii Where you hold the Product Licence but manufacture is contracted to third party: fill_17: iii Where you Contract Manufacture for third parties: fill_19: iv Wholesale unaltered from manufacturers: fill_21: v Parallel Import Repackaged or relabelled Wholesale Products: fill_23: fill_24: Please provide full details of how income is generated if appropriate please provide specimen contracts: 1: 2: 3: 4: 5: 6: 7: 8: 9: 10: 2 EXPORTS: fill_22: fill_23_2: fill_24_2: fill_25: fill_26: fill_27: fill_28: fill_29: fill_30: fill_31: fill_32: fill_33: fill_34: fill_35: fill_36: fill_37: fill_38: fill_39: fill_40: fill_41: Is there a formal contract in place regarding Quality Control 1: Is there a formal contract in place regarding Quality Control 2: Is there a formal contract in place regarding Quality Control 3: Please answer this question ONLY if you export to the: a A full list of all products exported and turnover derived from eachRow1: a A full list of all products exported and turnover derived from eachRow2: a A full list of all products exported and turnover derived from eachRow3: a A full list of all products exported and turnover derived from eachRow4: If NO do they maintain their own insurance for Completed OperationsProducts State limit if known 1: If NO do they maintain their own insurance for Completed OperationsProducts State limit if known 2: If NO do they maintain their own insurance for Completed OperationsProducts State limit if known 3: 4 IMPORTS: If you import products please state from which countries obtained and approximately percentage of total turnover against eachRow1: If you import products please state from which countries obtained and approximately percentage of total turnover against eachRow2: If you import products please state from which countries obtained and approximately percentage of total turnover against eachRow3: If you import products please state from which countries obtained and approximately percentage of total turnover against eachRow4: 5 PRODUCTS: Do products comply with all relevant: Are any new products likely to be marketed during the next 12 months: If YES please advise product name and product type 1: If YES please advise product name and product type 2: If YES please advise product name and product type 3: 6 QUALITY CONTROL: a Do you have a written policy relating to Quality Control: If YES how often is it reviewed 1: If YES how often is it reviewed 2: If YES how often is it reviewed 3: b Do you have a specific Quality Control Team: i Who has overall responsibility 1: i Who has overall responsibility 2: i Who has overall responsibility 3: ii Can control be overridden by Design Production or Marketing Personnel 1: ii Can control be overridden by Design Production or Marketing Personnel 2: ii Can control be overridden by Design Production or Marketing Personnel 3: i Percentage of products checked 1: i Percentage of products checked 2: i Percentage of products checked 3: ii Failure rate 1: ii Failure rate 2: ii Failure rate 3: d Are sampling inspections made on incoming raw materials: e 1: e 2: e 3: f Are records of complaints retained: If YES for how long 1: If YES for how long 2: 7 RECALL: a 1: a 2: a 3: b 1: b 2: b 3: c Has recall every been necessary or been considered: If YES please give details 1: If YES please give details 2: If YES please give details 3: potential hazards have been identified stating when manufacture or supply ceased 1: potential hazards have been identified stating when manufacture or supply ceased 2: potential hazards have been identified stating when manufacture or supply ceased 3: 8 MARKETING: a Are products labelled and supplied with clear instructions in the language of the country to which they are supplied: b Are products hazard warnings clearly shown on Products Packaging andor Instruction Manuals: d Are your Representatives warned against overstating usage or effectiveness of Products: 9 RECORDS: a Source of Productraw materialscomponent parts purchased: b Source of design of Products manufactured: c Quality control and testing procedures effective at the time of design andor manufacture: d Research undertaken to minimise risk to health and safety: 2378 Tetrachlorodibenzopdioxin TCDD: Lincomycin: 24 Dichlorophenoxyacetic acid 24D and: Lindane: 5Hydroxytryptophan 5HTP: LYMErix Lyme Disease Vaccine Recombinant OspA: 8 Hydroxy Quinolines: Megestrol Acetate: Alosetron: Meloxicam: Amiodarone: Metformin: Antipsycotics: Methyl Tertiary Butyl Ether MTBE: Any Product that does not have Regulatory: Methylphenidate MPH: Apomorphine: Metronidazole: Aprotinin Bovine Pancreatic Trypsin Inhibitor: Mibefradil: Astemizole: Minoxidil: Atomexetine: Monoclonal Antibodies mAb: Benfluorex: Nabilone: Benoxaprofen: Naproxen: Benzbromarone: Nefazodone: Blood Borne Pathogens: Nicotine: Bromfenac: Orlistat: Bromocriptine: Oxandrolone: Budesonide: Oxcarbazepine: Buproprion: Oxycodone: Butorphanol: Pemoline: Canthaxanthin: Pergolide: Cerivastatin andor any other Statins andor: Pertussis Vaccine: Chromated Copper Arsenate CCA: Phenylpropanolamine PPA: Chromium Picolinate: Pimecrolimus: Cisapride: Polychlorinated Biphenyls PCBs: Clindamycin: Practolol: Clioquinol: Pramipexole: Contraceptives including birth control pills fertility drugs and products specifically designed and marketed for use during and in connection with pregnancy: Pramlintide: Cox2 Inhibitors: PrimodosAmenorone Forte: Danthron Dorbanex: Rapacuronium Bromide: Debendox: Remoxipride: Dexfenfluramine Fenfluramine Phentermine or any weight control product: Rimonabant: Dicyclomine: RotaShield Vaccine: Diethylstilbestrol DES: Salbutamol or Albuterol: Dimeticone: Selective Serotonin Reuptake Inhibitors SSRIs: Dioxins: Serotonin Norepinephrine Reuptake Inhibitors SNRIs: Doxazosin: Sertindole: Drugs used in Erectile Dysfunction: Silicone: Ephedrine Pseudoephedrine: Skin whitening or lightening agents: Ephedrine Ma Huang Pseudoephedrin Chinese Ephedra Mahuang Extract Ephedra Ephedra Sinica Ephedra Extract Ephedra Herb Powder Epitonin or any derivative thereof: Somatropin: Erythropoietin EPO: Stavudine: Ethylenediaminetetraacetic Acid EDTA: Sumatriptan: Etretinate: SwineFlu Vaccine: Exenatide: SwissFlu Vaccine: Ezetimibe: Tacrolimus: Fentanyl: Tegaserod: Fialuridine: Temafloxacin: Filgrastim: Terbinafine: Finasteride: Terbutaline: Flosequinan: Terfenadine: Formoterol: Thalidomide: Gabapentin: Theophylline: GammaHydroxybutyric Acid GHB: Thiazolidinediones Glitazones: Genetically Modified Organisms GMOs andor Genetically Engineered Organisms GEOs: Thimerosal or Thiomersal: Germanium: Tiagabine: Grepafloxacin: TNF Blockers: Halons: Tobacco or any Tobacco products: Hormone Replacement Therapies HRTs: Tocrolimus: Hydromorphone Hydrochloride: Tolcapone: Hydroquinone: Tretinoin retinoic acid or its salts: Indoprofen: Trovafloxacin or Alatrofloxacin: Itraconazole: Tryptophan: Kava Kava Piper Methysticum: Urea Formaldehyde or any products containing Formaldehyde: Ketorolac: Valproic Acid: Latex andor latex protein andor latex derivatives andor latex substances: Varenicline: Lead: Vigabatrin: Leflunomide: Ximelagatran: Leuomethadyl: Levomethadyl: Levonorgestrel: If YES please provide details of licence 1: If YES please provide details of licence 2: If YES please provide details of licence 3: 11 PREMISES: a Have all Manufacturing location been inspected by MHRAIFDA or other regulatory body: If YES what was date of lost inspection 1: If YES please give details including remedies: 1_2: 2_2: 3_2: i Declined your proposal for Public andor Products Liability insurance: ii Refused your renewal for Public andor Products Liability insurance: iii Terminated your insurance for Public andor Products Liability insurance: If YES please give full details 1: If YES please give full details 2: If YES please give full details 3: Brief Details of Incident whether or not an insurance claim has been madeRow1: Paid AmountRow1: Brief Details of Incident whether or not an insurance claim has been madeRow2: Paid AmountRow2: Brief Details of Incident whether or not an insurance claim has been madeRow3: Paid AmountRow3: If possible please supply confirmed claims experience from previous current Insurers: If YES please give full details 1_2: If YES please give full details 2_2: If YES please give full details 3_2: If on a Claim made basis please state retroactive date currently applied to your policy: e 1_2: e 2_2: e 3_2: f 1: f 2: f 3: fill_13: Date: If in company name state position held: Text76: Group77: OffText78: Check Box81: OffCheck Box82: OffCheck Box83: OffCheck Box84: Off78: Off79: Off80: Off81: 082: Off83: Off84: Off85: Off86: Off87: Off88: Off89: Off90: Off91: Off92: Off93: Off95: Off96: Off97: Off98: Off99: OffIf YES what was date of lost inspection 2: If YES what was date of lost inspection 3: 100: 0101: Off102: Off103: OffText85: 104: OffDateRow1: Text86: 105: Off2_3: 1_3: 11: 12: 13: 14: 15: 16: 17: 18: 19: 20: 21: 22: 23: 24: 25: 26: 27: 28: 29: 30: Button23: Button24:

pharmaceutical and medical device proposal form · cisapride polychlorinated biphenyls (pcb's)...

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