Fillable Printable Drug Licence Application Form - UK

Drug Licence Application Form - UK

MD29

DEPARTMENT OF HEALTH, SOCIAL SERVICES AND PUBLIC

SAFETY (DHSSPS)

MISUSE OF DRUGS ACT 1971

APPLICATION FOR LICENCES FOR THE POSSESSION, SUPPLY, MANUFACTURE AND

PRODUCTION OF CONTROLLED DRUGS

DETAILS OF LICENCE APPLICANT

1. Name of Business

2. Registered Business Number

Please provide a copy of the Certificate of Company Registration/Incorporation. If the business is not

registered, please provide reasons

3. Registered Business Address

Postcode:

4. Address of Premises forwhich a Licence is sought (If different from 3. above)

Postcode:

5. Other contact details

Telephone Number:

Email Address

Fax Number

Website

6. Is the Company/Organisation a Registered Charity?Yes/No

If Yes, please specify below your Charity Registration Number and registration date

7. Details of Managing Director/Person in Charge

Name

Title

Telephone Number

Email Address

Fax Number

Address (if different from 3 above)

Postcode:

8. Has any member of the company/organisation, member of its board and/or senior management

team ever been subject to legal business proceedings (administrative or financial), including

bankruptcy?Yes/No

9. If you have answered YES to above, please specify details below

10. Has any member of the company/organisation, members of its board and/or senior

management team ever been subject to any criminal convictions, including those relating to drugs?

Yes/No

11. If you have answered YES to above, please specify below details of convictions only. This

request does notextend to non-convictions, e.g. cautions warnings, reprimands etc, nor to spent

convictions under provisions in the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975.

12. Has the company/organisation ever been refused a licence from a central and/or local

government body or Issuing Authority, including the police? Yes/No

13. If the answer to 12 above is YES, please specify details below

14. Does the registered business comprise

(i) A limited company Yes/No

(ii) An individualYes/No

(iii) A group of individuals (i.e. a partnership)Yes/No

(iv) A body corporate Yes/No

(v) None of the aboveYes

15. If you have answered YES to 14(v) above, please specify details below

16. What is the business/trading style in regard to your licensing requirement?

(i) Pharmaceutical Manufacturer/Producer (delete as appropriate) Yes/No

(ii) Pharmaceutical Wholesaler Yes/No

(iii) Veterinary Wholesaler Yes/No

(iv) Healthcare Distributor Yes/No

(v) Product Packaging/labelling Yes/No

(vi) Importer Yes/No

(vii) Exporter Yes/No

(viii)Private Hospital/Treatment Centre/Clinic (delete as appropriate) Yes/No

(ix) Doctors Deputising Service Yes/No

(x) Drugs Research and Development Yes/No

(xi) Private forensic/Toxicology Service (delete as appropriate) Yes/No

(xii) None of the above Yes

17. If you have answered YES to 16(xii) above, please specify details below

18. Please state below the purposes(s) for which a licence/licences is/are being sought

19. If you have answered YES to 16(i) above, please specify details of all preparations to be

produced by virtue of the licence(s) forwhich application is made.

Drug Form ScheduleDrug Form Schedule

20. If you have answered YES to 16(vi) and/or 16(vii) above, please specify details below:

Drug Form ScheduleQuantityImport/Export Country

21. Please specify below the number and type of companies that will comprise your customer

base

22. Does the business possess a current MHRA (Department of Health) Wholesale Dealers

Licence or other MHRA licence(s)?

Yes/No

If you have answered YES, please specify details below

Licence No.Type of LicenceIssue Date Expiry Date

23. Does the business possess a current HealthCare Commission/CSCI registration?Yes/No

If you have answered YES, please specify details below

Registration No. Issue Date Expiry Date

(You should be prepared to produce, upon request, your MHRA licence(s) and/or your

Registration documents.)

DETAILS OF PREMISES TO BE LICENSED

24. Are the premises to be licensed rented, leased or owned (Please tick appropriate box below)?

RentedLeasedOwned

25. If the premises are rented or leased, please state below details regarding owner

Name of Owner:

Address:

Postcode:

Telephone number:

26. What is the total commercial value of controlled drug stock held in (a) Schedule 1 & 2; and (b)

Schedule 3 (Buprenorphine, Diethylpropion, Flunitrazepam and Temazepam only) Delete as necessary.

(a) (i) Up to £50,000 (b) (i) Up to £50,000

(ii) £50,000 - £500,000 (ii) £50,000 - £500,000

(iii) Over £500,000 (iii) Over £500,000

27. Do the premises have an electronic alarm system?Yes/No

28. If you answeredyes is it (tick box)

NACOSS/SSAIB Registered

Redcare Connected

Police Unique Reference Number (URN)

Centrally Monitored

Annually Serviced

Level 1 or immediate police response

Separate zone alarm for controlled drug safe/store

29. Do the premises have:

(i) A CCTV system (centrally monitored*) Yes/No

(ii) Electronic stock recordingsystem(s)Yes/No

(iii) Perimeter fencing Yes/No

(iv) Lockable physical security e.g. room, safe, cabinet Yes/No

(v) The attendance of site security guards Yes/No

* Please delete if not applicable

30. Please state below the details of the manager/person responsible for the security of the

premises to be licensed.

Name

Title

Telephone Number

Email Address

Fax Number

31.You need to have on site arrangements for the receipt, storage, assembly, picking, distribution,

recording and destruction of Controlled Drugs written downas a set of Standard Operating Procedures

(SOPs). Do you have these?

32. Please state below the details of the manager/person responsible for legal compliance and

regulatory affairs in respect of the premises to be licensed.

Name

Address

Postcode

Telephone Number

Email Address

Fax Number

Please note that the manager/responsible person will be expected to ensure that there is full compliance

with the statutory requirements of the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations

(Northern Ireland) 2002, the stipulated conditions on any licence that may be issued and that there will

be in place written operating procedures that should accompany this application.

33. Is your ‘Responsible Person’ an employee or a consultant (please delete as appropriate)

34. Do you have the appropriate record keeping system in place? Yes/No

35 Please provide brief details of your record keeping

36. Do you require somebody within your company to be authorised towitness the destruction of

controlled drugs? Yes/No

37. Please provide details of the nominated authorised witness:

Name

Title

Telephone number

Email address

Fax number

Address*

line 2

line 3

postcode

SELECTION OF CONTROLLED DRUGS FOR INCLUSION ON LICENCE(S)

38. Please complete the attached Annex to this Application Form

DECLARATION UNDER MISUSE OF DRUGS ACT 1971

39. I/We hereby apply for the grant of DHSSPS drugs licence(s) in respect of those activities

included in this Application Form.

40. To the best of my/our knowledge and belief all the particulars I/we have declared in this

Application Form are correct and complete.

Signature(s):

Name(s) (BLOCK CAPITALS):

Position(s) held:

Date of signature:

APPLICATION FORM – GENERAL NOTES

41. Offences under Section 18(4)(a) of the Misuse of Drugs Act 1971. This Section of the Act

provides that a person commits an offence if, for the purposes of obtaining, whether for himself or

another, the issue or renewal of a licence under the Misuse of Drugs Act 1971, he makes anystatement

or gives any information which he knows to be false in a material particular or recklessly gives any

information which is false. Being found guilty of this offence is punishable byfine and/or

imprisonment of up to 2 years.

42. Confidentiality. Information provided in this Application Form and attached ‘Drugs List’ will

be treated as Commercial-in-Confidence.

43. Signature(s) on Application Form. Applications will not be considered unless they bear the

signature of the applicant, a company partner or director, or the company secretary.

RETURN OF APPLICATION FORM/CONTROLLED DRUGS ANNEX

44. These documents should be returned to

Linda Hutcheson

Department of Health, Social Services and Public Safety

Pharmaceutical Advice & Services

Room D4.29

Castle Buildings, Stormont

BT4 3SQ

45. You should take a copy of the completed Application Form and Annex for your retention.

46. Where the Application Form and controlled drugsAnnex do not provide sufficient space to

include all requested information, please provide typed supplementary sheets as appropriate.

FURTHER LICENSING INFORMATION/CONTACT POINTS

47. For further information and advice aboutlicensing matters,including the completion of this

Application Form, you should contact Linda Hutcheson on:

Telephone No. 028 90 523274

Fax No.028 90 522325

Emaillinda.hutcheson@dhsspsni.gov.uk

Department of Health, Social Services and Public Safety

Pharmaceutical Advice & Services

Room D4.29

Castle Buildings

Stormont

BT4 3SQ

SELECTION OF CONTROLLED DRUGS AND TYPE OF LICENCES

REQUIRED

1.Please tick appropriately the boxes in the list below to indicate the

controlled drugs (CDs) and the type of licence(s) for which application

is being made.

2. The drugs listed below are those most commonlyin use and have been

divided into their respective Schedules in accordance with the Misuse of

Drugs Legislation. Space has been left for the inclusion of drugs not

listed.

Names of Controlled Drugs

(CDs) in their respective

Schedules

TYPE OF LICENCE

manufacture

Base Drug(s)

To produce CDs in the

Schedules

To supply

and offer to

supply

To possess

only

1 2 3 4 5

Schedule 1

Cannabis

Cathinone

Coca Leaf

Concentrate of Poppy Straw

Ecstasy (MDMA)

Etryptamine

Lysergide

Mescaline

Methcathinone

Psilocin

Raw Opium

others (please specify)

Schedule 2

Alfentanil

Amphetamine

Cocaine

Codeine

Dextromoramide

Dextropropoxyphene

Diamorphine

Dihydrocodeine

Dihydroetorphine

Dipipanone

Ethlymorphine

Etorphine

Fentanyl

Hydromorphone

Medicinal Opium

Methadone

Names of Controlled Drugs

(CDs) in their respective

Schedules

TYPE OF LICENCE

manufacture

Base Drug(s)

To produce CDs in the

Schedules

To supply

and offer to

supply

To possess

only

1 2 3 4 5

Methylphenidate

Morphine (inc.papaveretum)

Oxycodone

Pethidine

Phenazocine

Phenmetrazine

Pholcodine

Remifentanil

Secobarbital

Others (please specify)

Schedule 3

Allobarbital

Amylobarbitone

Barbital

Buprenorphine

Butobarbital

Cathine

Cyclobarbital

Meprobamate

Pentazocine

Pentobarbital

Phenobarbitone

Temazepam

others (please specify)

Schedule 4.1

Alprazolam

Bromazepam

Clorazepate

Chlordiazepoxide

Clobazam

Clonazepam

Diazepam

Flurazepam

Loprazolam

Lorazepam

Lometazepam

Midazolam

Nitrazepam

Oxazepam

Triazolam

Zolpidem

others (please specify)

Names of Controlled Drugs

(CDs) in their respective

Schedules

TYPE OF LICENCE

manufacture

Base Drug(s)

To produce CDs in the

Schedules

To supply

and offer to

supply

To possess

only

1 2 3 4 5

Schedule 4.2

Chorionic gonadotrophin (HCG)

Clenbuterol

Gonadtrophin

Mesterolone

Non-human chorionic

gonadotrophin

Prasterone

Somatropin

Stanozolol

Testosterone

Trenbolone

others (please specify)

Schedule 5

Codeine

Dextropropoxyphene

Dihydrocodeine

Diphenoxylate

Morphine

Pholcodine

others (please specify)

Note:

No licence is required to "possess" Schedule 5 controlled drugs when in the

form of a medicinal product.