Dealership Application Form PDF Details

The Dealership Application Form serves as a crucial document for entities seeking to obtain a New Wholesale Dealer’s License, especially for those involved in the distribution of products for human use. This comprehensive form, as outlined by the Medicines and Healthcare products Regulatory Agency, demands detailed information from applicants to ensure compliance with regulatory standards. It includes sections that gather administrative data, such as the company's registered name, trading styles, and contact information, alongside specific details about each site for which the license is sought. Applicants must indicate the type of application, whether it's for a Wholesale Dealer's license or a General Sales List only license, and provide a checklist including payment confirmation and completed sections for administrative data, new and third-party site information, and responsible persons. The form inquires about the business's nature, querying if it's a registered pharmacy and details regarding its annual turnover to assess eligibility. Furthermore, it delves into site activities, asking about the use of products at the site, whether products of animal or human origin are present, the categories of products handled, and specific site activities, including the handling of special manufactured products, unlicensed medicinal products imported from other EEA member states, and parallel imported medicinal products. This diligent process is designed to ensure that only qualified and responsible dealers are granted the privilege to distribute medicinal products, safeguarding public health.

QuestionAnswer
Form NameDealership Application Form
Form Length17 pages
Fillable?No
Fillable fields0
Avg. time to fill out4 min 15 sec
Other namesdealer application form pdf, dealer registration form, dealer form format, dealership form

Form Preview Example

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Persons completing the application form

Title

First Name(s)

Surname

Contact Details

Telephone

Mobile

E-mail

Are you a consultant / representative applying on behalf of

 

the proposed Licence Holder?

YES

NO

Application Date

Purchase Order Number

Type of Application

Application for Wholesale Dealer’s licence (WL)

Application for Wholesale Dealer’s licence General Sales List only (GSL)

Checklist

Completed Application Form

Payment Conirmation

Section 1 - need only be completed once per application.

Section 2 - one copy for each new site to be named.

Section 3 - one copy for each third-party site to be named.

Section 4 - one copy for each new Responsible Person to be named, signed and dated. Section 5 - one copy for each current Responsible Person to be named, signed and dated. Section 6 - need only be completed once per application, signed and dated.

General Information

Is your business a registered pharmacy?

If ‘Yes’ does wholesale dealing form less then 15% of annual turnover?

If ‘No’, is your annual turnover by way of wholesale dealing less than £35,000?

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Section 1: Administrative

1.1 Company Information

1.1.1Licence Holder (Registered Company Name)

1.1.2Trading Style(s)

1.1.3DUNS Number

1.1.4Company Contacct Person

Title

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

First Name(s)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Surname

 

 

 

 

 

 

 

1.1.5 Contact Details

 

 

 

 

 

 

 

 

 

 

 

 

Telephone

 

 

 

Mobile

 

 

 

 

 

 

 

 

 

E-mail

 

 

 

Fax

 

 

1.1.6 Company Address

 

 

 

 

 

 

 

 

 

 

Name of department

 

 

 

 

 

 

 

 

 

 

 

Building Name

 

 

 

 

 

 

Industrial Complex

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unit Number(s)

 

 

 

 

 

 

Street Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Street Name

 

 

 

 

 

 

 

 

 

 

 

Town

 

 

 

 

 

 

 

 

 

 

 

 

Country

 

 

 

Postcode

 

 

 

 

 

 

 

 

 

 

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Section 1: Administrative Data

1.2 Company Information

1.2.1Address for Communication (Where your licence/post should be sent) and/or address for Invoicing (Where your invoices should be sent).

1.2.1.1Add a new address for communication

1.2.1.2Add a new address for invoicing

1.2.1.3Persons your communication should be addressed to:

Title

First Name(s)

Surname

1.2.1.4Company Name (If different to proposed licence holder)

1.2.1.5Address to be used Communication

Name of department

 

Building Name

 

Industrial Complex

 

Unit Number(s)

 

Street Number

 

Street Name

 

Town

 

Country

Postcode

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Section 2: New Site Information

2.1 Site Details

Site Number

 

Postcode

 

This is the main site?

 

YES

2.2 Site Name

 

 

NO

2.3Site Address Name of department Building Name Industrial Complex Unit Number(s) Street Number Street Name

Town

Country

2.4DUNS Number

2.5Company Contacct Person

Title

First Name(s)

Surname

2.5.1Contact Details Telephone

E-mail

Postcode

Mobile

Fax

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 2: Site Activities

2.6.1 Use of Products at Site

Are the products for administration to human beings?

YES

NO

2.6.1 Aminal Human Origin Products at Site

Products of Animal Human Origin (AHO) are present at this site?

YES

2.6.3 Site Types

Procurement/Administration only (no storage) #

Procurement and Administration

Storage and Handling (Picking of Goods)

Other (Specify)

NO

2.6.4 Categories of Products Handled at this Site

General Sales List (GSL) ONLY*

*Wholesale Dealer’s General Sales list (GSL) only licence; this is the only category which may be selected

Prescription Only (POM)

Pharmacy

General Sales List (GSL)

Traditional Herbal Medicinal Products

Biologicals

2.6.5 Speciic Site Activities

Are “special” manufactered products handled at this site?

Are unlicensed medicinal prodcuts imported from other EEA member states handled at this site?

Are parallel imported medicinal products handled at this site?

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

2.7 Product Classes Handled at this Site

Small volume streile liquids (includes eye drops)

Other sterile products (Must be speciied)

Solid sterile dosage forms (includes sterile powders)

Non-sterile liquids (includes solutions, syrups,and suspensions)*

Solid non-sterile dosage forms (includes tablets, capsules, suppositories & poweders)* Semi-solid non-sterile dosage forms (includes non-sterile creams and ointments)* Other non-sterile products (Must be speciied)*

Medicinal Gases

Semi-solid sterile dosage forms (includes sterile creams and ointments) Large volume sterile liquids

2.8 Speciic Site Activities

Controlled Drugs (Licensed by the Home Ofice) are handled at this site?

Do you supply stock which requires refrigeration or low temperature storage?

*Wholesale Dealer’s General Sales list (GSL) only licence; these are the only category which may be selected

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 2: Information

Section B: Inspectorate Information

1. Premises

1.1

Are the premises sound and secure?

YES

1.2

Do you have a lease/freehold for the premises named?

YES

1.3

Are the premises sound and secure?

YES

1.4

In the space below provide details of the security arrangements for the premises

NO

NO

NO

1.5Provide in the space below a deinitive statement that the premises are complete and fully prepared for wholesale dealing activities. This must include a description of what storage facilities are in place including shelving/racking, lockable storage etc?

If possible provide photographs of premises, facilities etc.

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 2: Site Information

Section B: Inspectorate Information

2. Equipment/facilities on site

2.1In the space below provide a drawing of your facilities. Alternativley, supply the information on additional pages.

2.2In the space below provide details of your Business Model and/or Business Plan. Alternatively, supply the information on additional pages.

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 2: Site Information

Section B: Inspectorate Information

3. Procedures

Quality Systems

Note: This information sought in this section must be relevant to the site detailed in Section 2: Site Information. If

-more than one site is to be named on your submission and

-if the same procedures apply to each of the named sites

This section only needs to be completed for one of the sites.

Remember, the information required in this section must be supplied for at least one site, if it is not the assesment will not proceed.

3.1 I conirm that these procedures apply to all sites.

3.2

Is a Quality System in place?

YES

3.3

Are there Standard Operating Procedures (SOPs) available for the

YES

 

distribution business processes?

 

3.4

Are these SOPs tailored for the business and premises named in the

YES

 

application form submitted to MHRA?

 

 

Note: commercially sourced generic SOPs that have not been tailored to

 

 

the business and premises named in the application form will not be

 

 

acceptted.

 

3.5

Do SOPs include details of deined stall roles and responsibilites?

YES

NO

NO

NO

NO

4. Transport and Distribution

4.1

Will you distribute products using postal services?

YES

4.2

Will you distribute products using a third party courier/van service?

YES

4.3

Will you distribute products using your own courier/van service?

YES

4.4

Will you distribute products using customer collection?

YES

4.5

Has provision been made for refrigerated products and has the

YES

 

proposed delivery system been tested?

 

NO

NO

NO

NO

NO

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

5.1 Are draft or signed Technical Agreements in place with third

YES

party contractors?

 

NO

5.2 Supply copies of contacts for services supplied by third parties

e.g. purchasing, invoicing, RP services, storage, distribution, etc. You must supply requited information.

Documentation

The documentation required in 5.2 is attached

6.1 Are maximum/minimum temperatures recorded in all areas

YES

Using calibrated monitoring devices?

 

NO

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 3: Site Personel

New Responsible Persons

This is a new nominated Responsible Person, not named on any current live MHRA licences.

This nominated Responsible Person is already named on a licence issued by the MHRA and has undergone the neccessary security checks (i.e. has provided copies of documentation such as utility bills and the passport information page and/or photo card drivers licence).

Note: Responsible Persons named on licences prior to 2006 (when the new system was Introduced) who have not yet provided this information will be expected to provide this before they may be named on new sites or licences. If you are unsure please email pcl@mhra.gsi.gov.uk and we will conirm.

3.1 Nominated Responsibility Person

Title

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

First Name(s)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Surname

 

 

 

 

 

 

 

 

3.1.1 Contact Details

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Telephone

 

 

 

Mobile

 

 

 

 

 

 

 

 

 

 

 

E-mail

 

 

 

Fax

 

 

 

3.1.2 Person Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.1.6 Company Address

 

 

 

 

 

 

 

 

 

 

 

Building Name

 

 

 

 

 

 

 

Industrial Complex

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unit Number(s)

 

 

 

 

 

 

 

Street Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Street Name

 

 

 

 

 

 

 

 

 

 

 

 

 

Town

 

 

 

 

 

 

 

 

 

 

 

Postcode

 

 

Country

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 3: Site Personel

Section 3B: Inspectorate Information

1. Status

1.1

Will you be a permanent employee of the proposed licence holder?

YES

1.2

If the answer to 1.1 is ‘no’, will you be a consultant/contract

YES

 

Ressponsible Person?

 

 

1.3

If the answer to 1.2 is ‘no’, is a technical agreement/contract between

YES

 

you and the licenceholder in place?

 

 

1.4If the answer to 1.2 is ‘yes’, please ensure a copy is supplied as part of the information submitted with this form, also complete 1.4.1 below.

NO

NO

NO

Documentation

A copy of the technical agreement is attached.

1.4.1Indicate itn the box below below the frequency that you intend to visit the site(s) to carry out RP duties (e.g. full-time, twice a week, once a month etc.)

2.Knowledge of legislation

2.1Do you have knowledge of the relavent provisions of the Medicines

 

Act 1968 (as amended) neccessary to carry out the role of RP?

YES

 

 

2.2

Do you have knowledge of the relevant provisions of the Medicines

YES

 

for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous)

 

 

 

Regulations 2005 (SI 2005/2789) neccessary to carry out the role RP?

 

2.3

Do you have knowledge of the relevant provisions of Directive

YES

 

2001/83/EC neccessary to carry out the role of RP?

 

 

2.4

Do you have knowledge of Guidelines for Good Distribution Practice

YES

 

of Medicinal products for human use (94/C 63/03) neccessary to

 

 

carry out the role of RP?

NO

NO

NO

NO

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 3: Site Personel

Section 3B: Inspectorate Information

3.Professional Information

3.1Are you a registered Pharmasist?

3.2Are you eligible to act as a Qualiied Person?

3.3Are you eligible under the provisions for Transitional Qualiied Person (TQP)?

3.4Are you a member of a professional association? If yes, write the name of the association and your registration/certiicate number below.

YES

YES

YES

YES

NO

NO

NO

NO

Name of Professional Association

Your registration number

3.5 Have you ever been disciplined and/or struck off a Professional register? YES

NO

If you answered ‘yes’ to 3.5 provide details below. If you need more space please write on additional pages.

4. Practical Experience

If you are not a Pharmasist or eligible to act as a Qualiied Person then please conirm that you have at least one years practical experience in:

4.1Handing, storage and distribution of medicimal products.

4.2Transactions in or selling or procuring medicinal products.

4.3Managerial experience in controlling and directing the wholesale distribution of medicinal products on a scale similar to the licence being nominated for.

4.4A Curriculum Vitae (CV) detailing qualiications and work experience relevant to this licence is attached.

YES

YES

YES

YES

NO

NO

NO

NO

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 3: Site Personel

Section 3B: Inspectorate Information

5.Identiication

5.1Photo ID - A copy of a document which may be used to identify the nominated Responsible Person such as the information page from a passport or a photo card driver’s licence.

5.2Proof of Residence - Photocopies of at least two recent (not older than three months) utility bills to conirm the residential address of the nominated Responsible Person.

6.Professional Reference

Provide details of referees who can substantiate the information you have provided. MHRA reserve the right to contact referees to verify the information provided.

Reference 1

Company:

Posittion you held:

Period you were in the position:

Referee’s name:

Position in company held by the referee:

Referee’s email address:

Referee’s telephone number:

Referee’s postal address:

Reference 1

Company:

Posittion you held:

Period you were in the position:

Referee’s name:

Position in company held by the referee:

Referee’s email address:

Referee’s telephone number:

Referee’s postal address:

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 3: Site Personel

Section 3B: Inspectorate Information

6. Professional References

Reference 3

Company:

Posittion you held:

Period you were in the position:

Referee’s name:

Position in company held by the referee:

Referee’s email address:

Referee’s telephone number:

Referee’s postal address:

7. Additional Information

If there is any further information you feel may ve relevant to the inspector when your nomination for that role of Responsible Person is considered; please supply it in the box below.

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 3: Site Personel

8. Declaration

Each new nominee for Responsible Person must complete the details in the declaration box below and sign and date the declaration.

I conirm that the information submitted about me in response to the questions in this form which this declaration forms a part of are to the best of my knowledge and belief correct, complete, true and accuarate. I agree to be nominated as Responsible Person.

Signed

 

Date

 

(Nominated Qaliied Person)

 

 

 

 

 

 

 

 

 

Print Name

 

 

 

 

 

 

 

 

Signed

 

Date

 

(Applicant)

 

 

 

 

 

 

 

 

 

 

Print Name

Medicines and Healthcare products Regulatory Agency

DOCUMENT 5

Sample/Template Application Form:

New Wholesale Dealer’s Licence (Human use)

Site Name of Number

Postcode

Section 4: Declaration

I/We apply for the grant of a Wholesale Dealer’s Licence to the proposed holder named in this application from in respect of activities to whichj the application refers,

4.1The activities are to be only in accordance with the information set out in the application or furnished in accordance with it.

4.2To the best of my knowledge and belief, the particulars I have given in this form are correct, truthful and complete.

Signed

(Applicant)

Print Name

Capacity in which signed

Date

Submission Information

Please return the application form along with supporting documentation to :

E-Mail: pcl@mhra.gsi.gov.uk

Or paper applications to :

Medicines and Healthcare products Regulatory Agency Process Licensing, (5Y, Desk 363)

151 Buckingham Palace Road London

SW1W 9SZ