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.
| Question | Answer |
|---|---|
| Form Name | Dealership Application Form |
| Form Length | 17 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 4 min 15 sec |
| Other names | dealer application form pdf, dealer registration form, dealer form format, dealership form |
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
Are you a consultant / representative applying on behalf of |
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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
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 |
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First Name(s) |
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Surname |
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1.1.5 Contact Details |
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Telephone |
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Mobile |
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Fax |
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1.1.6 Company Address |
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Name of department |
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Building Name |
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Industrial Complex |
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Unit Number(s) |
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Street Number |
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Street Name |
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Postcode |
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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 |
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Building Name |
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Industrial Complex |
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Unit Number(s) |
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Street Number |
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Street Name |
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Town |
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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 |
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Postcode |
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This is the main site? |
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YES |
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2.2 Site Name |
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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
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)
Solid
Medicinal Gases
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 |
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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 |
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distribution business processes? |
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3.4 |
Are these SOPs tailored for the business and premises named in the |
YES |
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application form submitted to MHRA? |
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Note: commercially sourced generic SOPs that have not been tailored to |
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the business and premises named in the application form will not be |
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acceptted. |
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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 |
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proposed delivery system been tested? |
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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 |
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party contractors? |
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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 |
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Using calibrated monitoring devices? |
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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 |
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First Name(s) |
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Surname |
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3.1.1 Contact Details |
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Telephone |
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Mobile |
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Fax |
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3.1.2 Person Number |
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1.1.6 Company Address |
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Building Name |
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Industrial Complex |
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Unit Number(s) |
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Street Number |
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Street Name |
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Town |
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Postcode |
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Country |
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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 |
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Ressponsible Person? |
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1.3 |
If the answer to 1.2 is ‘no’, is a technical agreement/contract between |
YES |
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you and the licenceholder in place? |
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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.
2.Knowledge of legislation
2.1Do you have knowledge of the relavent provisions of the Medicines
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Act 1968 (as amended) neccessary to carry out the role of RP? |
YES |
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2.2 |
Do you have knowledge of the relevant provisions of the Medicines |
YES |
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for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous) |
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Regulations 2005 (SI 2005/2789) neccessary to carry out the role RP? |
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2.3 |
Do you have knowledge of the relevant provisions of Directive |
YES |
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2001/83/EC neccessary to carry out the role of RP? |
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2.4 |
Do you have knowledge of Guidelines for Good Distribution Practice |
YES |
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of Medicinal products for human use (94/C 63/03) neccessary to |
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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 |
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Print Name |
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Signed |
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(Applicant) |
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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 :
Or paper applications to :
Medicines and Healthcare products Regulatory Agency Process Licensing, (5Y, Desk 363)
151 Buckingham Palace Road London
SW1W 9SZ