Application for a Wholesale Distribution Authorisation
Please note this application will be deemed invalid if the applicant is not ready for inspection
at the time of submission of this application.
1
APPLICANT DETAILS
(Relating to Schedule 1 of S.I. 538 of 2007, Medicinal Products (Control of Wholesale
Distribution) Regulations 2007 to 2013)
Legally registered name of proposed authorisation
holder:
For internal use only:
Draft authorisation no:
Legally registered address of proposed authorisation
holder:
(Please include certificate of incorporation.)
Licensing register ref no:
Fee codes:
CWS reference no:
Trading style (if applicable):
(Please provide business document from the Companies Registration Office if using a trading
style.)
Company Registration Office number:
Company Registration Office number for ‘Trading As’ company (if applicable):
Address of wholesaling site in Ireland:
If the authorisation holder address is different to the wholesaling address, please note that
if any wholesaling activities, as outlined in Section 2 below, occur at the address of the
authorisation holder, these activities will require a separate wholesale distribution
authorisation to cover the activity at that address. Please select the appropriate option:
N/A (the authorisation holder address is the same as the wholesaling site address.)
No wholesale activities occur at the address of the authorisation holder.
Wholesale activities occur at the address of the authorisation holder and a separate
application will be/has been submitted.
Name and address of applicant (if different from the proposed authorisation holder):
Contact telephone number:
Contact fax number:
E-mail address of applicant:
AUT-F0199-14
1/6
2
SCOPE OF WHOLESALE DISTRIBUTION
Name and address of the site:
1
MEDICINAL PRODUCTS
1.1 with a Marketing Authorisation in EEA country(s)
1.2 without a Marketing Authorisation in the EEA and intended for EEA market
1.3 without a Marketing Authorisation in the EEA and intended for exportation
2
AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS
(Relating to Schedule 1 of S.I. 538 of 2007, Medicinal Products (Control of Wholesale
Distribution) Regulations 2007 to 2013)
2.1 Procurement
(Obtaining, acquiring, purchasing or buying medicinal products from manufacturers,
importers or other wholesale distributors)
2.2 Holding
(Storing medicinal products)
2.3 Supply
(All activities of providing / selling / donating medicinal products to wholesalers;
pharmacists; or persons authorised or entitled to supply medicinal products to the
public)
2.4 Export
(All activities relating to the supply of a medicinal product to a state other than a EU
Member State or a Contracting State of the European Economic Area)
2.5 Other activities(s): (please specify)
3
MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS
(Relating to Schedule 1 of S.I. 538 of 2007, Medicinal Products (Control of Wholesale
Distribution) Regulations 2007 to 2013)
3.1 Products according to Art. 83 of 2001/83/EC 1
3.1.1 Narcotic or psychotropic products
3.1.2 Medicinal products derived from blood
3.1.3 Immunological medicinal products
3.1.4 Radiopharmaceuticals (including radionuclide kits)
3.2 Medicinal gases
3.3 Cold chain products (requiring low temperature handling)
3.4 Other products
3.4.1 Prescription only medicinal products
3.4.2 Medicinal products for general sale
3.4.3 Over the counter medicinal products for sale through pharmacies only
3.4.4 Unauthorised medicinal products (see note 1)
3.4.5 Vaccines
3.4.6 Parallel imported medicinal products authorised by Parallel Product
Authorisation (PPA)
3.4.7 Parallel imported medicinal product authorised by Dual Pack Registration
(DPR)
1
Without prejudice to further authorisations as may be required according to national legislation
AUT-F0199-14
2/6
3.4.8 Parallel distributed centrally authorised medicinal products
3.4.9 Traditional herbal medicinal products
3.4.10 Homeopathic medicinal products (HOR and HOA)
3.4.11 Exempt medicinal products (see note 2)
3.4.12 Biological products
3.4.13 Advance Therapeutic Medicinal products
Note 1: Unauthorised medicinal products are products which do not hold a marketing
authorisation in Ireland. A wholesaler may supply such products only to markets outside of
Ireland where the products are authorised. Unauthorised medicinal products are not for supply
on the Irish market.
Note 2: An exempt medicinal product is a medicinal product which does not hold a marketing
authorisation. It is supplied in response to a bona fide unsolicited order formulated in
accordance with the specification of a practitioner for use by their individual patients on their
direct personal responsibility. Guidance on exempt medicinal products can be found on the
‘Publications and Forms’ section of www.hpra.ie.
Note 3: Please be aware that a separate licence/registration is required to wholesale controlled
drugs. Please contact the HPRA Compliance Department (compliance@hpra.ie) for more
information.
4
PREMISES AND EQUIPMENT
(Relating to Schedule 1, 4 (2) of S.I. 538 of 2007, Medicinal Products (Control of Wholesale
Distribution) Regulations 2007 to 2013)
Please include a detailed statement indicating the facilities and equipment available at each
of the premises referred to in section 1 above. Factors to consider within this statement
include the following:
4.1 Storage
- Warehousing capacity
- Details of the temperature monitoring system
- Details of the Building Management System (if applicable)
- Details of temperature/humidity controls.
- Note: for applicants who will not be physically storing product, please provide the name,
address and wholesaler’s authorisation number for the contract storage site(s). This is
the site(s) where product is stored whilst title to product is maintained by the applicant.
4.2 Inventory control
- Details of inventory management/stock control systems
- Details of stock rotation controls
4.3 Picking
- Description of picking method (automated or manual)
4.4 Cold chain storage
- Detail of fridge units and associated temperature control and monitoring systems
- Details of freezers and associated temperature control and monitoring systems
- Details of alarm and alert systems within/outside of work hours.
4.5 Security arrangements
- Details of CCTV coverage internal and external
- Details of the access controls
- Details of the security monitoring and coverage
- Details of the alarm system
AUT-F0199-14
3/6
5
RECORDS AND DOCUMENTS
(Relating to Schedule 1- 4 (3) of S.I. 538 of 2007, Medicinal Products (Control of Wholesale
Distribution) Regulations 2007 to 2013)
Please provide an overview of the systems in place to ensure the maintenance of the
required documentation and records in respect of medicinal products stored on or
distributed from (each of) your premises.
6
RECALL PROCEDURE
A copy of the company’s recall procedure must be submitted.
Explanatory notes on the preparation of a recall procedure can be found on the
‘Publications and Forms’ section of www.hpra.ie.
7
QUALITY SYSTEM
The wholesaler is required to have a quality system in place prior to inspection. A quality
system requires the wholesaler to have a documented set of procedures which contain and
describe, in sufficient detail, all the activities which could affect the quality of the medicines.
The applicant must submit a list of the procedures in its quality system.
A guidance note on the wholesaling of medicinal products for human use in Ireland can be
found on the ‘Publications and Forms’ section of www.hpra.ie.
8
PERSONNEL
(Relating to Schedule 1 – 5(1&2) of S.I. 538 of 2007, Medicinal Products (Control of
Wholesale Distribution) Regulations 2007 to 2013)
8.1 Responsible Person
Curriculum vitae including qualifications (registration with PSI, if applicable), signed role
profile/job description and training records must be submitted for the Responsible
Person(s). Training records should provide evidence of training received in the principles
of Good Distribution Practice (GDP) and in relevant procedures (SOPs) within the
company’s quality system. These records should be signed by both the trainer and the
trainee.
(Note: The above information should be provided in respect of each RP acting at each
wholesaling premises associated with the authorisation. The information provided should
clearly indicate which wholesaling premises the RP has responsibility for.)
Please supply the name of the Responsible Person.
Name:
8.2 Deputy Responsible Person
If a Deputy Responsible Person is also to be included on the authorisation, their
curriculum vitae and training records should also be provided.
(Note: The above information should be provided in respect of each Deputy RP acting at
each wholesaling premises associated with the authorisation. The information provided
should clearly indicate which wholesaling premises the Deputy RP has responsibility for.)
Please supply the name of the Deputy Responsible Person.
Name:
8.3 Additional personnel
Please provide the names, qualifications and experience of any other person whose duty
it will be to supervise the operations at each of the premises(es) referred to in section 1,
AUT-F0199-14
4/6
and, in each case, the name and function of the person to whom he/she is responsible.
This includes additional personnel other than the RP/deputy RP, for example, warehouse
managers and quality personnel in large operations.
9
BROKERS
If a wholesaler of medicinal products uses the service of a broker, that broker is required by
the Falsified Medicines Directive to register with the HPRA.
Do you use the services of a broker?
Yes
No
Broker name:
Broker address:
10 CONTRACT WHOLESALE DISTRIBUTION SITES
(Relating to Schedule 1- 4 (3) of S.I. 538 of 2007, Medicinal Products (Control of Wholesale
Distribution) Regulations 2007 to 2013)
Please provide the name(s) and address(es) of any contract distribution sites and their
HPRA wholesale authorisation number. Where a contract wholesale distribution site is
located outside of Ireland but within the EEA, please provide a copy of the
authorisation/licence issued by the relevant national Competent Authority (NCA) which
clearly states the authorisation/licence number.
11 FEES / CLASSIFICATION OF FACILITY
(please tick)
An application fee must be submitted with each request for a wholesale distribution
authorisation. An annual maintenance fee is also payable in respect of each authorisation
and is related to the size of the facility.
A large site is one supplying a wide range of medicinal products to other wholesalers,
retail and hospital pharmacies, health boards, doctors, dentists and others.
A medium site is one supplying a limited range of medicinal products to retail and
hospital pharmacies, health boards, doctors, dentists and others.
A small site is a short line wholesaler supplying a limited range of medicinal products to
a limited range of customers, typically retail and hospital pharmacies.
A minor site fee applies only to wholesalers supplying a small range of analgesics,
antacids etc (which may be legally sold in non-pharmacy outlets) to retail outlets such as
grocery shops and newsagents.
A procurement and supply only site fee applies only to wholesalers that operate on
the basis of taking ownership and selling medicinal products onwards. They do not
directly store or conduct other wholesaling activities.
Please refer to the ‘Guide to Fees for Human Products’ on the ‘Publications and Forms’
section of www.hpra.ie and complete the fee application form.
AUT-F0199-14
5/6
12 DECLARATION
In the event of the authorisation being granted, I undertake to ensure fulfilment of the
obligations arising by virtue of the terms and conditions of the authorisation and declare
that the above particulars are, to the best of my knowledge and belief, correct.
Signature: ___________________________________
Date:
Print name:
Title/position:
13 CHECKLIST OF DOCUMENTS
The following information must be submitted with the application (except where not
applicable).
Please tick the checkboxes below to confirm the documents have been included with the
application.
Letter of application
Certificate of incorporation (section 1)
Business document from Companies Registration Office if using a trading style
Completed application form (section 1-3)
Statement on premises and equipment (section 4)
Overview of documents and records (section 5)
Recall procedure (section 6)
Statement on quality system (including a list of procedures section 7)
Details relating to Responsible Person(s) (section 8)
Classification of facility size (section 11)
Fee application form (section 11)
Relevant fee (section 11)
Signed declaration (section 12)
Send to:
Compliance Department, Health Products Regulatory Authority,
Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Tel: + 353 1 676 4971
Fax: + 353 1 676 7836
E-mail: compliance@hpra.ie
AUT-F0199-14
6/6