Licence No LM/ /
DEPARTMENT OF AGRICULTURE, FOOD AND THE MARINE
APPLICATIONFOR AN ANIMAL REMEDIES MERCHANTS LICENCE
I/We, the undersigned, hereby apply to the Minister for Agriculture, Food and the Marine for a licence
under Regulation 31 of the European Communities (Animal Remedies) (No. 2) Regulations, 2007 to
sell animal remedies by retail, at the premises indicated beneath and I/we declare that the particulars given
in this application are correct.
N.B. A separate form must be used in respect of each premises.
Status of Retail Business: Company Limited Company Partnership(Please tick as appropriate) Sole Trader Co-Operative
Veterinary Practitioner Yes □ No □
(Please tick as appropriate)
`
1. Particulars of Applicant
* (a) Name/Business Name: ______
* (b) Trading As: ______
(where applicable)
Address: ______
(of LM premises)
______
______
(c) Telephone No: ______
Fax No: ______
(if available)
Email Address: ______
(if available)
PPS No: ______Vat No: ______
(sole trader only) (if available)
Company Registration No. ______
* (a) Applications for Companies, Co- Operatives, Partnerships must be submitted in the official name of the Business
(b) A licence cannot be issued to a ‘Trading as’ entity.
2. Training of Retailers:
Have you or a member of your staff successfully completed the FETAC approved training course, which came into effect on 1st January 2013, in accordance with Regulation 32 of the European Communities (Animal Remedies) (No.2) Regulations, 2007 or are you or a member of your staff aVeterinary Nurse registered by the Veterinary Council of Ireland. (VCI)
Yes □ No □
If yes please give details of the person(s) as follows.
Name ______
Cert. No. / VCI Reg. No. ______
Course Provider ______
Name ______
Cert. No. / VCI Reg. No. ______
Course Provider ______
Name ______
Cert. No. / VCI Reg. No. ______
Course Provider ______
Name ______
Cert. No. / VCI Reg. No. ______
Course Provider ______
Name ______
Cert. No. / VCI Reg. No. ______
Course Provider ______
* Please note that under Regulation 31(5)(h) an animal remedy must only be sold from
the premises by a responsible person.
Declarations / Undertakings / Notes
I/We undertake to notify, in writing, the Department of Agriculture, Food and the Marine of any changes in or addition to the aforementioned particulars.I/We declare that the premises to which this application relates conforms to the conditions set down in the Schedule 6 to the European Communities (Animal Remedies) (No. 2) Regulations, 2007, and does not constitute part of a domestic dwelling.
I/We undertake to comply with the conditions, including the record-keeping requirements set out in the European Communities (Animal Remedies) (No. 2) Regulations, 2007 and the Animal Health and Welfare (Animal Remedies Veterinary Practice and Veterinary Medicine) Regulations 2017, relating to the possession, sale or supply of animal remedies and any conditions attached to a licence granted under the said Regulations.
I/We undertake to have in place arrangements to receive and return to the person from whom he or she purchased them, an animal remedy that is unused or has reached its expiry date and in addition take steps to ensure that customers are aware of the arrangements.
I/We am/are aware that a licence granted on foot of false or misleading particulars supplied by the applicant may be revoked.
It should be noted that information provided by you may be subject to disclosure under the FOI Acts 1997 and 2003. If you wish to have any of the records concerned protected under the Confidentiality, Commercially Sensitive, Personal Information or other exemption provisions of that legislation you should mark those records accordingly and state your reasons. The relevant exemptions will then be considered in the event of an FOI request relating to those records.
Personal data submitted by you in support of your application will be managed in line with Data Protection Veterinary Medicines Notice Number 01/2018 which is available for download on and the attached Annex.
I/We enclose licence fee €150.00(Tick Box)
(Payable to the Department of Agriculture, Food and the Marine)
Signature(s) of/on behalf of Applicant(s)
(in the case of a company or co-operative, a person authorised for such purpose on behalf of the applicant or if a partnership, all partners must sign). / ______
______
______
Names(s) in block capitals
/ ____________
______
Position / ______
Date / ______
Please note the following:
This form, when completed, should be returned to:
ERAD (Veterinary Medicines)
Department of Agriculture, Food and the Marine
Backweston Campus
Young’s Cross
Celbridge
Co Kildare
The licence fee €150 made payable to the Department of Agriculture, Food and the Marine must accompany this application.
Incomplete forms or forms not accompanied by the application fee will be returned to the applicant.
A licence will not be granted unless the premises conforms to the general conditions set out in the Schedule 6 to the Regulations, as detailed overleaf.
I/We have read the above notes and the contents of Schedule 6 overleaf
(Tick Box)
Office Use
Paid: ______
Date: ______
Rem: ______
Schedule 6 to the European Communities (Animal Remedies) (No. 2) Regulations, 2007
(S.I. No. 786 of 2007)
1.The premises shall be a permanent structure of sound construction.
2.The premises shall be capable of being adequately secured.
3.Premises contained within the curtilage of a domestic dwelling shall not be considered suitable. If a premises is attached to the dwelling, the limits of the premises to be used as a retail premises shall be clearly defined and it shall be possible to access the premises directly without trespass into the dwelling and animal remedies shall not be stored or kept for sale outside the confines of the licensed premises.
4.The premises shall preferably be a separate unit but if part of another retail facility all activities concerning the sale, supply, display and storage of animal remedies shall take place in a separate designated area.
5.The premises shall have adequate storage space to store animal remedies in the accordance with good pharmaceutical practice and in accordance with manufacturers directions.
6.Animal remedies shall be stored in a manner that will facilitate proper rotation of stock.
7.The premises shall have a designated area for the storage, prior to return or disposal, of out of date stock and damaged stock. This area shall also be used for the temporary storage of products subject to recall due to quality defect or for reasons relating to the pharmacovigilance system provided for under these regulations.
8.The premises shall have refrigerated storage and display facilities for animal remedies which require to be kept under controlled temperature conditions.
9.Storage and display facilities shall be adequate to ensure that animal remedies do not become contaminated by other animal remedies or stock on the premises or cause such contamination.
ANNEX
Information specific to the personal data provided on this application form
1.Specified Purpose:
Personal data submitted by you in support of your application, subsequently processed by this Department, will only be used for the specific purpose of issuing a licence to sell animal remedies by retail at the premises indicated on this application form.
2.Legal Basis
An Animal Remedies Merchant’s Licence is granted pursuant to Regulation 31 of the European Communities (Animal Remedies)(No. 2) Regulations 2007 (SI 786 of 2007) as amended.
3.Recipients
Not applicable
4.Transfer outside the EU
No personal data will be transferred outside the EU.
5.Retention Period
- Personal data submitted by you in support of your application will be retained for the duration of the validity of this licence which is currently of unlimited duration.
- It will be retained by DAFM only as long as there is a business need to do so in line with the purposes for which it is collected.
- After this time it will be marked for destruction and will be destroyed in line with Internal guidelines or guidelines for destruction received from the National Archives Office or associated permissions received from them.
Data required is a statutory obligation
7.Automated Decision Making
Not applicable
8.Information from Third Party
Not applicable
9.Technical information on data collected
Technical information on the cookies used on our Department’s website is available at the following link:
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LM/APPL Approved- Date Revised– 24/05/2018