Download Notification of Marketing Status of Veterinary Medicines

Notification of Marketing Status of Veterinary
Medicines
For details of the requirements, please see the ‘Guide to Notification
of Marketing Status of Veterinary Medicines’.
1
FOR HPRA USE ONLY
CRN:
PRODUCT DETAILS
(Invented)name:
Active substance(s):
Pharmaceutical form(s) and strength(s):
Authorisation or certificate number(s):
Name and address of authorisation or certificate holder:
Contact name:
Telephone number:
Fax number:
E-mail:
2
MARKETING NOTIFICATION
The product has been/will be marketed from (insert date):
Note: For the purposes of the legislation in force, the HPRA takes the date of authorisation as
being the date of placing the product on the market, unless advised by the authorisation holder
to the contrary.
3
NON-MARKETING NOTIFICATION (complete if section 2 does not apply)
The product has not been marketed for a consecutive period of three years
The product is not currently marketed. The product will not have been marketed for a
consecutive period of three years on (insert date)
An exemption is claimed for the following reason(s): tick appropriate box(es)
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The marketing authorisation(s) applies to a product(s):
1
Which is an animal remedy where lack of suitable alternative suppliers or alternative
treatments mean there is the potential for adverse impact on public or animal health
Please provide details:
2
Which is an animal remedy used in emergency situations in response to a public or
animal health crisis;
Please provide details:
3
Which is a critical animal remedies produced only when needed in the event of a
disease outbreak, such as certain vaccines for exotic diseases
Please provide details:
4
Which is an animal remedy used in a critical care setting
Please provide details:
5
Which is an animal remedy for a limited market (minor use or minor species)
Please provide details:
6
Which is supporting marketing authorisations in other member states (that is,
through the mutual recognition or decentralised procedures)
Please provide details:
7
Which is intended for certified export for use in third countries
Please provide details:
8
For which there is an on-going procedure affecting the marketing authorisation
critical for placing the product on the market
Please provide details:
9
For which there is an on-going planned change in manufacturing site or process and
continued authorisation is required to ensure future supply.
Please provide details:
10
Which is subject to regulatory activity related to company mergers and acquisitions or
to change of ownership of the marketing authorisation (both companies involved
need to apply)
Please provide details:
11
Which is not marketed as it is under litigation in Ireland
Please provide details:
12
Which is a product that cannot be placed on the market for Intellectual Property
reasons
Please provide details:
13
Other (to be provided by the marketing authorisation holder and assessed by the
HPRA).
Please specify:
4
REASONS FOR NON-MARKETING
Please tick the relevant box and provide brief details
Commercial
Quality, including GMP issues
Safety issues
Efficacy issues
Where the marketing of a product ceases for reasons of quality, safety or efficacy, please give
details of the main contact name and department in the HPRA which has been notified of the
issue.
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Contact HPRA name:
Contact HPRA department:
Date of notification:
5
DECLARATION BY THE MARKETING AUTHORISATION HOLDER
I declare that the above information is correct and is a true representation. I understand it is the
responsibility of the MAH to inform the HPRA if any of the exceptional circumstances should
change.
Signature: __________________________
Print/type name:
Status (job title):
Date:
Please return the completed form to [email protected] or
Receipts and Validations Department,
Health Products Regulatory Authority,
Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2.
Tel: +353 1 6764971
Fax: +353 1 6767836
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