Guide to
Notification of Marketing Status of Veterinary
Medicines
1
SCOPE
This guide relates to post-authorisation notifications of the marketing status of a veterinary
medicinal product (animal remedy) and the operation of the ‘sunset clause’. The requirements
detailed in this guide apply to all products except parallel import products.
For the withdrawal of an authorisation please see the ‘Guide to Withdrawal of Authorisations or
Certificates for Veterinary Medicines’.
2
INTRODUCTION
The European Communities (Animal Remedies) (No. 2) Regulations 2007 require the
authorisation holder to notify the HPRA of changes in the marketing status of authorised
veterinary medicinal products.
An animal remedy is deemed to have been placed on the market when it is placed in the
distribution chain, i.e. it leaves the control of the marketing authorisation holder. 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.
An animal remedy ceases to be marketed when the authorisation holder stops releasing it to the
distribution chain. Where marketing is temporarily interrupted, the authorisation or certificate
holder should notify the HPRA of the date that marketing resumes. Cessation of marketing is a
separate activity from the total recall of all batches from the market, which is handled through
the Compliance Department of the HPRA.
Under the Regulations, the marketing authorisation ceases to be valid if the product is either not
marketed at all for a period of three consecutive years or has been marketed but marketing
ceases for a period of three consecutive years. This provision is termed the ‘sunset clause’.
Exemptions from the three-year rule may be accepted, if justified on public health or animal
health grounds (see section 5 below).
3
NON-MARKETING FOR REASONS OF QUALITY, SAFETY OR EFFICACY
When the marketing of an animal remedy ceases for reasons of quality, safety or efficacy, the
quality defect or efficacy/safety issue must be reported to the Veterinary Sciences and/or
Compliance departments of the HPRA, as soon as possible. The formal notification of marketing
status includes information on the reasons for non-marketing for statistical purposes only and it
must not be used to notify the HPRA of the quality, safety or efficacy issue.
AUT-G0011-8
1/3
HPRA Guide to Notification of Marketing Status of Veterinary Medicines
In these circumstances, the sale or supply of batches which may be already on the market at
wholesale or retail level will be addressed during discussions between the HPRA and the
authorisation holder, and in the context of the quality, safety or efficacy issue identified. All
communication for healthcare professionals should be submitted to the HPRA for review and
approval, as well as the proposed timescale for communication.
4
SUNSET CLAUSE
The sunset clause applies to products which are not marketed for a period of three consecutive
years, whether originally marketed or not.
For new authorisations granted from 17 November 2005, the three-year period started from the
date of authorisation. This applied to all products where the application was made before 17
November 2005 and the authorisation granted after that date. It also applies to all products for
which the application was made after 17 November 2005, except for the specific case of
generics of reference products where the application for the reference product was made after
17 November 2005. For these generic products, the three-year period begins when the market
exclusivity period for the reference product expires. This will be ten years from the date of
authorisation of the reference product, or longer if an extension is granted for an indication for
minor species as outlined in the European Communities (Animal Remedies) (No. 2) Regulations
2007.
For marketing authorisations issued prior to 17 November 2005, the three-year period starts on
17 November, 2005.
For the purposes of this Regulation, the definition of a veterinary medicinal product
authorisation includes the concept of the global marketing authorisation (see Notice to
Applicants, Volume 6A, Chapter 1); therefore, the authorisation will remain valid if at least one
pack size of one presentation (i.e. strength, pharmaceutical form or other (line) extension) is
marketed. There is no minimum period of marketing required.
In exceptional circumstances and for public health or animal health reasons, non-marketed
products may qualify for exemption from the sunset clause. The Regulations do not specify the
situations in which an exemption may apply. It is up to the marketing authorisation holder to
justify why the sunset clause should not apply. It would generally be appropriate to consider a
marketing authorisation(s) exempt from the provisions of the sunset clause where the marketing
authorisation(s) applies to a product(s):
-
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
which is an animal remedy used in emergency situations in response to a public or animal
health crisis
which is a critical animal remedy produced only when needed in the event of a disease
outbreak, such as certain vaccines for exotic diseases
which is an animal remedy used in a critical care setting
which is an animal remedy for a limited market (minor use or minor species)
AUT-G0011-8
2/3
HPRA Guide to Notification of Marketing Status of Veterinary Medicines
-
-
which is supporting marketing authorisations in other Member States (that is, through the
mutual recognition or decentralised procedures)
which is intended for certified export for use in third countries
for which there is an on-going procedure affecting the marketing authorisation critical for
placing the product on the market
for which there is an on-going planned change in manufacturing site or process and
continued authorisation is required to ensure future supply
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)
which is not marketed as it is under litigation in Ireland
which is a product that cannot be placed on the market for Intellectual Property reasons
Should the HPRA be notified that an animal remedy has not been marketed for three
consecutive years, and does not qualify for exemption from the provisions of the sunset clause,
the authorisation will cease to be valid.
5
NOTIFICATIONS TO THE HPRA
In July 2008, the HPRA sent a letter to all marketing authorisation holders (attached to the
annual maintenance fee request) requesting that the holder advise the HPRA of any animal
remedy which will not have been marketed for a consecutive period of three years on the 17
November 2008, and, for those products not marketed, which if any exemptions apply. For those
products not marketed and not subject to exemption, the authorisation ceases to be valid and
HPRA records, including the list of authorised products on the HPRA website, will be updated
accordingly.
From 17 November 2008 onwards, marketing authorisation holders are requested to advise the
HPRA of any product that has not been marketed for a period of three consecutive years and,
for those products not marketed, what if any exemptions apply. For those products not
marketed and not subject to exemption, the authorisation will cease to be valid and HPRA
records, including the list of authorised products on the HPRA website, will be updated
accordingly.
Notifications of marketing status should be made using the form ‘Notification of marketing
status of veterinary medicines’. A separate form should be used for each pharmaceutical form
and strength in a product range; however different pharmaceutical forms and strengths may be
combined on one form, if the marketing status is the same for each.
Notifications should be sent to:
Veterinary Sciences Department
Health Products Regulatory Authority,
Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2.
AUT-G0011-8
3/3