Strategic Consultation document - The Health Products Regulatory

Stakeholder views on HPRA Strategy 2016 - 2020
The HPRA is the regulator of health products in Ireland. Our mission is to protect and enhance
public and animal health through the regulation of medicines, medical devices and other health
products. In carrying out our regulatory functions, the HPRA puts the health of people and
animals at the core of everything we do. We use our scientific and clinical expertise to review
and monitor health products available in Ireland or exported abroad. Our aim is to make sure
that the health products we regulate are as safe as possible and do what they are intended to
The full extent of our competent authority activities, which have been granted to us by
government over the past 20 years, are shown in the functions matrix available on our website.
The current Strategic Plan covers the years 2010 to 2015 and is based on the following five highlevel goals, each of which has a number of objectives and activities which have informed our
annual business planning and reporting.
1 Enhance healthcare product safety and patient outcomes by effective risk management and
market surveillance.
2 Deliver clear, relevant and timely communications to patients, consumers and healthcare
3 Improve service delivery within a high quality, risk-based regulatory framework.
4 Influence legislation and policy development at European and international levels for the
benefit of public and animal health.
5 Build future capabilities to meet evolving regulatory requirements, and scientific and
technological advances.
As we begin the development of the next strategic plan to cover the years 2016 – 2020, we
invite all stakeholders to give their views on areas that are relevant to them, using the format
below, firstly in relation to product areas and secondly in relation to key high-level areas.
Human medicines
Our role in relation to human medicines is to ensure the ongoing safety and quality of
medicines, from clinical trials through to production and supply to distributors and pharmacies
and other retailers. We will continue to licence new medicines which contribute to the safe and
effective treatment of patients’ medical conditions, and to work with EU partners, healthcare
professionals and patients when any identified risks need to be managed for optimum patient
As a key stakeholder we are interested in your views on what you feel our priorities should be in
the next five years in regulating human medicines on the Irish market.
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Medical devices
Monitoring the safety and performance of medical devices on the market in Ireland is a key
function of the HPRA as well as the designation and oversight of Irish notified bodies. The
regulation of medical devices will undergo significant changes during and beyond the lifetime of
this next strategic plan with EU proposals for a new regime expected to be agreed by the end of
While the specific details of the new regulatory regime are still under discussion, we wish to seek
your views on how and where we should focus our resources over the next five years.
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Blood, tissues and organs
Our role is to ensure the quality and safety of blood and blood components used in Ireland. In
relation to tissues and cells, we ensure that standards of quality and safety are adhered to for
their donation, procurement, testing, processing and preservation. We also ensure the quality
and safety of human organs intended for transplantation.
In your view, are there specific areas you feel could be prioritised by the HPRA over the next five
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Veterinary medicines
Our role in regulating veterinary medicines is similar to that in regulating human medicines.
However the European Commission has recently published proposals for a radical change which
would mean that the regulatory system would be quite different from the current one.
Discussions are at an early stage between the Commission and the Member States, and may
result in significant amendments to the proposals; nevertheless we would like to hear your views
as one our key stakeholders, on what you feel our priorities should be in the next five years.
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Stakeholder consultation 2015
Scientific animal protection
The HPRA regulates the use of animals for scientific purposes by means of authorisation at three
levels: breeders/suppliers/users; projects; and individuals. This authority was transferred from
the Department of Health which regulated this area until the end of 2012.
As we further develop this function, are there particular views you have, as a stakeholder, in how
we should develop this area?
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Controlled substances
The HPRA’s role in the regulation of controlled substances include the issuing of licences for
precursor chemicals and the preparation of other licences under the Misuse of Drugs Act for
issue from the Department of Health. It is expected that the responsibility for issuing other
licences will be transferred from the Department of Health to the HPRA in time.
Any views you may have on specific priorities or areas of concern would be welcomed.
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Our role is to regulate the manufacture, sale and supply of cosmetic products in Ireland, and to
identify and address cosmetic product quality and safety issues, in conjunction with the Health
Service Executive (HSE).
Please let us know your views on what our priorities should be for regulating cosmetics over the
next five years.
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We also welcome your views on the actions we can take in a number of key areas to
continuously improve how we:
 communicate with our stakeholders;
 contribute to patient, public and animal health within Ireland and abroad;
 influence the development of the regulatory system; and
 enforce the legislation.
Please add your comments to the following table.
Stakeholder consultation 2015
Communications and
stakeholder engagement
Your comments
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Contributing to the national
health system in Ireland.
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Contributing to the network of
competent authorities in the
EU and internationally
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Influencing legislation and
policy development
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Enforcing the legislation for
medicines and medical devices
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Any other comments?
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Name Click here to enter text.
Organisation Click here to enter text.
Address Click here to enter text.
Contact e-mail or telephone number Click here to enter text.
Thank you for your contributions which are greatly appreciated. Please e-mail this form to by the deadline of 27 March 2015 or by post to:
Chief Executive’s Office
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Stakeholder consultation 2015