HPRA 发布第 6 版爱尔兰 QP 资格取得指南（AUT-G0080）
Guide to attainment of Qualified Person status in Ireland
HPRA 发布第 6 版 AUT-G0080 指南，说明在爱尔兰取得 QP 资格的教育、经验与培训要求及 HPRA 审批方式。文件列出四条教育路径，实践经验通常至少两年，完成五年或六年单一课程时可分别缩减一年或一年半。附录 1 列出三所提供相关课程的爱尔兰院校，文件内日期为 2026 年 8 月 14 日。
文件列出爱尔兰 QP 资格的四条教育路径、实践经验与培训要求，并附 HPRA 认可课程清单，便于核对申请所需材料。
HPRA 人用药品质／GMP／GDP 指南：Guide to attainment of Qualified Person status in Ireland
文件编号：AUT-G0080；版本：6。
官方目录列示日期：2026-08-18（原文 18/08/2026，DD/MM/YYYY）；文件内日期另行保留。
适用范围及爱尔兰监管要求以原文件为准。
PDF 文字版；图形和原始排版请参阅官方 PDF。
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Guide to
Attainment of Qualified Person Status in Ireland:
Educational Requirements, Training and Licensing
1 INTRODUCTION
This document is intended to provide guidance to individuals considering pursuing a career in
the pharmaceutical industry as a Qualified Person (QP). It identifies the educational
requirements to become a QP and the way the Health Products Regulatory Authority (HPRA)
approves QP candidates. It also provides candidates with suggestions for additional reading
material which should be considered before embarking on further education.
2 DEFINITION
A Qualified Person or ‘QP’, is defined within Irish law applicable to human medicinal products as
‘a person with the qualifications and experience specified in Schedule 5 and named in the
manufacturer’s authorisation as being responsible at the manufacturer’s premises for the
functions set out in Regulation 13(3) of Medicinal Products (Control of Manufacture)
Regulations 2007 (S.I. No. 539 of 2007), as amended’. A similar definition is provided in Article
97 of the Regulation (EU)2019/6 on Veterinary Medicinal products. The qualifications,
experience and licensing requirements pertaining to QPs in Ireland are described further in this
document.
3 LEGAL BASIS
The legal requirements for QPs are described in the EU Regulations 536/2014 and 2019/6, and
the EU Directive 2001/83/EC. These Regulations and the Directive apply to the manufacturers of
investigational, veterinary and human medicinal products respectively. The Directive has been
transposed into Irish national law.
4 LEGAL RESPONSIBILITY
The primary legal responsibility of the QP is to certify batches of medicinal products prior to use
in a clinical trial, export or prior to release for sale and placing on the market. It is a legal
requirement for a manufacturer of medicinal products to have at least one QP available.
5 EDUCATIONAL REQUIREMENTS
There are four routes by which a person can qualify to become a QP in Ireland:
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HPRA Guide to Attainment of Qualified Person Status in Ireland: Educational Requirements, Training and Licensing
5.1 Route 1
A candidate has completed a recognised pharmacy degree course at a third level institution in
Ireland. If the pharmacy course has been completed outside of Ireland, then applicants should
provide one of the following documents:
- Evidence of Pharmaceutical Society of Ireland (PSI) registration.
- A letter from the EU/EEA competent authority where the pharmacy degree was pursued
which states that the candidate’s degree meets the educational requirements of Article 49 of
EU Directive 2001/83/EC and Article 97 of the EU Regulation 2019/6.
5.2 Route 2
A candidate has attained an academic qualification at least equivalent to a level 8 primary
course in a scientific discipline and has successfully completed a recognised post-graduate
course in Ireland that satisfies the educational requirements as defined in the EU Regulation
2019/6 and the EU Directive 2001/83/EC.
5.3 Route 3
At the time of application of the relevant EU Directives in Ireland or in another Member State,
the candidate was undertaking the activities of a QP. These were referred to as the ‘transitional
arrangements’ or ‘Grandfather Clauses’.
Applicants should provide evidence that the proposed person had acted as a QP, under a
relevant MIA in Ireland authorised for the type of medicinal product which is the subject of the
application (i.e. human, veterinary, IMP and/or traditional herbal medicinal products).
Refer to Article 50 of Directive 2001/83/EC for more details.
5.4 Route 4
A candidate that has completed a postgraduate QP eligibility course in another EU/EEA Member
State that satisfies the educational requirements. The candidate must also have fulfilled any
other requirement set out under the framework in the relevant Member State.
6 EXPERIENCE REQUIREMENTS
A candidate should have acquired practical experience, in one or more undertakings which are
authorised to manufacture medicinal products, in the activities of quality assurance of medicinal
products, of qualitative analysis of medicinal products, of quantitative analysis of active
substances and of testing and checking to ensure the quality of medicinal products. The
duration of practical experience is usually at least two years, but it may be reduced by one year
if the primary course of study lasts for at least five years and by a year and a half where the
course lasts for at least six years. Relevant work experience that counts towards the two years
criteria must have been obtained at sites which hold a MIA within the EEA.
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HPRA Guide to Attainment of Qualified Person Status in Ireland: Educational Requirements, Training and Licensing
Notes:
- Experience gained at a site that holds an active substance registration (ASR) but does not
hold an MIA does not count towards relevant work experience.
- Only experience gained at a site that holds an MIA in the United Kingdom (UK) up until 31
January 2020 (day the UK left the EU) counts as relevant work experience, with the exception
of Northern Ireland, where experience gained post 31 January 2020 still counts.
- Experience gained at a site prior to the issue of the site’s MIA does not count towards
relevant work experience.
- The reduction in the requirement for practical experience due to a university course being
five or six years in duration only applies when a single course was completed to meet the
educational requirements as defined in the EU Regulation 2019/6 and the EU Directive
2001/83/EC. Where more than one course is completed to meet the educational
requirements, combining the duration of multiple courses cannot be utilised to reduce the
number of years of practical experience required to less than 24 months.
7 TRAINING REQUIREMENTS
A candidate should have completed training in all key elements of the company’s quality
management system to enable them to effectively carry out the routine duties of a QP. This
should include a documented justification that the QP candidate has gained the necessary
knowledge and experience in relation to the types of products which they will be expected to
perform disposition.
8 QUESTIONS AND ANSWERS
8.1 My primary qualification fulfils the educational requirements outlined in section 5
(Route 2) above. What additional course do I need to study and complete before I
can become a QP candidate?
There are several educational institutes in Ireland that offer a course that will fulfil the
educational requirements as outlined above. These institutes and course are listed in Appendix 1
of this guidance document. The HPRA has evaluated each course and is satisfied that their
curricula cover the required subjects in line with the Directive’s requirements.
8.2 Where can I obtain further information on courses?
If you do not hold a pharmacy degree but have a scientific qualification which may be
acceptable to gain entry to one of the courses referenced in Appendix 1, contact a third level
institute of your choice to discuss your interest in studying the appropriate course. It is
important that candidates interested in pursuing courses leading to eligibility to act as a QP
verify in advance of registration that the course they are applying for meets the legal
educational requirements, as there are a number of courses with similar titles and not all are
accepted for this purpose.
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HPRA Guide to Attainment of Qualified Person Status in Ireland: Educational Requirements, Training and Licensing
8.3 What type of level 8 degree is considered suitable as a primary degree?
Any medical, health or relevant science-based level 8 degree. If the science-based degree has
been completed outside of Ireland, evidence that the course is recognised as meeting a level 8
degree should be provided.
8.4 Can I call myself a QP when I successfully complete my exams?
If you can demonstrate that you meet the requirements outlined in section 5 in this guidance
document, you are eligible to become a QP candidate on a HPRA MIA. As part of the
assessment of the application your experience and training are reviewed to determine if you can
act in the capacity of a QP. If approved, your name and qualifications are included on the MIA.
8.5 How do I become named as a QP on the MIA held by a finished product
manufacturer in Ireland?
Your employer should submit an application for variation to its MIA to request that you be
added as a QP.
8.6 I have satisfactorily completed studies in another country within the EEA and the
local competent authority for the regulation of medicinal products in that country
recognises the course as fulfilling the education requirements, as described above,
to enable me to become an eligible QP candidate. Do I have to complete another
university course in Ireland?
No. As the course you studied satisfies the EU Directive requirements for the EEA, the course is
recognised in Ireland as being equivalent to courses which are offered in Ireland. You may be
asked to provide documentary evidence from the competent authority in the Member State
where the studies were undertaken, indicating that it recognises the course as fulfilling the
educational requirements as defined in EU Directive 2001/83/EC and Regulation 2019/6, along
with evidence indicating that any other requirement for recognition or eligibility as QP under
the relevant framework in the Member State has also been fulfilled.
8.7 What level of training is required at the MIA holder site before my employer can
submit a variation to include me as a QP on the MIA?
Prior to undertaking any QP batch certification activity, you should be appropriately trained on
the pharmaceutical quality system, have knowledge of the type of products to be certified and
be familiar with the manufacturing operations performed at the MIA site where you are being
nominated as a QP. Previous experience at an MIA holder site for similar dosage forms may be
considered.
The following records should be submitted to support the application:
- A summary of training, relevant to the role of QP, performed at the manufacturing site
concerned. This should be in the form of a training programme for the role of QP at the site
rather than simply a printout of training in various standard operating procedures (SOPs), for
example as might be obtained from a learning management system. This should be signed
by the proposed QP and, if applicable, their relevant superior.
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- Details of product specific training should also be included in cases when the proposed QP
does not have previous experience of the product types to be certified.
- Where all relevant training has not been completed at the time of application, then a
statement should be included in the training summary or in the application submission
stating that the required minimum training will be completed prior to commencement of
batch certification activity by the proposed QP.
Further information is available on the HPRA website at www.hpra.ie.
HPRA
14 August 2026
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HPRA Guide to Attainment of Qualified Person Status in Ireland: Educational Requirements, Training and Licensing
APPENDIX 1 IRISH EDUCATIONAL INSTITUTIONS CURRENTLY OFFERING COURSES FOR WHICH
THE TAUGHT MODULES SATISFY THE EDUCATIONAL REQUIREMENTS FOR QPS
Institute Course title
Trinity College Dublin Pharmaceutical Manufacturing Technology
(MSc/P.Grad.Dip)
Atlantic Technological University MSc in Industrial Pharmaceutical Science
Sligo
University College Cork MSc in Pharmaceutical Technology and Quality
Systems
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来源：HPRA 人用药品质与 GMP 指南 · assets.hpra.ie