APPENDIX “A”

RELEVANT LEGISLATION

Directive 2005/36/EC of the European Parliament and of the Council on the
recognition of professional qualifications – Article 44 and Annex V.6. – section 5.6.1
(see extracts below)

Article 44 – Training as a pharmacist:

1. Admission to a course of training as a pharmacist shall be contingent upon possession
   of a diploma or certificate giving access, in a Member State, to the studies in question, at
   universities or higher institutes of a level recognized as equivalent.
2. Evidence of formal qualifications as a pharmacist shall attest to training of at least
   five years’ duration, including at least:
   

(a) four years of full-time theoretical and practical training at a university or at a higher institute of a level recognized as equivalent, or under the supervision of a university;

(b) six-month traineeship in a pharmacy which is open to the public or in a
hospital, under the supervision of that hospital’s pharmaceutical department.

That training cycle shall include at least the program described in Annex V, point
5.6.1. The contents listed in Annex V, point 5.6.1 may be amended in accordance with
the procedure referred to in Article 58(2) with a view to adapting them to scientific and
technical progress.

Such updates must not entail, for any Member State, any amendment of existing
legislative principles relating to the structure of professions as regards training and the
conditions of access by natural persons.

3. Training for pharmacists shall provide an assurance that the person concerned has
   acquired the following knowledge and skills:
   

(a) adequate knowledge of medicines and the substances used in the manufacture
of medicines;

(b) adequate knowledge of pharmaceutical technology and the physical, chemical,
biological and microbiological testing of medicinal products;

(c) adequate knowledge of the metabolism and the effects of medicinal products
and of the action of toxic substances, and of the use of medicinal products;

(d) adequate knowledge to evaluate scientific data concerning medicines to
be able to supply appropriate information based on this knowledge;

(e) adequate knowledge of the legal and other requirements associated with the
pursuit of pharmacy.

Annex V.6 – Section 5.6.1 Course of training for pharmacists:

— Plant and animal biology

— Physics

— General and inorganic chemistry

— Organic chemistry

— Analytical chemistry

— Pharmaceutical chemistry, including analysis of medicinal products

— General and applied biochemistry (medical)

— Anatomy and physiology; medical terminology

— Microbiology

— Pharmacology and pharmacotherapy

— Pharmaceutical technology

— Toxicology

— Pharmacognosy

— Legislation and, where appropriate, professional ethics.

The balance between theoretical and practical training shall, in respect of each
subject, give sufficient importance to theory to maintain the university character
of the training.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November
2001 on the Community Code relating to Medicinal Products for Human Use – Article
49 (see extract below):

Article 49:

1. Member States shall ensure that the qualified person referred to in Article 48
   fulfils the conditions of qualification set out in paragraphs 2 and 3.
   
2. A qualified person shall be in possession of a diploma, certificate or other
   evidence of formal qualifications awarded on completion of a university course of study,
   or a course recognized as equivalent by the Member State concerned, extending over a
   period of at least four years of theoretical and practical study in one of the following
   scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry,
   pharmaceutical chemistry and technology, biology.

However, the minimum duration of the university course may be three and a half years
where the course is followed by a period of theoretical and practical training of a
minimum duration of one year and including a training period of at least six months in a
pharmacy open to the public, corroborated by an examination at university level.

Where two university courses or two courses recognized by the State as equivalent co-
exist in a Member State and where one of these extends over four years and the other
over three years, the three-year course leading to a diploma, certificate or other
evidence of formal qualifications awarded on completion of a university course or its
recognized equivalent shall be considered to fulfil the condition of duration referred to in
the second subparagraph in so far as the diplomas, certificates or other evidence of
formal qualifications awarded on completion of both courses are recognized as
equivalent by the State in question.

The course shall include theoretical and practical study bearing upon at least the
following basic subjects:

– Experimental physics

– General and inorganic chemistry

– Organic chemistry

– Analytical chemistry

– Pharmaceutical chemistry, including analysis of medicinal products

– General and applied biochemistry (medical)

– Physiology

– Microbiology

– Pharmacology

– Pharmaceutical technology

– Toxicology

– Pharmacognosy (study of the composition and effects of the natural active
substances of plant and animal origin).

Studies in these subjects should be so balanced as to enable the person concerned to
fulfil the obligations specified in Article 51.

In so far as certain diplomas, certificates, or other evidence of formal qualifications
mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph,
the competent authority of the Member State shall ensure that the person concerned
provides evidence of adequate knowledge of the subjects involved.

3. The qualified person shall have acquired practical experience over at least two
   years, in one or more undertakings which are authorized to manufacture medicinal
   products, in the activities of qualitative analysis of medicinal products, of quantitative
   analysis of active substances and of the testing and checking necessary to ensure the
   quality of medicinal products.
   

The duration of practical experience may be reduced by one year where a university
course lasts for at least five years and by a year and a half where the course lasts for at
least six years.

Pharmacy Act 2007, Section 7 (1) (b) and (c) and 7 (2) (a)(iv), as follows:

Section 7

(1) The principal functions of the Society shall be—

(b) to promote and ensure a high standard of education and training for persons seeking to become pharmacists,

(c) to ensure that those persons and pharmacists obtain appropriate experience,

(2) Without prejudice to the generality of subsection (1), but subject to the other provisions of this Act—

(a) it is the duty of the Society to—

(iv) determine, approve, and keep under review programs of education and training suitable to enable persons applying for registration to meet those criteria and pharmacists to comply with those codes,

Pharmaceutical Society of Ireland (Education and Training) Rules 2008 (S.I. No. 493 of
2008), Part 3, Rule 7(1) and (2) and Schedule (extract of Schedule reproduced below):

SCHEDULE

CERTAIN MINIMUM DESIGNATED LEARNING AND COMPETENCIES TO BE ACQUIRED IN A PROGRAMME LEADING TO OBTAINING QUALIFICATION AS A PHARMACIST

1. 
   The period of time to be devoted by a person in acquiring the designated
   learning and competencies as required of a pharmacist shall consist of a program of
   education and training of at least five years duration including at least—

(a) four years of fulltime theoretical and practical training at a recognized
institution, and

(b) twelve months of in-service practical training in accordance with Part 4 of
these Rules.

2. (1) The aforementioned program of education and training in the course of
   training for pharmacists shall at least cover the following subjects—
   

(a) Plant and animal biology,

(b) Physics,

(c) General and inorganic chemistry,

(d) Organic chemistry,

(e) Analytical chemistry,

(f) Pharmaceutical chemistry including analysis of medicinal products,

(g) General and applied biochemistry (medical),

(h) Anatomy and Physiology,

(i) Medical terminology,

(j) Microbiology,

(k) Pharmacology,

(l) Pharmacotherapy,

(m) Pharmaceutical technology,

(n) Toxicology,

(o) Pharmacognosy,

(p) Legislation and the law generally pertaining to pharmacy and medicinal
products and to the practice of pharmacy in the State, and

(q) Professional conduct and ethics for a person practicing as a pharmacist in the
State.

(2) The balance between theoretical and practical training shall, in respect of
each subject, give sufficient importance to theory to maintain the university character of the training.

(3) The said program of education and training shall be such that on
successful completion it will provide an assurance that the person concerned has
acquired the following knowledge and skills—

(a) adequate knowledge of medicinal products and the substances used in their
manufacture,

(b) adequate knowledge of pharmaceutical technology and the physical,
chemical, biological, and microbiological testing of medicinal products,

(c) adequate knowledge of the metabolism and the effects of medicinal products
and of the action of toxic substances and of the use of medicinal products,

(d) adequate knowledge to evaluate scientific data concerning medicinal
products to be able to supply appropriate information based on
this knowledge,

(e) adequate knowledge of the legal and other requirements associated with the
pursuit of pharmacy, and such knowledge and skills shall be such as to enable that person to competently practice as a pharmacist and thereby be entitled to gain access to and to at least pursue the professional activities of a pharmacist as set out in Article 45(2) of the Professional Qualifications Directive.

(4) The said program of education and training shall, where appropriate, also
have regard to—

(a) the report on recommendations on pharmaceutical education undergone at
higher education institutions as adopted by the Advisory Committee on
Pharmaceutical Training of the 3rd and 4th of May 1994 (Report
15/E/84341/6/93), and

(b) the minimum conditions of qualification specified in paragraph (2) of Article
49 of Directive 2001/83/EC.

European Commission. Advisory Committee on Pharmaceutical Training (1995) Report
and Recommendations on pharmaceutical education undergone at higher education
institutions (adopted by the Committee at its meeting on 3 and 4 May 1994) (Ref.
XV/E/8341/6/93-EN) – see section 4 – ‘Recommendations on the organization and
structure of training at higher education institutions’ (see extract below):

Firstly, the Advisory Committee on Pharmaceutical Training points out that
The length of pharmaceutical training and the minimum range of subjects in
which theoretical and practical training must be undergone are laid down in
Directive 85/432/EEC, which also explicitly states that the balance between

theoretical and practical training must, in respect of each subject, give sufficient
importance to theory to maintain the university character of the training.
Future developments in pharmacy and medicine will lead to constant revisions of
syllabus as has been seen with the introduction of new subjects such as
molecular biology and biotechnology in recent years. This is essential if
pharmacists are to be equipped properly by their course of education and
training for practice in various fields.

The Committee makes the recommendations set out below without, however, excluding
individual national provisions which are not contrary to the principles in the Directive.

A thorough grounding in the basic sciences of chemistry, physics, and biology
plus mathematics should be accepted as a prerequisite for admission to studies
of the pharmaceutical sciences.

In view of the minimum period of four years’ training at a higher education
institution laid down in Article 2(3) of Directive 85/432/EEC, the number of hours
of such training should total at least 3000 directed and supervised by the
academic staff of the higher educational institution concerned.

At least half the higher education course identical for every student should
consist of theoretical instruction, and at least 35% of that course should take the
form of practical training.

During the training period, pharmacy students must be provided with a sound
and balanced grounding in the physical, chemical, and biological sciences that
represent the basis for their main training in:

biological systems, the chemistry of drugs and other constituents of
medicines, and the interaction between medicines and biological
systems.

medicines design and manufacture.

the actions and uses of drugs, medicines, and other products.

an introduction to the practice of pharmacy in hospital, industrial,
academic and community pharmacy settings, including an introduction
to the relevant aspects of the social and behavioral sciences.

At least one third of the whole course should be occupied by the components
which collectively deal with the actions, uses and manufacture of drugs and
medicines, and a broad balance should be maintained between the other sectors
of the course.

Intermediate examinations should be held during the course.

In addition to the core course, which all students must take, individual students
should be able to select one or more optional pharmaceutical subjects from a list
provided by the academic institution, to reflect their special interests.

Each student should carry out a personally directed research project covering
about three to six months under the supervision of the academic staff and
present a paper or dissertation on the project.