L.S. 451.04 Regolamenti dwar il-Kondizzjonijiet Minimi ta’ Taħriġ dwar il-Professjonijiet tas-Saħħa

(1)These regulations transpose Articles 24, 25, 28, 31, 34, 35, 40 and 44 regarding basic and specialist medical and dental training and the training of nurses responsible for general care, midwives and pharmacists and also Annex V 5.2.1, 5.3.1, 5.5.1 and 5.6.1 of Directive 2005/36/EC of the 7th September 2005 on the Recognition of Professional Qualifications. Scope. Amended by: L.N. 270 of 2016; L.N. 175 of 2024.

(2)In these regulations, unless the context otherwise requires: "ECTS credits" means the credit system for higher education used in the European Higher Education Area. 3.

(1)Admission to training for nurses responsible for general care shall be contingent upon either: (

1. a)completion of general education of twelve years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies or a certificate attesting success in an examination of an equivalent level and giving access to universities or to higher education institutions of a level recognised as equivalent; or Admission to training of nurses. Amended by: L.N. 270 of 2016. (
2. b)completion of general education of at least ten years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies or a certificate attesting success in an examination of an equivalent level and giving access to a vocational school or vocational training programme for nursing. Training of nurses responsible for general care shall be given on a full-time basis and shall include at least the programme described in the Schedule, Part 1.

(2)The training of nurses responsible for general care shall comprise a total of at least three years of study, which may in addition be expressed with the equivalent ECTS credits, and shall consist of at least 4 600 hours of theoretical and clinical training, the duration of the theoretical training representing at least one third and the duration of the clinical training at least one half of the minimum duration of the training. Partial exemptions may be granted to professionals who have received part of their training on courses which are of at least an equivalent level.

(3)It shall be ensured that institutions providing nursing Duration of training. 2 [ S.L.451.04 MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) training are responsible for the coordination of theoretical and clinical training throughout the entire study programme. Theoretical training of nurses.

(4)Theoretical education is that part of nurse training from which trainee nurses acquire the professional knowledge, skills and competences required under sub-regulations

(6)and

(7). The training shall be given by teachers of nursing care and by other competent persons, at universities, higher education institutions of a level recognised as equivalent or at vocational schools or through vocational training programmes for nursing. Clinical training of nurses.

(5)Clinical training is that part of nurse training in which trainee nurses learn, as part of a team and in direct contact with a healthy or sick individual and, or community, to organize, dispense and evaluate the required comprehensive nursing care, on the basis of the knowledge, skills and com pet ences w hich they have acquired. The trainee nurse shall learn not only how to work in a team, but also how to lead a team and organize overall nursing care, including health education for individuals and small groups, within the health institute or in the community. This training shall take place in hospitals and other health institutions and in the community, under the responsibility of nursing teachers, in cooperation with and assisted by other qualified nurses. Other qualified personnel may also take part in the teaching process. Trainee nurses shall participate in the activities of the department in question insofar as those activities are appropriate to their training, enabling them to learn to assume the responsibilities involved in nursing care. Knowledge and skills in training for nurses.

(6)Training for nurses responsible for general care shall provide an assurance that the professional in question has acquired the following knowledge and skills: (

1. a)comprehensive knowledge of the sciences on which general nursing is based, including sufficient understanding of the structure, physiological functions and behaviour of healthy and sick persons, and of the relationship between the state of health and the physical and social environment of the human being; (
2. b)knowledge of the nature and ethics of the profession and of the general principles of health and nursing; (
3. c)adequate clinical experience; such experience, which should be selected for its training value, should be gained under the supervision of qualified nursing staff and in places where the number of qualified staff and equipment are appropriate for the nursing care of the patient; (
4. d)the ability to participate in the practical training of health personnel and experience of working with such personnel; and (
5. e)experience of working together with members of other professions in the health sector.

(7)Formal qualifications as a nurse responsible for general care shall provide evidence that the professional in question is able to apply at least the following competences regardless of whether MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 3 the training took place at universities, higher education institutions of a level recognised as equivalent or at vocational schools or through vocational training programmes for nursing: (a) competence to independently diagnose the nursing care required using current theoretical and clinical knowledge and to plan, organise and implement nursing care when treating patients on the basis of the knowledge and skills acquired in accordance with subregulation

(6)(a), (

1. b)and (
2. c)in order to improve professional practice; (
3. b)competence to work together effectively with other actors in the health sector, including participation in the practical training of health personnel on the basis of the knowledge and skills acquired in accordance with sub-regulation

(6)(

1. d)and (e); (
2. c)competence to empower individuals, families and groups towards healthy lifestyles and self-care on the basis of the knowledge and skills acquired in accordance with sub-regulation

(6)(

1. a)and (b); (
2. d)competence to independently initiate life preserving immediate measures and to carry out measures in crises and disaster situations; (
3. e)competence to independently give advice to, instruct and support persons needing care and their attachment figures; (
4. f)competence to independently assure the quality of, and to evaluate, nursing care; (
5. g)competence to comprehensively communicate professionally and to cooperate with members of other professions in the health sector; (
6. h)competence to analyse the care quality to improve his own professional practice as a nurse responsible for general care. 4.

(1)Admission to basic dental training presupposes possession of a diploma or certificate giving access, for the studies in question, to universities or higher institutes of a level recognized as equivalent, in a Member State. Admission to dental basic training. Amended by: L.N. 270 of 2016.

(2)Basic dental training shall comprise a total of at least five years of study, which may in addition be expressed with the equivalent ECTS credits, and shall consist of at least 5,000 hours of full-time theoretical and practical training that comprises at least the programme described in Part 2 of the Schedule and that is provided in a university, in a higher institute providing training recognised as being of an equivalent level or under the supervision of a university. Duration of training.

(3)Basic dental training shall provide an assurance that the person in question has acquired the following knowledge and skills: Knowledge and skills in basic dental training. (

1. a)adequate knowledge of the sciences on which dentistry 4 MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 is based and a good understanding of scientific methods, including the principles of measuring biological functions, the evaluation of scientifically established facts and the analysis of data; (
2. b)adequate knowledge of the constitution, physiology and behaviour of healthy and sick persons as well as the influence of the natural and social environment on the state of health of the human being, insofar as these factors affect dentistry; (
3. c)adequate knowledge of the structure and function of the teeth, mouth, jaws and associated tissues, both healthy and diseased, and their relationship to the general state of health and to the physical and social well-being of the patient; (
4. d)adequate knowledge of clinical disciplines and methods, providing the dentist with a coherent picture of anomalies, lesions and diseases of the teeth, mouth, jaws and associated tissues and of preventive, diagnostic and therapeutic dentistry; (
5. e)suitable clinical supervision. experience under appropriate

(4)This training shall provide the person in question with the skills necessary for carrying out all activities involving the prevention, diagnosis and treatment of anomalies and diseases of the teeth, mouth, jaws and associated tissues. Admission to specialist dental training. Amended by: L.N. 270 of 2016. S.L. 451.03 Cap. 464 5.

(1)Admission to specialist dental training shall be contingent upon completion and validation of basic dental training referred to in regulation 4, or possession of the documents referred to in regulation 23 of the Recognition of Professional Qualifications Regulations and in the Health Care Professions Act. Minimum duration of training.

(2)Specialist dental training shall comprise theoretical and practical instruction in a university centre, in a treatment teaching and research centre or, where appropriate, in a health establishment approved for that purpose by the competent authorities or bodies. Full-time specialist dental courses shall be of a minimum of three years’ duration supervised by the competent authorities or bodies. They shall invo lve th e personal p articip at ion o f th e dental practitioner training to be a specialist in the activity and in the responsibilities of the establishment concerned. Contingent upon possession of basic dental training.

(3)The competent authorities shall make the issuance of evidence of specialist dental training contingent upon possession of evidence of basic d ental training referred to in the Second Schedule, PART II a, of the Health Care Professions Act. Cap. 464. The training of midwives. Amended by: L.N. 270 of 2016. 6.

(1)least: The training of midwives shall comprise a total of at (

1. a)specific full-time training as a midwife comprising at least three years of theoretical and practical study (Route I) comprising at least the programme described MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 5 in the Schedule Part 3, or (
2. b)specific full-time training as a midwife of eighteen months’ duration (Route II), comprising at least the study programme described in the Schedule Part 3, which was not the subject of equivalent training of nurses responsible for general care.

(2)It shall be ensured that institutions providing midwife training are responsible for coordinating theory and practice throughout the programme of study. Coordination of theory and practice.

(3)Admission to training as a midwife shall be contingent upon one of the following conditions: Admission to training for a midwife. (

1. a)completion of at least twelve years of general school education or possession of a certificate attesting success in an examination, of an equivalent level, for admission to a midwifery school for Route I; or (
2. b)possession of evidence of formal qualifications as a nurse responsible for general care referred to in Part V of the Second Schedule to the Health Care Professions Act for Route II.

(4)Training as a midwife shall provide an assurance that the professional in question has acquired the following knowledge and skills: Cap. 464. Knowledge and skills in training for a midwife. (

1. a)detailed knowledge of the sciences on which the activities of midwives are based, particularly midwifery, obstetrics and gynaecology; (
2. b)adequate knowledge of the ethics of the profession and the legislation relevant for the practice of the profession; (
3. c)adequate knowledge of general medical knowledge (biological functions, anatomy and physiology) and of pharmacology in the field of obstetrics and of the newly born, and also knowledge of the relationship between the state of health and the physical and social environment of the human being, and of his behaviour; (
4. d)adequate clinical experience gained in approved institutions allowing the midwife to be able, independently and under his own responsibility, to the extent necessary and excluding pathological situations, to manage the antenatal care, to conduct the delivery and its consequences in approved institutions, and to supervise labour and birth, postnatal care and neonatal resuscitation while awaiting a medical practitioner; (
5. e)adequate understanding of the training of health personnel and experience of working with such personnel. 7.

(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 recognised as equivalent. Admission to training as a pharmacist. Amended by: L.N. 270 of 2016. 6 [ S.L.451.04 Duration of training. MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS)

(2)Evidence of formal qualifications as a pharmacist shall attest to training of at least five years’ duration, which may in addition be expressed with the equivalent ECTS credits, comprising at least: (

1. a)four years of full-time theoretical and practical training at a university or at a higher institute of a level recognised as equivalent, or under the supervision of a university; (
2. b)during or at the end of the theoretical and practical training, 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.

(3)That training cycle shall include at least the programme described in the Schedule, Part 4. Knowledge and skills in training for pharmacists.

(4)Training for pharmacists shall provide an assurance that the person concerned has acquired the following knowledge and skills: (

1. a)adequate knowledge of medicines and the substances used in the manufacture of medicines; (
2. b)adequate knowledge of pharmaceutical technology and the physical, chemical, biological and microbiological testing of medicinal products; (
3. 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; (
4. d)adequate knowledge to evaluate scientific data concerning medicines in order to be able to supply appropriate information on the basis of this knowledge; (
5. e)adequate knowledge of the legal and other requirements associated with the pursuit of pharmacy. Admission to basic medical training. Added by: L.N. 270 of 2016. 8.

(1)Admission to basic medical training shall be contingent upon possession of a diploma or certificate providing access, for the studies in question, to universities.

(2)Basic medical training shall comprise a total of at least five years of study, which may in addition be expressed with the equivalent ECTS credits, and shall consist of at least 5 500 hours of theoretical and practical training provided by, or under the supervision of, a university. For professionals who began their studies before 1 January 1972, the course of training referred to in sub-regulation

(1)may comprise six months of full-time practical training at university level under the supervision of the competent authorities.

(3)Basic medical training shall provide an assurance that the person in question has acquired the following knowledge and skills: (

1. a)adequate knowledge of the sciences on which medicine is based and a good understanding of the scientific methods including the principles of MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 7 measuring biological functions, the evaluation of scientifically established facts and the analysis of data; (
2. b)sufficient understanding of the structure, functions and behaviour of healthy and sick persons, as well as relations between the state of health and physical and social surroundings of the human being; (
3. c)adequate knowledge of clinical disciplines and practices, providing him with a coherent picture of mental and physical diseases, of medicine from the points of view of prophylaxis, diagnosis and therapy and of human reproduction; (
4. d)suitable clinical experience appropriate supervision. in hospitals under 9.

(1)Admission to specialist medical training shall be contingent upon completion and validation of a basic medical training programme as referred to in regulation 8

(2)in the course of which the trainee has acquired the relevant knowledge of basic medicine.

(2)Specialist medical training shall comprise theoretical and practical training at a university or medical teaching hospital or, where appropriate, a medical care establishment approved for that purpose by the competent authorities or bodies. The minimum duration of specialist medical training courses referred to in Part Ic of Schedule 2 to the Health Care Professions Act shall be as stated in that Part. Training shall be given under the supervision of the competent authorities or bodies. It shall include personal participation of the trainee specialised doctor in the activity and responsibilities entailed by the services in question. Admission to specialist medical training. Added by: L.N. 270 of 2016. Cap. 464.

(3)Training shall be given on a full-time basis at specific recognised establishments. It shall entail participation in the full range of medical activities of the department where the training is given, including duty on call, in such a way that the trainee specialist devotes all his professional activity to his practical and theoretical training throughout the entire working week and throughout the year, in accordance with the procedures laid down by the competent authorities. These posts shall be the subject of appropriate remuneration.

(4)In the event that national legislation provides for partial exemptions from parts of the specialist medical training courses listed in Part 1c of the Second Schedule to the Health Care Professions Act, then such exemptions shall: (

1. a)be applied on a case-by-case basis provided that that part of the training has been followed already during another specialist training course listed in Part 1c of the Second Schedule, for which the professional has already obtained the professional qualification in a Member State; and (
2. b)shall equate to not more than half of the minimum duration of the specialist medical training course in question. Cap. 464. 8 [ S.L.451.04 MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) Any national legislation related to such partial exemptions shall be notified to the European Commission and other Member States by the relevant designated authority. Cap. 464. Specific training in general medical practice. Added by: L.N. 175 of 2024.

(5)The issuance of evidence of specialist medical training shall be contingent upon possession of evidence of basic medical training referred to in Part 1a of Schedule 2 to the Health Care Professions Act. 10.

(1)Admission to specific training in general medical practice shall be contingent on the completion and validation of six

(6)years of study as part of a training programme referred to in regulation 8: Provided that where the training programme referred to in regulation 8 comprises of practical training given by an approved hospital possessing appropriate general medical equipment and services or as part of an approved general medical practice or an approved centre in which doctors provide primary medical care, the duration of that practical training may, up to a maximum of one

(1)year, be included in the duration provided in this sub-regulation, for certificates of training issued on or after 1st January 2006.

(2)The specific training in general medical practice leading to the award of evidence of formal qualifications issued before 1st January 2006 shall be of a duration of at least two

(2)years on a fulltime basis. In the case of evidence of formal qualifications issued after that date, the training shall be of a duration of at least three

(3)years on a full-time basis: Provided that the option provided in this sub-regulation shall be available only for Member States in which the specific training in general medical practice lasted two

(2)years as of 1st January 2001.

(3)The specific training in general medical practice shall be carried out on a full-time basis under the supervision of the competent authorities or bodies. The said training shall be more practical than theoretical: Provided that the practical training shall: (a) be given, on the one hand, for at least six

(6)months in an approved hospital having appropriate equipment and services and, on the other hand, for at least six

(6)months as part of an approved general medical practice or an approved centre at which doctors provide primary medical care; (b) take place in conjunction with other health establishments or structures concerned with general medicine. Without prejudice to the minimum periods laid down in subregulation

(2), however, the practical training may be given MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 during a period of not more than six

(6)months in other approved establishments or health structures concerned with general medicine; and (c) require the personal participation of the trainee in the professional activity and responsibilities of the persons with whom he is working.

(4)The issuance of evidence of formal qualifications in general medical practice shall be subject to possession of evidence of formal qualifications in basic medical training referred to in point 5.1.1 of the Second Schedule to the Health Care Professions Act, point 5.1.1.

(5)Evidence of formal qualifications referred to in point 5.1.4 of the Second Schedule to the Health Care Professions Act may be issued to a doctor who has not completed the training provided in this regulation but who has completed a different supplementary training, as attested by evidence of formal qualifications issued by the competent authorities in a Member State. They may not however, award evidence of formal qualifications unless it attests knowledge of a level qualitatively equivalent to the knowledge acquired from the training provided in this regulation: Cap.

1. Cap.
2. Provided that Member States shall determine, inter alia, the extent to which the complementary training and professional experience already acquired by the applicant may replace the training provided in this regulation: Provided further that the Member States may only issue the evidence of formal qualifications referred to in point 5.1.4 of the Second Schedule to the Health Care Professions Act if the applicant has acquired at least six

(6)months' experience of general medicine in a general medical practice or a centre in which doctors provide primary medical care of the types referred to in sub-regulation

(3). Cap. 464. 9 MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 10 SCHEDULE Part 1 Training programme for nurses responsible for general care The training leading to the award of a formal qualification of nurses responsible for general care shall consist of the following two parts. A. Theoretical instruction a. Nursing: Nature and ethics of the profession - General principles of health and nursing - Nursing principles in relation to: - general and specialist medicine - general and specialist surgery - child care and paediatrics - maternity care - mental health and psychiatry - care of the old and geriatrics b. - - Basic sciences: Anatomy and physiology Pathology Bacteriology, virology and parasitology Biophysics, biochemistry and radiology Dietetics Hygiene: - preventive medicine - health education Pharmacology c. - Social sciences: Sociology Psychology Principles of administration Principles of teaching Social and health legislation Legal aspects of nursing B. Clinical instruction - Nursing in relation to - general and specialist medicine - general and specialist surgery - child care and paediatrics - maternity care - mental health and psychiatry - care of the old and geriatrics - home nursing One or more of these subjects may be taught in the context of the other disciplines or in conjunction therewith. The theoretical instruction must be weighted and coordinated with the clinical instruction in such a way that the knowledge and skills referred to in this Schedule can be acquired in an adequate fashion. Part 2 Study programme for dental practitioners The programme of studies leading to evidence of formal qualifications in dentistry shall include at least the following subjects. MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 11 One or more of these subjects may be taught in the context of the other disciplines or in conjunction therewith. A. Basic subjects - Chemistry Physics Biology B. Medico-biological subjects and general medical subjects - Anatomy - Embryology - Histology, including cytology - Physiology - Biochemistry (or physiological chemistry) - Pathological anatomy - General pathology - Pharmacology - Microbiology - Hygiene - Preventive medicine and epidemiology - Radiology - Physiotherapy - General surgery - General medicine, including paediatrics - Oto-rhino-laryngology - Dermato-venereology - General psychology - psychopathology - neuropathology - Anaesthetics c. Subjects directly related to dentistry - Prosthodontics Dental materials and equipment Conservative dentistry Preventive dentistry Anaesthetics and sedation Special surgery Special pathology Clinical practice Paedodontics Orthodontics Periodontics Dental radiology Dental occlusion and function of the jaw Professional organization, ethics and legislation Social aspects of dental practice Part 3 Training programme for midwives (Training types I and II) The training programme for obtaining evidence of formal qualifications in midwifery consists of the following two parts: A. Theoretical and technical instruction a. General subjects - Basic anatomy and physiology b. Subjects specific to the activities of midwives - Anatomy and physiology - Basic pathology - - Basic bacteriology, virology and parasitology Embryology and development of the foetus - Basic biophysics, biochemistry and radiology Pregnancy, puerperium - Paediatrics, with particular reference to new-born infant Gynaecological and obstetrical pathology - Preparation for childbirth and parenthood, including psychological aspects - childbirth and [ S.L.451.04 12 MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) - Hygiene, health education, preventive medicine, early diagnosis of diseases - Preparation for delivery (including knowledge and use of technical equipment in obstetrics) - Nutrition and dietetics, with particular r eference to women, new-born and young babies - Analgesia, resuscitation - Basic sociology and socio-medical questions - Physiology and pathology of the new-born infant - Basic pharmacology - Care and supervision of the newborn infant - Psychology - Psychological and social factors - Principles and methods of teaching - Health and social legislation and health organization - Professional ethics professional legislation - Sex education and family planning - Legal protection of mother and infant anaesthesia and and B. Practical and clinical training This training is to be dispensed under appropriate supervision: - Advising of pregnant women, involving at least 100 pre-natal examinations. - Supervision and care of at least 40 pregnant women. - Conduct by the student of at least 40 deliveries; where this number cannot be reached owing to the lack of available women in labour, it may be reduced to a minimum of 30, provided that the student assists with 20 further deliveries. - Active participation with breech deliveries. Where this is not possible because of lack of breech deliveries, practice may be in a simulated situation. - Performance of episiotomy and initiation into suturing. Initiation shall include theoretical instruction and clinical practice. The practice of suturing includes suturing of the wound following an episiotomy and a simple perineal laceration. This may be in a simulated situation if absolutely necessary. - Supervision and care of 40 women at risk in pregnancy, or labour or post-natal period. - Supervision and care (including examination) of at least 100 post-natal women and healthy new-born infants. - Observation and care of the new-born requiring special care, including those born pre-term, post-term, underweight or ill. - Care of women with pathological conditions in the fields of gynaecology and obstetrics. - Initiation into care in the field of medicine and surgery. Initiation shall MINIMUM TRAINING CONDITIONS (HEALTH CARE PROFESSIONS) [ S.L.451.04 13 include theoretical instruction and clinical practice. The theoretical and technical training (Part A of the training programme) shall be balanced and coordinated with the clinical training (Part B of the same programme) in such a way that the knowledge and experience listed in this Schedule may be acquired in an adequate manner. Clinical instruction shall take the form of supervised in-service training in hospital departments or other health services approved by the competent authorities or bodies. As part of this training, student midwives shall participate in the activities of the departments concerned insofar as those activities contribute to their training. They shall be taught the responsibilities involved in the activities of midwives. Part 4 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.