Commission Delegated Directive (EU) 2024/782 of 4 March 2024 amending Directive 2005/36/EC of the European Parliament and of the Council as regards the minimum training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist

Amendments to Directive 2005/36/EC

Article 1

Directive 2005/36/EC is amended as follows: (1) in Article 31, paragraph 6 is replaced by the following: ‘6.   Training for nurses responsible for general care shall provide an assurance that the professional in question has acquired the following knowledge and skills: (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; (b) knowledge of the nature and ethics of the profession and of the general principles of health and nursing; (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; (d) the ability to participate in the practical training of health personnel and experience of working with such personnel and with members of other professions in the health sector; (e) the ability to provide individualised nursing care and to empower patients, relatives and other relevant persons in relation to self-care and leading a healthy lifestyle; (f) the ability to develop an effective leadership approach and decision-making skills; (g) knowledge of the technical innovations related to healthcare and nursing methods.’ ; (2) in Article 34, paragraph 3 is replaced by the following: ‘3.   Basic dental training shall provide an assurance that the person in question has acquired the following knowledge and skills: (a) adequate knowledge of the sciences on which dentistry 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; (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, in so far as these factors affect dentistry; (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; (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; (e) suitable clinical experience under appropriate supervision; (f) adequate knowledge of digital dentistry and a good understanding of its use and safe application in practice. This training shall provide him 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.’ ; (3) in Article 44, paragraph 3 is replaced by the following: ‘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 in order to be able to supply appropriate information on the basis of this knowledge; (e) adequate knowledge of the legal and other requirements associated with the pursuit of pharmacy; (f) adequate knowledge of clinical pharmacy and pharmaceutical care, as well as the skills of their practical application; (g) adequate knowledge and skills of public health and its repercussions in health promotion and disease management; (h) adequate knowledge and skills on inter- and multidisciplinary collaboration, interprofessional practice and communication; (i) adequate knowledge of information technology and digital technology and skills on its practical application.’ ; (4) Annex V is amended in accordance with the Annex to this Directive.

Transposition

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 4 March 2026 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Entry into force

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Addressees

Article 4

This Directive is addressed to the Member States.

ANNEXSupplementary provisions

ANNEX Annex V is amended as follows: (1) point 5.2.1 is replaced by the following: ‘5.2.1 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, ethics and general principles of health and nursing, including person-centred care theories — Nursing principles in relation to: — general and specialist medicine — general and specialist surgery — childcare and paediatrics — maternity care — mental health and psychiatry — care of the elderly and geriatrics — Evidence-based nursing practice and research b.   General health 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 and management — Principles of teaching — Social and health legislation — Legal aspects of nursing d.   Science and technology: — e-health B.   Clinical instruction — Nursing in relation to: — general and specialist medicine — general and specialist surgery — childcare and paediatrics — maternity care — mental health and psychiatry — care of the elderly and geriatrics — nursing care in community settings — person-centred approach — Science and technology: — e-health One or more of these subjects may be taught in the context of the other disciplines or in conjunction therewith. Theoretical instruction must be weighted and coordinated with clinical instruction in such a way that the knowledge and skills referred to in this Annex can be acquired in an adequate fashion.’; (2) point 5.3.1 is replaced by the following: ‘5.3.1 Study programme for dental practitioners The programme of studies leading to evidence of formal qualifications in dentistry shall include at least the following subjects. 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, genetics and regenerative medicine 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 dental public health — Radiology — Physiotherapy — General surgery — General medicine, including paediatrics — Oto-rhino-laryngology — Dermato-venereology — General psychology — psychopathology — neuropathology — Anaesthetics — Immunology 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 — Practice management, professionalism, ethics and legislation — Social aspects of dental practice — Gerodontology — Oral implantology — Interprofessional collaborative care — Digital technology in dentistry’; (3) point 5.6.1 is replaced by the following: ‘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, physiology, pathology and pathophysiology; medical terminology — Microbiology — Pharmacology and pharmacotherapy — Pharmaceutical technology — Biopharmaceutical technology — Toxicology — Pharmacognosy — Legislation and, where appropriate, professional ethics — Genetics and pharmacogenomics — Immunology — Clinical pharmacy — Pharmaceutical care — Social pharmacy — Public health, including epidemiology — Pharmacy practice — Pharmacoeconomics 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.’.