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Commission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations

Directive (EU) 2019/1834 · Directive · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Annexes II and IV to Directive 92/29/EEC are replaced by the text in the Annex to this Directive.

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 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.

Article 3

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

Article 4

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This Directive is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX (1) Annex II to Directive 92/29/EEC is replaced by the following: ‘ANNEX II MEDICAL SUPPLIES (NON-EXHAUSTIVE LIST) (*) (Article 1(d)) (*) In light of Article 2(1)(a) Member States may, under exceptional circumstances, consider the use of alternative medicines or medical equipment for objectively justified reasons. I. MEDICINES Categories of vessels A B C 1. Cardiovascular (a) Cardio-circulatory sympathomimetics x x (b) Anti-angina preparations x x x (c) Diuretics x x (d) Anti-haemorrhagics including uterotonics if there are women on board x x (e) Anti-hypertensive x x 2. Gastro-intestinal system (a) Medicines for gastric and duodenal disorders — Medicine for treatment of stomach ulcer and gastritis x x — Anti-acid mucous dressings x x (b) Anti-emetics x x (c) Laxatives x (d) Anti-diarrhoeals x x x (e) Haemorrhoid preparations x x 3. Analgesics and anti-spasmodics (a) Analgesics, anti-pyretics and anti-inflammatory preparations x x x (b) Powerful analgesics x x (c) Spasmolytics x x 4. Nervous system (a) Anxiolytics x x (b) Neuroleptics x x (c) Seasickness remedies x x x (d) Anti-epileptics x x 5. Anti-allergics and anti-anaphylactics (a) Anti-histaminics x x (b) Glucocorticoids x x 6. Respiratory system (a) Bronchiospasm preparations x x (b) Anti-tussives x x (c) Medicines used for colds and sinusitis x x 7. Anti-infection (a) Antibiotics (at least two classes) x x (b) Anti-parasitics x x (c) Anti-tetanus vaccines and immunoglobulins x x (d) Anti-malaria medicines, carriage shall be dependent upon operational area x x 8. Compounds promoting rehydration, caloric intake and plasma expansion x x 9. Medicines for external use (a) Skin medicines — Antiseptic solutions x x x — Antibiotic ointments x x — Anti-inflammatory and analgesic ointments x x — Anti-mycotic skin creams x — Burn preparations x x x (b) Eye medicines — Antibiotic and anti-inflammatory x x — Anaesthetic drops x x — Saline solution for eyewash x x x — Hypotonic myotic drops x x (c) Ear medicines — Anaesthetic and anti-inflammatory solutions x x (d) Medicines for oral and throat infections — Antiseptic mouthwashes x x (e) Local anaesthetics — Local anaesthetics using freezing x — Local anaesthetics given by subcutaneous injection x x II. MEDICAL EQUIPMENT Categories of vessels A B C 1. Resuscitation equipment — Ambu bag (or equivalent); supplied with large, medium and small masks x x — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container ( 1 ) x x — Mechanical aspirator to clear upper respiratory passages x x 2. Dressing and suturing equipment — Tourniquets x x x — Disposable suture stapler or suture kit with needles x x — Adhesive elastic bandage x x x — Gauze strips x x — Tubular gauze for finger bandages x — Sterile gauze compresses x x x — Sterile sheet for burns victims x x — Triangular sling x x — Disposable gloves x x x — Adhesive dressings x x x — Sterile compression bandages x x x — Adhesive sutures or zinc oxide bandages x x x — Non-absorbable sutures with needles x — Vaseline gauze x x 3. Instruments — Disposable scalpels x — Instrument box made of suitable material x x — Scissors x x — Dissecting forceps x x — Haemostatic clamps x x — Needle forceps x — Disposable razors x 4. Examination and monitoring equipment — Disposable tongue depressors x x — Reactive strips for urine analysis x — Temperature charts x — Medical evacuation sheets x x — Stethoscope x x — Sphygmomanometer x x — Medical thermometer x x — Hypothermic thermometer x x — Quick malaria test, carriage shall be dependent upon operational area x x 5. Equipment for injection, perfusion, puncture and catheterisation — Bladder drainage equipment (suitable for men and women) x — Intravenous infusion set x x — Disposable syringes and needles x x 6. General medical equipment — Personal protective medical and nursing equipment x x — Bedpan x — Hot-water bottle x — Urine bottle x — Ice bag x 7. Immobilisation and setting equipment — Set of splints of different sizes for the extremities x x — Collar for neck immobilisation x x 8. Disinfection, disinsectisation and prophylaxis — Water-disinfection compound x — Liquid insecticide x — Powder insecticide x III. ANTIDOTES 1. Medicines — General — Cardio-vascular — Gastro-intestinal system — Nervous system — Respiratory system — Anti-infective — For external use 2. Medical equipment — Necessary for the administration of oxygen (including maintenance requisites) Note: For the detailed implementation of Section III, Member States may refer to the IMO Medical First Aid Guide for use in accidents involving dangerous goods (MFAG) contained in the 1990 consolidated edition of the IMO International Maritime Dangerous Goods Code, as amended. Any adaptation of Section III in implementation of Article 8 may take account, inter alia, of any updating of the MFAG. ’ (2) Annex IV to Directive 92/29/EEC is replaced by the following: ‘ANNEX IV General Framework for the Inspection of Vessels’ Medical Supplies (Article 2(1)(c), Article 3(3)) SECTION A CATEGORY A VESSELS I. Details of the vessel Name: … Flag: … Home port: … II. Medical supplies Quantities required Quantities actually carried on board Remarks (in particular, any expiry date) 1. MEDICINE 1.1. Cardiovascular (a) Cardio-circulatory sympathomimetics 0 0 0 (b) Anti-angina preparations 0 0 0 (c) Diuretics 0 0 0 (d) Anti-haemorrhagics including uterotonics if there are women on board 0 0 0 (e) Anti-hypertensive 0 0 0 1.2. Gastro-intestinal system (a) Medicines for gastric and duodenal disorders 0 0 0 — Medicine for treatment of stomach ulcer and gastritis 0 0 0 — Anti-acid mucous dressings 0 0 0 (b) Anti-emetics 0 0 0 (c) Laxatives 0 0 0 (d) Anti-diarrhoeals 0 0 0 (e) Haemorrhoid preparations 0 0 0 1.3. Analgesics and anti-spasmodics (a) Analgesics, anti-pyretics and anti-inflammatory preparations 0 0 0 (b) Powerful analgesics 0 0 0 (c) Spasmolytics 0 0 0 1.4. Nervous system (a) Anxiolytics 0 0 0 (b) Neuroleptics 0 0 0 (c) Seasickness remedies 0 0 0 (d) Anti-epileptics 0 0 0 1.5. Anti-allergics and anti-anaphylactics (a) Anti-histaminics 0 0 0 (b) Glucocorticoids 0 0 0 1.6. Respiratory system (a) Bronchiospasm preparations 0 0 0 (b) Anti-tussives 0 0 0 (c) Medicines used for colds and sinusitis 0 0 0 1.7. Anti-infection (a) Antibiotics (at least two classes) 0 0 0 (b) Anti-parasitics 0 0 0 (c) Anti-tetanus vaccines and immunoglobulins 0 0 0 (d) Anti-malaria medicines, carriage shall be dependent upon operational area 0 0 0 1.8. Compounds promoting rehydration, caloric intake and plasma expansion 0 0 0 1.9. Medicines for external use (a) Skin medicines 0 0 0 — Antiseptic solutions 0 0 0 — Antibiotic ointments 0 0 0 — Anti-inflammatory and analgesic ointments 0 0 0 — Anti-mycotic skin creams 0 0 0 — Burn preparations 0 0 0 (b) Eye medicines 0 0 0 — Antibiotic and anti-inflammatory 0 0 0 — Anaesthetic drops 0 0 0 — Saline solution for eyewash 0 0 0 — Hypotonic myotic drops 0 0 0 (c) Ear medicines 0 0 0 — Anaesthetic and anti-inflammatory solutions 0 0 0 (d) Medicines for oral and throat infections 0 0 0 — Antiseptic mouthwashes 0 0 0 (e) Local anaesthetics 0 0 0 — Local anaesthetics using freezing 0 0 0 — Local anaesthetics given by subcutaneous injection 0 0 0 2. MEDICAL EQUIPMENT 2.1. Resuscitation equipment — Ambu bag (or equivalent); supplied with large, medium and small masks 0 0 0 — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container ( 2 ) 0 0 0 — Mechanical aspirator to clear upper respiratory passages 0 0 0 2.2. Dressing and suturing equipment — Tourniquets 0 0 0 — Disposable suture stapler or suture kit with needles 0 0 0 — Adhesive elastic bandage 0 0 0 — Gauze strips 0 0 0 — Tubular gauze for finger bandages 0 0 0 — Sterile gauze compresses 0 0 0 — Sterile sheet for burns victims 0 0 0 — Triangular sling 0 0 0 — Disposable gloves 0 0 0 — Adhesive dressings 0 0 0 — Sterile compression bandages 0 0 0 — Adhesive sutures or zinc oxide bandages 0 0 0 — Non-absorbable sutures with needles 0 0 0 — Vaseline gauze 0 0 0 2.3. Instruments — Disposable scalpels 0 0 0 — Instrument box made of suitable material 0 0 0 — Scissors 0 0 0 — Dissecting forceps 0 0 0 — Haemostatic clamps 0 0 0 — Needle forceps 0 0 0 — Disposable razors 0 0 0 2.4. Examination and monitoring equipment 0 0 0 — Disposable tongue depressors 0 0 0 — Reactive strips for urine analysis 0 0 0 — Temperature charts 0 0 0 — Medical evacuation sheets 0 0 0 — Stethoscope 0 0 0 — Sphygmomanometer 0 0 0 — Medical thermometer 0 0 0 — Hypothermic thermometer 0 0 0 —Quick malaria test, carriage shall be dependent upon operational area 0 0 0 2.5. Equipment for injection, perfusion, puncture and catheterisation 0 0 0 — Bladder drainage equipment (suitable for men and women) 0 0 0 — Intravenous infusion set 0 0 0 — Disposable syringes and needles 0 0 0 2.6. General medical equipment 0 0 0 — Personal protective medical and nursing equipment 0 0 0 — Bedpan 0 0 0 — Hot-water bottle 0 0 0 — Urine bottle 0 0 0 — Ice bag 0 0 0 2.7. Immobilisation and setting equipment 0 0 0 — Set of splints of different sizes for the extremities 0 0 0 — Collar for neck immobilisation 0 0 0 2.8. Disinfection, disinsectisation and prophylaxis 0 0 0 — Water-disinfection compound 0 0 0 — Liquid insecticide 0 0 0 — Powder insecticide 0 0 0 3. ANTIDOTES 3.1. General 0 0 0 3.2. Cardio-vascular 0 0 0 3.3. Gastro-intestinal system 0 0 0 3.4. Nervous system 0 0 0 3.5. Respiratory system 0 0 0 3.6. Anti-infective 0 0 0 3.7. For external use 0 0 0 3.8. Other 0 0 0 3.9. Necessary for the administration of oxygen (including maintenance requisites) 0 0 0 Venue and date: … Captain’s signature: … Authorisation by competent person or authority: … SECTION B CATEGORY B VESSELS I. Details of the vessel Name: … Flag: … Home port: … II. Medical supplies Quantities required Quantities actually carried on board Remarks (in particular, any expiry date) 1. MEDICINE 1.1. Cardiovascular (a) Cardio-circulatory sympathomimetics 0 0 0 (b) Anti-angina preparations 0 0 0 (c) Diuretics 0 0 0 (d) Anti-haemorrhagics including uterotonics if there are women on board 0 0 0 (e) Anti-hypertensive 0 0 0 1.2. Gastro-intestinal system (a) Medicines for gastric and duodenal disorders 0 0 0 — Medicine for treatment of stomach ulcer and gastritis 0 0 0 — Anti-acid mucous dressings 0 0 0 (b) Anti-emetics 0 0 0 (c) Anti-diarrhoeals 0 0 0 (d) Haemorrhoid preparations 0 0 0 1.3. Analgesics and anti-spasmodics (a) Analgesics, anti-pyretics and anti-inflammatory preparations 0 0 0 (b) Powerful analgesics 0 0 0 (c) Spasmolytics 0 0 0 1.4. Nervous system (a) Anxiolytics 0 0 0 (b) Neuroleptics 0 0 0 (c) Seasickness remedies 0 0 0 (d) Anti-epileptics 0 0 0 1.5. Anti-allergics and anti-anaphylactics (a) Anti-histaminics 0 0 0 (b) Glucocorticoids 0 0 0 1.6. Respiratory system (a) Bronchiospasm preparations 0 0 0 (b) Anti-tussives 0 0 0 (c) Medicines used for colds and sinusitis 0 0 0 1.7. Anti-infection (a) Antibiotics (at least two classes) 0 0 0 (b) Anti-parasitics 0 0 0 (c) Anti-tetanus vaccines and immunoglobulins 0 0 0 (d) Anti-malaria medicines, carriage shall be dependent upon operational area 0 0 0 1.8. Compounds promoting rehydration, caloric intake and plasma expansion 0 0 0 1.9. Medicines for external use (a) Skin medicines 0 0 0 — Antiseptic solutions 0 0 0 — Antibiotic ointments 0 0 0 — Anti-inflammatory and analgesic ointments 0 0 0 — Burn preparations 0 0 0 (b) Eye medicines 0 0 0 — Antibiotic and anti-inflammatory 0 0 0 — Anaesthetic drops 0 0 0 — Saline solution for eyewash 0 0 0 — Hypotonic myotic drops 0 0 0 (c) Ear medicines 0 0 0 — Anaesthetic and anti-inflammatory solutions 0 0 0 (d) Medicines for oral and throat infections 0 0 0 — Antiseptic mouthwashes 0 0 0 (e) Local anaesthetics 0 0 0 — Local anaesthetics given by subcutaneous injection 0 0 0 2. MEDICAL EQUIPMENT 2.1 Resuscitation equipment — Ambu bag (or equivalent); supplied with large, medium and small masks 0 0 0 — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container ( 3 ) 0 0 0 — Mechanical aspirator to clear upper respiratory passages 0 0 0 2.2. Dressing and suturing equipment — Tourniquets 0 0 0 — Disposable suture stapler or suture kit with needles 0 0 0 — Adhesive elastic bandage 0 0 0 — Gauze strips 0 0 0 — Sterile gauze compresses 0 0 0 — Sterile sheet for burns victims 0 0 0 — Triangular sling 0 0 0 — Disposable gloves 0 0 0 — Adhesive dressings 0 0 0 — Sterile compression bandages 0 0 0 — Adhesive sutures or zinc oxide bandages 0 0 0 — Vaseline gauze 0 0 0 2.3. Instruments — Instrument box made of suitable material 0 0 0 — Scissors 0 0 0 — Dissecting forceps 0 0 0 — Haemostatic clamps 0 0 0 2.4. Examination and monitoring equipment 0 0 0 — Disposable tongue depressors 0 0 0 — Medical evacuation sheets 0 0 0 — Stethoscope 0 0 0 — Sphygmomanometer 0 0 0 — Medical thermometer 0 0 0 — Hypothermic thermometer 0 0 0 —Quick malaria test, carriage shall be dependent upon operational area 0 0 0 2.5. Equipment for injection, perfusion, puncture and catheterisation 0 0 0 — Intravenous infusion set 0 0 0 — Disposable syringes and needles 0 0 0 2.6. General medical equipment 0 0 0 — Personal protective medical and nursing equipment 0 0 0 2.7. Immobilisation and setting equipment 0 0 0 — Set of splints of different sizes for the extremities 0 0 0 — Collar for neck immobilisation 0 0 0 3. ANTIDOTES 3.1. General 0 0 0 3.2. Cardio-vascular 0 0 0 3.3. Gastro-intestinal system 0 0 0 3.4. Nervous system 0 0 0 3.5. Respiratory system 0 0 0 3.6. Anti-infective 0 0 0 3.7. For external use 0 0 0 3.8. Other 0 0 0 3.9. Necessary for the administration of oxygen (including maintenance requisites) 0 0 0 Venue and date: … Captain’s signature: … Authorisation by competent person or authority: … SECTION C CATEGORY C VESSELS I. Details of the vessel Name: … Flag: … Home port: … II. Medical supplies Quantities required Quantities actually carried on board Remarks (in particular, any expiry date) 1. MEDICINE 1.1. Cardiovascular (a) Anti-angina preparations 0 0 0 1.2. Gastro-intestinal system (a) Anti-diarrhoeals 0 0 0 1.3. Analgesics and anti-spasmodics (a) Analgesics, anti-pyretics and anti-inflammatory preparations 0 0 0 1.4. Nervous system (c) Seasickness remedies 0 0 0 1.5. Medicines for external use (a) Skin medicines 0 0 0 — Antiseptic solutions 0 0 0 — Burn preparations 0 0 0 (b) Eye medicines 0 0 0 — Saline solution for eyewash 0 0 0 2. MEDICAL EQUIPMENT 2.1. Dressing and suturing equipment — Tourniquets 0 0 0 — Adhesive elastic bandage 0 0 0 — Sterile gauze compresses 0 0 0 — Disposable gloves 0 0 0 — Adhesive dressings 0 0 0 — Sterile compression bandages 0 0 0 — Adhesive sutures or zinc oxide bandages 0 0 0 3. ANTIDOTES 3.1. General 0 0 0 3.2. Cardio-vascular 0 0 0 3.3. Gastro-intestinal system 0 0 0 3.4. Nervous system 0 0 0 3.5. Respiratory system 0 0 0 3.6. Anti-infective 0 0 0 3.7. For external use 0 0 0 3.8. Other 0 0 0 3.9. Necessary for the administration of oxygen (including maintenance requisites) 0 0 0 Venue and date: … Captain’s signature: … Authorisation by competent person or authority: … ’ ( 1 ) Under the conditions of use prescribed by national laws and/or practices ( 2 ) Under the conditions of use prescribed by national laws and/or practices. ( 3 ) Under the conditions of use prescribed by national laws and/or practices.

Other acts of the same type

Council Directive 96/72/EC of 18 November 1996 amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed Council Directive 96/67/EC of 15 October 1996 on access to the groundhandling market at Community airports Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT)Council Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international traffic Council Directive 96/52/EC of 23 July 1996 amending Directive 85/350/EEC with regard to the Community list of less-favoured farming areas within the meaning of Directive 75/268/EEC (Ireland)Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (Text with EEA relevance)Commission Directive 96/40/EC of 25 June 1996 establishing a common model for an identity card for inspectors carrying out port State control (Text with EEA relevance)Council Directive 96/30/EC of 13 May 1996 amending Directive 94/80/EC laying down detailed arrangements for the exercise of the right to vote and to stand as a candidate in municipal elections by citizens of the Union residing in a Member State of which they are not nationals Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Commission Directive 96/20/EC of 27 March 1996 adapting to technical progress Council Directive 70/157/EEC relating to the permissible sound level and the exhaust system of motor vehicles (Text with EEA relevance)Commission Directive 96/18/EC of 19 March 1996 amending various Council Directives on the marketing of seeds and propagating materials (Text with EEA relevance)Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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