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The Medicines (Labelling and Advertising to the Public) Regulations 1978
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- UK Statutory Instruments
- 1978 No. 41
- SCHEDULE 2
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Regulation 4
SCHEDULE 2
PART IINFECTIONS, DEGENERATIVE AND DEFICIENCY CONDITIONS
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Description of disease | Purpose for which advertising is permitted | Restrictions on permitted advertisements |
| 1. Infections including viral, bacterial and fungal diseases. | Treatment or prevention of minor cutaneous infections where a medicinal product is to be administered to an external surface of the body, including treatment by means of preparations for the relief of pruritus or exanthematous rashes of childhood infection and treatment of boils and the treatment or prevention of athlete's foot. | None. |
| Aphthous ulcers. | None. | |
| Relief of symptoms of common colds, coughs, conditions commonly referred to as influenza and similar upper respiratory tract infections. | None. | |
| Treatment of minor acute inflammatory conditions of the buccal cavity and pharynx. | None. | |
| 2. Parasitic diseases. | Treatment of scabies or an infestation by thread-worms, lice, or round-worms. | That advertisements consist solely of labelled containers or packages in which, or leaflets with which, a medicinal product is supplied. |
| 3. Senility and degenerative conditions associated with ageing. | None. | |
| 4. Treatment of diseases of malnutrition including vitamin and mineral deficiency states. | Dietary supplements. | None. |
PART II
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| System or part of the body | Purposes for which advertising is permitted | Restrictions on permitted advertisements |
| 1. The gastro-intestinal system. | Relief of such symptoms as are commonly referred to as indigestion, heart-burn, hyperacidity, dyspepsia, halitosis (bad breath) or flatulence. | None. |
| Symptomatic relief of colicky pain, stomach ache or nausea. | None. | |
| Relief of occasional or non-persistent diarrhoea or constipation. | None. | |
| Prevention of travel sickness or related symptoms. | None. | |
| 2. Liver, biliary system and pancreas. | None. | |
| 3. Kidneys and ureters. | None. | |
| 4. The nervous system. | Symptomatic relief of headache including migrainous headache. | |
| Prevention of migraine. Treatment of the condition known as neuralgia. | That advertisements consist solely of labelled containers or packages in which, or leaflets with which, a medicinal product is supplied. | |
| 5. The genito-urinary system and mammary glands. | Symptomatic relief of dysmenorrhea. | None. |
| Relief of sore nipples during lactation by means of local applications. | None. | |
| Contraception by means of the use of spermicidal contraceptives. | The restrictions and requirements imposed by regulation 6 of these regulations. | |
| 6. The skin, hair and scalp. | Treatment, where applied to an external surface of the body, of acne. | None. |
| Prevention or treatment of dandruff by means of external applications. | None. | |
| Temporary relief of psoriasis by application to an external surface of the body. | ||
| Treatment, where applied to an external surface of the body, of eczema and skin allergies. | ||
| Treatment of hard skin and corns by means of the application of corn plasters or solvents. | None. | |
| Prevention or treatment of contact dermatitis by means of protective applications. | None. | |
| Relief or prevention of common minor skin conditions including dry and chapped skin, cold sores, nettle rashes, pruritus, insect bites and napkin rash. | None. |
PART III
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| System or part of the body | Adverse conditions of those systems | Purposes for which advertising is permitted. |
| 1. The cardio-vascular system. | (a) All diseases of the myocardium and heart valves, including rheumatic heart disease and coronary artery disease. | None. |
| (b) Hypertension. | None. | |
| (c) Thrombosis. | None. | |
| (d) Oedema. | None. | |
| (e) Peripheral artery disease. | Treatment of chilblains. | |
| (f) Peripheral venous disease. | Treatment of haemorhoids by relief of symptoms by means of locally effective preparations or stool softening agents and lubricants. | |
| (g) Retinal vascular change. | None. | |
| 2. The blood and the lymphatic system. | (a) Anaemia. | Prophylactic administration of iron and folic acid to avoid deficiency states in persons with inadequate diet or with increased dietary requirements. |
| (b) Bleeding disorders. | None. | |
| (c) Leukaemia or other lymphoproliferative diseases. | None. | |
| 3. The endocrine system. | Any organic or functional condition related to under or over activity of any part of the system. | Weight reduction dependent upon mechanism involving a reduced calorie or joule intake. |
| 4. The optical and auditory system. | Any organic condition affecting sight, hearing or balance. | Relief of symptoms by means of the local administration of eye preparations. Relief of symptoms by means of the local administration of preparations as a solvent for ear wax. |
| 5. The musculo-skeletal system. | Any condition referred to as slipped disc, arthritis, osteoarthritis, rheumatoid arthritis or gout. | Symptomatic relief of muscular pain and stiffness including backache, sciatica, lumbago, fibrositis, rheumatic pain and cramp. |
| 6. The respiratory system. | Diseases of the lungs, pleura and bronchial tree. | Temporary relief of symptoms of hay fever, rhinitis or catarrh. Relief of blocked-up sinuses. Alleviation of an attack of bronchial asthma. |
| 7. The teeth and gums. | Pyorrhoea. Gingivitis. | Prevention and treatment of gingivitis and prevention of pyorrhoea by means of oral hygiene. |
PART IV
| Column 1 | Column 2 |
|---|---|
| Physical Injuries | Purposes for which advertising is permitted |
| Skeletal fractures and extensive burns, scalds or injuries. | Dressings, plasters, bandages or preparations applied to a surface of the body for the purpose of alleviation of any discomfort, or for the protection of an injured part of the body (including the prevention of infection and sunburn). |
PART VPURPOSES FOR WHICH IT IS PROHIBITED TO ADVERTISE ANY MEDICINAL PRODUCT TO THE PUBLIC
1. Diagnosis of any disease or the ascertainment of the existence, degree or extent of any physiological condition specified in Schedule 1 to these regulations or in Part I, III or IV of this Schedule, or any disease of any system or part of the body specified in column 1 of Part II of this Schedule.
2. Treatment or prevention of any clinical psychiatric or psychotic condition.
3. Restoration or enhancement of sexual potency or libido.
4. Alleviation of fatigue or tiredness of a chronic or persistent nature.
5. Rejuvenation or the prevention of ageing.
6. Contraception except by means of spermicidal contraceptives.
7. Increasing or decreasing fertility.
8. Treatment of addiction to any substance, except for the purpose of diminishing the desire to smoke tobacco by means of the administration of a medicinal product sold or supplied for that purpose.
9. The treatment of sleeplessness or insomnia other than by the secondary effect of relief of pain or other symptoms.
10. Sedation or tranquillising.
11. General anaesthesia.
12. Regulation of menstrual flow.
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