Jersey R & O 1/2000
Medicines (Jersey) Law 1995
____________
MEDICINES (PRESCRIPTION ONLY) (AMENDMENT No. 2) (JERSEY) ORDER 2000
____________
THE HEALTH AND SOCIAL SERVICES COMMITTEE,
in pursuance of Articles 57 and 111 of the Medicines (Jersey) Law 1995, and after consultation with the Medicines Advisory
Council and having otherwise complied with Article 111 of that Law, orders as
follows –
1. In Article 9(3)(b)(ii) of the Medicines (Prescription
Only) (Jersey) Order 1997, as
amended (in this Order called “the principal Order”), there
shall be inserted before the words “an aerosol for the relief of asthma” the
words “a preparation of insulin,”.
2.-(1) In Part I of the First Schedule to the
principal Order, in column 1, the word “Desmopressin” shall be deleted in the
second place where it occurs.
(2) In Part I of the First
Schedule to the principal Order, there shall be substituted for the entries
relating to minoxodil, in the columns (and under the headings) respectively
indicated in Schedule 1 to this Order, the entries specified in Schedule 1 to
this Order.
(3) In Part I of the First
Schedule to the principal Order, there shall be inserted –
(a) in their appropriate
alphabetical order; and
(b) in the columns (and
under the headings) respectively indicated in Schedule 2 to this Order,
the entries specified in Schedule 2 to this Order.
(4) In Part I of the First
Schedule to the principal Order, in column 1, there shall be inserted in their
appropriate alphabetical order the substances specified in Schedule 3 to this
Order.
3. For Part IV of the First Schedule to the
principal Order, there shall be substituted the Part set out in Schedule 4 to
this Order.
4. In Part I of the Second Schedule to the
principal Order, in column 2 of paragraph 4 (which relates to certified
midwives), beneath the words “Pentazocine hydrochloride” there shall be
inserted the word “Phytomenadrone”.
5. In Part III of the Second Schedule to the
principal Order, in column 2 of paragraph 1 (which relates to state registered
chiropodists), beneath the second entry relating to “Lignocaine hydrochloride”
there shall be inserted the words “Mepivacaine hydrochloride”.
6. This Order may be cited as the Medicines
(Prescription Only) (Amendment No. 2) (Jersey) Order 2000 and shall come into
force on the first day of February 2000.
By Order of the Health and Social Services Committee,
C.M. NEWCOMBE
Deputy Greffier of the States.
12th January 2000.
SCHEDULE 1
(Article 2(2))
Entry to be substituted in Part I of First Schedule to principal
Order in columns (and under headings) indicated
|
Prescription Only Medicine
|
Circumstances In Which Substances
Are Not
Prescription Only Medicines
|
|
Column 1
|
Column 2
|
Column 3
|
Column 4
|
|
Substance
|
Maximum strength
|
Use, pharmaceutical
form or route of administration
|
Maximum dose and
maximum daily dose
|
|
Minoxidil
|
(1) 2.0 per cent
|
External
|
|
|
|
(2) 5.0 per cent
|
External, for the treatment of alopecia
androgenetica in men who have attained the age of 18 years but have not
attained the age of 65 years
|
|
SCHEDULE 2
(Article 2(3))
Entries to be inserted in Part 1 of First Schedule to principal
Order in columns (and under headings) indicated
|
Prescription Only
Medicine
|
Circumstances In Which Substances
Are Not
Prescription Only Medicines
|
|
Column 1
|
Column 2
|
Column 3
|
Column 4
|
|
Substance
|
Maximum strength
|
Use, pharmaceutical
form or route of administration
|
Maximum dose and
maximum daily dose
|
|
Diphenhydramine Hydrochloride
|
|
All preparations except liquid-filled capsules
|
|
|
Ibuprofen Lysine
|
|
Rheumatic and muscular pain, pain of non-serious
arthritic conditions, backache, neuralgia, migraine, headache, dental pain,
dysmenorrhoea, feverishness, symptoms of colds and influenza
|
|
|
|
|
Internal
|
(a) In the case of a prolonged release preparation 600
mg (MD) 1,200 mg (MDD)
|
|
|
|
|
(b) In any other case 400 mg (MD) 1,200 mg (MDD)
|
|
Phytomenadine
|
|
Any use except the prevention or treatment of
haemorrhagic disorders
|
|
SCHEDULES 3
(Article 2(4))
Substances to be inserted in Column 1 of Part 1 of First Schedule
to principal Order
|
Aloxiprin
|
|
Hydrocyanic Acid
|
|
Levocabastine Hydrochloride
|
|
Lornoxicam
|
|
Nebivolol Hydrochloride
|
|
Nilutamide
|
|
Nisoldipine
|
|
Phenolphthalein
|
|
Pirenzepine
Dihydrochloride Monohydrate
|
|
Propiverine Hydrochloride
|
|
Quinapril Hydrochloride
|
|
Strychnine Nitrate
|
|
Sulphabenzamide
|
|
Tacalcitol Monohydrate
|
SCHEDULE 4
New Part IV to be substituted in First Schedule to principal Order
(Article 3)
PART IV
(Article 3(4))
OTHER MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES
1. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance aciclovir, where –
(a) the maximum strength
of the aciclovir in the medicinal product does not exceed 5 per cent;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 2 g of
the medicinal product; and
(c) the medicinal product
is indicated only for external application for the treatment of herpes simplex
virus infections of the lips and face (Herpes labialis).
2. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance acrivastine, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 240 mg
of acrivastine; and
(b) the container or
package is labelled to show a maximum daily dose of 24 mg of acrivastine.
3. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance aloxiprin, where –
(a) the medicinal product
is in the form of non-effervescent tablets or capsules;
(b) the maximum strength
of the medicinal product in each tablet or capsule does not exceed 620 mg;
(c) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied in one container or package does not exceed thirty-two; and
(d) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied to a person at any one time does not exceed one hundred.
4. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance aloxiprin, where it is not in the form of a non-effervescent tablet
or capsule.
5. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance aspirin, where –
(a) the medicinal product
is in the form of non-effervescent tablets or capsules;
(b) the maximum strength
of the medicinal product in each tablet or capsule does not exceed 75 mg;
(c) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied in one container or package does not exceed one hundred; and
(d) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied to a person at any one time does not exceed one hundred.
6. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance aspirin, where –
(a) the medicinal product
is in the form of non-effervescent tablets or capsules;
(b) the maximum strength
of the medicinal product in each tablet or capsule does not exceed 325 mg;
(c) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied in one container or package does not exceed thirty-two; and
(d) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied to a person at any one time does not exceed one hundred.
7. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance azelastine hydrochloride, where –
(a) the medicinal product
is in non-aerosol, aqueous form for nasal administration;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 36
doses each of which contains not more than 140 mcg of azelastine hydrochloride;
(c) the container or
package is labelled to show a maximum dose of 140 mcg per nostril and a maximum
daily dose of 280 mcg per nostril of azelastine hydrochloride; and
(d) the medicinal product
is indicated only for the treatment of seasonal allergic rhinitis, in persons
aged not less than 12 years.
8. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance beclomethasone dipropionate, where –
(a) the medicinal product
is in non-aerosol form for nasal administration;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 5,600
mcg of beclomethasone diopropionate;
(c) the container or
package is labelled to show a maximum dose of 100 mcg per nostril and a maximum
daily dose of 200 mcg per nostril of beclomethasone dipropionate; and
(d) the medicinal product
is indicated only for the prevention of treatment of allergic rhinitis, in
persons aged not less than 12 years.
9. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance budesonide, where –
(a) the medicinal product
is in non-aerosol, aqueous form for nasal administration;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 10 mg
of the medicinal product;
(c) the container or
package is labelled to show a maximum dose, and a maximum daily dose, of 200
mcg per nostril of budesonide; and
(d) the medicinal product
is indicated only for the prevention of treatment of seasonal allergic
rhinitis, in persons aged not less than 12 years.
10. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance carbenoxolone sodium, where –
(a) the medicinal product
is in the form of granules;
(b) the maximum strength
of the carbenoxolone sodium in the medicinal product does not exceed one per
cent, calculated in terms of weight in weight;
(c) the medicinal product
is sold or supplied in a container, or package, containing not more than 560 mg
of carbenoxolone sodium;
(d) the container or
package is labelled to show a maximum dose of 20 mg and a maximum daily dose of
80 mg of carbenoxolone sodium; and
(e) the medicinal product
is indicated only for treatment by mouthwash, in persons aged not less than 12
years.
11. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance cetirizine, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 100 mg
of cetirizine; and
(b) the container or
package is labelled to show a maximum daily dose of 10 mg of cetirizine.
12. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance cimetidine, where –
(a) the container or
package in which the medicinal product is sold or supplied is labelled to show
a maximum dose of 200 mg and a maximum daily dose of 800 mg of cimetidine for a
maximum period of 14 days; and
(b) the medicinal product
is indicated for the short-term symptomatic relief of heartburn, dyspepsia and
hyperacidity and for the prophylaxsis of meal-induced heartburn.
13. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance cimetidene, where –
(a) the medicinal product
is for the prophylactic management of nocturnal heartburn; and
(b) the container or
package in which the medicinal product is sold or supplied is labelled to show
a maximum dose of 100 mg of cimetidine to be taken once daily at night for a
maximum period of 14 days.
14. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance diclofenac diethylammonium, where –
(a) the maximum strength
of the diclofenac diethylammonium in the medicinal product does not exceed 1.16
per cent, calculated in terms of weight in weight;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 30 g
of the medicinal product;
(c) the container or
package is labelled to show a maximum period of use of 7 days; and
(d) the medicinal product
is indicated for external application for the local symptomatic relief of pain
and inflammation in trauma of the tendons, ligaments, muscles and joints and in
localized forms of soft tissue rheumatism, in persons aged not less than 12
years.
15. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance domperidone maleate, where –
(a) the medicinal product
is sold in a container, or package, containing not more than 100 mg of
domperidone maleate;
(b) the container or
package is labelled to show a maximum dose of 10 mg and a maximum daily dose of
40 mg; and
(c) the medicinal product
is indicated for use for the relief of postprandial symptoms of excessive
fullness, nausea, epigastric bloating and belching, accompanied by epigastric
discomfort and heartburn.
16. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance famotidine, where –
(a) the container or
package in which the medicinal product is sold or supplied is labelled to show
a maximum dose of 10 mg and a maximum daily dose of 20 mg of famotidine for a
maximum period of 14 days; and
(b) the medicinal product
is indicated for –
(i) the short-term
symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion or
hyperacidity; or
(ii) the prevention of the
symptoms of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity
where they are associated with the consumption of food or drink, including the
prevention of sleep disturbance because of those symptoms.
17. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance felbinac, where –
(a) the maximum strength
of the felbinac in the medicinal product does not exceed 3.17 per cent,
calculated in terms of weight in weight;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 30 mg
of the medicinal product;
(c) the container or
package is labelled to show a maximum period of use of 7 days; and
(d) the medicinal product
is indicated for external application for the relief of symptoms associated
with soft tissue injury such as strains, sprains and contusions, in persons
aged not less than 12 years.
18. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance fluconazole, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 150 mg
of the medicinal product;
(b) the container or
package is labelled to show a maximum dose of 150 mg of fluconazole; and
(c) the medicinal product
is indicated for oral administration for the treatment of vaginal candidiasis,
in persons aged not less than 16 years but less than 60 years.
19. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance flunisolide, where –
(a) the medicinal product
is in the form of a non-pressurized nasal spray;
(b) the maximum strength
of the flunisolide in the medicinal product does not exceed 0.025 per cent,
calculated in terms of weight in volume;
(c) the medicinal product
is sold or supplied in a container, or package, containing not more than 240
metered doses of the medicinal product;
(d) the container or
package is labelled to show a maximum dose of 50 mcg per nostril and a maximum
daily dose of 100 mcg per nostril of flunisolide in the case of persons aged not
less than 16 years, and a maximum dose of 25 mcg per nostril and a maximum
daily dose of 75 mcg per nostril in the case of children aged not less than 12
years but less than 16 years; and
(e) the medicinal product
is indicated for the prevention and treatment of seasonal allergenic rhinitus,
including hay fever, in persons aged not less than 12 years.
20. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance hydrocortisone, where –
(a) the maximum strength of
the hydrocortisone in the medicinal product does not exceed 0.5 per cent,
calculated in terms of weight in weight;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 15 g
of the medicinal product; and
(c) the medicinal product
is indicated for external use in combination with nystatin of a maximum
strength of 3.0 per cent, for intertrigo, in persons aged not less than 10
years.
21. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance hydrocortisone, where –
(a) the medicinal product
is in the form of a cream, ointment or spray;
(b) the maximum strength
of the hydrocortisone in the medicinal product does not exceed 1.0 per cent,
calculated in terms of weight in weight;
(c) the medicinal product
is sold or supplied in a container, or package, containing –
(i) where the medicinal
product is in the form of a cream or ointment, not more than 15 g of the
medicinal product; or
(ii) where the medicinal
product is in the form of a spray, not more than 30 ml of the medicinal
product;
(d) the medicinal product
is indicated for external use, either alone or in conjunction with crotamiton
in irritant dermatitis, contact allergic dermatitis, insect bite reactions or
mild to moderate eczema, and either in combination with clotrimazole or
miconazole nitrate for athlete’s foot and candidal intertrigo or in combination
with lignocaine for anal and perianal itch associated with haemorrhoids; and
(e) the medicinal product
is indicated for use in persons aged not less than 10 years.
22. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance hydrocortisone acetate, where –
(a) the medicinal product
is in the form of a cream or ointment, or suppositories;
(b) the maximum strength
of the hydrocortisone acetate in the medicinal product is equivalent to 1.0 per
cent of hydrocortisone, calculated in terms of weight in weight;
(c) the medicinal product
is sold or supplied in a container, or package, containing –
(i) where the medicinal
product is in the form of a cream or ointment, not more than 15 g of the
medicinal product; or
(ii) where the medicinal
product is in the form of suppositories, not more than 12 suppositories;
(d) the medicinal product
is indicated for external use, in irritant dermatitis, contact allergic
dermatitis, insect bite reactions, or mild to moderate eczema, and in
combination with one or more of the following, namely benzyl benzoate bismuth
oxide, bismuth subgallate, peru balsam pramoxine hydrochloride and zinc oxide,
for haemorrhoids; and
(e) the medicinal product
is indicated for use in persons aged not less than 10 years.
23. A medicinal product
shall not be a prescription only medicine by reason that it contains the substance
hydrocortisone sodium succinate, where –
(a) the medicinal product
is in the form of pellets;
(b) the maximum strength
of the hydrocortisone sodium succinate in the medicinal product is equivalent
to 2.5 mg of hydrocortisone, calculated in terms of weight in weight;
(c) the medicinal product
is sold or supplied in a container, or package, containing the equivalent of 50
mg of hydrocortisone; and
(d) the medicinal product
is indicated for external use for aphthous ulceration of the mouth, in persons
aged not less than 12 years.
24. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance hydroxyzine hydrochloride, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 750 mg
of the medicinal product;
(b) the container or
package is labelled to show a maximum dose of 25 mg, and to show a maximum
daily dose of 75 mg in the case of persons aged not less than 12 years and a
maximum daily dose of 50 mg in the case of children aged not less than 6 years
but less than 12 years; and
(c) the medicinal product
is indicated for the management of pruritus associated with acute or chronic
urticaria or atopic dermatitis or contact dermatitis, in persons aged not less
than 6 years.
25. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance hyoscine butylbromide, where –
(a) the route of
administration of the medicinal product is internal and is otherwise than by
means of an inhaler;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 240 mg
of the medicinal product; and
(c) the container or
package is labelled to show a maximum dose of 20 mg and a maximum daily dose of
80 mg of the medicinal product.
26. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance ketoconazole, where –
(a) the medicinal product
is in the form of a shampoo;
(b) the maximum strength
of the ketoconazole in the medicinal product does not exceed 2 per cent,
calculated in terms of weight in weight;
(c) the medicinal product
is sold or supplied in a container, or package, containing not more than 120 ml
of the medicinal product and containing in the medicinal product not more than
2,400 mg of ketoconazole;
(d) the container or
package is labelled to show a maximum frequency of application of once every
three days; and
(e) the medicinal product
is indicated for the prevention and treatment of dandruff and seborrhoeic
dermatitis of the scalp.
27. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance ketoprofen, where –
(a) the maximum strength
of the ketoprofen in the medicinal product does not exceed 2.5 per cent, calculated
in terms of weight in weight;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 30
grams of the medicinal product; and
(c) the medicinal product
is indicated only for treatment by external topical application, for rheumatic
and muscular pain, in persons aged not less than 12 years, for a maximum period
of 7 days.
28. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance levocabastine hydrochloride, where –
(a) the medicinal product
is in the form of a nasal spray;
(b) the maximum strength
of the medicinal product does not exceed the equivalent of 0.05 per cent
levocabastine;
(c) the medicinal product
is sold or supplied in a container, or package, containing not more than 10 ml
of the medicinal product; and
(d) the medicinal product
is indicated for the symptomatic treatment of seasonal allergic rhinitis.
29. A medicinal product
shall not be a prescription only medicine by reason that it contains the substance
levocabastine hydrochloride, where –
(a) the medicinal product
is in the form of aqueous eye drops;
(b) the maximum strength
of the medicinal product does not exceed the equivalent of 0.05 per cent
levocabastine;
(c) the medicinal product
is sold or supplied in a container, or package, containing not more than 4 ml
of the medicinal product; and
(d) the medicinal product
is indicated for the symptomatic treatment of seasonal allergic conjunctivitis.
30. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance loratadine, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 100 mg
of loratadine; and
(b) the container or
package is labelled to show a maximum daily dose of 10 mg of loratadine.
31. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance mebendazole, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 800 mg
of mebendazole;
(b) the container or
package is labelled to show a maximum dose of 100 mg of mebendazole; and
(c) the medicinal product
is indicated for oral use in the treatment of enterobiasis, in persons aged not
less than 2 years.
32. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance nedocromil sodium, where –
(a) the maximum strength
of the nedocromil sodium in the medicinal product does not exceed 2.0 per cent,
calculated in terms of weight in volume;
(b) the medicinal product
is sold in a container, or package, containing not more than 3 ml of the
medicinal product; and
(c) the medicinal product
is indicated for the prevention, relief and treatment of seasonal and perennial
allergic conjunctivitis.
33. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance nizatidine, where –
(a) the container or
package in which the medicinal product is sold or supplied is labelled to show
a maximum dose of 75 mg of nizatidine and a maximum of 4 such doses in any
period of 14 days; and
(b) the medicinal product
is indicated only for the prevention of the symptoms of food-related heartburn,
in persons aged not less than 16 years.
34. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance nystatin, where –
(a) the maximum strength
of the nystatin in the medicinal product does not exceed 3.0 per cent,
calculated in terms of weight in weight;
(b) the medicinal product
is sold in a container, or package, containing not more than 15 g of the
medicinal product; and
(c) the medicinal product
is indicated for external use in combination with hydrocortisone of a maximum
strength of 0.5 per cent for intertrigo, in persons aged not less than 10
years.
35. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance oxethazaine, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 400 ml
of oxethazaine; and
(b) the container or
package is labelled to show a maximum dose of 10 ml and a maximum daily dose of
30 ml of oxethazaine.
36. A medicinal product
shall not be a prescription only medicine by reason that it contains the substance
paracetamol, where –
(a) the medicinal product
is in the form of non-effervescent tablets or capsules;
(b) the maximum strength
of the medicinal product in each tablet or capsule does not exceed 500 mg;
(c) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied in one container or package does not exceed thirty-two;
(d) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied to a person at any one time does not exceed one hundred; and
(e) the medicinal product
is indicated for use by administration to persons aged not less than 12 years.
37. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance paracetamol, where –
(a) the medicinal product
is in the form of non-effervescent tablets or capsules;
(b) the maximum strength
of the medicinal product in each tablet or capsule does not exceed 120 mg;
(c) the quantity (of
tablets or capsules, or of any combination of tablets and capsules) that is
sold or supplied in one container or package does not exceed thirty-two; and
(d) the quantity (of
tablets and capsules, or of any combination of tablets and capsules) that is
sold or supplied to a person at any one time does not exceed one hundred.
38. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance piroxicam, where –
(a) the maximum strength
of the piroxicam in the medicinal product does not exceed 0.5 per cent;
(b) the medicinal product
is sold or supplied in a container, or package, containing not more than 30 mg
of the medicinal product;
(c) the container or
package is labelled to show a maximum period of use of 7 days; and
(d) the medicinal product
is indicated for external application for the relief of rheumatic pain, pain of
non-serious arthritic conditions and muscular aches, pains and swellings such
as strains, sprains and sports injuries, in persons aged not less than 12
years.
39. A medicinal product shall
not be a prescription only medicine by reason that it contains the substance
pyrantel embonate, where –
(a) the medicinal product
is sold or supplied in a container, or package, containing not more than 750 mg
of the medicinal product;
(b) the container or
package is labelled to show a maximum daily dose (to be taken as a single dose)
of pyrantel embonate of 750 mg in the case of persons aged not less than 12
years, of 500 mg in the case of children aged not less than 6 years but less
than 12 years, and of 250 mg in the case of children aged not less than 2 years
but less than 6 years; and
(c) the medicinal product
is indicated for the treatment of enterobiasis, in persons aged not less than 2
years.
40. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance ranitidine hydrochloride, where –
(a) the container or
package in which the medicinal product is sold or supplied is labelled to show
a maximum dose equivalent to 75 ml and a maximum daily dose equivalent to 300
ml of ranitidine for a maximum period of use of 14 days; and
(b) the medicinal product
is indicated for the short-term symptomatic relief of heartburn, dyspepsia and
hyperacidity, or the prevention of those symptoms when associated with the consumption
of food and drink.
41. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance sodium cromoglycate, where –
(a) the medicinal product
is in the form of aqueous eye drops;
(b) the maximum strength
of the sodium cromoglycate in the medicinal product does not exceed 2 per cent,
calculated in terms of weight in volume;
(c) the medicinal product
is sold or supplied in a container containing not more than 10 ml of the
medicinal product; and
(d) the medicinal product
is indicated for treatment of acute seasonal allergic conjunctivitis.
42. A medicinal product
shall not be a prescription only medicine by reason that it contains the
substance sodium cromoglycgate, where –
(a) the medicinal product
is in the form of an eye ointment;
(b) the maximum strength
of the sodium cromoglycate in the medicinal product is 4 per cent, calculated
in terms of weight in weight;
(c) the medicinal product
is sold or supplied in a container, or package, containing not more than 5 g of
the medicinal product; and
(d) the medicinal product
is indicated for the treatment of acute seasonal allergic conjunctivitis or
perennial allergic conjunctivitis.