The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 and shall come into force on 16th September 1998.

(2) In this Order “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997(1).

Amendment of article 8 of the principal Order

2.  In paragraph 4(b)(i) of article 8 of the principal Order (exemptions for emergency sale or supply), before the words “an aerosol” there are inserted the words “a preparation of insulin,”.

Amendment of Schedule 1 to the principal Order

3.  In Schedule 1 to the principal Order (which specifies substances which when included in medicinal products make those products prescription only medicines and exemptions from restrictions on the sale and supply of prescription only medicines)–

(a) in relation to the substance Aspirin(2), there is substituted for the entry “(1) 325 mg” in column 2, “(1) 500 mg”;

(b) in relation to the substance Astemizole, the entries in columns 3, 4 and 5 are deleted;

(c) in relation to each of the substances Beclomethasone Dipropionate and Budesonide–

(i) there are substituted for the entry “For use in adults and children not less than 12 years” in column 3, the entry “For use in persons aged 18 years and over”, and

(ii) there is inserted in column 4, after the entry “200 mcg per nostril (MDD)”, the entry “For a maximum period of 3 months”;

(d) in relation to the substance Domperidone Maleate(3), there is substituted for the entry “10 mg (MD) 40 mg (MDD)” in column 4, the following entry

“10 mg of Domperidone as Domperidone Maleate (MD)

40 mg of Domperidone as Domperidone Maleate (MDD)”;

(e) in relation to the substance Felbinac, there is substituted for the entry “For the relief of symptoms associated with soft tissue injury such as strains, sprains and contusions” in column 3, the entry–

“For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions”;

(f) in relation to the substance Flunisolide–

(i) there are substituted for the entry “For use in adults and children not less than 16 years” in column 3, the entry “For use in persons aged 18 years and over”,

(ii) there is inserted in column 4, after the entry “100 mcg per nostril (MDD)”, the entry “For a maximum period of 3 months”, and

(iii) the entries under the letter “(b)” in columns 3, 4 and 5 are deleted;

(g) in relation to the substance Ketoconazole–

(i) there is inserted in column 3, before the entry “For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp”, the entry “External”,

(ii) there are inserted in the entries in columns 3, 4 and 5, at the beginning of each of the first entries, the letter “(a)”, and

(iii) there is inserted in column 3, after the entry “In the form of a shampoo”, the entry “(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo”;

(h) in relation to the substance Nedocromil Sodium there are inserted the following entries–

• in column 2

  “2.0 per cent”,

• in column 3

  “For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis”, and

• in column 5

  “Container or package containing not more than 3 ml of medicinal product”; and

(i) there are inserted in column 1, and, as the case may be, columns 2, 3, 4 and 5, at the appropriate point in the alphabetical order of the entries as they appear in column 1, each of the entries set out in column 1 of the Schedule to this Order, together with the corresponding text in columns 2, 3, 4 and 5 respectively of that Schedule.

Amendment of Schedule 5 to the principal Order

4.  In Schedule 5 to the principal Order (exemptions for certain persons from the provisions of section 58(2) of the Medicines Act 1968)–

(a) in Part I there is inserted in the list in column 2 of paragraph 4, after the substance Pentazocine Hydrochloride, “Phytomenadione”, and

(b) in Part III there is inserted in the list in column 2 of paragraph 1, after the substance Lignocaine hydrochloride with adrenaline(4), “Mepivacaine hydrochloride”.

Signed by authority of the Secretary of State for Health

Paul Boateng

Parliamentary Under Secretary of State,

Department of Health

21st August 1998

Jon Owen Jones

Parliamentary Under Secretary of State, The Welsh Office

27th August 1998

Sam Galbraith

Minister for Health, The Scottish Office

25th August 1998

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

D.C. Gowdy

Permanent Secretary

24th August 1998.