The Prescription Only Medicines (Human Use) Amendment Order 1998

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 1998 and shall come into force on 13th February 1998, except for article 2 and article 3(e)(ii) which shall come into force on 13th August 1998.

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

Amendment of article 3 of the principal Order

2.  In article 3 of the principal Order (medicinal products on prescription only), in paragraph (c) the words “, other than preparations of insulin for parenteral administration” are deleted.

Amendment of Schedule 1 to the principal Order

3.  In Schedule 1 to the principal Order (which specifies substances which if 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 Hydrocortisone, there are inserted in the entry in column 3, after the word “Clotrimazole”, the words “or Miconazole Nitrate”;

(b) in relation to the substance Mebeverine Hydrochloride, there are substituted for the entry in column 3 the following entries—

“(a) For the symptomatic relief of irritable bowel syndrome

(b) For uses other than the symptomatic relief of irritable bowel syndrome”

and for the entry in column 4 the following entries—

“(a) 135 mg (MD)

405 mg (MDD)

(b) 100 mg (MD)

300 mg (MDD)”;

(c) in relation to the substance Ranitidine Hydrochloride, there are added at the end of the entry in column 3 the words “or the prevention of these symptoms when associated with consuming food and drink”;

(d) in relation to the substance Sodium Cromoglycate, there are inserted in entry (b) in column 3, after the words “acute seasonal allergic conjunctivitis”, the words “or perennial allergic conjunctivitis”; and

(e) there is inserted in column 1, at the appropriate point in the alphabetical order of the entries in that column, each of the following substances—

(i) “Estramustine Sodium Phosphate”

• “Mizolastine”

• “Niceritrol”

• “Piroxicam Beta-cyclodextrin”

• “Torasemide”; and

(ii) “Insulin”.

Amendment of Schedule 3 to the principal Order

4.  In Schedule 3 to the principal Order (descriptions and classes of prescription only medicines in relation to which appropriate nurse practitioners are appropriate practitioners) the following entries are inserted at the appropriate point in the alphabetical order of the entries in that Schedule—

• “Co-danthramer Capsules NPF”

• “Co-danthramer Capsules, Strong NPF”

• “Co-danthrusate Oral Suspension NPF”.

Amendment of Schedule 5 to the principal Order

5.—(1) At the end of Part I of Schedule 5 to the principal Order (exemptions for certain persons from the provisions of section 58(2) of the Medicines Act 1968) there are inserted the entries set out in the Schedule to this Order.

(2) In Part III of Schedule 5 to the principal Order for the three substances listed in column 2 of paragraph 1 there is substituted the following list—

• “Bupivacaine hydrochloride

• Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride

• Lignocaine hydrochloride

• Lignocaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride

• Prilocaine hydrochloride.”

Signed by authority of the Secretary of State for Health

Jay

Minister of State,

Department of Health

16th January 1998

Ron Davies

Secretary of State for Wales

23rd January 1998

Sam Galbraith

Parliamentary Under Secretary of State, Minister of State, The Scottish Office

20th January 1998

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

L.S.

D. C. Gowdy

Permanent Secretary

19th January 1998.