Citation, commencement and interpretation

1.-(1) This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996 and shall come into force on 13th January 1997.

(2) In this Order "the principal Order" means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983(3).

Amendment of article 4 of the principal Order

2. In article 4 of the principal Order (medicinal products that are not prescription only)-

(a)in paragraph (1C) (mebendazole) for "400 milligrams" substitute "800 milligrams";

(b)in paragraph (1N) (famotidine) for sub-paragraph (a) there is substituted the following sub-paragraph-

"(a)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 due to those symptoms, and".

Amendment of Part I of Schedule 1 to the principal Order

3. In Part I of Schedule 1 to the principal Order (which lists substances which render a medicinal product a prescription only medicine except in the circumstances also listed)-

(a)in Column 1-

(i)after the entry "Amygdalin" there is inserted the entry "Amyl Nitrite",

(ii)after the entry "Argipressin" there are inserted the following entries-

"Aristolochia

Aristolochia Clematitis

Aristolochia Contorta

Aristolochia Debelis

Aristolochia Fang-chi

Aristolochia Manshuriensis

Aristolochia Serpentaria",

(iii)for the entry "Lodoxomide Trometamol" there is substituted the entry "Lodoxamide Trometamol",

(iv)after the entry "Tolmetin Sodium" there is inserted the entry "Trandolapril",

(v)in the entry for Vaccines, after "Meningococcal Polysaccharide Vaccine" there is inserted "Mumps Vaccine";

(b)in Column 3 in relation to Mebeverine Hydrocholoride there is inserted the following entry-

"For the symptomatic relief of irritable bowel syndrome",

(c)in Column 4-

(i)for the entry relating to Mebeverine Hydrocholoride there is substituted the following entry-

"135mg (MD)

405mg (MDD)",

(ii)in the entry relating to Pseudoephedrine Hydrochloride for "90mg (MD)" there is substituted "120mg (MD)".

Amendment of Table A of Part IV of Schedule 1 to the principal Order

4. In Table A of Part IV of Schedule 1 to the principal Order (name and product licence number of medicinal products that are not prescription only medicines), the following entries are inserted at the appropriate points in the alphabetical order of the entries in that Table-

Amendment of Schedule 3 to the principal Order

5. In Part I of Schedule 3 to the principal Order (exemptions for certain persons from the provisions of section 58(2)(a) of the Medicines Act 1968) at the end there are inserted the entries set out in the Schedule to this Order.

Article 5

THE SCHEDULEENTRIES INSERTED IN PART I OF SCHEDULE 3 TO THE PRINCIPAL ORDER

Explanatory Note

(This note is not part of the Order)

This Order further amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 ("the principal Order") which specifies descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner). Under the principal Order products are included in a class of such medicines by reason of the substances contained in them, subject to their being excluded in specified circumstances.

The amendments made by this Order are as follows-

• amendments to the exclusions for certain products containing mebendazole or famotidine (article 2);

• the inclusion of products containing mumps vaccine, trandolapril or various forms of the substance aristolochia (article 3);

• the inclusion of products containing amyl nitrite subject to an exemption where it is sold or supplied as an antidote for cyanide poisoning (articles 3 and 5 and the Schedule);

• the substitution of the British Approved Name lodoxamide trometamol for that in an existing entry (article 3);

• amendments to the conditions under which medicines containing Mebeverine Hydrochlo ride or Pseudoephedrine Hydrochloride may be sold or supplied otherwise than as prescription only medicines (article 3);

• the exclusion of the products listed in article 4.