Jersey R&O 94/2002

 

Medicines (Jersey) Law 1995

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MEDICINES (PRESCRIPTION ONLY) (AMENDMENT No. 4) (JERSEY) ORDER 2002

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                THE HEALTH AND SOCIAL SERVICES COMMITTEE, in pursuance of Articles 57 and 111 of the Medicines (Jersey) Law 1995,[1] as amended, and after consultation with the Medicines Advisory Council and having otherwise complied with Article 111 of that Law, orders as follows -

 

                1.      In this Order, “principal Order” means the Medicines (Prescription Only) (Jersey) Order 1997,[2] as amended.[3]

 

                2.-(1)  In Part I of the First Schedule to the principal Order, in relation to the substance “Stannous Fluoride”, the entries in columns 2 and 3 shall each be numbered “(1)”, and after those entries there shall be inserted -

 

                (a)     in Column 2, “(2) 0.4 percent”;

 

                (b)     in Column 3, “(2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth”.

 

                (2)     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 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.

 

                3.-(1)  In Part IV of the First Schedule to the principal Order, after paragraph 7 there shall be inserted the following paragraph -

 

          “7A.  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 the form of eye drops; and

 

          (b)     it is indicated only for the treatment of allergic conjunctivitis, in persons aged not less than 12 years.”.

 

                (2)     In Part IV of the First Schedule to the principal Order, after paragraph 13 there shall be inserted the following paragraph -

 

          “13A.  A medicinal product shall not be a prescription only medicine by reason that it contains the substance clobetasone butyrate, where -

 

          (a)     the medicinal product is in the form of a cream;

 

          (b)     the maximum strength of the clobetasone butyrate in the medicinal product does not exceed 0.05 per cent;

 

          (c)     the medicinal product is sold or supplied in a container, or package, containing not more than 15 g of the medicinal product; and

 

          (d)     the medicinal product is indicated only for external application for the short-term treatment of eczema and dermatitis, in persons aged not less than 12 years.”.

 

                (3)     In Part IV of the First Schedule to the principal Order, in paragraph 18(c), after the words “vaginal candiasis” there shall be inserted the words “or associated candidal balanitis”.

 

                (4)     In Part IV of the First Schedule to the principal Order, for paragraph 22(d) there shall be substituted the following sub-paragraph -

 

                          “(d)   the medicinal product is indicated for external use -

 

(i)      for irritant dermatitis, contact allergic dermatitis, insect bite reactions or mild to moderate eczema,

 

(ii)     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, or

 

(iii)    in combination with miconazole nitrate, for tinea pedis or candidal intertrigo; and”.

 

                (5)     In Part IV of the First Schedule to the principal Order, after paragraph 38 there shall be inserted the following paragraph -

 

          “38A.  A medicinal product shall not be a prescription only medicine by reason that it contains the substance prochlorperazine maleate, where -

 

          (a)     the medicinal product is in the form of tablets;

 

          (b)     the maximum amount of the prochlorperazine maleate in the medicinal product, in each tablet, does not exceed 3 mg;

 

          (c)     the medicinal product is sold or supplied in a container, or package, containing not more than eight tablets; and

 

          (d)     the medicinal product is indicated only for nausea, and vomiting, in previously diagnosed migraine, in persons aged not less than 18 years.”.

 

                (6)     In Part IV of the First Schedule to the principal Order, after paragraph 42 there shall be inserted the following paragraph -

 

          “42A.  A medicinal product shall not be a prescription only medicine by reason of the fact that it contains terbinafine, where -

 

          (a)     the maximum strength of the terbinafine in the medicinal product does not exceed one per cent;

 

          (b)     the medicinal product is sold or supplied in a container, or package, containing not more than 30 g of the medicinal product; and

 

          (c)     the medicinal product is indicated for external use as a gel for the treatment of tina corporis, tinea pedis and tinea cruris.”.

 

                (7)     In Part IV of the First Schedule to the principal Order, after paragraph 43 there shall be inserted the following paragraph -

 

          “43A.  A medicinal product shall not be a prescription only medicine by reason of the fact that it contains terbinafine hydrochloride, where -

 

          (a)     the maximum strength of the terbinafine hydrochloride in the medicinal product does not exceed one per cent;

 

          (b)     the medicinal product is sold or supplied in a container containing not more than 30 ml of the medicinal product; and

 

          (c)     the medicinal product is indicated for external use as a spray solution for the treatment of tina corporis, tinea pedis and tinea cruris.”.

 

                4.      This Order may be cited as the Medicines (Prescription Only) (Amendment No. 4) (Jersey) Order 2002 and shall come into force on 1st October 2002.

 

                By Order of the Health and Social Services Committee,

 

                                                                                            C.M. NEWCOMBE

 

Greffier of the States.

 

16th September 2002.

SCHEDULE 1

 

(Article 2(2))

 

Substances to be inserted in Column 1 of Part 1 of

First Schedule to principal Order

 

SCHEDULE 2

 

(Article 2(3))

 

Entries to be inserted in Part 1 of First Schedule to principal Order in columns (and under headings) indicated