Regulation 2 Amendment of regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980
United Kingdom
In regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980f1 (pack size on retail sale or supply of certain medicinal products on a general sale list)—
in paragraph (1), for “paragraphs (2) to (2I) and (3)” there is substituted “paragraphs (2) to (2L) and (3)”;
in paragraph (2), for sub-paragraph (b) there is substituted—
“(b)in the case of tablets that are not effervescent—
(i)where they are enteric-coated, contain aspirin only, and the amount of aspirin in each tablet does not exceed 75 milligrams, not more than 28 tablets,
(ii)where they contain aloxiprin, or aspirin or paracetamol or a combination of any or all of those substances, and do not satisfy the conditions specified in head (i) of this sub-paragraph, not more than 16 tablets;”;
in paragraph (2B) after sub-paragraph (d) add the following sub-paragraph—
“(e)in the case of liquid preparations of ibuprofen, individual unit doses of not more than 5 millilitres each to a maximum of 20 unit doses.”; and
after paragraph (2I) there are inserted the following paragraphs—
“(2J)Where a medicinal product for human use containing cetirizine hydrochloride is sold by retail in the course of a business elsewhere than at a registered pharmacy or is so offered or exposed for sale by retail or so supplied in circumstances corresponding to retail sale, the product shall be presented for sale in a separate and individual container or package containing not more than 7 tablets.
(2K)Where a medicinal product for human use containing loratadine is sold by retail in the course of a business elsewhere than at a registered pharmacy or is so offered or exposed for sale by retail or so supplied in circumstances corresponding to retail sale, the product shall be presented for sale in a separate and individual container or package containing not more than 7 tablets.
(2L)Where a medicinal product for human use containing ibuprofen lysine is sold by retail in the course of a business elsewhere than at a registered pharmacy or is so offered or exposed for sale by retail or so supplied in circumstances corresponding to retail sale, the product shall be presented for sale in a separate and individual container or package containing not more than 16 tablets.”.