Regulation 2 Amendment of the Medicines (Labelling) Regulations 1976

The Medicines (Labelling) Regulations 1976^f1 are amended in accordance with the following paragraphs of this regulation.

To regulation 14A there is added, after paragraph (4), the following paragraph:—

“(5)

Without prejudice to the operation of paragraph (1) of this regulation, every container and every package immediately enclosing a container of a medicinal product which is a product referred to in regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980^f2 which is not presented for sale in the manner described in relation to that product in that regulation and which is not a dispensed medicinal product shall, where the product—

(a)

is sold by retail, or

(b)

is supplied in circumstances corresponding to retail sale, or

(c)

is in the possession of a person for the purpose of such sale or supply, or

(d)

is sold by way of wholesale dealing,

be labelled to show the capital letter “P” within a rectangle within which there shall be no other matter of any kind.”.

After regulation 19, there is inserted the following regulation:—

““Temporary provision for products sold or supplied by retail

19A

Where, by reason of the coming into operation of an order made under section 51 (general sale list), section 57 (exemptions from restrictions on retail sale or supply) or section 58 (prescription only) of the Act, a container or package of a medicinal product would, but for this regulation, be required by regulations 14A, 14B, 14C or 14D of these regulations to be labelled with new or different words or particulars, that container or package may, during a period of six months from the date of coming into operation of that order, be labelled either—

(a)

so as to show those new or different words or particulars, or

(b)

so as to comply with such of the requirements imposed by regulations 14A, 14B, 14C or 14D of these regulations as were applicable to it immediately before that date.”.