The Medicines (Leaflets) Regulations 1977

Temporary and transitional provisions

6.—(1) These regulations shall not have effect—

(a) in relation to a proprietary medicinal product in respect of which a product licence was granted prior to the coming into operation of these regulations, until 1st October 1977;

(b) in relation to a leaflet which was printed before the date of the coming into operation of these regulations with a view to being enclosed in the container or package of a proprietary medicinal product by or on behalf of the holder of the product licence, the licence not being a licence granted after the date of the coming into operation of these regulations, until 1st April 1980;

(c) in relation to a leaflet which is printed after the date of the coming into operation of these regulations and is a copy of a leaflet printed before that date, in a period ending not later than 1st April 1980 during which an amended form of the leaflet which complies with the provisions of these regulations is in course of preparation, provided that the holder of the product licence has delivered a copy of the leaflet to the licensing authority and the authority have not within the period of 21 days after receipt of the leaflet by the authority notified the holder of the licence that the leaflet ought not to be supplied with the proprietary medicinal product.

(2) These regulations shall not have effect in relation to a leaflet which before the date of the coming into operation of these regulations has been enclosed in the container or package of a proprietary medicinal product by or on behalf of the holder of the product licence, the licence not being a licence granted after that date.