Insertion of regulation 3A into the principal Regulations

4.  After regulation 3 of the principal Regulations (standard requirements relating to leaflets), there shall be inserted the following regulation—

“Standard requirements relating to leaflets for radiopharmaceuticals and radiopharmaceutical-associated products

3A.  Subject to the following provisions of these regulations, any leaflet which is enclosed with the packaging of a proprietary medicinal product which is a radiopharmaceutical or a radiopharmaceutical-associated product shall, in addition to containing any particulars required by any other provision of these regulations, contain—

(a)details of any precautions to be taken by the user and the patient during the preparation and administration of the product;

(b)details of any special precautions to be taken in respect of the disposal of the container and its unused contents.”.