On 24 February 2014, the Medicines and Healthcare Products Regulatory Agency ("MHRA") circulated to interested parties certain proposals for amendments to medicines legislation, which would effectively simplify the information required to be included in some advertisements to prescribers and suppliers of medicines. These changes would only apply in respect of healthcare professionals and other medicines retailers and not to members of the public. The MHRA proposes that in respect of certain products, a pointer to the detailed prescribing information be provided as opposed to the information itself.
At present, in accordance with Article 91 of Directive 2001/83/EC, certain essential information including a summary of the product characteristics, indications for use, dosage and contraindications, safety precautions and side effects ("Prescribing Information") must be displayed as a small section across the lower part of a journal advertisement or the promotional medium being used. The proposals reflect the considerable costs incurred by the industry in printing and re-printing the Prescribing Information in light of updates. These costs have been estimated by the MHRA at just under £1,000,000 annually.
For general sale list medicines, it has been suggested that it may be sufficient to include a pointer to a website where the full SPC information can be found if needed, rather that including the Prescribing Information. Also, in light of products which may avail to the abbreviated advertisement format, it has been proposed that they may adopt the pointer format after two years, as pharmacists become more familiar with the OTC use of the product.
The MHRA is seeking the views of interested parties on queries relating to the proposed changes which can be tendered here and which must be submitted by 22 April 2014.