Change Details Section (SmPC only)

Some emc users need to know exactly what has changed in an updated SmPC. For example NHS Medicines Information Pharmacists (UKMi) monitor SmPC changes in case they need to change the way medicines are used. You need to provide this information for every SmPC update, unless you are only correcting typos or the SmPC electronic presentation.

Important tips for this section

• Please give detailed, specific information about the SmPC changes.
• The information is displayed on the Latest medicine updates page, exactly as you enter it.
• Be consistent with your font type. Try to avoid italics as this can be difficult to read.
• Do not just enter a telephone contact number, which users can call for further details.
• Do not copy and paste the new SmPC section into the change details box, with no explanation or indication of the changes.
• Do not copy and paste the whole SmPC text. Just include the sections or the relevant paragraphs that have changed.

Good examples:

• In section 4.8 (undesirable effects), headache and rash have been added, and nausea removed.
• In section 6.3, the shelf-life has been changed from 2 to 3 years.
• This product was distributed by Company A. It is now distributed by Company B.
• A slow-release 15mg tablet has been introduced for this product.
• This product is now licensed for the treatment of rheumatoid arthritis.