Labelling of medicines
Regulation, guidelines, and major reports
Information design for patient safety Link pdf-file pdf-file second edition by designer Thea Swayne gives guidance on the design of prescription medicine packsó including blister packs and all types of secondary packaging. The book is the result of a collaboration by the National Patient Safety Agency, the Helen Hamlyn Research Centre and the Royal College of Art in UK.
Medicines and Healthcare Products Regulatory Agency (MHRA) in UK has published a report:
'Always read the leaflet - getting the best information with every medicine.'
Design for patient safety. A report issued by the Departement of Health and the Design Council, UK. February 25, 2004. Abstract pdf-file Link More than medicine labels - look at the illustrations and think !!
Building a safer NHS for patients Improving Medication Safety.
A report by the Chief Pharmaceutical Officer (United Kingdom). January 22, 2004.
Communication Research Institute of Australia issues
Designing medicine labels for people; a Code of practice for designing usable labels for non-prescription medicines.
Main European Union Product Information Guidelines
- National guidelines may be different.
- There are additional guidelines and draft guidelines on specific topics.
Guideline on Summary of Product
Guideline on the packaging information of medicinal products for human use authorised by the Community (August 2002):http://pharmacos.eudra.org/F2/eudralex/vol-2/C/bluebox_082002.pdf
Guideline on the readability of the
label and package leaflet of medicinal product for human use:
Excipients in the Label and Package leaflet of Medicinal Products for Human Use:
Product information templates and QRD reference documents providing guidance on various aspects concerning terminology and style:
Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Community
Bluebox information - Bluebox is a blue frame within which the national pecularities are
Main US Product information guidelines and regulations
Labeling-related sections of the Code of Federal Regulations (look under 201 and 208, in particular):
FDA's December 2000 proposal to change content and format of US prescribing information ('Proposed Rule"):http://www.fda.gov/cber/rules/labelfrm.pdf
Content and format of Medication
Content and format of "Drug Facts" for Over The Counter medicines:http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr201.66.pdf
FDA's list of guidance documents (see "Labeling" and "Labeling (Draft)" section)
last revision 14122003