Labelling of medicines
Regulation, guidelines, and major reports
A guide to labelling and packaging of injectable medicines. Link pdf-file From the National Patient Safety Agency in UK. May 2008
Information design for patient safety Link pdf-file pdf-file second edition by designer Thea Swayne gives guidance on the design of prescription medicine packs— 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.'
Medicines and Healthcare Products Regulatory Agency (MHRA) in UK has published guidelines on naming products in umbrella sectors, March 2004. pdf-file Link What is umbrella branding?
FDA Rule Requires Bar Codes on Drugs and Blood, February 25, 2004. FDA fact sheet. The requirement.
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.
Internet URL or pdf file. Foreword
Communication Research Institute of Australia issues
Designing medicine labels for people; a Code of practice for designing usable labels for non-prescription medicines.
Best Practice Guidance on the Labelling and Packaging of Medicines. Internet URL or pdf file. Issued by MCA, Medicines Control Agency in UK, March 2003. My comments.
FIP Guidelines for the labels of prescribed medicines. Internet URL or Word document. Issued at the FIP Congress in Singapore September 2001.
Directive 2001/83/EC. pdf file The main EU regulation document. Definitions in article 1. Labelling in articles 54-69.
Directive 2004/27/EC. pdf file Supplementary to 2001/83/EC. The two have to be read parallel to each other. About package leaflet templates, see Karel van der Warde's important comments.
Main European Union Product Information Guidelines
Note:
- National guidelines may be different.
- There are additional guidelines and draft guidelines on specific topics.
Guideline on Summary of Product
Characteristics:
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:
http://pharmacos.eudra.org/F2/eudralex/vol-3/pdfs-en/3bc7aen.pdf
Product information templates and QRD reference documents providing guidance on various aspects concerning terminology and style:
http://www.emea.eu.int/htms/human/qrd/qrdintro.htm
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
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/bluebox_03_2005.pdf pdf-file
Main US Product information guidelines and regulations
Labeling-related sections of the Code of Federal Regulations (look under 201 and 208, in particular):
http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfrv4_03.html
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
Guides:
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)
http://www.fda.gov/cder/guidance/index.htm
last revision 14122003