Adverse Drug Reporting (ADR) text, Yellow Card Scheme Update Deadline 30 June 2015

All MA holders have a responsibility to ensure that all of their products are updated to include the Yellow Card information and website reporting link, the deadline to make this submission to the MHRA is 30 June 2015 (1) for both mutually recognised and national MAs.

Summary of Product Characteristics wording (2)

For ALL medicinal products:
The following sub-heading should appear at the end of section 4.8
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Patient Information Leaflet wording

For ALL medicinal products:
The following sub-heading should appear at the end of section 4
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

N.B The specific healthcare professional can be omitted if the medicine will never be given in that setting.

(1) Deadline stated Q25.
http://webarchive.nationalarchives.gov.uk/20130922173433/http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatientinformationleafletsandpackaging/Frequentlyaskedquestions/index.htm

(2) Yellow Card information.
http://webarchive.nationalarchives.gov.uk/20130922173433/http://www.mhra.gov.uk/SearchHelp/Sitemap/index.htm