The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use.
The first updated annex focussed the inclusion and declaration of all the excipients in the medicine’s labelling, which was not addressed earlier. The update also focusses on the safety of excipients usage on women and children.
The second updated annex focussed on including five new excipients (Boric acid, Cyclodextrins, Phosphate buffers, Sodium Laurilsulfate and Fragrances containing allergens) and new safety for the already existing ten excipients. The idea was to help the patients and healthcare professional to make conscious decision while prescribing the medicine.
The third update annex would take the comments received during public consultation for each excipient and would publish it in all the European languages with scientific report included.
The revised annex is applicable to both central and national authorised products.
The new product’s marketing authorization would be applicable from its day of publication. Whereas, for the already existing authorised medicine, the marketing authorisation should use the first authority to make amends to the wording and compliance with the updated annex.