The MHRA has recently received several enquiries related to the mention of vitamin C on product labelling for cough and cold products. Applicants are reminded that efficacy claims may only be made for this compound if it is declared as an active constituent and this will require supporting clinical evidence.
Article 62 of Council Directive 2001/83/EC permits the inclusion of additional information on the outer packaging and the package leaflet which is compatible with the summary of product characteristics, useful for the patient and non-promotional.
Under the current provisions, it is permissible for an applicant to include a factual statement that the product contains a particular excipient. For example, in the case of vitamin C a statement such as “This product also contains vitamin C, 50mg per dosage unit” would be allowable. However, this factual statement must be subordinate to the statutory information both in prominence and placement and must not appear as promotional. It may appear on either the front of pack or elsewhere, provided it is not confused with other statutory particulars.
Product names will not be permitted to include reference to vitamin C unless its efficacy is supported by clinical evidence, and similarly there can be no mention of vitamin C within straplines on medicines labelling.
Contacts for further information
For further information on marketing authorisation issues please contact Dr Andrew French on 020-7084 2479 and for information on labelling issues contact Mrs Jan MacDonald on 020-7084 2267 or e-mail info@mhra.gsi.gov.uk.
