Labelling must contain all elements required by Article 54 of Council Directive 2001/83/EEC.
By 30 October 2010, all medicine packs must include the name of the product in Braille to allow clear identification of the medicine by blind people who read Braille.
This Code of Practice should be read alongside the legislative requirements as set out in Council Directive 2001/83/EC, Article 54. The outer packaging of medicinal products is required to include the information set out below. It is a legal requirement for companies to submit full colour actual size mock-ups of packaging to the MHRA as part of an application for a Marketing Authorisation, a variation to an existing Marketing Authorisation which affects the information on the label or an application or notification submitted under Article 61(3) of Council Directive 2001/83/EC to propose changes to the label not impacting on the SmPC.
By 30 October 2010, all medicine packs must include the name of the product in Braille to allow clear identification of the medicine by visually impaired people who read Braille. There is no requirement to include Braille in the critical health information panel nor is it necessary to add the Braille to an otherwise clear part of the pack, but it is essential that the Braille does not obscure information for sighted people. The information presented in Braille may appear on more than one face of the packaging, provided it is presented logically.
Guidance on Braille requirements has been issued by the European Commission. Separately, the MHRA has prepared a series of Q and As and additional practical guidance for Marketing Authorisation holders to aid compliance with this requirement.
For further information, please click here.
The batch number and expiry date need not appear in the critical health information panel.
The expiry date should be written in clear unambiguous terms. The date printed on medicines labels should be taken to mean the last day of that month. For example “use before March 10” would mean that the product expires on 28 February 2010. Similarly “expires March 10” would mean that the product expires on 31 March 2010. Where possible, this should be printed on packaging for clarity, rather than embossed.
Where the labelling requirements of Article 54 of the Council Directive 2001/83/EEC cannot be legibly applied to a container, the requirements of Article 55(3) should be applied.
The criteria for small container status would normally be considered to apply to containers with a nominal volume of 10ml or less.
The following particulars at least shall appear on small immediate packaging units.
In addition to the above requirements, for traceability purposes, the MHRA recommends that the following additional information is included on the labelling of small containers:
For further information regarding criteria for small container status, please refer to the MHRA guidance document “Best practice guidance on labelling and packaging of medicines”.
The warnings which are specifically required to be on the labelling by the terms of the Marketing Authorisation must be included in the critical health information panel. The terminology used for some ingredients set out in regulations (see the Other Statutory Information section). Other warnings are agreed through the Marketing Authorisation and need to be taken into account on a case-by-case basis. Where warnings are agreed for a class of products these will be included in the Other Statutory Information section.
The labelling of THM’s should meet the requirements of Articles 54 to 65 of Directive 2001/83/EC (as amended by directive 2004/27/EC).
Labelling for products with a traditional use registration will be required to include information and instructions about the safe use of the product, as with any licensed medicine. In addition, it will also need to be made clear to the consumer that the indications are based on information obtained from long-standing use and experience.
The following wording would be considered to be acceptable.
“Traditional herbal medicinal product used to relieve (condition) exclusively based upon long-standing use”.
There will also need to be advice that the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
The THR certification mark is a type of trademark that indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.
The Certification Mark is owned by the MHRA and can only be used by those companies granted a THR for their traditional herbal medicinal products. Permission to use the THR Certification Mark would normally be granted as part of the THR registration process.
For further details about the use of the Certification Mark please visit the MHRA’s website. Click here.
In the UK, there are additional statutory warnings required in certain circumstances for some medicines available over-the-counter. These are set out below. Other medicines may have additional label warnings added as a condition of the Marketing Authorisation. These are not included here and MA holders should refer to the details of their Marketing Authorisation for specific requirements.
For information on the development of artwork for OTC medicines containing codeine and dihydrocodeine, please refer to the MHRA’s guidance document “Guidance on the development of artwork in relation to medicines containing codeine and dihydrocodeine” which can be accessed via the following link: