Other Statutory Information

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.

Statutory Label Requirements

(Article 54 of Council Directive 2001/83/EC)

  1. The name of the product, followed by strength and pharmaceutical form and, if appropriate, if it is intended for babies, children or adults. Where the product contains up to three active substances, the INN shall be included or if one does not exist, the common name.
  2. A statement of the active ingredients of the product expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using the common names of the ingredients.
  3. The pharmaceutical form of the product and the contents of the product by weight, by volume or by number of doses of the product.
  4. A list of excipients known to have a recognised action or effect and included in the detailed guidance published under Article 65 of the Directive. However, if the product is injectable or a topical or eye preparation, all excipients must be stated.
  5. The method and, if necessary, the route of administration of the product.
  6. A special warning that the product must be stored out of sight and reach of children.
  7. Any special warnings required by the product licence for the product concerned.
  8. The expiry date of the product (stating the month and year) in clear terms.
  9. Any special storage precautions for the product.
  10. Any special precautions for the disposal of any unused products or waste materials derived from such products.
  11. The name and address of the holder of the Marketing Authorisation.
  12. The number of the Marketing Authorisation – in the UK, this is preceded by the letters PL.
  13. The manufacturer’s batch reference.
  14. Where a product is intended for self medication, any instruction on the use of the product. For OTC medicines, this includes the authorised indications.

Additional information which may be included on medicine labels pursuant to Article 62 of Council Directive 2001/83/EC:

  • Symbols or pictograms designed to clarify certain information
  • Other information compatible with the SmPC, which is useful for the patient, to the exclusion of any element of a promotional nature.

Braille

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.

Batch number and expiry date

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.

Small containers

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.

  • The name of the medicinal product (as laid down in point (a) of Article 54, and, if necessary, the route of administration)
  • The method of administration
  • The expiry date
  • The batch number
  • The content by weight, by volume or by unit

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:

  • PL number
  • The MA holder’s name

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”.

Warnings

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.

Registered Traditional Herbal Medicines (THM’s)

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.

THR certification mark

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.

Statutory warnings

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.

Required statutory warnings and the conditions which apply:

  • Warning: Do not exceed the stated dose – for Pharmacy Only (P) medicines where the product would be prescription only if it contained a higher proportion of the active ingredient unless it is an antihistamine or for external use (e.g. ibuprofen, codeine, paracetamol). This should be placed adjacent to the directions for use or the recommended dosage and should be in a box.
  • Warning: Asthmatics should consult their doctor before using this product – for Pharmacy Only (P) medicines and where the product is for asthma, bronchial spasm or contains ephedrine (or its salts), e.g. theophylline, aminophylline. This statement must appear in a box.
  • Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink – for Pharmacy Only (P) medicines and General Sales List (GSL) products which contain sedating antihistamines, unless they are for external use (e.g. chlorpheniramine, diphenhydramine). This statement must appear in a box.
  • For external use only – the product is for external use only and is an embrocation, liniment, lotion, cream, liquid antiseptic or other liquid preparation or gel. Where the medicine is a Pharmacy Only (P) medicine, this statement must appear in a box.
  • Either: Not to be used in babies. Or: A warning that the product is not to be administered to children under two years, except on medical advice – if the product contains hexachlorophene. This statement must appear in a box.
  • If symptoms persist, consult your doctor – if the product contains aspirin, aloxiprin or paracetamol.
    Contains aspirin – if the product contains aspirin, unless the product name includes “aspirin” or the product is for external use. This wording must appear in a box and must be placed prominently on the packaging.
  • Contains an aspirin derivative – if the product contains aloxiprin. This wording must appear in a box and must be placed prominently on the packaging.
  • Do not give to children aged under 16 years, unless on the advice of a doctor – if the product contains aspirin or aloxiprin.
  • There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason, aspirin should not be given to children aged under 16 years, unless on the advice of a doctor – if the product contains aspirin or aloxiprin, these statements must be included on the label where a PIL is NOT separately available.
  • Contains paracetamol – where the product contains paracetamol, unless this forms part of the product name. This wording must appear in a box and must be placed prominently on the packaging.
    Do not give with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the child seems well – for paracetamol-containing products intended principally for children aged 12 years and younger where a PIL is separately available. This statement must appear prominently on the packaging in a box.
  • Do not give with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage – for inclusion on the label of paracetamol-containing products intended principally for children aged 12 years and younger where a PIL is NOT separately available. This statement must appear prominently on the packaging in a box.
  • Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well – for paracetamol-containing products intended principally for adults and children aged 12 years and over where a PIL is separately available. This statement must appear prominently on the packaging within a box.
  • Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage – for inclusion on the label of paracetamol-containing products intended principally for adults and children aged 12 years and over where a PIL is NOT separately available. This statement must appear prominently on the packaging in a box.
  • P – for medicines which are available as Pharmacy Only. The P must appear in a box in which there is no other text.

OTC medicines containing codeine and dihydrocodeine

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:

SmPCs - Section 1

Sections of the SPC relevant to this section of the Code of Practice are:

Braille

Section 1
Name of medicinal product