Clause 11 Marketing Authorisation and Temporary Supply Authorisation

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Clause 11
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11.1

A medicine must not be promoted prior to the grant of the marketing authorisation which permits its sale or supply subject to the provisions of Clause 11.3 below.

  • Clause 11.1 Conditional Marketing Authorisation

    If a medicine has been granted a conditional marketing authorisation then it can be promoted in accordance with the terms of that licence and is considered to meet the definition of a medicine. Material should clearly state at the outset that the medicine has a conditional marketing authorisation.

    Relevant information should be added wherever possible to national horizon scanning databases.

  • Clause 11.1 Early Access to Medicines Scheme (EAMS)

    Medicines that are approved under the EAMS meet one of the following two conditions. Either the medicine does not have a marketing authorisation or the medicine has a marketing authorisation but no licence for the specific indication. Medicines or indications that are approved for EAMS must therefore not be promoted.

    Relevant information should be added wherever possible to national horizon scanning databases.

  • Clause 11.1 Compassionate Use

    Companies may provide an unlicensed medicine or a medicine for use in an unlicensed indication on a compassionate use basis for those with an unmet medical need. Such availability is for companies to decide in line with relevant requirements. If the medicine does not have a relevant marketing authorisation, then it cannot be promoted.

  • Clause 11.1 Promotion at International Events/Meetings

    Promotion at international events/meetings held in the UK may, on occasion, pose certain problems with regard to medicines or indications for medicines which do not have a marketing authorisation in the UK although they are so authorised in another major developed country.

    The display and provision of promotional material for such medicines is permitted at international events/meetings in the UK provided that the following conditions are met:

    • the event/meeting must be truly international, of high scientific standing and with a significant proportion of the attendees from countries outside the UK in which the product is licensed

    • the medicine or indication must be relevant and proportional to the purpose of the event/meeting

    • promotional material for a medicine or indication that does not have a UK marketing authorisation must be clearly and prominently labelled to that effect

    • in relation to an unlicensed indication, UK approved prescribing information must be readily available for a medicine authorised in the UK even though it will not refer to the unlicensed indication

    • the names must be given of countries in which the medicine or indication is authorised which must include at least one major developed country; and it must be stated that registration conditions differ from country to country

    • the material is certified in accordance with Clause 8, except that the signatories need certify only that in their belief, the material is a fair and truthful presentation of the facts about the medicine.

11.2

The promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics subject to the provisions of Clause 11.3 below.

11.3

A medicine with a temporary supply authorisation must not be promoted unless it is part of a campaign that has been approved by the health ministers.

  • Clause 11.3 Temporary Authorisation for Sale or Supply Without a Marketing Authorisation

    In response to certain types of public health emergency, under UK law, the licensing authority may temporarily authorise the sale or supply of a medicine without a marketing authorisation. This might apply to medicines without UK marketing authorisations or indications without UK marketing authorisations. The campaign must be approved by the health ministers, and all relevant requirements of the Code will apply. If there is no marketing authorisation, then the requirement for inclusion of the marketing authorisation number in the prescribing information will not apply. The name and address of the holder of the temporary authorisation or the business name and address of the part of the holder’s business that is responsible for its sale or supply must be given in addition to the name and address of the marketing authorisation holder where there is one. Companies should contact the MHRA for information regarding approval of materials and activities.