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    New law strengthens punishment for assaulting health sector workers

    Friday, 27 July 2018 16:08
  • Home Office gives go ahead to allow cannabis-derived medicinal products on prescription

    Home Office gives go ahead to allow cannabis-derived medicinal products on prescription

    Friday, 27 July 2018 15:58
  • Review on prescribed medicines sets out scope and terms of reference

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    Tuesday, 24 July 2018 12:30
  • AMs recommend that pharmacists have access to palliative care data in Wales

    AMs recommend that pharmacists have access to palliative care data in Wales

    Wednesday, 18 July 2018 17:41
  • APTUK questions claims about pharmacy technicians’ desire to supervise medicines supplies

    APTUK questions claims about pharmacy technicians’ desire to supervise medicines supplies

    Wednesday, 18 July 2018 17:17

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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pills4April 25 2016

Medicines marketing authorisations will require medicines packaging to comply with the European safety features legislation from this month. New products will be among the first to feature the additional requirements to allow traceability of a medicine through the supply chain.

The medicines regulator, the MHRA, has updated it guidance on medicines packaging, labelling and patient information leaflets to reflect the new safety requirments. Products will have to bear a unique identifier - a 2D data matrix code and human readable information - and tamper evident features on the pack.

All medicines will have to meet the requirements from February 2019, allowing manufacturers to phase in new packaging for existing products over the next three years. However, from now on, any new marketing authorisations will have to comply from their launch.

The MHRA guidance discusses how the legislation will apply to products depending on whether the tamper evident feature is on the outer packaging or on the immediate packaging affecting the container-closer system.

It also points out that the unique identifier will comprise:

  • a product code which allows the identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type
  • a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated
  • a batch number
  • an expiry date.

“MHRA, the Department of Health and the Devolved Administrations will continue to work with the European Commission and other member states on implementation plans for the new regulation. We will also be working with stakeholders throughout the supply chain to secure implementation within the three years,” said the MHRA. “Further guidance will be published as it becomes available.”

Link:

MHRA ‘Medicines: packaging, labelling and patient information leaflets’ guidance

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