Key Facts

• The amendment seeks to require the Secretary of State to publish a fees regime within three months of Royal Assent.
• Current fees for human medicines are subject to consultation, published online at gov.uk, and reviewed regularly by the MHRA.
• New fee proposals will continue to be subject to consultation and approval from HM Treasury.
• Clause 8 provides power to amend or supplement the Veterinary Medicines Regulations 2013.
• The clause ensures that the appropriate authority must have regard to the availability of veterinary medicines throughout the supply chain.
• The amendment seeks to add 'services' after 'the availability of veterinary medicines'.
• New clause requires an assessment of veterinary industry capacity within 12 months.
• Government is working with stakeholders on veterinary resourcing needs.
• DEFRA has secured a place for the veterinary profession on the Home Office shortage occupation list.
• The cascade allows veterinary surgeons to prescribe human medicines for animals if appropriate conventional animal medicines are unavailable.
• The Veterinary Medicines Regulations 2013 set out provisions regarding the prescribing cascade.
• Clause 9(1) of the Bill confers discretionary powers to update regulations related to the cascade when it is necessary.
• Clause 9(1) of the Medicines and Medical Devices Bill allows amendments to the Veterinary Medicines Regulations 2013.
• The clause covers manufacturing, importation, distribution, marketing authorisations, active substances supply, internet sales regulation, administration conditions, notification requirements, labelling, advertising, and animal test certificates.
• Subsection (h) could make the voluntary UK-based internet retailer accreditation scheme mandatory to provide assurance for UK customers.
• The Veterinary Medicines Directorate (VMD) is required to recover costs from fees and charges.
• Clause 10 enables changes to existing fees or introduction of new fees to cover regulatory functions.
• Breaches of requirements introduced under clause 8(1) may be made criminal offences punishable by up to two years imprisonment.
• Amendment 15 seeks to add 'the environmental sustainability of medical devices' as a factor for consideration.
• The Environmental Permitting (England and Wales) Regulations 2016 already exist to address environmental concerns.
• Baroness Cumberlege’s report on medical devices will be released on 8 July.
• Amendment 16 is proposed in clause 13.
• The amendment aims to keep the medical device market aligned with UK medical needs.
• Medical devices are subject to changing regulations post-Brexit.
• Manufacturers based outside the UK must designate a UK representative.
• Clause 13(1)(h) empowers the Secretary of State to create a device register.
• The register would hold information about medical devices available for sale in the UK market, including non-UK manufacturers.
• Clause 13 enables changes to regulatory requirements for manufacturing, marketing, and supply of medical devices.
• The clause provides for the creation of a register by the MHRA containing information about devices available on the UK market.
• Regulations can refer to international agreements or standards for marketing or supplying medical devices.