Explanatory note

These Regulations contain measures regulating the importation and marketing of unlicensed medicinal products for human use in order to minimise the risk of the transmission of Transmissible Spongiform Encephalopathies via those products.

Regulation 2 prohibits the importation or marketing of unlicensed medicinal products for human use, apart from some exempt medicinal products such as herbal remedies and clinical trial products, unless they have been manufactured in accordance with the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products” as published and updated by the European Commission. There is a procedure for enabling the appropriate Minister (the Secretary of State or the Minister of Health, Social Services and Public Safety) to determine compliance with this Note for Guidance (regulation 3), and a notice procedure enabling the appropriate Minister to take action against non-compliant products (regulation 4). In cases where non-compliance has been determined, there is a procedure for revisiting the determination where the appropriate Minister is satisfied that there is new evidence of compliance (regulation 5).

If products are manufactured using materials to which the Note for Guidance applies, designated record-keepers for the products have to keep records of evidence of compliance for five years, or for one year after the expiry date of the product, whichever is the longer (regulation 6).

Local authorities are relieved of their responsibilities to enforce these Regulations, which are transferred in Great Britain to the Secretary of State, and in Northern Ireland to the Minister of Health, Social Services and Public Safety, and summary prosecutions for breach of regulation 2 may be commenced within twelve months (regulation 7).

These Regulations have been notified to the European Commission and to other Member States of the Community in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and rules on Information Society services^f1, as amended^f2. A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.