Secure medicine supply a pillar of MHRA's 2015-16 plans

The UK medicines regulator says the implementation of EU legislation on falsified medicines will be a major pillar of its workload in the coming year.

The Medicines and Healthcare products Regulatory Agency (MHRA) says in its Business Plan document for 2015-16 that it wants to implement the requirements of the Falsified Medicines Directive "in a timely and proportionate manner."

The next inflection point in the implementation of the FMD will be the adoption of the delegated act on safety features - expected imminently - setting the clock ticking on a three-year deadline for pharma companies to start adding 2D barcode-based unique identifiers and tamper evidence to their product packages.

The MHRA says it expects the delegated act to be enacted by "end quarter three" with subsequent "ongoing implementation to 2019."
 
The agency also pledges to continue to collaborate with international stakeholders on a safe and secure supply chain for medicines, for example by contributing to the development of Good Manufacturing Practices (GMP) with the International Coalition of Medicines Regulatory Authorities (ICMRA) and "developing a strategic threat assessment to the medical products supply chain."

The business plan notes that the MHRA is however facing a reduction in funding and resources that are forcing it to reduce headcount by 125 over the next three years and trim costs.

"Although the UK economy continues to show signs of recovery, money remains tight and the agency’s financial position is getting more challenging," it says.