New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
The new guidelines were developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and are intended to replace the 1968 Medicines Act and the 200 separate legal instruments in place at present with a simplified set of laws.
They also introduces some changes, including: the removal of warnings for over the counter (OTC) products, other than paracetamol ; a revision of the rules on review panels; changes to who can sell drugs; and how they can be distributed.
The Human Medicines Regulations also set out how new European Union legislation of Pharmacovigilance should be implemented.
MHRA Chief executive Professor Kent Woods, MHRA Chief Executive said: “These regulations will simplify 40 years of legislation, much of which has become outdated and fragmented.
“They will help ensure that medicines regulation is supported by a modern and straightforward legal framework, and provide a platform for further burden reduction initiatives through the MHRA’s Regulatory Excellence programme.”
The new rules were issued for industry consultation earlier this year and while the MHRA did receive responses from pharmaceutical manufacturers, it has not made any significant changes.
This includes the decision not to extend the rule that pharmacies and persons authorised to supply drugs “take all reasonable steps to ensure appropriate and continued supplies of the product” to require manufacturers to inform the Department of Health of any planned withdrawals of a product from the market.
In its response the MHRA said: “We do not believe that it is appropriate at this point to add the suggested obligations in this area. There are already legal obligations on manufacturer’s licence holders to help ensure continuous supply, and introducing the suggested obligation in the consultation responses would go beyond the requirements of Directive 2001/83/EC.”