MHRA proposals to strengthen UK medicines distribution system
At the end of 2008 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a consultation paper setting out proposals for strengthening the UK medicines distribution chain and reducing the risk from counterfeit medicines. That consultation ran up to March 2009 and at the end of last year the Agency issued a second consultation paper making revised proposals in the light of the response to its first consultation.
At the end of 2008 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a consultation paper setting out proposals for strengthening the UK medicines distribution chain and reducing the risk from counterfeit medicines. That consultation ran up to March 2009 and at the end of last year the Agency issued a second consultation paper making revised proposals in the light of the response to its first consultation.
The new proposals, which are issued as MLX 365, cover a number of areas of activity where control will be strengthened. These include:
Requirements for applicants to be granted Wholesale Dealers' Licenses including a "fit and proper person" provision and requirement of disclosure by applicants of criminal records. Also there will be no £35,000 turnover concession regarding reduced fees for wholesale dealers" licences
Changes to the requirements for Responsible Persons (RPs) at wholesale dealers' premises including an approved training course for RPs and certification by examination of successful completion of that course. There will also be a register of RPs
Exemption from the necessity to hold a wholesale dealer's licence for exchange of medicines between pharmacies which would normally require such a licence will be restricted to certain circumstances. There will need to be public health grounds for doing so and such transfer may only be occasional, in small quantities (i.e. to meet an individual patient's needs) and not for profit. The circumstances meeting these criteria will be outlined in guidance.
Creation of new offences. There will be a new offence created of dealing with/trading in/brokering sales of counterfeit medicines. There will also be a new offence of trading of medicines by pharmacists without a wholesale dealer's licence.
The consultation period will run up to Friday 12 March2010 and will no doubt be the subject of much scrutiny between now and then. It is the Agency's intention to have the ensuing revised provisions agreed by April of this year.