We at the PCA have just been notified by the MCA of the following
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals which will impact on the distribution of prescription and pharmacy only medicines within 'Category C first aid kits' found on board a wide range of vessels and within Liferafts. The consultation is related to the Falsified Medicines Directive 2011/62/EU.
The implication of the proposals would mean that service stations and chandleries selling CAT C first aid kits to commercial organisations (Masters or Companies) will require a "wholesalers dealer’s licence" due to the prescription and pharmacy only medicines within the kits.
The consultation period is only for four weeks and ends on the 19th November. Im afraid I have been away and just returned today so have only just seen this.
MCA have met with the MHRA, so they are aware of the possible impact on the maritime industry. However, the consultation documents do not include information on the effects on the supply of medical stores to ships.
If you believe this may impact on your business and the ability to comply with the coding requirements then please read the public consultation and make some reasoned responses to MHRA
This is a very short consultation period until 19-11-12-If you have concerns about the impact of the proposals on your business or on their ability to comply with the medical stores requirements, you may wish to respond to the consultation exercise.
This will also affect your suppliers like, OceanSafety, Viking, Adec etc etc. If they need licenses then up goes the price or we have to buy the medicines required from other outlets to put in kits