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Old 31 October 2012, 11:39   #1
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Medical Cat C kits

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.

http://www.mhra.gov.uk/Publications/...MLXs/CON195906

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
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Old 31 October 2012, 12:31   #2
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I was amazed by how many tabs are in those sealed packs 600+, I noticed the pack that came with the boat had expired, so I disposed all the tabs and burn cream etc, everything that was individually dated tbh, but i've kept all the plasters bandages slings, they don't go out of date.. do they? and they pack the best scissors i've every used.
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Old 31 October 2012, 12:34   #3
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Yep, very similar, empty the out of date packs, pain killers to house/van for my use. All other items are kept aboard boats in tupperware boxes to be used if we need plasters etc. Saves breaking seals on Cat C kit just for a grazed knee etc.
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Old 31 October 2012, 12:45   #4
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Quote:
Originally Posted by C2 RIBS View Post
Yep, very similar, empty the out of date packs, pain killers to house/van for my use.
If there out of date tabs chuck em all, not worth messing with med stuff.
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Old 31 October 2012, 15:19   #5
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They been doing this since September last year! i was refused purchase of CAT C first aid kit.

I was told that I could supply to registered coded vessels if skipper filled in the correct paper.

regards

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Old 31 October 2012, 20:59   #6
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This goes WAAAY beyond needing to fill in proper paperwork for the supply. In Sep last year the kit manufacturers were required to have a wholesale dealer licence, and the onward installation by SOLAS liferaft servicers was pragmatically ignored by the MHRA. They restricted supply to others. That is ALL now changing...

If you want to supply the stuff you're gonna need a wholesale dealers licence - if you are supplying POMs, GSLs and Ps, and selling less than 35k of medicines (is that the whole Cat C kit or just the proportion that is a medicine(?)) costing a mere 2633. However thats the easy part! The harder part is you'd be expected to comply with GDP - which means they will come and inspect you and pull all your files appart for a day desperately trying to find something you forgot to document. You'll need things like temperature plots for where you store the medicines. If you store on more than one shelf they'll expect you to prove that every shelf is the same temperature. You'll need procedures galore, including procedures for if its too hot, too cold etc. Procedures for receipt, storage, stock rotation, managing counterfiet meds, self inspection. Not to mention youd need to contract the services of a responsible person(RP)... as I suspect the MHRA won't accept the supply of Cat C kits for the past X years as acceptable previous experience.

A question to ask would be about batch numbers. Cat C kits are sealed from my understanding. The new regulation will require you to document the batch number of each pack if its deemed at risk of counterfiet. Thats a pain to do if you have the loose packs... but impossible if the pack is sealed in an outer - unless you can record the BN of the outer. Since the outer isn't a medicine I'm not at all sure thats legal! (I'm not sure any of you Cat C meds would be at risk they are low value and non-abusable anyway). If anyone supplies more complex stuff then expect issues!

There are further implications for those of you who may supply via the net.
Unless I'm mistake the master of a ship (thats any vessel used for navigation [I assume coded but can't swear to that]) can still requisition medicines direct from a pharmacy. Although changes to wholesale dealing to community pharmacies may also have affected this summer. That said I think the standard Cat C stuff is all GSL/P so they can just walk in and buy it. I'm thinking you'll be supplying Cat C kits with no drugs in them and the drugs will come seperately from a pharmacy. Thats no great shakes for the kit on the boat but I can see it being a pain in the proverbial for a liferaft supplier/servicer.

Maybe SOLAS should review their requirement - keep the pack sizes small and the only thing I can see an issue with is the GTN spray... ...rest is available GSL in small packs I think. Always seemed odd that you'd have a GTN spray, but no salbuatmol inhaler or insulin/glucagon... someone at SOLAS clearly had angina!

C2 Ribs says the guidance affects Pharmacy and POM medicines. AFAIK it also affects GSL medicines.

Chandlers would still be able to sell kits (containing only GSL medicines in appropriate) to the general public from my understanding ;-)
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