Answers - Legal

Now that you have bought your property in the Languedoc,and are thinking of turning it into a Gite, you may consider having a swimming pool to attract more income and more clients into your Gite. Here are the laws surrounding swimming pools.

Everyone should be aware of the law governing pool security in France. It is the law and despite many arguments ag

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ainst it, all in-ground pools in France must now have one of the four approved methods of security system in place. The fine for not complying with the law is ?45,000.

Above-ground or semi in-ground pools are not affected by the law and normally just rely on a security ladder or one that gets taken away when the pool is not in use.

The law has been speci

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

fically put in place to protect children under five years old but anyone with children will understand that no security device, no matter how well approved can replace the vigilance of a responsible adult at all times.

The law was originally passed on Jan 1 2003. To comply with the law, the standards for pool security systems have been set by AFNOR (the b

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ody responsible for French safety standards) so that any method of security fitted must conform to the specifications set out in each category of security device.

There are four types of approved security system:

1. Security Barriers, AFNOR standard: NF P 90-306.
2. Pool Alarms, AFNOR standard: NF P 90-307.
3. Pool Covers, AFNOR standard: NF P

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

90-308.
4. Pool Abris, AFNOR standard: NF P 90-309.

Any security device can either be self certificated by the manufacturer who declares that it has made the system in accordance with the AFNOR standard, or certificated by the manufacturer and also certified and tested by the LNE (Laboritoire National d'Essai). Any device tested by the LNE will be g

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

iven its own certification number, it's considered to be homologated (agreed to) and will carry the NF mark.

1 Security barriers
There are dozens of types of pool security fencing now available in France. There are flexible mesh barriers, metal barriers, UPVC barriers, Perspex and transparent PVC panelled barriers and wooden fences. Although not eve

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ryone's cup of tea, a barrier is one of the best options for pool security.

Note that no natural boundaries can be considered as a security barrier eg: hedges, banks, ditches etc. Neither will any other sort of fencing not specifically made as a pool security system, no matter how impenetrable it is.

For collective usage pools (pools used by more than on

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

e family) particularly gites, campsites and so on, there must be a self-closing, self-latching gate which opens outwards away from the pool. Most systems available have this type of gate as standard.

For private pools a barrier system can be fitted with a manually operated gate, but it makes sense if you are going to have a go, to fit a child-proof latch,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

as high as you can out of reach of little ones.

The main advantage of a barrier is that it needs very little maintenance or testing, so once it's installed you can pretty much forget about it. As long as any gate fitted is tested occasionally, it doesn't rely on anyone else doing anything apart from opening the gate.

Another option for a barrier is of c

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ourse, a wall. There are important parts of the standard that must be adhered to, the most important of these is the barrier must be further than 1m from the edge of a pool, and be over 1.10m high. There must also be no foot holds so natural stone walls are not legal, but a smooth rendered wall is quite acceptable.

The AFNOR standard also states that the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

barrier must not be so far away from the pool so as to be ineffective, in other words if you fit a wall all around your property it won't be deemed as secure as the house is inside the protected area. This all gets very complicated and in many cases the best thing to do is protect the pool area only and make it a designated area for swimming only.

Another

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

great advantage of a wall is that it will keep a lot of debris out of the water and it really does define the pool area.

One disadvantage is that it does reduce visibility from outside the pool.

2 Pool alarms
Alarms come in two main types, immersion detector or perimeter alarm. The immersion detector senses a fall into the pool and then must activ

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ate within 12 seconds. The perimeter alarm works by infra red beams, when broken the alarm sounds. These systems, although approved, are not the best option for pool security and are best used in conjunction with another approved device.

There are many downsides to using an alarm system: some alarms require wristbands or keys to be worn by swimmers, other

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

s need a code to be entered which disarms the alarm while people swim. They don't work under a cover so need to be removed if you want to winterise your pool.

There are also some grey areas. Alarms must be tested monthly, they are susceptible to false alarms and the AFNOR standards state that a responsible adult must be able to respond to an alarm in less

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

than three minutes. Although a five year old should have an adult with them at all times, if they don't and there is a fatality, ultimately the responsibility lies with the pool owner.

The only benefit is cost. But the cheapest option is very rarely the best one.

3 Pool covers
As with the other options, there are lots of different security covers

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

available, so the main thing to remember is that whichever sort of cover you choose, it must be put back on whenever your pool is left unattended, so a cover which is easy to put on and take off is important, especially if you expect anyone else using the pool to put the cover on when they aren't using it.

Any cover used to winterise your pool must also b

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

e AFNOR approved (unless you have an alternative form of security),so if your cover is more than three years old the chances are that it won't be approved and will need changing.

There are covers which do the job of a security system, summer and winter cover and are even available solar or mains powered so all you have to do is turn a key to operate them.

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

4 Pool abris
An abri looks a bit like a greenhouse and they are available in many shapes and sizes, fixed or telescopic. Apart from the price, (this is about the most expensive option) there are many advantages. As well as it being an approved security device, it will help heat the water in your pool, keep out debris, reduce chemical usage and evap

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

oration, and if you heat your pool, it effectively turns it into an indoor pool you can use all year round.

The main disadvantage to fitting an abris is the cost. A low fixed abri, although cheaper, doesn't give a lot of room underneath and some people find them claustrophobic: high abris, normally up to 3m tall give plenty of space but also need a great

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

deal of room to install them.

Whichever system you choose, it should be practical and easy to use, and your local pool professional should be able to advise you on the pros and cons of each system and discuss the suitability of each system in your particular application.

(You are advised to get Professional opinion on the Law for swimming pools in France

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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