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Marketing Authorisation – Medicinal Products

Marketing Authorisation: Medicinal Products The case of R (on the application of Merck Sharp and Dohme Ltd) v Licensing Authority [2005], concerned the application for marketing authorisation for a generic product which was based on Product C (see below).

The claimant had marketing authorisations for three medicinal products used in the treatment of osteoporosis and three generic companies sought marketing authorisation for Product C.

Product A – was authorised by the European Community in 1993;

Product B – was authorised in 2000

Product C – was a generic product based on Product B (a copy of Product B).

When a company applies for marketing authorisation for a product, it is a requirement under the European Parliament and Council Directive (EC) 2001/83 (the “Directive”), to supply a full set of data in order to show the safety and efficacy of the product.

There are instances under the Directive when an applicant can simply rely on data submitted in respect of a previously authorised product. For instance, the applicant could refer to data already submitted in respect of a product with marketing authorisation, where the applicant is seeking authorisation for a product ‘essentially similar’ to a product holding a marketing authorisation for ten years (as per the United Kingdom and pursuant to art 10(i)(a)(iii) of the Directive).

In seeking marketing authorisation for Product C, the generic companies relied on data submitted in relation to Product A and Product B. However, although Product A and Product B contained the same active ingredient, they were not ‘essentially similar’ within the meaning of the Directive. This meant that they differed in respect of their posology (the schedule of dosage). The defendant accepted that the generic companies did not have to provide any further data but the claimant argued that such an approach was unlawful and in breach of the Directive. The claimant made a reference to the European Court of Justice (“Court of Justice”).

The claimant contended that the issue was as yet unresolved by the rules laid down in previous decisions of the ECJ. In particular, it was argued, that there had been no cases where a difference in posology had been the subject of a decision.

The application was dismissed. The ECJ held that:

The principles laid down by the ECJ in earlier decisions were clearly applicable in this case and there was no uncertainty;

Although it was true that a change in posology had not previously been the subject of a decision, it was for the ECJ to interpret the EC Treaty and the relevant principles by which it was to be interpreted, and for the domestic court to apply those principles to the particular case.
No new principles arose in the instant case.

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© RT COOPERS, 2005. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.

What Are The Added Features You Can Get With New Car Stereo Systems?

Bluetooth capability

Bluetooth capabilities allow you to seamlessly stream music and calls from your phone directly through the stereo system. This not only allows you to keep your eyes on the road while driving, but it also keeps you safer. Many car accidents are caused by people who aren’t paying attention because they’re distracted with their phones. When you are looking for cars for sale in Wellington, make sure that the car stereo installed in it has this very useful feature.

DVD playback

DVD Playback is another option you get in newer car stereo models. This gives you the luxury of enjoying your favourite movies while in transit. It is great for long road trips, and helps keep kids entertained while on the road.

Satellite radio

While older models of car stereo had only AM/FM radio, these days you can actually listen to satellite radio. Satellite radio is a great option because there are no commercials and you can get your favourite music, talk shows, or even the latest news reports while on the road. Satellite radio connects you to a large network of stations across the country, so you are sure to find one that suits your tastes.

CD player with MP3 compatibility

If you love music then the CD player with MP3 compatibility is a must. This will give you the ability to listen to your favourite CDs, as well as play downloaded music files from your phone or other device like an iPod. Many newer cars come equipped with USB ports and auxiliary jacks so you can plug in any number of devices and enjoy all the music you want.

USB port for iPod/iPhone connectivity and charging

USB ports are a great accessory to have in your car, and they come in handy for a variety of reasons. For example, many newer cars have USB ports built into the dash that allow you to connect your iPod or iPhone and play music directly through the stereo system. You can also use USB ports to charge your phone while you are driving, which is a great way to stay connected and keep your battery from dying.

Auxiliary input jack for connecting other devices such as a gaming system or MP3 player to the car stereo system

An auxiliary input is another great accessory that comes with many new car stereo systems. You can connect nearly any device to it and play your favourite music through the system’s speakers. This includes MP3 players, gaming devices, DVD players or virtually anything you have at home that has an auxiliary input jack on it.

The latest car stereo systems offer more than just music

With newer models of car stereos, you don’t just get music. You also get a variety of other features that can make your driving experience better. These features can include GPS navigation and hands-free calling, among many others. They have been built to make your life easier while you are on the go.

You can use your phone to access the internet, make calls, and send texts while you are on the road

Some systems can even be synced with your phone so that you can use it to control various functions of your car stereo. With just a few taps on the screen of your phone, you can do things like change the song that is playing, make or answer calls, and send text messages. This can be really helpful if you need to stay connected while you are driving.

As an added bonus, many newer systems also come with built-in Wi-Fi hotspots. This means that you can access the internet without having to rely on your data plan or find a public Wi-Fi network. You can simply hop on the internet whenever you need to by using the hotspot feature of your car stereo system.

Car stereos have a wide range of features that improve safety and convenience

The safety features of these newer models of car stereos can really be life-saving. For example, many car stereos now come with built-in collision detectors. This means that if you get into an accident, the stereo will automatically contact emergency services and provide them with your location.

In addition to safety features, car stereos also offer a wide range of convenience features. For instance, many newer models allow you to control various functions of your car from the stereo itself. This includes things like turning on the lights or unlocking the doors.

So, if you are looking for a way to improve both the safety and convenience of your driving experience, upgrading to a new high-end car stereo system is definitely a step in the right direction.

There are many different types of car stereos for any budget or driving style

There are many different types and models of car stereos on the market these days, so no matter what your budget or driving style is, you are sure to find a stereo that is perfect for you.

If you are looking for a high-end system with all the bells and whistles, there are plenty of options available. These systems typically offer features like touch screens, DVD players, Bluetooth connectivity, and more.

However, if you are on a tighter budget, don’t worry, there are also plenty of affordable car stereos out there that still offer great sound quality and a wide range of features. So, no matter what your needs are, you will be able to find a stereo system that is perfect for you.

When buying a new car stereo however, make sure that the vendor also provides services such as car stereo installation in Wellington as well as upgrade offers which will come in handy.