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.

If you require further information contact us.

Email: [email protected]

© 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.

Direct Sellers: LinkedIn for Business

The recent years have brought about the huge growth and popularity of social and business networking sites. Though people were skeptical in the beginning that these sites would really work, nowadays, most people and businesses have realized that these networking channels have opened up opportunities that had not been available in the past.

LinkedIn is the largest business networking site online, with over 120 million users and still growing. As a direct seller, you may have set up a profile with LinkedIn, and you may occasionally visit the site to keep updated with what’s happening, but are you really using this site to the best of your advantage? Have you realized the various ways you can use LinkedIn for building your business?

Though you may think that LinkedIn is great for increasing your sales, the real power of this business networking site is that it’s a powerful tool for building and maintaining relationships. Successful companies and entrepreneurs know the importance of networking in the world of business. And as the saying goes, sometimes it’s not what you know but who you know.

Here’s a step-by-step guide in using LinkedIn for Business:

1. Craft a Compelling Profile

Before you should go ahead with networking and using other LinkedIn features for building your business, it’s important to start with creating and crafting a compelling profile. A good profile will help you attract people’s attention, increase your visibility, and help you achieve better rankings in the search engines. As a direct seller, there’s a lot of value in achieving these three things.

Some quick tips for creating a compelling profile:

• Put up a professional-looking photo

• Make sure your professional headline really sums up what you do

• Take advantage of linking to your websites

• Include your work history and education

• Write a great summary of what you do

• Add a bit of personal information

• Complete your profile as much as you can

2. Form connections and build up your personal brand

Since LinkedIn is a social networking site specifically for professionals and business owners, the real power of it comes from the connections you form within it. After you’ve created an attractive profile, it’s now time to add people you know and connect with these people. This is the best way to build up your personal brand and increase your credibility.

To be truly successful in business, one of the most important things is to build trust. The more you form healthy connections and build relationships with people, the more people trust you.

Here are some tips for using LinkedIn to form connections and build your personal brand:

• Post status updates

• Comment, like and share other people’s status updates

• Contribute to Answers

• Contribute to Groups and participate in discussions

• Show off your expertise

3. Find people who can help you achieve your goals

As a direct seller, what exactly are your business goals? Do you want to increase sales, get new customers, acquire new partners, or generate new leads? It’s a good idea to be very specific with your goals.

After you’ve defined your business goals, you can now use LinkedIn to find people who can help you achieve these goals. The power of LinkedIn lies in the network you have.

When you think about it, the real value of LinkedIn actually comes from your 2nd and 3rd degree connections, not your 1stdegree ones. Your 1st degree connections are people you already know and interact with, but if you really want to take your business further, you need to network with people whom you don’t know but may be able to help you achieve your goals. And because LinkedIn easily shows the connections you have, you can ask the person you know to introduce you to the person they know who can help you. This is the best way to get their attention – through a mutual friend or acquaintance.

4. Harness the power of LinkedIn Groups

Perhaps the greatest value of using LinkedIn for your business is its Groups feature. Because here is where discussions happen, where people exchange ideas and information, and where relationships and connections really form.

Through LinkedIn Groups, you can ask questions and get valuable answers from the members. You can also answer questions to help you gain visibility and build credibility. Don’t try to do a sales pitch – this is not the platform for that. By providing really useful information, you increase people’s trust in you, which is more valuable.

Also, when you’re a member of a group, you can actually contact other members directly, even those not within your first, second, or third degree network. This can prove invaluable in business, since it’s all about forming connections and building relationships.

Truly, there’s a lot of value that LinkedIn can provide for your business. Once you really understand how to use this excellent platform, you can really take your direct selling business to new heights it has yet to reach. So if you haven’t gotten started, the right time to do so is now.

Network Marketing Vs Losing Your Shirt On Penny Stocks

Home based businesses come in many varieties such as network marketing (MLM or multi-level marketing), internet marketing, direct mail sales, and even stock investing. Some stock market gurus claim to have found the secret to making money with penny stocks. These are extremely inexpensive stocks with a cost of anywhere from a penny or less to a few dollars. It seems exciting to be able to buy and own 10,000 or 20,000 shares of a stock with the promise of it bringing in 2000 percent returns. It takes just a small cash outlay, and the potential for a profit may be quite large. However, unfounded potential and hope may be found everywhere. Perhaps the penny stock arena is one of the worst for creating broken dreams.

Penny stocks are cheap stocks, but they are not proven. They are start up companies with no track record. They have not shown that they can perform. They may be a train wreck waiting to happen with your money at stake. It is a gamble at best to buy penny stocks.

It is tempting to join the many penny stock newsletters and services which claim that you can make a killing in the stock market if you follow their advice. Although they acknowledge that they are risky, they claim that there is little risk because of their expertise in picking winners. However, many of those stock services have infinitely more losers than winners among their stock picks.

It might be more prudent to find a different home based business which has the potential to bring more reliable returns. Network marketing has been creating wealth for decades. Although it is not an easy business in which to succeed and it has more failures than successes, many people are doing it everyday. The potential exists to find success by steadily working hard at a home based business without the pipe dreams and unfulfilled expectations. Network marketing is generally a slow path, but it can be worthwhile.

Although many people also fail at network marketing, there are many opportunities and companies which offer the chance for success in an industry which requires little training or experience. Anyone can do it with the proper company, training, and determination coupled with hard work and dedication. Success is being achieved regularly by people who take a chance on network marketing and put in the work required. Network marketing continues to create success.

Life is full of broken dreams and broken promises, but it is also full of achievements and success. A home based business can bring hope and sometimes wealth.

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