There is an excessive amount of traffic coming from your Region.

#EANF#

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: Make the Most of LinkedIn Updates and Upgrades

Though there are many popular social networking sites out there, LinkedIn continues to be the leading social media platform for making social and business connections. It’s a great way for professionals and business owners to connect, engage, and interact with each other, and information shared within the site is usually very valuable and informative, unlike other social networking sites such as Facebook and Twitter, where posts tend to be more on the personal side.

Just recently, both Facebook and Google+ have rolled out some new features, and it seems LinkedIn isn’t planning on being left behind, updating and upgrading as well. It recently acquired IndexTank, which provides real-time hosted search technology, and plans to improve the internal search within LinkedIn in the months to come.

This is definitely cause for excitement among LinkedIn users. An excellent search feature can really help direct sellers and small entrepreneurs in their branding campaign, as they will be able to search for and react to information about their brand as well as those related to it. This could also help them in gaining valuable feedback on how other people see them, and find new connections and network with fellow entrepreneurs who can potentially become partners and colleagues.

Another new feature that LinkedIn has released is the ability of companies to post status updates on LinkedIn, which is somewhat similar to how Facebook company pages can post updates that will appear in people’s newsfeeds. This is an excellent addition to LinkedIn that people are excited about. Users can now get company updates right in their newsfeeds, so that they’re always updated with the current news and ongoing events of the companies they’re following.

What does this mean for direct sellers? Well, it’s definitely a great way for them to make sure that they’re always kept up to date with any happenings in their company. Since you’re also given the ability to like and comment on the update, this also helps with your branding campaign as it can foster recognition of your name as you participate in discussions and comment on posts.
You can engage with both your company and its entire network through these company updates. Don’t be a wallflower – be part of the conversation so you can gain new prospects and generate new leads. Maximize this new feature by building better relationships with your company and network.

LinkedIn has also recently acquired a whole slew of other services, and many are still speculating on how these will improve the social networking site for professionals and business owners. Their recent acquisitions include:

• Connected, a personal relationship contact manager. No plans yet on how this will be integrated with LinkedIn, but it will be interesting to see what the site comes up with in the coming months.

• Cardmunch, an iPhone app that can digitize business cards. Again, it’s still up for speculation how LinkedIn plans to use this on their site.

• ChoiceVendor, a provider of reviews and ratings of B2B service providers.

• mSpoke, a technology that recommends content, and which is actually already a LinkedIn Today feature on people’s homepages. The technology suggests new articles that may be of interest to the users.

Social networking sites are really pushing the limits on what they offer to the people, so users should definitely use these new additions and features to their advantage. For direct sellers, LinkedIn continues to be a great way to connect with other professionals and network with your peers, so it’s really important that you understand these new updates so you can utilize them in your branding campaign.

As a direct seller, you don’t just represent yourself – you’re also representing your company. So it’s important to make sure that your values are on par with the company you’re representing. Also, you should make sure that you’re always updated with the current news and events of your company so that you aren’t left behind. With this new feature of LinkedIn’s, you can easily subscribe to your company’s status updates so you don’t miss out on any important information it wants to deliver.

So to direct sellers: make sure you aren’t left behind by the additions and upgrades that the social networking sites you’re part of are releasing. Learn and understand them so you can utilize them in your branding campaign.

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