Medicine Information

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: enquiries@rtcoopers.com

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.

Rosanna Cooper is a partner in RT Coopers Solicitors a full service law firm in London. The firm specialises in patents, trade marks, copyright, designs, technology transfer, biotechnology and pharmaceutical law. The firm has a flexible approach to fees and provides the highest quality legal advice.

Contact us at enquiries@rtcoopers.com. visit our website at http://www.rtcoopers.com


MORE RESOURCES:
This RSS feed URL is deprecated, please update. New URLs can be found in the footers at https://news.google.com/news


Medical News Today

How does complementary medicine impact cancer survival?
Medical News Today
Although complementary and alternative medicine has risen in popularity, little is known about its impact on cancer survival. A new study takes a look.

and more »


Davis Enterprise

Nature is proving to be awesome medicine for PTSD
Davis Enterprise
The awe we feel in nature can dramatically reduce symptoms of post-traumatic stress disorder, according to UC Berkeley research that tracked psychological and physiological changes in war veterans and at-risk inner-city youth during white-water rafting ...

and more »


Washington Post

China's push to export traditional medicine may doom the magical pangolin
Washington Post
Already almost wiped out in China, the pangolin is fast disappearing from the jungles of the rest of Asia and, increasingly, from Africa to supply China's booming market in traditional medicine. Now, as China pushes to export traditional medicine ...



NBCNews.com

Complementary medicine for cancer can decrease survival
Science Daily
Use of complementary medicine -- medical therapies that fall beyond the scope of scientific medicine -- is growing in the United States and often used by patients with cancer. Although many patients believe that a combination of complementary medicine ...
Cancer patients who use alternative medicine die sooner, study findsNBCNews.com
Does using complementary medicine for cancer reduce patients' survival?Philly.com
Cancer patients who choose complementary medicine are twice as likely to die within seven years, study suggestsTelegraph.co.uk
Medscape -The JAMA Network
all 38 news articles »


BioEdge

Does medicine have a telos?
BioEdge
A new edition of the Journal of Medicine and Philosophy attempts to grapple with these changes -- and the entrenchment of pluralism in Western liberal democracies -- by developing novel concepts of health, illness and disease that make no reference to ...



Investor's Business Daily

Precision Medicine Side Effects
Investor's Business Daily
It's important to note that both drugs have, so far, had minimal side effects. The goal of precision therapy is to only block what the drugs tell them to obstruct. Accidentally inhibiting other kinase can cause a number of unintended side effects, also ...



HuffPost

With Culinary Medicine, Doctors Are Finally Learning About Food
HuffPost
Culinary medicine picks up where basic (and brief) med school nutrition education leaves off. It's nutrition with context. Immersive, holistic and food-focused, it takes place in the kitchen as well as the classroom, with med students working side by ...



Medicine recall
The Express Tribune
In the past week, the Provincial Pharmacovigilance Center Punjab alerted the manufacturers to review their sources of raw materials of Valsartan — a formula for manufacturing medicines used in the treatment of hypertension and serious heart conditions.

and more »


Michigan Medicine's critical care transport team gets new $10M jet
EMS1.com
Michigan Medicine recently added a $10 million specially-designed jet to its fleet to serve more critically injured patients and improve organ procurement services. The Bombardier Learjet 75 was designed by Survival Flight team members and includes:.



Healthline

When a Parent's Beliefs About Medicine Become Child Abuse
Healthline
An Oregon couple who believed in faith healing were sentenced to six years in prison earlier this month for criminal charges related to the death of their newborn daughter, Ginnifer, last year. Sarah and Travis Mitchell are members of the Followers of ...


Google News

home | site map | Dr. Thad Thomas
© 2006