European Medicines Agency - Progress?

Am I reading this right?

It looks to me as if pan-European licensing has progressed further than I realised.

Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)

ema.europa.eu/ema/index.jsp...

Mutual-recognition procedure

Companies that have a medicine authorised in one EU Member State can apply for this authorisation to be recognised in other EU countries.

More information is available on:

Coordination Group for Mutual Recognition and Decentralised Procedures – Human

ema.europa.eu/ema/index.jsp...

No thyroid mdicines seem to have gone through the processes yet. Nor am I clear exactly what happens when a product has been approved. Can the compnay immediately sell it everywhere? Will Patient Information Leaflets be posted on EMC?

Have we got anyone familiar with the interpretation of EU documents? They are daunting. :-(

3 Replies

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  • It would be good if they did accept medications from other european countries and vice versa.

  • The paper you refer to does say"The centralised procedure is compulsory for:

    human medicines for the treatment of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS), cancer, diabetes, neurodegenerative diseases, AUTO-IMMUNE AND OTHER IMMUNE DUSFUNCTIONS, and viral diseases;"

    This might include Hashimoto thyroid. Maybe Sanofi Aventis should apply for approval of CYNOMEL in the UK?

  • Yes - I saw that and took it to refer to the medicines that are used such as:

    Many people take medicines to reduce the immune system's abnormal response. These are often called immunosuppressive medicines. Examples include corticosteroids (such as prednisone) and nonsteroid drugs such as azathioprine, cyclophosphamide, mycophenolate, sirolimus, or tacrolimus.

    My thought being that they are directed at the disfunctions whereas thyroid hormone is simply replacing what isn't there without being specific to auotimmune disorders. I'd be happy to see that I am wrong!

    Quite a number of medicines seem to be in process - for example, amitriptyline - but either they are still in porcess, or it has had little effect yet in the UK.

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