vi er forpliktet å godkjenne alt som er godkjent i USA (betyr i praksis at vi kan få alt amerikansk på registreringsfritak, ikke noe mer)

Sunny Wilmington fra wesern Research laboratories (som lager Westhroid some r omtrent like gammel som Armour) gikk gjennom hele prosessen å få nature-throid sentralt godkjent i Eu noen år siden.

http://forums.about.com/n/pfx/forum.asp ... redirCnt=1

Se også noe som stod på forumet


Siste nytt fra England: fra legemiddeltilsynet i England: lettere å få blå resept på Armour Thyroid etc.
http://forums.about.com/ab-thyroiduk/me ... redirCnt=1

Hi everyone,
Dr. Martin Hawkings, Consultant in Public Health Medicine, Harrogate (Primary Care Trust), has today sent me the following reply which MHRA has sent to him regarding my query on the prescribing specifically of Armour Thyroid to patients who were unable to tolerate (for whatever reason) licensed medicines in the UK. I.e. synthetic T4 or T3. To those of you who are being told by their NHS GP's or Endocrinologists that they will not prescribe Armour Thyroid because ".. of the difficulty in ensuring adequate quality control" - I would suggest you print this off and give it to your doctor. I am seeing my Endo. on 6th Jan. I am going to send him a copy of this today, so that he can read and digest the information here before I see him. I am also passing a copy to my GP.


Sheila.
-------------------------------------------------

Medicines and Healthcare Products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel 020 72730000
e-mail info@mhra.gsi.gov.uk
www.mhra.gov.uk
Direct Line – 020 72730715
Fax 020 72730676


"Dear Dr. Hawkings,

ARMOUR THYROID AND PORCINE THYROID EXTYRACT FOR THYROIOD REPLACEMENT THEREAPY.

As you know, synthetic levothyroxine T4 and Liothyronine T3 are available in the UK as licensed medicinal products. "Natural" desiccated thyroid hormone, which contains both T4 and T3, is extracted from the thyroid glands of pigs, and is marketed in the USA under a number of brands. Some of these brands are marketed under US law as food supplements and as such are not authorised by the Food and Drugs Administration (FDA). These products can vary considerably in the content of thyroid hormones, because they are not standardised, and as a result could potentially be dangerous. However, other brands are authorised by the FDA as medicines, and are standardised to the specification of the United States Pharmacopoeia (USP). The specification of the USP for the content of T4 (85 to 115% of labelled strength ) and T3 (90 to 110%) in natural thyroid tablets are similar to the specifications for the content in the individual synthetic hormones (90 to 110% T4, 90 to 110% T3). Thyroid tablets USP contain approximately 38 micrograms of T4 and 9 micrograms of T3 per 65 mgs. Of desiccated thyroid, and are available in a wide variety of strengths.

UK and European law recognises that there may be circumstances when licensed products may not be suitable for some patients. The regulations on medicines allow doctors to prescribe an unlicensed medicine for a patient to meet such a special clinical need, on their own direct personal responsibility. Where these unlicensed medicines are not available in the UK they can be imported by appropriately licensed medicines wholesalers, for supply to a doctor or pharmacy, to meet these needs. The importer is required to notify the MHRA in advance of every occasion that they wish to import such a product.

The MHRA can object to importation of an unlicensed medicine if there are concerns about the safety or quality of the product. The MHRA cannot object to importation of an unlicensed medicine solely on the grounds of efficacy.
In the case of these thyroid preparations, the MHRA has not objected to their importation provided that they are FDA approved products, standardised to the USP, and that they are for the treatment of patients with thyroid diseases, for whom the UK licensed synthetic thyroid hormones are not suitable. We have not told importers that they must provide evidence from prescribers, as this is a matter of clinical judgement. Consequently, these products can be made available to those people who need them, subject to them being prescribed by a doctor.

I hope that this answers your concerns. If you have any further questions, please do not hesitate to contact me.

Yours sincerely,

Graham Matthews,
--------------------------------------------------------

Men:

From: SHEILATURNE1 Jan-16 10:10 am
To: ALL
The previous information I have now found out is not necessarily true.
Just had a reply to my letter to Primary Care Trust - who e-mailed the MHRA
again, and now the PCT has just written the following to me. It seems a letter may be required after all. Can't quite work it out from what they say - I'm leaving this up to Lyn Mynott to sort out. If you have printed out the information in the 'Pack', please destroy the page where it says that this is not required. I wish they would get their information right in the first place - but, what can one expect!!!. Luv - Sheila
http://tinyurl.co.uk/cq2q
---------------------------------------

Sheila

Please find below the response from the MHRA which means, in effect, that you may require a letter in order for you to obtain the drug after all..
Regards
Martin

Dr Martin D Hawkings
Consultant in Public Health Medicine
Craven, Harrogate and Rural District (CHARD) PCT
The Hamlet, Hornbeam Park,
Harrogate, HG2 8RE
Tel: 01423 859683
e-mail: martin.hawkings@chrd-pct.nhs.uk


-----Original Message-----
From: Matthews, Graham [mailto:Graham.Matthews@mhra.gsi.gov.uk]
Sent: 14 January 2004 09:57
To: HAWKINGS MARTIN (5KJ) CONSULTANT IN PUBLIC HEALTH MEDICINE
Subject: RE: MHRA letter

Dear Dr Hawkings,

The MHRA does not routinely require letters to prove special clinical need for the importation of unlicensed medicines and does not require importers to obtain such a letter provided they are satisfied that a special clinical need does exist. It is, however, up to the importer how they wish to verify this requirement is met and there is nothing to prevent them or other persons in the supply chain requesting such a letter.

The MHRA would not wish to issue a letter of the sort you propose, as this could be misleading given that each notification for importation of an unlicensed medicine is assessed on an individual basis.

I hope this assists.

Yours sincerely,

Graham Matthews
Pharmaceutical Assessor
Defective Medicines Report Centre
MHRA
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2715
Fax: 020 7084 2676
-----------------------------------
fra http://forums.about.com/ab-thyroiduk/me ... redirCnt=1 det va r der jeg fant det ihvertfall

RELIS er vel norsk tilsvarende organ tror jeg.