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<titleinf>
<title><acronym>MCA</acronym></title>
<subtitle>Medicines Control Agency</subtitle>
<subtitle>Ensuring safe medicines in the <acronym>UK</acronym></subtitle>
<author>A Person</author>
<subauthor>The subauthor</subauthor>
<titledet>
<p>The <acronym>MCA</acronym> is available for everyone. Please use this service.</p>
</titledet>
</titleinf>
<extraneous>
<p>This is a bit of extraneous text, with <acronym>PEP</acronym>s and <acronym>ISA</acronym> mentioned. Decimal numbers 12.4, 3.45 and some money: -ú6.30. -ú103.30, $45.00 and 4.50.</p>
<extrsection>
<p>This is a para in a new extraneous section. How do you say Dymo and A4 paper? Phone 0845 123 5678 to find out. Here is a code: <stext say="spell-out">A13278B</stext></p>
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<extrsection>
<head>This is an extraneous section heading</head>
<p>This is a para.</p>
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<contents>
<head>Contents</head>
<entry1>
<secname>What is the <acronym>MCA</acronym>?</secname>
<pageno>1</pageno>
</entry1>
<entry1>
<secname>How are the <acronym>UK</acronym>'s medicines controlled?</secname>
<pageno>2</pageno>
</entry1>
<entry1>
<secname>The role of the <acronym>MCA</acronym></secname>
<pageno>4</pageno>
</entry1>
<entry1>
<secname>Better medicines, faster</secname>
<pageno>5</pageno>
</entry1>
<entry1>
<secname>Bits and pieces</secname>
<pageno>7</pageno>
</entry1>
</contents>
<section>
<head><ppage>1</ppage>What is the <acronym>MCA</acronym>?</head>
<p>The Medicines Control Agency (<acronym>MCA</acronym>) is responsible for safeguarding public health by ensuring that all medicines on the <acronym>UK</acronym> market meet acceptable standards.</p>
<p>New and better medicines are vitally important for treating many illnesses. The <acronym>MCA</acronym> helps ensure this by applying strict standards laid down by law, and also working to keep red tape to a minimum so that treatments that could save lives are made available to patients as quickly as possible.</p>
<p>Staff at the <acronym>MCA</acronym> include many highly trained doctors, pharmacists and scientists, whose task is to balance carefully the benefits of medicines against any possible risks, before they are approved for use in patients.</p>
</section>
<section>
<head><ppage>2</ppage>How are the <acronym>UK</acronym>'s medicines controlled?</head>
<p>Medicines which meet the standards are granted a marketing authorisation (previously a product licence), which is normally necessary before they can be prescribed or sold. Products that have been granted a marketing authorisation carry a number beginning with the letters <acronym>PL</acronym> on the manufacturer's pack.</p>
<p>There are three categories for the supply of medicines:</p>
<list>
<litem><b>General Sale List (<acronym>GSL</acronym>)</b>: medicines that are widely available for sale and use without supervision of a pharmacist or doctor.</litem>
<litem><b>Pharmacy (P)</b>: medicines that can only be obtained from a pharmacy, where they are supplied under the supervision of a pharmacist who may ask questions to ensure that, <ppage>3</ppage>if a medicine is necessary, you get the best one to suit your needs.</litem>
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<litem><b>Prescription Only Medicines (<acronym>POM</acronym>)</b>: medicines which must be prescribed by a doctor or a dentist. They can be obtained from a pharmacy.</litem>
</list>
<p>You should, of course, always follow the instructions for taking any medicine and ask your pharmacist's or doctor's advice if you don't understand the directions or are unsure about whether you should be taking it.</p>
</section>
<section>
<head><ppage>4</ppage>The role of the <acronym>MCA</acronym></head>
<subsect1>
<head>Licensing of medicines</head>
<p>Before a medicine can be marketed in this country, an application must be submitted, normally by a pharmaceutical company, to the <acronym>MCA</acronym>. This must include full details about how the medicine is made and used and the research that has been carried out to assess its safety, effectiveness and quality. The <acronym>MCA</acronym> examines all this information and test results in detail before a decision is made on whether the product should be granted a marketing authorisation.</p>
<subsect2>
<head>A subsect 2 heading</head>
<p>The assessment of new medicines is a very specialised activity and the <acronym>MCA</acronym> often seeks further advice from independent experts before reaching a decisiom</p>
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<head>A subsect 3 heading</head>
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<p>Only when the experts are satisfied that the medicine meets the standards of the Medicines Act or the relevant <acronym>EC</acronym> legislation is a licence granted and this will stipulate the dosage, the form (tablets, liquid, cream etc.), the specific diseases to be treated by the medicine and the type of person it is suitable or unsuitable for, e.g. children. If manufacturers want to alter the use, or sell the product in a different form, such as a syrup instead of a tablet, they have to apply to the <acronym>MCA</acronym> to change the criteria. Approval is only given if the medicine is still shown to be sufficiently safe and still works in its new form or for its new use.</p>
</subsect2>
</subsect1>
<subsect1>
<head>Monitoring of medicines</head>
<p>Even after medicines have been licensed, the <acronym>MCA</acronym> monitors them while they are in use and keeps records of any side effects reported. Potential problems can then be quickly identified and dealt with by making changes, if necessary, to ensure the safety of patients remains as high as possible. In a few cases, safety concerns may lead to the medicine being withdrawn from the market.</p>
</subsect1>
<subsect1>
<head>Inspection and enforcement</head>
<p>Everyone involved in the manufacture or distribution of medicines also has to be approved. Regular inspections ensure that required standards are maintained. Suspected illegal activities are investigated and those breaking the law may be prosecuted.</p>
<p>Licences can be taken away and production stopped if standards are not met.</p>
</subsect1>
</section>
<section>
<head><ppage>5</ppage>Better medicines, faster</head>
<p>Rigorous medicines control is a key part of protecting public health in the <acronym>UK</acronym>, to ensure that the medicines we take for granted are sufficiently safe, of high quality and that they work as they are supposed to. It is the responsibility of the <acronym>MCA</acronym> to ensure that the stringent standards we expect are maintained, while new medicines are made available to patients who need them as quickly as possible.</p>
<p>If you would like to know more about the work of the <acronym>MCA</acronym>, a book entitled "Towards Safe Medicines" is available from many public libraries or direct from the <acronym>MCA</acronym>.</p>
<p>Today and every day, millions of people in the <acronym>UK</acronym> will need to take some sort of medicine.</p>
<p>Whether it's a medicine you buy for yourself, or a course of treatment prescribed by a doctor, it's reassuring to know that all medicines available in the <acronym>UK</acronym> have to undergo very strict tests by the <acronym>MCA</acronym> before they are licensed for sale. These tests ensure that medicines on the <acronym>UK</acronym> market meet acceptable standards of:</p>
<p2> <ppage>6</ppage>1. Safety: they are sufficiently safe to take.</p2>
<p2> 2. Efficacy: they work as they are supposed to.</p2>
<p2> 3. Quality: they are made to the highest possible standards.</p2>
</section>
<section>
<head><ppage>7</ppage>Bits and pieces</head>
<subhead>A subheading</subhead>
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<p>Some more examples of various bits of notation: x<sup>24</sup> and y<sup>-2</sup> and z<sup>+2</sup>.</p>
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<p>This is a paragraph.</p>
<table>
<head>This is a Table</head>
<tablebody>
<colheads>
<chead>Car</chead>
<chead>Colour</chead>
<chead>Date</chead>
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<row>
<di>Ford</di>
<di>Blue</di>
<di>1999</di>
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<row>
<di>Morris</di>
<di></di>
<di>1976</di>
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<p>This is a new paragraph followed by an address.</p>
<address>
<addline>25 The Avenue</addline>
<addline>Peterborugh</addline>
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</section>
<end>
<p>How to contact us: Market Towers, 1 Nine Elms Lane, Vauxhall, London <acronym>SW8</acronym> 5<acronym>NQ</acronym>.Telephone: 020 7273 0000, Facsimile: 020 7273 0353</p>
<p>E-mail: <email>info@mca.gov.uk</email>, Website: <web>www.open.gov.uk/mcaJmcahome.htm</web></p>
</end>
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