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exporters of medicinal products to satisfy the import requirements of other countries. The
certificates issued by MHRA indicate whether the product or manufacturer to which the certificate
applies has met statutory requirements. Where necessary, the format of certificates complies
with that specified by international authorities, for example, the World Health Organisation
(WHO) and the MHRA will not deviate from the agreed format. Details about charges for issuing
certificates, further details about the certificates available and forms to make applications are
available in this section.
In this section...
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Certificate of manufacturing status (CMS) does not provide any product specific information, but it confirms
whether named sites meet Good Manufacturing Practice (GMP) requirements on a specified manufacturing
licence number. All or any of the sites named on the manufacturing licence may be listed on the certificate.
Certificate for the importation of a pharmaceutical constituent (CPC) is available for a named constituent of
a medicinal product.
The MHRA will only issue certificates for unlicensed medicinal products that are manufactured in the UK on a site
holding a manufacturer's licence appropriate to the dosage form of the product for which the certificate applies. If
an application is made for a certificate for a medicinal product that is not manufactured in the UK it will only be
issued if the product has a UK (not EMA) product licence. It is not possible to issue a certificate for unlicensed
products manufactured outside the UK.
Britains strong intellectual heritage in pharmaceuticals and bioscience, the receptive commercial
environment fostered by the Pharmaceutical Price Regulation Scheme (PPRS), and a highly skilled
workforce have, for many years, allowed the UK generally and the NHS in particular to benefit from
modern pharmaceutical discovery and development. Since 1948 when the NHS was first set up
pharmaceutical companies have worked in a highly successful partnership with Government, policy
makers and healthcare professionals to ensure that the most effective innovative medicines reach
patients as quickly as possible.
For more than 60 years, this partnership has encouraged pharmaceutical research and development
(R&D), manufacturing and marketing in the UK. In turn, the pharmaceutical sectors increasing
importance bolstered the economy, generated high-quality jobs, and supported local communities
across the UK. The partnership has led to a remarkably successful R&D programme that has
produced numerous medicines responsible for reducing mortality and morbidity, while enhancing
quality of life for countless patients.
In the following sections you can find more information about these topics:
Note: Using the new definition of high and medium high tech sector (SIC2007).
Source: ONS Annual Business Survey 2010, Section C Manufacturing, Release date 17 November
2011
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Source: IMS Health British Pharmaceutical Index, IMS Hospital Pharmacy Audit
www.imshealth.com
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USA
Germany
Ireland
Belgium
Finland
Netherlands
Austria
France
Sweden
Spain
Italy
UK
2008
DH estimate
252
142
134
122
119
115
111
108
116
109
101
100
2008
rank
1
2
3
4
5
6
7
8
9
10
11
12
2009
DH estimate
249
169
144
132
113
125
115
126
118
1208
100
2009
rank
1
2
3
4
10
12
6
9
5
8
7
11
2010
DH estimate
281
155
133
122
105
117
104
130
106
113
100
2010
rank
1
2
3
5
9
12
6
10
4
8
7
11
Sources:
Department of Health 'PPRS Report to Parliament' 10th and 11th reports
2009 ABPI calculations using 'PPRS Report to Parliament' methodology
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As discussed in Global pharmaceutical trade section, a trade balance refers to the difference between
the value of a countrys exports to other countries compared with imports from them.
Britain has a tradition of generating a positive balance overall, ie all business sectors combined, but
some business sectors have a negative trade balance reducing the size of the total. The
pharmaceutical industry in the UK, however, creates a substantial positive trade balance and is
placed at the top of the list amongst trading businesses in the UK.
Figure 1 Pharmaceutical trade in the UK, 19992009
Figure 2 Trade balance for selected industry sectors in the UK, 2011
Source: HM Revenue and Customs, UK Trade Info 2011, released February 2012
Figure 2 Trade balance for selected industry sectors in the UK, 2011
The pharmaceutical sectors contribution to the overall balance of trade was the greatest of nine major
industrial sectors, up from fifth in 1975 and third in 1990. The graph below shows the trade balance of
some of the UKs industry sectors.
Note: Data subject to revision. Sectors displayed are top and bottom five in terms of trade balance.
OHE calculations performed in 2012. Based on HM Customs and Excise data. The pharmaceutical
sector's trade balance compared with other industrial sectors.
Source: HM Revenue and Customs, UK Trade Info 2011, released February 2012.