The MHRA, on behalf of the Department of Health, issues export certificates on request to assist

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...

Information on types of export certificates

Export certificate application forms

Information for completion of export certificate application forms

Quick guide to licence/certificate requirements

Contacts for further information

While the issuing of certificates is managed by MHRA, the requirement for having a certificate is not - it is
determined by the importing country. As such, the MHRA has no legislative authority over the requirements of the
importing country and cannot specify whether or not certificates are needed. If there is doubt about whether or
not the regulatory authorities in an importing country may require an export certificate the embassy of the country
for which the importation is intended should be contacted. Foreign consulate contact details can be accessed on
the Foreign Office website.
Guidance published on UK exporting of medicines - 13 November 2009
Guidance helping pharmaceutical manufacturers and distributors to meet their obligations regarding the supply of
medicines has been jointly published by nine organisations including the MHRA. The new guidance aims to
reduce future problems with the export of medicines for profit by setting out the key legal and ethical obligations
for manufacturers, wholesalers, NHS Trusts, registered pharmacies and dispensing doctors in relation to the
supply and trading of medicines.
Trading Medicines for Human Use: Shortages and Supply Chain Obligations

(32Kb)

Information on types of export certificates

The MHRA issues four different types of export certificates, two of which comply with the format established by
the WHO and reflect UK participation in the WHO scheme. Each type of certificate is country specific, naming
one individual country - the EU is not acceptable as a one-country unit. The fee charged is the same for each
type of certificate but varies dependant on the service level (24-hour or five-day turnaround) requested and the
number of original copies required. Details about charges for issuing certificates can be found in our licensing
fees section. The certificates that can be supplied are:
Certificate of a pharmaceutical product (CPP). This certificate complies with the format specified by WHO.
The certificate will provide details about a single named medicinal product which may be licensed or unlicensed
in the UK. It provides details about the product and its manufacture including (but not limited to) the marketing
authorisation (MA) holder, the active ingredients and excipients, the manufacturing and packaging sites and
whether or not the product is placed on the market in the UK. CPPs for licensed products are generally but not
exclusively, applied for by the marketing authorisation holder. For the MHRA to issue a certificate to an applicant
other than the marketing authorisation holder written permission from the marketing authorisation holder will be
required before the application can be accepted.
Certificate of licensing status (CLS). This certificate complies with the format specified by the WHO. It is
intended for use by importing agents who are required to screen bids made in response to an international tender
and can apply to licensed or unlicensed products. It provides less information than the CPP and can include a
maximum of ten products per certificate.

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:

The pharmaceutical industry and market in the UK

Pharmaceutical companies are making a great contribution to the UK economy, higher than
most other high-tech industries. The pharmaceutical sectors relative importance becomes even more
obvious when considering productivity, measured as Gross Value Added (GVA).
Figure 1 The economic value of the pharmaceutical industry, 20082010
Figure 2 Annual growth and sales to NHS, 20032011
Figure 3 Components of growth for the pharmaceutical market in the UK, 19952011
Figure 4 International price comparisons
Figure 5 UK price indices
Section 6 Industry profitability

Figure 1 The economic value of the pharmaceutical industry, 20082010

Economists use Gross Value Added (GVA) to represent the contribution made by busines
and industry to the UKs national income. To measure GVA the value of output generated by the
business or industry is calculated and from this the cost goods and services involved in production are
deducted.
The graph below shows how the pharmaceutical industrys contribution to the UKs national income
has evolved over recent years. This has been compared to other medium and high-tech industries as
defined by the Department for Business, Innovation and Skills. For information on annual average
GVA produced per employee for a cross-section of industry sectors, please visit ourEmployment in
the pharmaceutical industry in the UK section.

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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Figure 2 Annual growth and sales to NHS, 20032011

The first graph below shows the total sales of prescription medicines to the NHS over the last nine
years. The share of medicines sold via primary care is marked in dark purple and the share sold in
hospitals (secondary care) is marked in light purple. The second graph below shows the growth
profile for the same time period.

Source: IMS Health British Pharmaceutical Index, IMS Hospital Pharmacy Audit
www.imshealth.com
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Figure 3 Components of growth for the pharmaceutical market in the UK,

19952011
The average annual growth (%) of the pharmaceutical market in terms of sales is shown on the ylabel in the graph below. The bars show the contribution to growth attributable to factors such
as volume increases, price changes, new products and other factor (new formulations or pack sizes).
Prices have had a deflationary impact on the market in recent years.

Source: IMS Health MIDAS

www.imshealth.com
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Figure 4 International price comparisons

This table shows a comparison of prices of branded medicines in the UK with prices in a range of
European countries and the USA. It compares the prices of all preparations for the top 150 branded
medicines in the UK with other countries, depending on the availability of matching preparations
elsewhere.

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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Figure 5 UK price indices

The graph below shows the development of Retail Price Index (RPI) and Producer Price Index (PPI)
for pharmaceutical manufacturing between 1998 and 2010. PPIs are a series of economic indicators
that measure the price movement of goods bought and sold by UK manufacturers. It is a baseweighted index using the 'basket of goods' concept. The PPI line graph shown below is for
pharmaceutical products only and refers to the prices of these products when leaving the
manufacturing plant, also often referred to as 'ex-factory prices'.
The comparison between pharmaceutical PPI and the RPI demonstrates that prices for medicines in
the UK have lagged behind prices generally.

Source: ONS MM22 Producer Prices Indices

Notes: RPI = Retail Price Index
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Section 6 Industry profitability

Many pharmaceutical and biopharmaceutical companies are registered on the global stock markets in
order for the public to be able to invest in and part-own those companies. Over the last decade these
markets have seen a large interest in biotechnological companies.
There are currently 10 biotechnology companies and 11 pharmaceutical companies on The London
Stock Exchange (LSE) UK Main Market (FTSE100, FTSE250, FTSE500 etc), and 16 biotechnology
companies and 13 pharmaceutical companies on the Alternative Investment Market (AIM) for smaller
companies. The profitability measure on the LSE is market capitalisation, which is a measurement in
terms of size of a company equal to the share price times the number of shares outstanding (i.e.
shares that have been authorised, issued, and purchased by investors).
Health care sector indices
Financial Times (FT) and Reuters both publish indices for the healthcare sector as a whole as well as
for individual companies:
Financial Times health care market data
Reuters health care market data
The Reuters website also publishes figures on profitability measures such as Return on Investment
(ROI), performance measures used to evaluate the efficiency of an investment, and Profit Margins.
For more information, please see the Reuters: Pharmaceuticals diversified web page or the Reuters:
Pharmaceuticals generic/specialty web page. These data are updated daily and should be extracted
directly from their websites for accuracy.

Pharmaceutical trade in the UK

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

Figure 1 Pharmaceutical trade in the UK, 19992011

For 2010 and 2011 the trade balance for pharmaceuticals has declined. Not since 1954 has the
balance declined in two consecutive years.

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.