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#GMDPevents
MHRA GDP SymposiumNovotel London West, London
8 & 10 December 2015
#GMDPevents
Export and Introduction
Presented by: Cheryl Blake, Senior GDP Inspector
3 #GMDPevents#GMDPevents
Export and Introduction.
WHICH – activities are covered by a WDA(H)
WHAT – must we consider when exporting
products
WHEN – is a product defined as being
‘introduced’ and when is it ‘imported’
HOW – are products introduced to the EEA
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WDA(H) – Authorised activity definitions.
According to Article 1(17) of Directive 2001/83/EC,
wholesale distribution of medicinal products is ‘all
activities consisting of procuring, holding, supplying
or exporting medicinal products’.
Procure Hold Supply Export
BUY STORE SELL OUTSIDE EEA
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Medicinal Products - Ranges.
‘with a Marketing Authorisation in EEA
country(s)’.
‘without a Marketing Authorisation in
the EEA and intended for the EEA
market’.
‘without a Marketing Authorisation in
the EEA and intended for exportation’.
This final category defines ‘Introduced’
Medicinal products.
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Trade with a fellow member state is not
defined as Export.
Medicinal product should stay in the
licensed supply chain. – Are you
delivering to a site which is licensed to
‘Hold’ that product?
Use of Incoterms such as EXW (Ex Works)
FCA (Free Carrier) DAT (Delivered at
Terminal) or FOB (Free on Board) do not
relieve the seller of all responsibility.
Export: some considerations
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What will inspectors expect?
Evidence of an unbroken supply chain.
Evidence of customer qualification.
Evidence of suitable shipment methods.
Export documentation specifically the
entry made via CHIEF (the Customs
Handling of Import and Export Freight
system).
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Introduction to Introduction.
‘introduced’ medicines are sourced from a non-
EEA country for the sole purpose of export to a
(usually different) non-EEA country.
They will not have a marketing authorisation
within the EEA.
Frequently and wrongly referred to as ‘Import
for Export’.
Misnomer – technically these items are not
imported as they do not enter ‘free circulation’
within the EEA.
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What is the difference.
Importation of product manufactured in a
third country for use in the EEA is a GMP
activity requiring a Manufacturing Licence
(either MIA or MS dependent upon product).
This activity requires Q.P. release of product.
Introduction of a product manufactured in a
third country to the EEA (either physically or
financially) may not be placed on the market.
This is a GDP activity.
The intention is crucial and should be
reflected by the customs procedure code.
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What is a Customs Procedure Code?
The CPR is entered in box 37 of the C88
It is a 7 digit code made up from 3 groups
of numbers.
Where the digits are 40 to 49 inclusive,
this indicates goods have been entered to
‘free circulation’ and implies import.
It is crucial that your shipping department
or freight forwarder understands and
reflects your intention correctly.
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What documentation is it necessary to retain?
Import form C88 stating the correct CPC code
for the procedure.
Corresponding Export form C99 Discharge of
Goods to 3rd Country.
Tariff codes and quantities should match on
both sets of documents.
Certificate of Origin obtained from
International Chambers of Commerce. This
must reflect the non EEA country where the
majority of manufacturing occurred.
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Facilitating and invoicing trade between two
third countries.
Any trade between two non EEA countries
being invoiced from a member state will be
subject to the GDP guidelines in their entirety.
Therefore it is necessary for the supplying
WDA(H) holder to demonstrate (amongst other
requirements) that transportation has been
compliant with GDP guidelines.
Financial introduction. Product has been
procured and supplied by a Member State.
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Regulatory Position.
To accord with Regulation 44(1) of the Human
Medicines Regulations the holder of a wholesale
distribution authorisation may not obtain supplies of
medicinal products from anyone except:
(a) the holder of a manufacturer’s licence or
wholesale dealer’s authorisation in relation to products
of that description; or
(b) a person who holds an authorisation granted by
another EEA State authorising the manufacture of
products of that description or their distribution by way
of wholesale dealing.
Therefore these requirements will prohibit the sourcing
of medicines via a company in a third country.
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Summary.
Trade within Europe is not defined as Export.
Import and Introduction are different activities.
Ensure correct procedure codes are used.
These describe the Intent.
Upon Export, certificates of origin must reflect
the correct country of origin (manufacture).
Where title of medicinal product is transferred
outside of the EEA and back in, this is
considered Import and therefore requires a
manufacturing licence.
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Thank you for your attention.
Cheryl Blake
Senior GDP Inspector
Inspection, Enforcement and Standards
Medicines and Healthcare products Regulatory Agency
+ 44 203 080 6050
cheryl.blake@mhra.gsi.gov.uk.
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© Crown copyright 2015
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