DEPARTMENT OF AGRICULTURE AND FOOD
INFORMATION NOTE
SPECIFIC REQUIREMENTS FOR IMPORTATION OF SERUM OF EQUIDAE TO BE USED FOR
TECHNICAL PURPOSES, INCLUDING PHARMACEUTICALS, IN VITRO DIAGNOSIS AND
LABORATORY REAGENTS FROM THIRD COUNTRIES & EU Member States
The following conditions as set out under Council Regulation (EC) No 1774/2002 as amended by
Council Regulation (EC) 668/2004 apply to the importation of serum of equidae to be used for
technical purposes, including pharmaceuticals, in vitro diagnosis and laboratory reagents, from
countries outside the European Community and EU Member States.
A reference to an Article, Chapter or Annex is a reference to an Article, Chapter or Annex of Council
Regulation (EC) No 1774/2002 unless otherwise stated.
Definitions (1774/2002)
“Blood Products” means products derived from blood or fractions of blood, excluding blood meal but
including dried/frozen/liquid plasma, dried whole blood, dried /frozen/liquid red cells or fractions
thereof and mixtures.
“Product used for in vitro diagnosis” means a packaged product, ready for use by the end user,
containing a blood product, and used as a reagent, reagent product, calibrator, kit or other system,
whether used alone or in combination, intended to be used in vitro for the examination of samples of
human or animal origin.
“Laboratory Reagent” means a packaged product, ready for use by the end user, containing a blood
product, and intended for laboratory use as reagent or reagent product, whether used alone or in
combination.
Requirements for Serum of Equidae Used For Technical Purposes, Including Pharmaceuticals,
In Vitro Diagnosis And Laboratory Reagents
Must come from equidae which show no signs of the serious transmissible diseases referred to in
Council Directive 90/426 or of any other serious transmissible disease to which equidae are susceptible
and must have been obtained in bodies or centres not subject to health restrictions pursuant to that
Directive.
The serum must come from equidae in a country where infectious diseases are compulsorily notifiable
and must have been obtained under the supervision of a veterinarian from equidae, which, at the time
of collection were free from the clinical signs of infectious disease or from equidae which passed an
ante-mortem inspection.
Importation of Serum of Equidae

Importers of animal products are required to register with the Department of Agriculture and
Food. Application forms may be sourced from the Department Website or by contacting
Animal Product Import Section at:
Animal Product Import Section, Food Safety Liaison Division, Department of
Agriculture and Food, Agriculture House 7 West, Kildare Street, Dublin 2 (Ph
01-6072896 & Fax 01- 6072513)

Importers of Serum of Equidae from Third Countries, must have a licence to import each
consignment of serum of equidae used for technical purposes, including pharmaceuticals, in
vitro diagnosis and laboratory reagents in accordance with Importation of Carcases and
Animal Products (Prohibition) Order 1966. Licence application forms may be obtained from
the Department of Agriculture & Food in advance of importation at Animal Product Import
Section – contact details as above.
Imports from Third Countries must be through an EU Approved Border Inspection Post (BIP) and at
least 24 hours notice of intent to import must be given to the BIP at which it is intended to import of
pharmaceutical and other technical products into the EU by means of part 1 of a completed and signed
Common Veterinary Entry Document (CVED) (Annex III Commission Regulation (EC) No 136/2004)
Photocopied versions will not be accepted. Forms are available on request from Animal Product Import
Section (contact detail as above) and from:

EU Approved Border Inspection Posts as follows:
Dublin Port, Portal Veterinary Office, Eirfreeze, Bond Road, Dublin 3, Phone No 018556250, Fax 01-8363457
Shannon Airport Portal Veterinary Office, Shannon Airport, Co. Clare, Phone No 061-471546
Fax 061- 471549
A veterinary inspection fee will be levied at the BIP.
Documentation
Imports from other Member States
The Serum of Equidae being imported from EU Member States must be accompanied by an original
Commercial Document that conforms to the model set out in Chapter X, Annex II as amended by
Commission Regulation (EC) No 93/2005.
Imports from Third Countries
The Serum of Equidae must:

Be accompanied a health certificate that conforms to the model set out in Chapter 4(A) of
Annex X of 1774/2002 as amended by 668/2204 (see page 33).
Approved Country
Serum of Equidae used for technical purposes, including pharmaceuticals, in vitro diagnosis and
laboratory reagents may only come from:

If it comes from equidae born and raised in a third country that is listed in Part XIII of Annex
XI. (Third Countries or parts of Third Countries listed in Annex I to Commission Decision
2004/211/EC from which the importation of horses for slaughter is allowed)
Attention must be paid to the particular animal species the third countries listed in 79/542/EEC have
been approved for export as well as any Safeguard Decisions in place banning or controlling the import
of animal products due to animal disease outbreaks.
Approved Plant
Serum of Equidae used for technical purposes, including pharmaceuticals, in vitro diagnosis and
laboratory reagents must come from a plant approved by the Competent authority of the third country
(Article 29(5)) meeting the specific conditions laid down in Council Regulation (EC) No 1774/2002.
Transportation
The consignment must have undergone all precautions to avoid contamination with pathogenic agents
during production, handling and packaging and must be packed in sealed impermeable containers
clearly labelled:
 “Serum from Equidae” and must also bear the registration number of the
establishment of collection.
The consignment must be transported directly from the point of entry to the plant of destination.
Food Safety Liaison Division
March 2006
DISCLAIMER
While every attempt is made to keep this information note current, import conditions
may change and importers are responsible for checking the current status of the
requirements. Safeguard measures, which prohibit imports from countries affected by
animal diseases or other public or animal health hazards can prohibit or restrict import
at very short notice.
Alternatively you can keep up to date with amendments to legislation by checking the
Commission Website. http://europa.eu.int/comm/index_en.htm