Instituto Valenciano de Microbiología
(IVAMI)

Masía El Romeral
Ctra. de Bétera a San Antonio Km. 0.3
46117 Bétera (Valencia)
Phone. 96 169 17 02
Fax 96 169 16 37
Email: 
www.ivami.com
CIF B-96337217

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Rage. Quantification of rabies antibodies in vaccinated animals. Laboratory authorized by the European Union (EU) and European Community (EC) Regulation No. 576/2013).

This laboratory is authorized by the European Union for anti-rabies antbodies quantification testing in vaccinated animals. We are the only private laboratory currently authorized to perform these tests in Spain, and along with the Animal Health Laboratory Santa Fe (Granada), under the Ministry of Environment, Rural and Marine Affairs, the only centers authorized in Spain. Other centers that receive samples for this test refer tthe tets tp laboratories in other countries.

As you know, in order to perform these tests with valid results to move pets to some countries of the European Union, it is necessary to have passed the tests to be authorized by the European Union. Our Center passed these tests and is included among laboratories authorized to perform them . In addition, each year we are subjected to a control test, we must overcome to continuebeing authorized.

This authorization can be corroborated in the list of laboratories located at the following website of the European Union:

http://ec.europa.eu/food/animals/pet-movement/approved-labs/index_en.htm

When you are accessing go to country SPAIN

Regulation (EC) No. 998/2003 of 26 May 2003 on health requirements applicable to non-commercial movement of pet animals, which amended the previous Council Directive 92/65/EEC, which approved the animal health rules guidance for the movement of non-commercial pets, establishing the conditions for moving them between Member States and those from third countries which comes into the EU countries. Decision of the European Commission on 2 February 2005 (Official Journal of the European Union of 4 February 2005), establishing the period after which is considered valid rabies vaccination. This legislation was subsequently amended by Regulation (EU) No. 576/2013 of the European Parliament and of the Council of 12 June 2013 concerning the non-commercial movement of pet animals and amending Regulation (EC) No. repealing. 998/2003 and previous standards.

The most important points of Regulation (EU) No. 576/2013, are listed below:

Minimum required in the test result of rabies antibody quantification:

The test results of quantitation of rabies antibodies, to consider protected the animal, and thus able to move (travel), must show protective antibody titer of at least 0.5 International Units (IU).

Oros general requirements for the animals, and documentation:

  1. Animals that applies. Dogs and cats. Under this legislation the provisions regarding determination of antibodies do not apply to ferrets.
  2. Age of the animal to move. Animals must have at least 3 months old, as some countries do not accept animals with this age (Cyprus, Finland, Italy, Ireland, Latvia, Malta, Poland, UK), unless it has been subjected to a test of antibody titration. However, some European countries accept younger animals with appropriate identification and certificate of good health, and may authorize the movement of animals less than 3 months if accompanied by passport and was born on a farm without contact with wild animals or accompanying his mother, if still depends on it.
  3. Animal identification. The animals that was administered the rabies vaccination should be  necessarily microchipped to issue the passport and to allow entry into some countries and having th test for determination of rabies neutralizing antibodies. In some countries are not available microchips, and can be replaced by a tattoo.
  4. Passport animals. Pets must be accompanied by a passport, accompanied by the quantification test antibody when required. For animals introduced from third countries is valid a certificate issued by an official veterinarian.
  5. Determination of neutralizing rabies antibody. Some Member States (Ireland, Malta, Sweden and the United Kingdom) to confirm the existence of protective antibodies in sufficient amounts, until December 31, 2011 and may be extended by the European Parliament and the Council, require a determination of neutralizing antibodies against rabies. This determination is required for animals from other countries of the European Union, and from third countries listed in Annex II, Section 2, Part A and B (see below). This requirement is also needed for animals from third countries which are introduced into the European Union. According to the regulation 576/2013, vaccines are considered effective from 21 days (Annex III to that regulation), but nevertheless the sample for the quantitative determination of rabies antibodies can not be obtained within 30 days of vaccination (Annex IV of that regulation), so we recommend you follow within 30 days of vaccination completed, not be affected by the interpretation between 21 and 30 days.
  6. Retest rabies antibody: After obtaining a satisfactory result, need not be repeated if the analysis have been carried out provided corresponding revaccination, within the time specified by the manufacturer.
  7. Pre-trip for antibody determination period. For the movement from third countries it requires that the determination is made 30 days after vaccination and that this determination has been made at least 3 months before they are introduced into the European Union. Within 3 months it is not necessary in case of reintroduction, when the passport certifies that it had a result of protective antibodies before the animal departure.

Annexes III and IV of Regulation (EU) No. 576/2013:

ANNEX III

Requirements valid rabies vaccination

1. The rabies vaccine:

a) will not be a modified live vaccine and thus included in one of the following categories:

  1. inactivated vaccine of at least one antigenic unit per dose (recommendation of the World Health Organization), or
  2. recombinant vaccine expressing the immunising glycoprotein of rabies virus on a live virus vector;

b) if administered in a Member State, it must have been the subject of a marketing authorization in accordance with:

i) Article 5 of Directive 2001/82/EC, or

ii) Article 3 of Regulation (EC) No 726/2004;

c) if administered in a territory or a third country, it should have been subject to an authorization or license from the competent authority and meet at least the requirements of the relevant part of the chapter on rabies Manual Testing Diagnostic and Vaccines for Terrestrial Animals of the World Organization for Animal Health.

2. The rabies vaccine must meet the following conditions:

a) the vaccine was administered by a licensed veterinarian;

b) the pet had at least twelve weeks at the time vaccination was given;

c) a licensed veterinarian or an official veterinarian has indicated the date of administration of the vaccine in the appropriate section of the identification document;

d) the date of administration to point c) refers not precede the date of application of microchip or tattoo, or the date of reading microchip or tattoo indicated in the corresponding section of the identification document;

e) the period of validity of the vaccination begins with the establishment of protective immunity, which may not be less than twenty days after completion of the vaccination protocol required by the manufacturer for the primary vaccination, and continues until the end of the period protective immunity, as prescribed technical specification marketing authorization in point 1, point b), or the approval or license point 1, paragraph c a), for rabies vaccine in the member State refers to or in the territory or third country where the vaccine is administered.

An authorized veterinarian or an official veterinarian shall indicate the period of validity of the vaccination in the appropriate section of the identification document;

f) a revaccination must be considered a primary vaccination if it was not carried out during the period of validity of the previous vaccination referred to in point e).

Annex IV

Validity requirements for antibody titration test for rabies

1. The taking of the blood sample required for testing antibody titration for rabies should be performed by an authorized and documented by him in the appropriate document section of the veterinarian identification;

2. The antibody titration test for rabies:

a) it must be conducted with a sample collected at least thirty days after vaccination date and

i) not less than three months before the date:

- the non-commercial movement from a territory or third country other than those listed in the implementing acts adopted pursuant to Article 13, paragraph 1 or 2, or

- transit through the territory or third country, if not the conditions set out in Article 12, point c) comply, or

ii) before the pet has left the Union to move to a territory or third country other than those listed in the implementing acts adopted pursuant to Article 13, paragraph 1 or 2, or transit through; the identification document in the format provided for in Article 21, paragraph 1, you must confirm that it has carried out a test antibody titer of rabies with a favorable result before the date of travel;

b) to measure a level of neutralizing antibodies rabies virus in serum or above 0.5 IU / ml, using a method described in the corresponding part of the chapter on rabies Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organization for Animal Health;

c) must be carried out in an approved laboratory in accordance with Article 3 of Decision 2000/258/EC;

d) does not have to be renewed after a satisfactory result as described in point b), provided that the animal is revaccinated within the validity period mentioned in point 2, point e), Annex III previous vaccination .

Animals to Regulation (EU) No. 576/2013) applies:

Pets

Part A: dogs and cats.

Part B: ferrets.

Part C: invertebrates, ornamental tropical fish, amphibians, reptiles. Birds (except poultry). Mammals (rodents and domestic rabbits).

Countries and territories under Regulation

 

Part A: Ireland, Malta, Sweden, United Kingdom.

Part B (Section 1): Denmark (including Greenland and Faroe Islands); Spain (including Balearic Islands, Canary Islands, Ceuta and Melilla); France (including French Guayana, Guadeloupe, Martinique and Reunion); Gibraltar; Portugal (including the Azores and Madeira); Other Member States than those listed in Part A and related services in this part.

Part B (Section 2): Andorra, Switzerland, Croatia, Iceland, Liechtenstein, Monaco, Norway, San Marino, State of the Vatican City.

Part C: Ascension Island, United Arab Emirates, Netherlands Antilles, Antigua and Barbuda, Argentina, Australia, Araba, Bosnia and Herzegovina, Barbados, Bahrain, Bermuda, Belarus, Canada, Chile, Fiji, Falkland Islands, Hong Kong, Jamaica, Japan, Saint Kitts and Nevis, Cayman Islands, Montserrat, Mauritius, Mexico, Malaysia, New Caledonia, New Zealand, French Polynesia, Saint Pierre and Miquelon, Russian Federation, Singapore, Saint Helena, Trinidad and Tobago, Taiwan, United States America including Guam, Saint Vincent and Granada, British Virgin Islands, Vanuatu, Wallis and Futuna, Mayotte.

Clarification of doubts about official requirements for travel to other countries:

Questions about the movement of pets within the European Union may be addressed to the General Department of Health of the Primary Production (Ministry of Environment and Rural and Marine Affairs, sganimal@marm.es). Movements to or from third countries are the responsibility of the General Direction of Health Agreements and Border Control (sgveget@marm.es).         

Regulation (EU) No. 576/2013