The following vaccines against bovine brucellosis are hereby approved for immunisation of female bovine animals under the conditions set out in Article 3:

Member States availing of the use of the vaccines approved under Article 2 shall ensure that the conditions set out in paragraphs 2 to 6 are met.

all or some of the female bovine animals have been vaccinated at not more than six months old with live Buck 19 vaccine or other vaccines approved under the procedure laid down in Article 29;

A newly developed vaccine offers additional advantages to those already approved and in particular does not interfere with the diagnostic procedures applied in the framework of eradication programmes in force in some Member States in accordance with Community legislation.

It is therefore appropriate to approve, subject to certain conditions, the use of live strain RB 51 and live strain Rev.1 vaccines within brucellosis eradication programmes approved pursuant to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(3), as last amended by Decision 2001/572/EC(4), in order to take into account scientific developments and international standards.

have been vaccinated, using officially approved vaccines (6).

regulations are in force on the marketing of anti-rabies vaccines (list of authorised vaccines and laboratories).

(e) regulations are in force on the marketing of anti-rabies vaccines (list of authorised vaccines and laboratories).

that the chicks have been vaccinated, using officially approved vaccines, against:

(b) all or some of the ovine or caprine animals have been vaccinated with Rev. 1 vaccine or any other vaccine approved under the procedure laid down in Article 15 of this Directive.

Safety and potency testing of foot-and-mouth disease vaccine and bluetongue vaccine can only be carried out at laboratories being operated under approved biose-curity levels.

- it has received anti-foot-and-mouth disease serum treatment within the prescribed ten-day time limit4 with an anti-foot-and-mouth disease serum officially approved and tested in the exporting country and officially authorised in the country of destination1;

- they have received anti-foot-and-mouth disease serum treatment within the prescribed ten day time limit with anti-foot-and-mouth disease serum officially approved and tested in the exporting country and officially authorised in the country of destination3;

(ii) they must have been vaccinated with Rev. 1 vaccine or any other vaccine approved in accordance with the procedure laid down in Article 15 of this Directive before the ere of seven months and not less than 15 days before entering the bolding of destination.

(b) which contains no ovine or caprine animals which have been vaccinated against brucellosis (B. mefitensis), save those vaccinated at least two years previously with Rev. 1 vaccine or any other vaccine approved under the procedure laid down in Article 15 of this Directive;

shall proceed, in the zone laid down in (c), with the systematic vaccination of all equidae using a vaccine authorized by the competent authority, and shall identify them by a clear, indelible mark applied by an approved method in accordance with the procedure laid down in Article 19. However, on the basis of the epizootiological, meteorological, geographical or climatological circumstances, the vaccination requirements may be waived by the competent authority.

In case of a pandemic situation with respect to the human influenza virus, duly recognised by the World Health Organisation or by the Community in the framework of Decision 2119/98/EC of the European Parliament and of the Council(8), the Commission may exceptionally and temporarily consider the variation to the terms of the market authorisation for human influenza vaccines to be accepted after an application has been received and before the end of the procedure laid down in Article 7. Nevertheless, complete clinical safety and efficacy data can be submitted during this procedure.

Why has the vaccine been approved?

conditions for secure storage of antigen and authorised vaccines;

with other vaccines approved under the procedure laid down in Article 17;

This is the first vaccine to be licensed for horses in the EU against strangles.

The vaccine will only be used as part of an approved national disease control programme.

Nobivac Bb was the first live B. bronchiseptica vaccine licensed for use in cats.

before the age of 15 months old with killed 45/20 adjuvant vaccine which has been officially inspected and approved, or

It is worthy of note that the first EU marketing authorisation for Bovilis BVD was granted in 1998, and the vaccine is currently authorised in 14 EU Member States.

before the age of six months old with live strain 19 vaccine or other vaccines approved under the procedure laid down in Article 17, or

all or some of the ovine or caprine animals have been vaccinated with Rev. 1 vaccine or any other vaccine approved under the procedure laid down in Article 15 of this Directive.

The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.

the handling of live foot-and-mouth disease virus for the manufacturing of either inactivated antigens for the production of vaccines or vaccines and related research is carried out only in the approved establishments and laboratories listed in Part B of Annex XI;

Safety and potency testing of foot-and-mouth disease vaccine and bluetongue vaccine can only be carried out at laboratories being operated under approved biosecurity levels.

The same fee shall be charged in respect of vaccines. In the event of the same variation being introduced, this fee shall cover all authorised strengths, pharmaceutical forms and presentations.

Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines.

Member States may within the framework of the contingency plan establish or maintain national antigen and vaccine banks for the storage of reserves for emergency vaccination of antigens or vaccines authorised in accordance with Directive 2001/82/EC.

The information on quantities and subtypes of antigens or authorised vaccines stored in the Community antigen and vaccine bank shall be treated as classified information and in particular shall not be published.

The information on quantities and subtypes of antigens or authorised vaccines stored in the national antigen and vaccine bank shall be treated as classified information and in particular shall not be published.

the manipulation of foot-and-mouth virus for research, diagnosis and/or manufacture of vaccines shall be carried out only in approved establishments and laboratories listed in Annex A and B,

The conditions for the establishment and maintenance of Community reserves of antigen and authorised vaccines at the premises of preferably at least two manufacturing establishments shall be laid down in contracts concluded between the Commission and the manufacturing establishments.

The active substance in Fendrix has been available in other vaccines authorised in the European Union (EU) for a number of years, including Engerix-B, Ambirix, Twinrix, Tritanrix-HepB and Infanrix- HepB.

The vaccine will only be used as part of an approved national disease control programme. This is because control of bluetongue is the responsibility of national veterinary authorities in consultation with the European Commission

After a 3, 5, 12 months schedule, immune responses were compatible with the sought clinical protection and of the same magnitude as those reported previously for HEXAVAC or other licensed combination vaccines during the second year of life

Celvapan can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Celvapan takes due account of the officially declared pandemic strain.

Daronrix can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Daronrix takes due account of the officially declared pandemic strain.

shall proceed, in the zone laid down in (c), with the systematic vaccination of all equidae using a vaccine authorized by the competent authority, and shall identify them by a clear, indelible mark applied by an approved method in accordance with the procedure laid down in Article 19.

they must have been vaccinated with Rev. 1 vaccine or any other vaccine approved in accordance with the procedure laid down in Article 15 of this Directive before the age of seven months and not less than 15 days before entering the holding of destination.

which contains no ovine or caprine animals which have been vaccinated against brucellosis (B. melitensis), save those vaccinated at least two years previously with Rev. 1 vaccine or any other vaccine approved under the procedure laid down in Article 15 of this Directive;

The active substances in Ambirix have been available in other vaccines authorised in the European Union (EU): Ambirix contains the same ingredients as Twinrix Adult, which has been authorised since 1996, and as Twinrix Paediatric, which has been authorised since 1997.

Efficacy and Safety conclusions The immunogenicity data indicates that Menitorix will be at least as effective as the licensed PRP-T and MenC conjugate vaccines when used for priming and/ or for boosting in accordance with the SPC.

For that purpose, the number of doses and the diversity of strains and subtypes of antigen of foot-and-mouth disease virus and, if necessary, of authorised in accordance with Directive 2001/82/EC vaccines stored in the Community antigen and vaccine bank shall be decided in accordance with the procedure referred to in Article 89(2), taking into account the needs as estimated in the context of the contingency plans provided for in Article 72 and the epidemiological situation, where appropriate after consultation with the Community Reference Laboratory.

Following written information from the contractor about the supply and distribution to the approved premises of the antigen purchased in accordance with Decision 2000/569/EC, it appears appropriate to update the Annex to Decision 2000/112/EC detailing the distribution between antigen banks of antigen reserves established within the framework of the Community action concerning reserves of foot-and-mouth disease vaccines and amending Commission Decisions 93/590/EC and 97/348/EC.

In case of a pandemic situation with respect to the human influenza virus, duly recognised by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council(8), competent authorities may exceptionally and temporarily consider the variation to the terms of the marketing authorisation for human influenza vaccines to be accepted after an application has been received and before the end of the procedure laid down in Article 7.