Benzathine benzylpenicillin intended for administration to food-producing species

Current status
European Commission final decision


The Commission Decision for this referral procedure was subsequently made void by the European Court of Justice. For more information, see the judgement of the Court of First Instance of 31 January 2006.

Benzylpenicillin is a bactericidal antibiotic with a spectrum of activity against most Gram-positive bacteria, Gram-negative cocci and some other Gram-negative bacteria, spirochaetes and actinomycetes.

On 3 October 2001, Ireland presented to the Agency a referral notification under Article 20 of Council Directive 81/851/EEC, as amended, regarding the marketing authorisations for veterinary medicinal products containing benzathine benzylpenicillin intended for intramuscular and/or subcutaneous administration to food producing species. The CVMP was requested to give its opinion regarding the adequacy and consumer safety of the withdrawal periods for the above-mentioned products.

The referral started on 7 November 2001. The Committee appointed R. Kroker as rapporteur. Written explanations were provided by the marketing authorisation holders on 25 March 2002 and 27 March 2002. Oral explanations were given on 3 September 2002.

Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as on the basis of the available data was not possible to establish withdrawal periods. The CVMP therefore adopted by majority a negative opinion on 2 October 2002, recommending suspension of the marketing authorisations for the above-mentioned veterinary medicinal products.

By 21 October 2002, seventeen marketing authorisation holders notified the Agency of their intention to request a re-examination of the CVMP opinion of 2 October 2002.

During its meeting of 12-14 November 2002 the CVMP appointed J. Hoogland as rapporteur for the re-examination procedure.

Detailed grounds for the re-examination were submitted by thirteen marketing authorisation holders by 3 December 2002. The re-examination procedure started on 4 December 2002. Oral explanations were given by two marketing authorisation holders on 10 December 2002 and 11 December 2002.

On 15 January 2003, the CVMP adopted an opinion confirming the recommendation for suspension of the marketing authorisations for the above-mentioned veterinary medicinal products.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.

The opinion was converted into a Decision by the European Commission on 22 April 2003.

Key facts

Approved name
Benzathine benzylpenicillin intended for administration to food-producing species
International non-proprietary name (INN) or common name
benzathine benzylpenicillin
Associated names
See annex I
Current status
European Commission final decision
Reference number
Article 35

Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Opinion date
EC decision date

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of CVMP
  • Divergent positions – divergent positions of the CVMP members (if applicable)
  • Changes to the summary of product characteristicslabelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)

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