SmithKline Beecham (Approximation of laws) [2005] EUECJ C-74/03 (20 January 2005)

SmithKline Beecham (Approximation of laws) [2005] EUECJ C-74/03 (20 January 2005)

Article 4.8(a)(iii) of Directive 65/65/EEC does not preclude use of the abridged procedure for a product containing the same therapeutic moiety as the reference product but combined with a different salt, provided no significant differences in safety or efficacy exist; applicants may submit additional data to demonstrate essential similarity.

Citation
[2005] EUECJ C-74/03
Parties
Applicant: SmithKline Beecham plc; Respondent: Synthon BV; Respondent: Genthon BV
Jurisdiction
European Union
Judgment Date
20 January 2005
Procedural Posture
Preliminary Ruling Reference / Judgment on Referred Questions
Outcome
Questions answered; interpretation of Article 4.8(a)(iii) provided.
Legal Topics
Marketing Authorisation, Essential Similarity, Abridged Procedure, Medicinal Products, Data Exclusivity
European Union Law Pharmaceutical Law Marketing Authorisation Essential Similarity Abridged Procedure Medicinal Products Data Exclusivity

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Parties

SmithKline Beecham plc

Applicant

Synthon BV

Respondent

Genthon BV

Respondent

Procedural Posture

Preliminary Ruling Reference / Judgment on Referred Questions

Legal Issues

  1. 1 Whether a medicinal product with a different salt form of the active substance can be authorised under the abridged procedure as essentially similar to a reference product under Article 4.8(a)(iii) of Directive 65/65/EEC
  2. 2 Whether additional pharmacological or toxicological data may be submitted in an abridged application to demonstrate essential similarity

Ratio Decidendi

Article 4.8(a)(iii) of Directive 65/65/EEC does not preclude use of the abridged procedure for a product containing the same therapeutic moiety as the reference product but combined with a different salt, provided no significant differences in safety or efficacy exist; applicants may submit additional data to demonstrate essential similarity.

Court Disposition

Questions answered; interpretation of Article 4.8(a)(iii) provided.

Orders

  • Article 4.8(a)(iii) of Directive 65/65/EEC does not prevent an abridged procedure application where the product contains the same therapeutic moiety as the reference product but with a different salt.
  • Applicants may submit additional pharmacological and toxicological data to demonstrate essential similarity under Article 4.8(a)(iii).